CN1660250A - Chinese materia medica preparation for treating dysmenorrhea of women - Google Patents
Chinese materia medica preparation for treating dysmenorrhea of women Download PDFInfo
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Abstract
A Chinese medicine in the form of softgel or dispersing tablet for treating menalgia is prepared from 8 Chinese-medicinal materials including white peony root, Chinese angelica root, notoginseng, motherwort, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of gynecological Chinese medicine compound preparation and preparation method that improves bioavailability and drug effect, i.e. FUKANGNING preparation and preparation method.
Technical background
The compound Chinese medicinal preparation that tablet for women's health and tranquilness is made up of 8 flavor Chinese medicines such as the Radix Paeoniae Alba, Radix Angelicae Sinensis, Herba Leonuri, Radix Ophiopogonis, Rhizoma Cyperi, Radix Notoginseng, Folium Artemisiae Argyi (charcoal), Radix Codonopsis.Be mainly used in treatment women deficiency of both QI and blood, abdominal pain in menstruation.The method for making of a kind of coated tablet of this FUKANGNING is recorded in first of Chinese people's Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ".Along with the continuous variation and the human adaptive variation for medicine of environment, people have had higher requirement for the bioavailability and the drug effect of Chinese medicine.
Summary of the invention
The object of the invention is to add appropriate amount of auxiliary materials in the prescription medicinal substances extract based on Chinese medicine, and a kind of gynecological Chinese medicine compound preparation and preparation method that improves bioavailability and drug effect is provided, and the present invention takes following design:
The component weight proportion of FUKANGNING preparation of the present invention is:
The Radix Paeoniae Alba 180～220 Rhizoma Cyperis 25～35 Radix Angelicae Sinensis 20～30
2～6 Radix Ophiopogonis 40～60 of Radix Notoginseng 15～25 Folium Artemisiae Argyis (charcoal)
Radix Codonopsis 20～40 Herba Leonuris 120～180
The preferred proportioning of using is:
25 parts of 30 parts of Radix Angelicae Sinensis of 200 portions of Rhizoma Cyperis of the Radix Paeoniae Alba
50 parts of 20 portions of Folium Artemisiae Argyis of Radix Notoginseng (charcoal) 4 parts of Radix Ophiopogonis
150 parts of 30 parts of Herba Leonuris of Radix Codonopsis
The prescription Chinese crude drug all uses by Chinese Pharmacopoeia record kind, and Folium Artemisiae Argyi (charcoal) is meant the processed product after Folium Artemisiae Argyi is processed by Chinese Pharmacopoeia
The medicinal substances extract of above-mentioned component cooperates pharmaceutically alleged adjuvant that adopts suitable kind or soft capsule, the dispersible tablet that substrate is made; As making soft capsule with disperse medium, suspending agent, antiseptic; Or make dispersible tablet with filler, disintegrating agent, wetting agent, lubricant.
Make dispersible tablet with filler (20～350 parts), disintegrating agent (10～160 parts), lubricant (1～5 part); Or make soft capsule with disperse medium (50～400 parts), suspending agent (3～50 parts), antiseptic (0.1～3 part).
The disperse medium of making soft capsule is the oiliness disperse medium; as: olive oil or other crude vegetals; or triglyceride oils; or oleic acid sorbitol ester; or olein: propylene glycol is 90: 10 mixture by weight; or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters; or Oleum Cocois C8/C10 propylene glycol ester; or the Oleum Cocois triglyceride, or the acetylizad monoglyceride of purification, or olein; or glyceryl linoleate; or Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more
Or the water solublity disperse medium, as PEG400 or Polyethylene Glycol 500 or Macrogol 600 or isopropyl alcohol or glycerol or propylene glycol and water one or more, the best oiliness disperse medium that uses.
The suspending agent of making soft capsule is: can increase the solid matter of disperse medium viscosity, as Cera Flava or aluminum monostearate or ethyl cellulose etc.; The preferred Cera Flava that uses: 50: 25 mixture of second class cellulose.
Its described antiseptic of making soft capsule is: one or more in glycerol or propylene glycol or methyl parahydroxybenzoate or ethylparaben or propyl p-hydroxybenzoate or butyl p-hydroxybenzoate or benzyl p-hydroxybenzoate or the P-hydroxybenzoic acid phenyl ester, or best ethylparaben.
