CN103948742B - Pharmaceutical composition for improving male animal sexual dysfunction - Google Patents
Pharmaceutical composition for improving male animal sexual dysfunction Download PDFInfo
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- CN103948742B CN103948742B CN201410198478.XA CN201410198478A CN103948742B CN 103948742 B CN103948742 B CN 103948742B CN 201410198478 A CN201410198478 A CN 201410198478A CN 103948742 B CN103948742 B CN 103948742B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/68—Plantaginaceae (Plantain Family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D459/00—Heterocyclic compounds containing benz [g] indolo [2, 3-a] quinolizine ring systems, e.g. yohimbine; 16, 18-lactones thereof, e.g. reserpic acid lactone
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Abstract
The invention provides a pharmaceutical composition for improving male animal sexual dysfunction. The pharmaceutical composition comprises the following material medicines in parts by weight: 4-6 parts of fruits of Chinese wolfberry, 2-4 parts of seeds of Chinese dodder, 1.5-3.5 parts of raspberries, 1-2 parts of schisandra chinensis, 1-2 parts of semen plantaginis and 1.5-2.5 parts of yohimbine. According to the invention, the five traditional Chinese medicines such as fruits of Chinese wolfberry, seeds of Chinese dodder, and the like are matched with the yohimbine extract to use, so that the improvement effect on male animal sexual dysfunction is obviously superior to that of the classical prescription wuzi yanzong pill; and meanwhile, after being matched for use, the medicines effectively avoid adverse reaction of the yohimbine, so that a safer and more effective novel choice is provided for clinical medication.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for improving reproduction of male animal systemic-function and its production and use.
Background technology
In recent years, due to the impact of the factors such as psychology, environment, society, in world wide, the fertility of the couple at child-bearing age is in
Downward trend year by year, and most of reason is because that male fecundity declines what is caused among these.Male sterility, i.e. reproduction
System dysfunction mainly have of both reason, first semen quality it is low, which two is male sexual disorder.
The male sterility that wherein semen quality problem is caused can be attributed to following three aspects reason：
1. dysspermatism：Mainly include azoospermia, oligoasthenospermia, hemospermia, sperm deformity and necrospermia etc.；
2. semen deposition is obstructed：Such as the pathological changes of epididymis, deferent duct, ejaculatory duct and urethra, the obstacle that seminal fluid can be caused to convey, clinic
On be usually expressed as Obstructive azoospermia；
3. dyszoospermia：Varicocele, congenital testicular hypoplasia, cryptorchidism, orchitiss or atrophy of testis, interior point
Secrete the factors such as disease to cause.
Male sexual disorder is clinically important male sterility reason, and erection disturbance (sexual impotence) is main
Male sexual disorder.In MMAS whole samples, the sexual impotence sickness rate of the 40-70 year male in the U.S. is 52%, on China also has
Hundred million people suffer from different degrees of sexual impotence, and sickness rate increases with the age and increases.With the increase of social pressure, the generation of sexual impotence
Also there is obvious rejuvenation trend, the male of many 20-30 year age brackets also occurs in that the symptom of obvious sexual impotence.
For the male sterility caused because of semen quality problem is mainly carried out by modus operandi or hormonal medicaments at this stage
Treatment, though there is certain effect, big to actual bodily harm, toxic and side effects are more obvious.For the infertility caused because of sexual dysfunction
There can be the modes such as operation, intervention and medicine to treat at present.With certain traumatic, complication is more, suffers from for operation and interventional therapy
Person is not easily accepted by；Other drugs gonadal hormone, viagra, phentolamine etc. have certain therapeutic effect, but cure the symptoms, not the disease,
It is often accompanied by the side effect such as headache, Blushing, dyspepsia, visual disorder.
Chinese medicine has advantageous advantage in terms for the treatment of male sterility, and the traditional Chinese medical science thinks kidney for congenital dirty, reproduction it
This, influences whether male reproductive function if deficiency of kidney-QI.In the case where Basic Theories of Chinese Medicine is instructed, Chinese medicine reasonable formula is using not only
The surface symptoms such as sexual impotence, premature ejaculation, erection heavily fortified point can be improved；Can also comprehensive regulation reproductive system function, fundamentally improve azoospermia,
The symptoms such as few essence, necrospermia, inside and outside conditioning, treating both the principal and secondary aspects of a disease.WUZIYANZONG WAN originates from the Tang Dynasty famous traditional tonic medicine prescription, because of which
The name of five kinds of Chinese crude drugs in dispensing has " son " word, and therefore named five is sub.For kidney-replenishing, improve semen quality, treat
Infertility, is described as " seed first party at all times ", its prescription be Fructus Lycii 400g, Semen Cuscutae (stir-fry) 400g, Fructus Rubi 200g, five
Taste (steaming) 50g, Semen Plantaginiss (salt stir-fry) 100g.For WUZIYANZONG WAN, current researcher it is also proposed various improvement prescriptions, such as
Patent application：103211915A, there is provided the formula and consumption of Six-herb-seed sperm increasing soup be：Mulberry chess piece, Fructus Lycii, Semen Cuscutae, the five tastes
Son, Fructus Rubi, Semen Plantaginiss (are wrapped), each 9 grams, 30 grams of the Radix Astragali, 15 grams of Herba Epimedii, 15 grams of teasel, 12 grams of Radix Polygoni Multiflori, Radix Angelicae Sinensis 12
Gram, can kidney-tonifying sperm-generating, it is adaptable to sperm rareness infertility.Patent application：103100025A, discloses a kind of for kidney-reinforcing Yang-strengthening
Pharmaceutical composition：5～10 parts of Radix Ginseng, 2.5～5 parts of the Radix Astragali, 2.5～5 parts of Fructus Psoraleae (salt stir-fry), Radix Morindae Officinaliss (system) 2.5～5
Part, 2.5～5 parts of Herba Cistanches, 2.5～5 parts of Fructus Corni (system), 2.5～5 parts of Fructus Lycii, 2.5～5 parts of Fructus Rubi, Radix Polygoni Multiflori Preparata
2.5～5 parts, 2.5～5 parts of the Cortex Eucommiae (salt system), 2.5～5 parts of Cortex Cinnamomi, 2.5～5 parts of Semen Cuscutae, 2.5～5 parts of Rhizoma Dioscoreae, Fructus Amomi 2.5
～5 parts, 2.5～5 parts of the Rhizoma Atractylodis Macrocephalae, 2.5～5 parts of Radix Ophiopogonis, 2.5～5 parts of Radix Asparagi, 2.5～5 parts of Fructus Schisandrae Chinensis, 2.5～5 parts of Radix Rehmanniae Preparata, chrysanthemum
Spend 2.5～5 parts, 2.5～5 parts of Cortex Phellodendri (salt stir-fry), 2.5～5 parts of Semen Plantaginiss (salt stir-fry), 2.5～5 parts of Semen Platycladi, Radix Polygalae (system) 2.5
～5 parts, with clear and definite kidney invigorating and YANG supporting, vigorate qi and replenish the blood, controlling nocturnal emission with astringent drugs antidiarrheal, improve immunity of organisms, significantly improve male's sexual,
Improve life quality, and can be used to prevent and treat the sexual dysfunctions such as sexual impotence, premature ejaculation, with preferable clinical effectiveness.But
At present to the improved prescription of WUZIYANZONG WAN in, prescription flavour of a drug are more, and which is relatively costly, and are unfavorable for Chinese medicine plant variety
Protection.
If can providing, a kind of flavour of a drug are less, and drug activity is better than the new drug of WUZIYANZONG WAN, it will provide for patient
Preferably select.
The content of the invention
It is an object of the invention to provide a kind of effect is even more ideal and the improvement buck sexual function of safety non-toxic barrier
The pharmaceutical composition for hindering.Another object of the present invention is to provide the preparation method and purposes of this pharmaceutical composition.
The invention provides a kind of pharmaceutical composition for improving reproduction of male animal systemic-function, its crude drug includes as follows
The flavour of a drug of weight proportion：
Fructus Lycii 4-6 parts, Semen Cuscutae 2-4 parts, Fructus Rubi 1.5-3.5 parts, Fructus Schisandrae Chinensis 1-2 parts, Semen Plantaginiss 1-2 parts, educate henry
Guest's 1.5-2.5 parts.
Flavour of a drug, are the general names to medicine used in pharmaceutical composition.
Further, its crude drug includes the flavour of a drug of following weight proportion：
4 parts of Fructus Lycii, 3 parts of Semen Cuscutae, 2.5 parts of Fructus Rubi, 1.2 parts of Fructus Schisandrae Chinensis, 1.25 parts of Semen Plantaginiss, 2 parts of Yohimbine.
Further, the weight proportion of its crude drug is as follows：
Fructus Lycii 4-6 parts, Semen Cuscutae 2-4 parts, Fructus Rubi 1.5-3.5 parts, Fructus Schisandrae Chinensis 1-2 parts, Semen Plantaginiss 1-2 parts, educate henry
Guest's 1.5-2.5 parts.
Further, the weight proportion of its crude drug is as follows：
4 parts of Fructus Lycii, 3 parts of Semen Cuscutae, 2.5 parts of Fructus Rubi, 1.2 parts of Fructus Schisandrae Chinensis, 1.25 parts of Semen Plantaginiss, 2 parts of Yohimbine.
Wherein, the Semen Cuscutae is Semen Cuscutae (parched), and Fructus Schisandrae Chinensis are Fructus Schisandrae Chinensis (steamed), and Semen Plantaginiss are Semen Plantaginis (parched with salt).
In the present invention, the stir-fry product of each taste raw material, product, salt stir-fry product etc. are steamed, can be carried out using Chinese medicine processing conventional method,
Or buy commercially available processed product.
Wherein, it be by Fructus Lycii, Semen Cuscutae, Fructus Rubi, Fructus Schisandrae Chinensis, Semen Plantaginiss, the medicated powder of Yohimbine, water extract or/
And extractive with organic solvent, add the dosage form that pharmaceutically acceptable adjuvant or complementary composition are prepared from.
The extractive with organic solvent, can carry out extraction preparation using the organic solvent having no toxic side effect to human body,
Can be prepared using other organic solvents, but need to ensure no solvent residue in the final product.It is organic molten that the present invention is used
Agent extract is preferably ethanol extraction.Wherein, concentration of alcohol can be determined by normal experiment according to extraction effect, example
Such as can be extracted by 30%, 40%, 50%, 60%, 70%, 80%, 95% ethanol of concentration.