A kind of comparatively preferred soft capsule accessory formula is combined as:
Its disperse medium is: olive oil, consumption are 210 parts;
Its suspending agent is a Cera Flava: 6: 1 mixture of Ka Baibo resin (Carbopol resin), and consumption is 21 parts;
Emulsifying agent: soybean lecithin, consumption are 12 parts;
Antiseptic is: ethylparaben, consumption are 3 parts;
The uniform film of thickness is made with dissolvings such as gelatin and glycerol, distilled water by the capsule material of its soft capsule system; The capsule material prescription that is fit to this preparation can be: gelatin: arabic gum: glycerol: syrup: distilled water=1: 0.23: 0.75: 0.12: 1.45.
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone, or be preferably 50% alcoholic solution of 3%～9% polyvinylpyrrolidone.
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.
The disintegrating agents of dispersible tablets is: carboxymethyl starch sodium: the mixture of crospolyvinylpyrrolidone (1.5: 4.5); Consumption is 20 parts;
Binding agent is: 70% alcoholic solution of 3.5% polyvinylpyrrolidone;
Filler is: starch: precoking starch (3: 2); Consumption is 220 parts
Lubricant in the dispersible tablet is: micropowder silica gel, consumption are 3 parts;
The extraction of the inventive method medical material can realize by following steps:
Its preparation process is as follows:
1) technology of medicinal material extract, processed:
Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, the Folium Artemisiae Argyi pulverize separately of getting Radix Paeoniae Alba 80g and recipe quantity become micropowder, sieve mixing.The Radix Ophiopogonis of all the other Radix Paeoniae Albas and recipe quantity, Radix Codonopsis, Herba Leonuri add 8～16 times of amounts of water and decoct 2～3 times, and collecting decoction filters, relative density was 1.05～1.35 thick paste when filtrate was concentrated into 25 ℃, add above-mentioned powder, mix homogeneously is the medicinal substances extract for preparing soft capsule, dispersible tablet.
2) moulding process of preparation
Preparation dispersible tablet: get the said extracted thing, add filler and part disintegrating agent mix homogeneously, granulate drying with the wetting agent moistening, granulate adds remaining residue disintegrating agent and lubricant, mix homogeneously, tabletting, promptly get dispersible tablet, or coating behind the tabletting, coated dispersing tablet promptly got; Or
Preparation soft capsule: get the medicinal substances extract of above-mentioned preparation soft capsule, add one or more of suspending agent disperse medium, antiseptic etc., stir, grind homogenizing, promptly get soft capsule content, drip system or be pressed into soft capsule.
Effect of the present invention:
Be the treatment of objective evaluation FUKANGNING (soft capsule, dispersible tablet) novel form
Advantage of the present invention is:
Soft capsule: the soft capsule introduction also claims the flexible glue pill, and it is not have a kind of preparation that forms in sealings such as the non-water-soluble liquid of dissolution or suspension and the capsule shells with oils or to the gelatin thing.Soft capsule is the tablet that continues, and a kind of novel form that grows up after the injection, its shell are to form with the gelatin compacting, the aqueous medicinal liquid of bag in the softgel shell.An also available general system technology is dripped and is made soft capsule.Be characterized in slower than injection onset, but than tablet, capsule, granule is rapid-action.More easy to carry than oral liquid.Because the optimization of soft capsule liquid of the present invention prescription, its content can be in human body self emulsifying to a certain degree, increase absorption area, thus the bioavailability height.
Dispersible tablet: be a kind of solidified liquid form of administration, disintegrate fully in 3 minutes at normal temperatures, the effective ingredient stripping is rapid.But solid state is taken, but also liquid condition is taken, and makes things convenient for the patient.The development of dispersible tablets of Chinese medicine need overcome and extract the technological difficulties that the extractum moisture absorption influences disintegrate, and the present invention is by the screening adjuvant, thereby it is stable to reach end product quality, and disintegrate is characteristics rapidly.
According to 2000 editions dissolution methods of Chinese Pharmacopoeia, be index with the peoniflorin, measure with high-efficient liquid phase technique, relatively by the result of extraction of prepared soft capsule, dispersible tablet and former tablet of the inventive method, the effect of preparation of the present invention is obvious.