Water extract is used as medicine with medicated powder, is Chinese medicine tradition occupation mode, after water extraction, due to the soluble end of water it is wide, energy
It is enough to make medicine be easier to be absorbed by the body most of effective ingredient dissolution, work faster, the form of medication such as such as decoction；With
Former powder is used as medicine, and the surface area of medicated powder is larger, is also beneficial to effective ingredient absorption in vivo in medical material, but medical material is un-extracted,
Effective ingredient still needs to dissolution re-absorption in vivo, and its relative water extract that works is slower, but is harmful in also weakening medical material simultaneously
Divide the toxicity caused to human body, be suitable for long-term taking, former powder is prepared into into the form of medication such as pill such as.At present in pharmacy
During, ethanol is extracted to medicine as solvent, is also one of most commonly seen extracting mode, and ethanol is that semi-polarity is molten
Agent, solubility property circle can dissolve water miscible some compositions between polarity and non-polar solven, can also dissolve nonpolar molten
Some compositions of agent dissolving, are generally extracted with ethanol and replace decocting, so as to avoid the dissolution of a large amount of invalid components, improve effectively into
The concentration divided and extraction efficiency, but the price of ethanol is expensive compared with water, in the big production of modern pharmaceutical industry, produces into save
This, generally or based on decocting.It is in the case where known compositions ethanol extract of the present invention has physiologically active, each in order to adapt to
Kind of production and demand when using, can optionally water extraction, original powder, alcohol extraction or combinations thereof method preparing specific dosage form.
Pharmaceutically acceptable adjuvant of the present invention includes but are not limited to filler (diluent), lubricant (fluidizer
Agent or antitack agent), dispersant, wetting agent, binding agent, regulator, solubilizing agent, antioxidant, antibacterial, emulsifying agent, disintegrating agent
Deng.Binding agent comprising syrup, arabic gum, gelatin, Sorbitol, tragacanth, cellulose and its derivates (as Microcrystalline Cellulose,
Sodium carboxymethyl cellulose, ethyl cellulose or hydroxypropyl methylcellulose etc.), gelatine size, syrup, starch slurry or polyvinylpyrrolidine
Ketone etc.；Filler is comprising Lactose, Icing Sugar, dextrin, starch and its derivant, cellulose and its derivates, inorganic calcium salt (such as sulphuric acid
Calcium, calcium phosphate, calcium hydrogen phosphate, precipitated calcium carbonate etc.), Sorbitol or glycine etc.；Lubricant includes micropowder silica gel, stearic acid
Magnesium, Pulvis Talci, aluminium hydroxide, boric acid, hydrogenated vegetable oil, Polyethylene Glycol etc.；Disintegrating agent includes starch and its derivant (such as carboxylic first
Base Starch Sodium, Explotab, pregelatinized Starch, modified starch, hydroxypropyl starch, corn starch etc.), polyvinylpyrrolidine
Ketone or Microcrystalline Cellulose etc.；Wetting agent includes sodium lauryl sulphate, water or alcohol etc.；Antioxidant packages contain sodium sulfite, sulfurous acid
Hydrogen sodium, sodium pyrosulfite, dibutyl benzoic acid etc.；Antibacterial includes 0.5% phenol, 0.3% cresol, 0.5% chlorobutanol etc.；
Regulator (includes phosphoric acid dioxy sodium and phosphoric acid hydrogen two comprising hydrochloric acid, citric acid, potassium hydroxide (sodium), sodium citrate and buffer agent
Sodium) etc.；Emulsifying agent comprising Tween-80, do not have that sour Pyrusussuriensiss are smooth, pluronic gram F-68, lecithin, fabaceous lecithin etc.；Solubilizing agent
Comprising tween 80, bile, glycerol etc..
The pharmaceutically acceptable complementary composition, it has certain physiologically active, but the addition of the composition will not change
Become leading position of the aforementioned pharmaceutical compositions in treatment of diseases, and only play auxiliary effect, these auxiliary effects are only
Only it is the utilization to the composition known activity, is the usual adjuvant treatment modality of field of medicaments.
Wherein, the dosage form is Jing gastrointestinal absorption dosage forms.For example, tablet, powder, pill, capsule, granule or mouth
Take liquid.
Certainly, pharmaceutical composition of the present invention, also including the extract of above-mentioned each medical material, is changed by said ratio and extraction ratio
The compositionss that each extract compatibility for obtaining is used.
Present invention also offers the preparation method of aforementioned pharmaceutical compositions, it includes following operating procedure：
(1) crude drug is weighed by weight ratio；
(2) Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine are taken, merges water extraction, collect Aqueous extracts, plus
Upper pharmaceutically acceptable adjuvant or complementary composition are prepared into pharmaceutically common formulations；
Or, (3) take Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine, and each medicine is collected in water extraction respectively
Material Aqueous extracts, add pharmaceutically acceptable adjuvant or complementary composition is prepared into pharmaceutically common formulations.
Further, in step (2), the concrete operations of water extraction are as follows：Take Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, car
Front son, Yohimbine, merging are added water to cook 2～4 times, more than 4 times for medical material gross mass of each amount of water, and each decocting time is
1～3 hour；
In step (3), the concrete operations of water extraction are as follows：Take Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, educate henry
Guest, each medical material add water to cook 2～4 times respectively, and each amount of water is more than 4 times of medical material gross mass, and each decocting time is 1～
3 hours.
Present invention also offers the preparation method of aforementioned pharmaceutical compositions, it includes following operating procedure：
(1) crude drug is weighed by weight ratio；
(2) Yohimbine is taken, in acid condition, is extracted as solvent with ethanol or ethanol water, united extraction liquid,
It is dried, obtains final product Yohimbine extract；
(3) Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss are taken, merges water extraction, collect decocting liquid, concentration is done
It is dry, mix with Yohimbine extract, add pharmaceutically acceptable adjuvant or complementary composition is prepared into pharmaceutically common formulations；
Or, (4) take Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, merge water extraction, collect Aqueous extracts, and concentration is dried, with
Yohimbine extract mixes, and adds pharmaceutically acceptable adjuvant or complementary composition is prepared into pharmaceutically common formulations.
Further, in step (2), the pH of the acid condition is 2～4, preferably 2～3.
Further, in step (2), the concentration of alcohol in the ethanol water be 60～80%v/v, preferably 70～
80%v/v.
Further, in step (2), Extracting temperature is 30～60 DEG C, preferably uses 40～50 DEG C.
Further, in step (2), extraction time is 2～3 times.
Preferably, the concrete operations of the Yohimbine method for preparing extractive are as follows：
Yohimbe bark is taken, is extracted with the 75%v/v ethanol solution of pH=2.5 after crushing, Extracting temperature is 45 DEG C, solid-liquid
Than for 1:12g/ml, extracts twice, and each 2.5h is filtered, and is spray-dried, is obtained final product Yohimbine extract.
Present invention also offers aforementioned pharmaceutical compositions improve buck sexual dysfunction, improve fertility in preparation
Medicine in purposes.
Further, the sexual dysfunction refers to erection disturbance, dysaphrodisia, sexual dysfunction, defective ejaculation, property
Sensory disturbance or penis weakness dysfunction.
Further, the sexual dysfunction refers to the sexual dysfunction caused by the factor beyond antidepressants.
Further, the medicine is to improve buck libido, improves Plasma testosterone levels, improves sperm quantity and essence
The medicine of sub- vigor.
Further, the buck is kidney yang deficiency syndrome buck.
Further, the animal is mammal.
Further, the mammal is primate, artiodactylous animals or rodent.
Wherein, the primate refers to the mankind.
After the present invention is by the 5 taste Chinese medicine such as Fructus Lycii, Semen Cuscutae and Yohimbine extract compatibility use, collaboration is played and has increased
Effect is acted on, and sexual dysfunction, fertility to buck etc. all improve significantly, and can effectively improve male dynamic
Physical property is intended to, and improves Plasma testosterone levels, improves sperm quantity and motility of sperm, and its activity is substantially better than classic prescriptions five-seed Yanzong
Ball, provides a kind of new selection for clinical application.
In addition, for Yohimbine, medicine common on the market is Yohimbine Hcl at present, but its toxic and side effects is more
Substantially, in external report 2000, adverse reaction rate up to 6.8%, including loss of appetite, nausea, stomach discomfort, diarrhoea,
Vomiting, blood pressure rising, headache, dizziness, cardiopalmus, nervousness, restless, insomnia, flush, tremble, excitement, dysuria, the back of the body
Pain and allergic rash etc..It was unexpectedly observed that after by Yohimbine and WUZIYANZONG WAN compatibility use, not only can show in the present invention
Write and improve sexual dysfunction, fertility, also effectively prevent the toxic and side effects of Yohimbine, safety is good.
Below by way of specific embodiment, the present invention is described in further detail, but is not intended to limit the present invention, ability
Field technique personnel are variously modified according to the present invention and replace, and without departing from the spirit of the present invention, all should belong to the present invention
Scope of the following claims.
Specific embodiment
The preparation method of 1 pharmaceutical composition of the present invention of embodiment
Prescription：
Fructus Lycii 4kg Semen Cuscutae (stir-fry) 3kg Fructus Rubi 2.5kg Fructus Schisandrae Chinensis (steaming) 1.2kg Semen Plantaginiss (salt stir-fry) 1.25kg, educate
Prosperous guest 2kg
Preparation method：
1. Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss are taken respectively, add water to cook three times.Add which for the first time
The water of 6 times of amounts of weight, soaks 1 hour, then decocts 2 hours；Second plus 5 times of amount water of its weight, decoct 1 hour；For the third time
Plus 4 times of water of its weight, decocting 1 hour, filtration, merging filtrate, it is 1.09- that heating is concentrated into the relative density at 60-65 DEG C
1.12；
2. above-mentioned concentrated solution is spray-dried by Highspeedcentrifugingandsprayingdrier, is prepared into 80-120 mesh dry extracts；
3. Yohimbine is taken, after crushing, uses pH=2.5,75% ethanol solution to extract, Extracting temperature is 45 DEG C, and solid-to-liquid ratio is 1:
12, extract twice, then each 2.5h is filtered, is dried using Highspeedcentrifugingandsprayingdrier, is prepared into Yohimbine dry extract
Powder, as Yohimbine extract.
4. the dry extract for step 2 being obtained is mixed homogeneously with Yohimbine extract, adds suitable excipients routinely side
Method prepares into capsule.
The preparation method of 2 pharmaceutical composition of the present invention of embodiment
Prescription：
Fructus Lycii 4kg Semen Cuscutae (stir-fry) 3kg Fructus Rubi 2.5kg Fructus Schisandrae Chinensis (steaming) 1.2kg Semen Plantaginiss (salt stir-fry) 1.25kg, educate
Prosperous guest 2kg
Preparation method：
1. Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine are taken respectively, add water to cook three times.For the first time
The water of 6 times of amounts of its weight is added, is soaked 1 hour, is then decocted 2 hours；Second plus 5 times of amount water of its weight, decoct 1 hour；
Third time plus 4 times of water of its weight, decoct 1 hour, and filtration, merging filtrate, heating are concentrated into the relative density at 60-65 DEG C and are
1.09-1.12；
2. above-mentioned concentrated solution is spray-dried by Highspeedcentrifugingandsprayingdrier, is prepared into 80-120 mesh dry extracts；
3. the dry extract that step 2 is obtained, adds suitable excipients to be prepared into granule according to a conventional method.