4 hours burst sizes of simulated gastric fluid accumulative total compare:
| 10 of tablet for women's health and tranquilness | Soft capsule (being equivalent to 10 in tablet) | Dispersible tablet (being equivalent to 10 in tablet) | |
| 1 | ?44.2％ | 74.2％ | 73.5％ |
| 2 | ?49.2％ | 73.3％ | 73.4％ |
| 3 | ?44.6％ | 72.3％ | 74.6％ |
| 4 | ?51.5％ | 76.2％ | 75.3％ |
| 5 | ?52.1％ | 75.1％ | 74..2％ |
Former tablet is taken 8 at every turn, and every day, dose reached 24 more than, and the patient uses comparatively inconvenience.72～100 slices/bottle of commercially available backs, the patient buys poor selectivity, perhaps because of taking the relatively poor often therapy discontinued of mouthfeel.Novel form of the present invention, it is convenient that the patient is taken, thereby can follow the doctor's advice, and finishes the treatment of the corresponding course of treatment.
The specific embodiment:
Embodiment 1: the preparation of the medicinal substances extract that preparation FUKANGNING soft capsule, dispersible tablet are used:
Medical material component weight proportion:
The Radix Paeoniae Alba 220 Rhizoma Cyperis 35 Radix Angelicae Sinensis 30
6 Radix Ophiopogonis 60 of Radix Notoginseng 25 Folium Artemisiae Argyis (charcoal)
Radix Codonopsis 40 Herba Leonuris 180
Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, the Folium Artemisiae Argyi powder of getting Radix Paeoniae Alba 80g and recipe quantity are broken into 80 purpose fine powders, sieve mixing.The Radix Ophiopogonis of all the other Radix Paeoniae Albas and recipe quantity, Radix Codonopsis, Herba Leonuri add 16 times of amounts of water and decoct 3 times, and each 1.0 hours, collecting decoction, filter, relative density was 1.35 thick paste when filtrate was concentrated into 25 ℃, added above-mentioned powder, mix homogeneously is the direct material for preparing soft capsule, dispersible tablet.
Embodiment 2: the preparation of the medicinal substances extract that preparation FUKANGNING soft capsule, dispersible tablet are used:
Medical material component weight proportion:
The Radix Paeoniae Alba 180 Rhizoma Cyperis 25 Radix Angelicae Sinensis 20
2 Radix Ophiopogonis 40 of Radix Notoginseng 15 Folium Artemisiae Argyis (charcoal)
Radix Codonopsis 20 Herba Leonuris 120
Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, the Folium Artemisiae Argyi powder of getting Radix Paeoniae Alba 80g and recipe quantity are broken into the above micropowder of 300 orders, sieve mixing.Radix Ophiopogonis, Radix Codonopsis, the Herba Leonuri of getting the Radix Paeoniae Alba and recipe quantity add 8 times of amounts of water and decoct 2 times, and each 2.5 hours collecting decoctions filter, relative density was 1.05～1.35 thick paste when filtrate was concentrated into 25 ℃, add above-mentioned powder, mix homogeneously is the direct material for preparing soft capsule, dispersible tablet.
Embodiment 3: the preparation of the medicinal substances extract that preparation FUKANGNING soft capsule, dispersible tablet are used:
Medical material component weight proportion:
The Radix Paeoniae Alba 200 Rhizoma Cyperis 30 Radix Angelicae Sinensis 25
4 Radix Ophiopogonis 50 of Radix Notoginseng 20 Folium Artemisiae Argyis (charcoal)
Radix Codonopsis 30 Herba Leonuris 150
Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, the Folium Artemisiae Argyi powder of getting Radix Paeoniae Alba 80g and recipe quantity are broken into 100 purpose fine powders, sieve mixing.The Radix Ophiopogonis of all the other Radix Paeoniae Albas and recipe quantity, Radix Codonopsis, Herba Leonuri add 12 times of amounts of water and decoct 2 times, and each 1.5 hours, collecting decoction, filter, relative density was 1.25 thick paste when filtrate was concentrated into 25 ℃, added above-mentioned powder, mix homogeneously is the direct material for preparing soft capsule, dispersible tablet.
Embodiment 4: the preparation of the medicinal substances extract that preparation FUKANGNING soft capsule, dispersible tablet are used:
Radix Ophiopogonis, Radix Angelicae Sinensis, the Rhizoma Cyperi of getting recipe quantity add 75% alcohol heating reflux of 9 times of amounts, reclaim ethanol, concentrating under reduced pressure gets the alcohol extraction dry extract, the Radix Paeoniae Alba, Radix Codonopsis, the Herba Leonuri of Radix Angelicae Sinensis, Rhizoma Cyperi medicinal residues and recipe quantity add 9 times of amounts of water and decoct 2 times with Radix Ophiopogonis, each 1.5 hours collecting decoctions filter, and relative density was 1.25 thick paste when filtrate was concentrated into 25 ℃, adding is crushed to 100 purpose Radix Notoginseng, Folium Artemisiae Argyi (charcoal) fine powder, promptly gets the direct material for preparing soft capsule, dispersible tablet.
Embodiment 5: the FUKANGNING preparation of soft capsule
Medical material component weight proportion:
Radix Paeoniae Alba 200g Rhizoma Cyperi 30g Radix Angelicae Sinensis 25g
Radix Notoginseng 20g Folium Artemisiae Argyi (charcoal) 4g 50g Radix Ophiopogonis
Radix Codonopsis 30g Herba Leonuri 150g
Ratio of adjuvant: suspending agent Cera Flava 3g;
Disperse medium olive oil 80g;
Antiseptic methyl parahydroxybenzoate 0.1g
Emulsifying agent soybean lecithin 15g;
Step 1: the material of getting it filled, by embodiment 1 or 2 or 3 or 4 medicinal substances extracts that make.
Step 2: get the medicinal substances extract fine powder of step 1, miscible in being preheated to 60 ℃ of disperse medium olive oil with the Cera Flava of above-mentioned share; Soybean lecithin, the methyl parahydroxybenzoate of getting above-mentioned share add in the said mixture, stir, and add above-mentioned medicinal substances extract fine powder, stir, and grind homogenizing, make 500 FUKANGNING soft capsules.
The disperse medium of making soft capsule is the oiliness disperse medium; as: olive oil or other crude vegetals; or triglyceride oils; or oleic acid sorbitol ester; or olein: propylene glycol is 90: 10 mixture by weight; or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters; or Oleum Cocois C8/C10 propylene glycol ester; or the Oleum Cocois triglyceride, or the acetylizad monoglyceride of purification, or olein; or glyceryl linoleate; or Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more
Or the water solublity disperse medium, as PEG400 or Polyethylene Glycol 500 or Macrogol 600 or isopropyl alcohol or glycerol or propylene glycol and water one or more, the best oiliness disperse medium that uses.
The suspending agent of making soft capsule is: can increase the solid matter of disperse medium viscosity, as Cera Flava or aluminum monostearate or ethyl cellulose etc.; The preferred Cera Flava that uses: 50: 25 mixture of second class cellulose.
Its described antiseptic of making soft capsule is: one or more in glycerol or propylene glycol or methyl parahydroxybenzoate or ethylparaben or propyl p-hydroxybenzoate or butyl p-hydroxybenzoate or benzyl p-hydroxybenzoate or the P-hydroxybenzoic acid phenyl ester, or best ethylparaben.
Embodiment 6: the FUKANGNING preparation of soft capsule
Medical material component weight proportion:
Radix Paeoniae Alba 200g Rhizoma Cyperi 30g Radix Angelicae Sinensis 25g
Radix Notoginseng 20g Folium Artemisiae Argyi (charcoal) 4g 50g Radix Ophiopogonis
Radix Codonopsis 30g Herba Leonuri 150g
Adjuvant:
Suspending agent Cera Flava: Ka Baibo resin 21g;
Disperse medium olive oil 210g;
Antiseptic ethylparaben 3g;
Emulsifying agent soybean lecithin 12g;
Capsule material: gelatin: arabic gum: glycerol: syrup: distilled water=1: 0.23: 0.75: 0.12: 1.45.
Step 1: the material of getting it filled, by embodiment 1 or 2 or 3 medicinal substances extracts that make.
Step 2: get the medicinal substances extract fine powder of step 1, miscible in being preheated to 60 ℃ of disperse medium olive oil with the Cera Flava of above-mentioned share; Soybean lecithin, the ethylparaben of getting above-mentioned share add in the said mixture, stir, and add above-mentioned medicinal substances extract fine powder, stir, and grind homogenizing, make 500 FUKANGNING soft capsules.