The preparation method of 3 pharmaceutical composition of the present invention of embodiment
Fructus Lycii 6kg Semen Cuscutae (stir-fry) 4kg Fructus Rubi 1.5kg Fructus Schisandrae Chinensis (steaming) 1kg Semen Plantaginiss (salt stir-fry) 1kg, Yohimbine
1.5kg
Preparation method：
1. Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine are taken, three times are added water to cook.Add for the first time
The water of 6 times of amounts of its weight, soaks 1 hour, then decocts 2 hours；Second plus 5 times of amount water of its weight, decoct 1 hour；3rd
Secondary plus 4 times of water of its weight, decoct 1 hour, filtration, merging filtrate, and it is 1.09- that heating is concentrated into the relative density at 60-65 DEG C
1.12；
2. above-mentioned concentrated solution is spray-dried by Highspeedcentrifugingandsprayingdrier, is prepared into 80-120 mesh dry extracts；
3. the dry extract for step 2 being obtained is mixed homogeneously with Yohimbine extract, adds suitable excipients routinely side
Method is prepared into oral liquid.
The preparation method of 4 pharmaceutical composition of the present invention of embodiment
Fructus Lycii 4kg Semen Cuscutae (stir-fry) 2kg Fructus Rubi 3.5kg Fructus Schisandrae Chinensis (steaming) 2kg Semen Plantaginiss (salt stir-fry) 2kg, Yohimbine
2.5Kg
Preparation method：
1. Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss are taken respectively, add water to cook three times respectively.Add for the first time
Enter the water of 6 times of amounts of its weight, soak 1 hour, then decoct 2 hours；Second plus 5 times of amount water of its weight, decoct 1 hour；The
Three times plus 4 times of water of its weight, decoct 1 hour, and filtration, merging filtrate, heating are concentrated into the relative density at 60-65 DEG C and are
1.09-1.12；
2. above-mentioned each medical material concentrated solution is spray-dried by Highspeedcentrifugingandsprayingdrier, is prepared into the dry leaching of 80-120 mesh
Cream powder；
3. Yohimbine is taken, after crushing, uses pH=4,80% ethanol solution to extract, Extracting temperature is 50 DEG C, and solid-to-liquid ratio is 1:8,
Extract three times, then each 1.5h is filtered, be dried using Highspeedcentrifugingandsprayingdrier, is prepared into Yohimbine dry extract, i.e.,
For Yohimbine extract.
4. the various dry extracts that step 2 is obtained are mixed homogeneously with Yohimbine extract, suitable excipients are added by normal
Rule method prepares piece agent.
The preparation method of 5 pharmaceutical composition of the present invention of embodiment
Fructus Lycii 4kg Semen Cuscutae (stir-fry) 3kg Fructus Rubi 2.5kg Fructus Schisandrae Chinensis (steaming) 1.2kg Semen Plantaginiss (salt stir-fry) 1.25kg, educate
Prosperous guest 2kg
Preparation method：
Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine are taken, after pulverizing medicinal materials, with 60～65%v/v
Alcohol dipping is extracted, and after extracting solution reclaims ethanol, concentration is dried, and adds appropriate amount of auxiliary materials to prepare pill.
The preparation method of 6 pharmaceutical composition of the present invention of embodiment
Fructus Lycii 4kg Semen Cuscutae (stir-fry) 3kg Fructus Rubi 2.5kg Fructus Schisandrae Chinensis (steaming) 1.2kg Semen Plantaginiss (salt stir-fry) 1.25kg, educate
Prosperous guest 2kg
Preparation method：
1. Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine are taken, after pulverizing medicinal materials, with 85～90%v/
V alcohol reflux 2 times, after extracting solution reclaims ethanol, concentrated solution is standby；
2. step 1 Chinese medicine slag adds water to cook 2 times.The water of 8 times of amounts of its weight is added for the first time, is soaked 1 hour, is then decocted
1 hour；Second plus 4 times of amount water of its weight, decoct 1 hour, and filtration, merging filtrate are mixed with the concentrated solution in step 1, then
Relative density is evaporated to for 1.09-1.12；
3. above-mentioned concentrated solution is spray-dried by Highspeedcentrifugingandsprayingdrier, is prepared into 80-120 mesh dry extracts；
3. the dry extract that step 2 is obtained, adds suitable excipients to be prepared into granule according to a conventional method.
Beneficial effects of the present invention are illustrated below by way of test example.Experimental drug agent is using prepared by embodiment 1
Medicine.
1 toxicity test of test example and the test of pesticide effectiveness
1. acute toxicity test
(1) the continuous gavage of mice is given by test preparation 50g (crude drug)/kg, within experimental period has no animal dead, can
The maximum tolerated dose for determining its mice single administration is 50g (crude drug)/kg, equivalent to it is clinical people's consumption per day is provided 125 times (with
Everyone 60kg weighing machines, each take capsule 2, and one time a day, per 12g containing crude drug, and people's consumption per day is 24g, counts 0.4g/kg/
Day).
(2) gavage of rat is given by test preparation 42g/kg, experimental period, without animal dead, its maximum tolerated dose is
42g/kg, equivalent to clinical provide people's consumption per day 105 times.
2. long term toxicity test
It is administered 16 weeks to rat continuous gavage with 20g (crude drug)/kg dosage, compares with matched group distilled water, have no animal
Occur general clinical symptoms, body weight increase, hematology, blood biochemical analysis check indices, about organ systems and pathology
The toxicity of tissue changes.After being discontinued 4 weeks, the slowness toxicity that the above-mentioned identical items inspection of animal also has no the by reagent is retained.
Illustrate the present composition by oral administration successive administration without obvious toxic-side effects.
3. pharmacodynamic experiment
In each trial drug, dosage is and is calculated with crude drug amount g/kg that raw material is extracted equivalent to correspondence.