Embodiment 7: the FUKANGNING preparation of soft capsule
Medical material component weight proportion:
Radix Paeoniae Alba 200g Rhizoma Cyperi 30g Radix Angelicae Sinensis 25g
Radix Notoginseng 20g Folium Artemisiae Argyi (charcoal) 4g 50g Radix Ophiopogonis
Radix Codonopsis 30g Herba Leonuri 150g
Ratio of adjuvant:
Suspending agent Cera Flava 50g
Disperse medium glyceryl linoleate 300g;
Antiseptic, co-emulsifier propylene glycol 3g;
Emulsifying agent soybean lecithin 40g;
Step 1: the medicinal substances extract that obtains by embodiment 1 or embodiment 2 or embodiment 3 or embodiment 4 technologies one step 4;
Step 2: get the medicinal substances extract fine powder of step 1, miscible in being preheated to 60 ℃ of disperse medium glyceryl linoleates with the Cera Flava of above-mentioned share; Soybean lecithin, the propylene glycol of getting above-mentioned share add in the said mixture, stir, and add above-mentioned medicinal substances extract fine powder, stir, and grind homogenizing, make 500 FUKANGNING soft capsules.
Embodiment 8: the preparation of FUKANGNING dispersible tablet
The component weight proportion:
Radix Paeoniae Alba 200g Rhizoma Cyperi 30g Radix Angelicae Sinensis 25g
Radix Notoginseng 20g Folium Artemisiae Argyi (charcoal) 4g 50g Radix Ophiopogonis
Radix Codonopsis 30g Herba Leonuri 150g
Filler: pregelatinized Starch 20g;
Disintegrating agent: crospolyvinylpyrrolidone 10g;
Lubricant: magnesium stearate 1g;
Binding agent: starch slurry is an amount of.
Step 1: the material of getting it filled, the medicinal substances extract that makes by embodiment 3.
Step 2: get the said extracted thing, add filler and part disintegrating agent mix homogeneously, granulate drying with the wetting agent moistening, granulate adds remaining residue disintegrating agent and lubricant, mix homogeneously, and tabletting promptly gets dispersible tablet, or coating behind the tabletting, promptly get coated dispersing tablet, promptly get the FUKANGNING dispersible tablet.
The range of choice that is fit to the adjuvant of FUKANGNING dispersible tablet is:
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone, or be preferably 50% alcoholic solution of 6%～9% polyvinylpyrrolidone.
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.
Embodiment 9: the preparation of FUKANGNING dispersible tablet
The component weight proportion:
Radix Paeoniae Alba 200g Rhizoma Cyperi 30g Radix Angelicae Sinensis 25g
Radix Notoginseng 20g Folium Artemisiae Argyi (charcoal) 4g 50g Radix Ophiopogonis
Radix Codonopsis 30g Herba Leonuri 150g
Filler: pregelatinized Starch 200g and lactose 150g 350g;
Disintegrating agent: cross-linked carboxymethyl cellulose sodium 60g;
Lubricant: micropowder silica gel 5g;
Binding agent: 65% alcoholic solution is an amount of.
Step 1: the material of getting it filled, the medicinal substances extract that makes by embodiment 3.
Step 2: get the said extracted thing, add filler and part disintegrating agent mix homogeneously, granulate drying, granulate with the wetting agent moistening, add remaining residue disintegrating agent and lubricant, mix homogeneously, tabletting promptly gets dispersible tablet, or coating behind the tabletting, promptly get coated dispersing tablet, make 1000 FUKANGNING dispersible tablets.
Embodiment 10: the preparation of FUKANGNING dispersible tablet
The component weight proportion:
The Radix Paeoniae Alba 200 Rhizoma Cyperis 30 Radix Angelicae Sinensis 25
4 Radix Ophiopogonis 50 of Radix Notoginseng 20 Folium Artemisiae Argyis (charcoal)
Radix Codonopsis 30 Herba Leonuris 150
Filler: pregelatinized Starch 150g and lactose 60g 210g;
Disintegrating agent: carboxymethyl starch sodium, 20g;
Lubricant: Pulvis Talci, 3g;
Correctives: xylitol: 5g;
Binding agent: 50% alcoholic solution of 4.5% polyvinylpyrrolidone
Step 1: the material of getting it filled, the medicinal substances extract that makes by embodiment 3.
Step 2: get the said extracted thing, add filler and part disintegrating agent mix homogeneously, granulate drying, granulate with the wetting agent moistening, add remaining residue disintegrating agent and lubricant, mix homogeneously, tabletting promptly gets dispersible tablet, or coating behind the tabletting, promptly get coated dispersing tablet, make 1000 FUKANGNING dispersible tablets.
Embodiment 11: the preparation of FUKANGNING dispersible tablet
The component weight proportion:
Radix Paeoniae Alba 200g Rhizoma Cyperi 30g Radix Angelicae Sinensis 25g
Radix Notoginseng 20g Folium Artemisiae Argyi (charcoal) 4g 50g Radix Ophiopogonis
Radix Codonopsis 30g Herba Leonuri 150g
Filler: starch 132g and pregelatinized Starch 88g;
Disintegrating agent: carboxymethyl starch sodium: the mixture of crospolyvinylpyrrolidone (1.5: 4.5); 20g;
Lubricant: micropowder silica gel 3g;
Binding agent is: 70% alcoholic solution of 3.5% polyvinylpyrrolidone, and an amount of.
Step 1: the material of getting it filled, the medicinal substances extract that makes by embodiment 3.
Step 2: get the said extracted thing, add filler and part disintegrating agent mix homogeneously, granulate drying, granulate with the wetting agent moistening, add remaining residue disintegrating agent and lubricant, mix homogeneously, tabletting promptly gets dispersible tablet, or coating behind the tabletting, promptly get coated dispersing tablet, make 1000 FUKANGNING dispersible tablets.
Claims (9)
1, a kind of gynecological Chinese medicine compound preparation that improves bioavailability and drug effect is characterized in that: used medical material join for:
The Radix Paeoniae Alba 180～220g Rhizoma Cyperi 25～35g Radix Angelicae Sinensis 20～30g
Radix Notoginseng 15～25g Folium Artemisiae Argyi (charcoal) 2～6g 40～60g Radix Ophiopogonis
Radix Codonopsis 20～40g Herba Leonuri 120～180g
The medicinal substances extract of above-mentioned component cooperates pharmaceutically alleged adjuvant that adopts suitable kind or soft capsule or the dispersible tablet that substrate is made; As making soft capsule with disperse medium, suspending agent, antiseptic; Or make dispersible tablet with filler, disintegrating agent, wetting agent, lubricant.
2, a kind of gynecological Chinese medicine compound preparation that improves bioavailability and drug effect according to claim 1, it is characterized in that: the best proportioning of its used medical material is:
Radix Paeoniae Alba 200g Rhizoma Cyperi 30g Radix Angelicae Sinensis 25g
Radix Notoginseng 20g Folium Artemisiae Argyi (charcoal) 4g 50g Radix Ophiopogonis
Radix Codonopsis 30g Herba Leonuri 150g
With filler (20～350g), disintegrating agent (10～60g), (1～5g) makes dispersible tablet to lubricant; Or with disperse medium (80～300g), suspending agent (3～50g), (0.1～3g) makes soft capsule to antiseptic.
3, according to claim 1 or 2 described a kind of preparation methoies that improve the gynecological Chinese medicine compound preparation of bioavailability and drug effect, it is characterized in that: its preparation process is as follows:
1) preparation medicinal substances extract:
Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, the Folium Artemisiae Argyi pulverize separately of getting Radix Paeoniae Alba 80g and recipe quantity become micropowder, sieve mixing.The Radix Ophiopogonis of all the other Radix Paeoniae Albas and recipe quantity, Radix Codonopsis, Herba Leonuri add 8～16 times of amounts of water and decoct 2～3 times, and collecting decoction filters, relative density was 1.05～1.35 thick paste when filtrate was concentrated into 25 ℃, add above-mentioned powder, mix homogeneously is the medicinal substances extract for preparing soft capsule, dispersible tablet;
2) preparation soft capsule or dispersible tablet
Preparation dispersible tablet: get the said extracted thing, add filler and part disintegrating agent mix homogeneously, granulate drying with the wetting agent moistening, granulate adds remaining residue disintegrating agent and lubricant, mix homogeneously, tabletting, promptly get dispersible tablet, or coating behind the tabletting, coated dispersing tablet promptly got; Or
Preparation soft capsule: get the medicinal substances extract of above-mentioned preparation soft capsule, add one or more of suspending agent disperse medium, antiseptic etc., stir, grind homogenizing, promptly get soft capsule content, drip system or be pressed into soft capsule.