3.1 experiment material
Estradiol benzoate, progesterone injection, viagra, the present composition, WUZIYANZONG WAN (commercially available), Kunming kind
Mice and SD rats
3.2 experimental techniques and result
3.2.1 animal feeding and packet
By rat male and female sub-cage rearing, per 3, cage, raettin is per 5, cage for male Mus.Male rat is carried out into adaptability raising,
Environment is adapted it to, nursing time is 1 week.It is grouped after weighing at random, is divided into following 6 groups, i.e.,：Blank control group, positive drug
Matched group, present composition high dose group, present composition middle dose group, present composition low dose group, five sons spread out
Ancestor's group (being the commercially available prescribed preparation for being not added with Yohimbine), 12 per group.
Rat is enable freely to ingest and drink water in whole experiment process, full-valence pellet feed is fed, drinking water is changed daily.
Keep in the range of activities in rats, having preference temperature and humidity, at 18-22 DEG C, the scope that relative humidity is maintained is 60- to temperature control
70%.Illumination in 12 hours, 12 hours dark surrounds are manufactured in space.3.2.2 raettin prepares
Before mating test is carried out, have acclimatization training every night, i.e., raettin is positioned over the glass of mating test
In inspection box so as to adapt to environment as early as possible.Formal experiment starts front 48 hours intramuscular injection estradiol benzoates, and dosage is 200 μ g/
kg；Mate first 4 hours with male Mus, inject progesterone injection, dosage is 2mg/kg, promotees its heat.
3.2.3 male Mus medication
Blank control group：Daily gavage gives distilled water, and dosage is 2ml/d；
Positive drug control group：Before mating test, gavage gives viagra, and dosage is 10mg/kg；
Present composition high dose group：Daily gavage gives present composition 8g/kg；
Present composition middle dose group：Daily gavage gives present composition 5g/kg；
Present composition low dose group：Daily gavage gives present composition 3g/kg；
WUZIYANZONG WAN group：Daily gavage gives five-seed Yanzong compositionss 5g/kg (crude drug amount).
Impact of 3.3 present compositions to laboratory animal sexual behaviour
Kept quite during observation as far as possible, the light is dusky, and laboratory animal can not be made to get a fright.1 male Mus is placed first in glass
In glass inspection box, 2 heat raettins are placed after which adapts to environment, observe 30min, observed and to record each group big within the observation period
Flutterring for Mus is caught number of times and its incubation period, rides number of times and its incubation period, erection number of times.As a result record such as table 1.
Impact of 1 present composition of table to rat sexual behaviour
| Group | n | Flutter and catch number of times | Flutter and catch incubation period | Riding number of times | Ride incubation period |
| Blank | 12 | 10.22±3.1 | 107.55±22.14 | 1.24±1.07 | 360±45.32 |
| Positive control | 12 | 28.14±9.72** | 40.64±15.86** | 4.45±2.11** | 180±56.44** |
| High dose group | 12 | 27.11±6.5** | 42.27±12.66** | 3.89±2.76** | 185.69±35.65** |
| Middle dose group | 12 | 20.48±7.89** | 54.12±9.88** | 3.18±1.57** | 204.12±22.45** |
| Low dose group | 12 | 11.27±8.55* | 77.83±7.29* | 2.21±1.04** | 223.54±31.27** |
| Five-seed Yanzong group | 12 | 14.21±2.66* | 98.66±14.32 | 1.85±0.44 | 245.11±62.45* |
Note：Compared with blank control group：* p ＜ 0.01；Compared with blank control group：* p ＜ 0.05
As can be seen from Table 1, positive controls and present composition height, middle dose group can dramatically increase laboratory animal
Flutter to catch number of times and shorten to flutter and catch incubation period；Positive controls and present composition height, middle dose group can dramatically increase rat
Riding number of times and shortening ride incubation period.The commercially available WUZIYANZONG WAN group for being not added with Yohimbine extract is affected on rat sexual behaviour
It is not notable.
Experimental result shows that the present composition can effectively lift laboratory animal libido, and Enhancement test animal sexuality makes
Flutter and catch number of times and riding number of times increase, flutter to catch incubation period and ride and substantially shorten incubation period.
Impact of 3.4 present compositions to mice with kidney-yang deficiency fertility
60 male mices are taken, 6 groups are randomly divided into, 10 per group.In addition to blank control group, remaining uses hydrocortisone
The continuous modelings on the 9th of 0.5ml/kg ip, start simultaneously at gavage in modeling, continuous 12 days.1h Jing eye sockets blood sampling after last dose, surveys
The indexs such as examination blood plasma testosterone content, testis, epididymis weight, epididymal sperm content, motility of sperm.Result of the test is shown in Table 2.
Impact of 2 present composition of table to mice with kidney-yang deficiency fertility
Note：The * * p ＜ 0.01 compared with blank control group；The ##p ＜ 0.01 compared with model group；The △ compared with positive controls
△ p ＜ 0.01
Positive drug group is all remarkably higher than model with each dosage group of the present composition, five-seed Yanzong group Plasma testosterone levels
Group, and the present composition is to lifting Plasma testosterone levels apparently higher than positive drug group, five-seed Yanzong group effect and the present invention
Compositionss middle dose group effect is suitable.
Each test group animal testis, epididymis weight differential be not notable.The each dosage group of the present composition and five-seed Yanzong group
Sperm quantity, motility of sperm are apparently higher than positive drug control group, five-seed Yanzong group effect and present composition middle dose group
Effect is suitable.The present composition is aobvious for the indices such as kidney yang deficiency syndrome plasma testosterone, sperm count, motility of sperm have
Write and lifted, and there is doses dependency, effect is substantially better than positive drug control group.
The impact of 3.5 pairs of chronic suspension stress sexual dysfunction mices
The male mice 70 with normal sexual behavior is chosen, matched group and model group is randomly divided into, except Normal group
Outward, remaining mouse tail is sling, mice hangs the 20min on the water bath with thermostatic control water surface (22 DEG C or so) by the feet, once a day, continuous 9 days,
After last suspention, animal pattern is randomly divided into 6 groups and is tested by next day, according to dosage gavage medicine simultaneously in experimentation.Formally
Sufficient sexual behaviour training is carried out before experiment to experiment mice, the first 48 hours cervical region subcutaneous injection estradiol in raettin are tested
(0.5mg/kg),
Injection progesterone (0.5mg/kg) in first 6 hours is tested, heat rat animal model is set up standby.By female after last dose
Hero compares 3:Mice is placed in 15min in same cage by 1, observes and record that male mice rides, number of copulations is used as observation index.System
Meter result such as table 3.
Table 3 is affected on chronic suspension stress sexual dysfunction mouse sexual function
| Group | Dosage | Ride number of times | Number of copulations |
| Blank | 0 | 22.6±3.7 | 5.2±0.4 |
| Model control group | 0 | 8.9±2.2 | 1.4±0.9 |
| Positive control | 10mg/kg | 17.3±4.2** | 4.1±0.5** |
| High dose group | 8g/kg | 16.5±5.1** | 3.7±0.6** |
| Middle dose group | 5g/kg | 12.3±5.8** | 2.9±0.8** |
| Low dose group | 3g/kg | 10.1±4.7** | 2.1±0.3** |
| Five-seed Yanzong group | 5g/kg | 10.3±2.9* | 1.7±0.6* |
Note：Compared with model control group：* p ＜ 0.01；Compared with model control group：* p ＜ 0.05
From table 3 it can be seen that model group animal its ride number of times and number of copulations is substantially reduced, each experimental group medicine is to changing
The kind sexual dysfunction for causing that suspends in midair has remarkable effect, rides number of times and number of copulations is dramatically increased.Wherein present invention combination
Thing is high, middle dose group effect is substantially better than five-seed Yanzong group.As a result illustrate that the present composition has the sexual function that improves significantly
Obstructive action.
Summary experiment is as can be seen that reproductive system function improvement result of the pharmaceutical composition of the present invention to buck
Classic prescriptions WUZIYANZONG WAN is substantially better than, meanwhile, after each flavour of a drug compatibility use, effectively prevent the bad anti-of Yohimbine presence
Should, safer, effectively new selection is provided for clinical application.
Claims (24)
1. a kind of pharmaceutical composition for improving reproduction of male animal systemic-function, it is characterised in that：Its crude drug is by weighing as follows
The flavour of a drug composition of amount proportioning：
Fructus Lycii 4-6 parts, Semen Cuscutae 2-4 parts, Fructus Rubi 1.5-3.5 parts, Fructus Schisandrae Chinensis 1-2 parts, Semen Plantaginiss 1-2 parts, Yohimbine
1.5-2.5 part.
2. pharmaceutical composition according to claim 1, it is characterised in that：Its crude drug is by the flavour of a drug of following weight proportion
Composition：
4 parts of Fructus Lycii, 3 parts of Semen Cuscutae, 2.5 parts of Fructus Rubi, 1.2 parts of Fructus Schisandrae Chinensis, 1.25 parts of Semen Plantaginiss, 2 parts of Yohimbine.
3. pharmaceutical composition according to claim 1 and 2, it is characterised in that：The Semen Cuscutae be Semen Cuscutae (parched), Fructus Schisandrae Chinensis
For Fructus Schisandrae Chinensis (steamed), Semen Plantaginiss are Semen Plantaginis (parched with salt).
4. pharmaceutical composition according to claim 1 and 2, it is characterised in that：It is by Fructus Lycii, Semen Cuscutae, Fructus Rubi,
Fructus Schisandrae Chinensis, Semen Plantaginiss, the medicated powder of Yohimbine, water extract or/and extractive with organic solvent, add pharmaceutically acceptable adjuvant or
The dosage form that complementary composition is prepared from.
5. pharmaceutical composition according to claim 4, it is characterised in that：The dosage form is Jing gastrointestinal absorption dosage forms.
6. the preparation method of Claims 1 to 5 any one described pharmaceutical composition, it is characterised in that：It includes following operation
Step：
(1) crude drug is weighed by weight ratio；
(2) Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine are taken, merges water extraction, collected Aqueous extracts, add medicine
On, acceptable adjuvant or complementary composition are prepared into pharmaceutically common formulations；
Or, (3) take Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine, and each medical material water is collected in water extraction respectively
Extract, adds pharmaceutically acceptable adjuvant or complementary composition is prepared into pharmaceutically common formulations.
7. preparation method according to claim 6, it is characterised in that：In step (2), the concrete operations of water extraction are as follows：Take five
Taste, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine, merging are added water to cook 2～4 times, and each amount of water is that medical material is total
More than 4 times of quality, each decocting time are 1～3 hour；
In step (3), the concrete operations of water extraction are as follows：Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss, Yohimbine are taken,
Each medical material is added water to cook 2～4 times respectively, more than 4 times for medical material gross mass of each amount of water, and each decocting time is 1～3 little
When.
8. the preparation method of Claims 1 to 5 any one described pharmaceutical composition, it is characterised in that：It includes following operation
Step：
(1) crude drug is weighed by weight ratio；
(2) Yohimbine is taken, in acid condition, is extracted as solvent with ethanol or ethanol water, united extraction liquid, done
It is dry, obtain final product Yohimbine extract；
(3) Fructus Schisandrae Chinensis, Semen Cuscutae, Fructus Rubi, Fructus Lycii, Semen Plantaginiss are taken, merges water extraction, collect decocting liquid, concentration is dried, with
Yohimbine extract mixes, and adds pharmaceutically acceptable adjuvant or complementary composition is prepared into pharmaceutically common formulations.
9. preparation method according to claim 8, it is characterised in that：In step (2), the pH of the acid condition is 2～
4。
10. preparation method according to claim 9, it is characterised in that：In step (2), the pH of the acid condition is 2～
3。
11. preparation methoies according to claim 8, it is characterised in that：In step (2), the second in the ethanol water
Determining alcohol is 60～80%v/v.
12. preparation methoies according to claim 11, it is characterised in that：In step (2), the second in the ethanol water
Determining alcohol is 70～80%v/v.
13. preparation methoies according to claim 8, it is characterised in that：In step (2), Extracting temperature is 30～60 DEG C.
14. preparation methoies according to claim 13, it is characterised in that：In step (2), Extracting temperature is 40～50 DEG C.
15. preparation methoies according to claim 8, it is characterised in that：In step (2), extraction time is 2～3 times.
16. preparation methoies according to claim 8, it is characterised in that：The Yohimbine method for preparing extractive it is concrete
Operation is as follows：
Yohimbe bark is taken, is extracted with the 75%v/v ethanol solution of pH=2.5 after crushing, Extracting temperature is 45 DEG C, solid-to-liquid ratio is
1:12g/ml, extracts twice, and each 2.5h is filtered, and is spray-dried, is obtained final product Yohimbine extract.
17. Claims 1 to 5 any one described pharmaceutical compositions improve buck sexual dysfunction, improve life in preparation
Educate the purposes in the medicine of ability.
18. purposes according to claim 17, it is characterised in that：The sexual dysfunction refers to erection disturbance, property
It is intended to obstacle, sexual dysfunction, defective ejaculation, property sensory disturbance or penis weakness dysfunction.
19. purposes according to claim 17 or 18, it is characterised in that：The sexual dysfunction is referred to beyond antidepressants
Factor caused by sexual dysfunction.
20. purposes according to claim 18, it is characterised in that：The medicine is to improve buck libido, improves blood
Slurry testosterone levels, improve the medicine of sperm quantity and motility of sperm.
21. purposes according to claim 17 or 20, it is characterised in that：The buck is that kidney yang deficiency syndrome male is dynamic
Thing.
22. purposes according to claim 17,20 or 21, it is characterised in that：The animal is mammal.
23. purposes according to claim 22, it is characterised in that：The mammal is primate, Artiodactyla is moved
Thing or rodent.
24. purposes according to claim 23, it is characterised in that：The primate refers to the mankind.
Priority Applications (2)
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|---|---|---|---|
| CN201410198478.XA CN103948742B (en) | 2014-05-12 | 2014-05-12 | Pharmaceutical composition for improving male animal sexual dysfunction |
| PCT/CN2014/077932 WO2015172399A1 (en) | 2014-05-12 | 2014-05-20 | Pharmaceutical composition for improving male sexual dysfunction |
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| CN201410198478.XA CN103948742B (en) | 2014-05-12 | 2014-05-12 | Pharmaceutical composition for improving male animal sexual dysfunction |
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| CN107913357B (en) * | 2018-01-04 | 2021-03-02 | 扬子江药业集团四川海蓉药业有限公司 | New use of a Chinese medicinal composition in preparing medicine/health product for treating asthenospermia |
| EP3646871A1 (en) * | 2018-10-30 | 2020-05-06 | SEROJAC PME Handels GmbH | Treatment and prevention of premature ejaculation (pe) |
| CN114949091A (en) * | 2022-06-27 | 2022-08-30 | 张凤霞 | Traditional Chinese medicine formula for treating female pathological and climacteric dryness and astringency syndrome |
| CN115645485A (en) * | 2022-11-22 | 2023-01-31 | 海南中希医疗科技有限公司 | Traditional Chinese medicine preparation for promoting inoculation |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1970007A (en) * | 2006-05-11 | 2007-05-30 | 苟春虎 | Capsule for improving sexual function for men |
| CN102895409A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology and production method for integrated new formulation of wu zi yan zong pill |
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| CN101632750B (en) * | 2008-07-22 | 2011-12-14 | 天津达仁堂京万红药业有限公司 | Chinese medicinal composition for replenishing essence, filling marrow, boosting kidney and strengthening yang and preparation method thereof |
| CN101422570B (en) * | 2008-12-08 | 2011-09-28 | 济南老来寿生物股份有限公司 | Functional food capable of increasing male sexual function |
| CN102002039B (en) * | 2010-11-12 | 2012-05-09 | 天医堂(厦门)生物工程有限公司 | Method for extracting yohimbine from yohimbine bark |
| CN102863439A (en) * | 2011-07-07 | 2013-01-09 | 天津市尖峰天然产物研究开发有限公司 | Method for extracting yohimbine hydrochloride from yohimbe barks |
| CN103494952A (en) * | 2013-10-12 | 2014-01-08 | 洛阳顺势药业有限公司 | Wuzi Yanzong pill and preparation process thereof |
| CN103666964B (en) * | 2013-12-02 | 2015-07-29 | 天津达仁堂京万红药业有限公司 | A kind of kidney healthful tonic wine and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1970007A (en) * | 2006-05-11 | 2007-05-30 | 苟春虎 | Capsule for improving sexual function for men |
| CN102895409A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology and production method for integrated new formulation of wu zi yan zong pill |
Non-Patent Citations (1)
| Title |
|---|
| 治疗ED药物及其各自特点;瞿可庆，等。;《Strait Pharmaceutical Journal》;20051030;第17卷(第5期);第97-99页 * |
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