4; according to claim 1 or 2 or 3 described a kind of gynecological Chinese medicine compound preparations that improve bioavailability and drug effect; it is characterized in that the disperse medium of making soft capsule is: olive oil or other crude vegetals; or triglyceride oils; or oleic acid sorbitol ester; or olein: propylene glycol is 90: 10 mixture by weight; or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters; or Oleum Cocois C8/C10 propylene glycol ester; or Oleum Cocois triglyceride; or the acetylizad monoglyceride of purification, or olein, or glyceryl linoleate; or Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more.
5, a kind of gynecological Chinese medicine compound preparation that improves bioavailability and drug effect according to claim 1 and 2, it is characterized in that: the suspending agent of making soft capsule is: can increase the solid matter of disperse medium viscosity, as Cera Flava or aluminum monostearate or ethyl cellulose etc. one or both;
6, its described antiseptic of making soft capsule is: one or more in glycerol or propylene glycol or methyl parahydroxybenzoate or ethylparaben or propyl p-hydroxybenzoate or butyl p-hydroxybenzoate or benzyl p-hydroxybenzoate or the P-hydroxybenzoic acid phenyl ester, or best ethylparaben.
7 a kind of gynecological Chinese medicine compound preparations that improve bioavailability and drug effect according to claim 3, its disperse medium is: olive oil; Its suspending agent is a Cera Flava: 6: 1 mixture of Ka Baibo resin (Carbopol resin); The uniform film of thickness is made with dissolvings such as gelatin and glycerol, distilled water by the capsule material of its soft capsule system; The capsule material prescription that is fit to this preparation can be: gelatin: arabic gum: glycerol: syrup: distilled water=1: 0.23: 0.75: 0.12: 1.45.
8, a kind of gynecological Chinese medicine compound preparation preparation method that improves bioavailability and drug effect according to claim 3, it is characterized in that: its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone.
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.
9, a kind of gynecological Chinese medicine compound preparation preparation method that improves bioavailability and drug effect according to claim 8, it is characterized in that: its The disintegrating agents of dispersible tablets is: carboxymethyl starch sodium: the mixture of crospolyvinylpyrrolidone (1.5: 4.5); Binding agent is: 70% alcoholic solution of 3.5% polyvinylpyrrolidone; Filler is: starch: precoking starch (3: 2); Lubricant in the dispersible tablet is: micropowder silica gel.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100774047A CN100370969C (en) | 2004-12-20 | 2004-12-20 | Chinese materia medica preparation for treating dysmenorrhea of women |
Applications Claiming Priority (1)
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| CNB2004100774047A CN100370969C (en) | 2004-12-20 | 2004-12-20 | Chinese materia medica preparation for treating dysmenorrhea of women |
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| CN1660250A true CN1660250A (en) | 2005-08-31 |
| CN100370969C CN100370969C (en) | 2008-02-27 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102397461A (en) * | 2011-11-27 | 2012-04-04 | 苏州派腾生物医药科技有限公司 | Preparation method of tablet for treating gynecological diseases |
| CN109419847A (en) * | 2017-09-03 | 2019-03-05 | 大德仟年生物技术有限公司 | A kind of fresh leonurus Radix Notoginseng Chinese medicine composition and preparation method thereof |
| CN111228452A (en) * | 2020-03-21 | 2020-06-05 | 武汉天天健康生物工程有限公司 | Health-preserving health-care foot bath bag and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1091308A (en) * | 1993-02-22 | 1994-08-31 | 高景树 | A kind of " Fukangling " medicine for treatment of gynecopathy for the treatment of common gynecological disease and preparation method thereof |
| CN1522728A (en) * | 2003-02-18 | 2004-08-25 | 毛友昌 | Female health granule preparation method |
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2004
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102397461A (en) * | 2011-11-27 | 2012-04-04 | 苏州派腾生物医药科技有限公司 | Preparation method of tablet for treating gynecological diseases |
| CN102397461B (en) * | 2011-11-27 | 2013-03-20 | 苏州派腾生物医药科技有限公司 | Preparation method of tablet for women's health and tranquilness |
| CN109419847A (en) * | 2017-09-03 | 2019-03-05 | 大德仟年生物技术有限公司 | A kind of fresh leonurus Radix Notoginseng Chinese medicine composition and preparation method thereof |
| CN111228452A (en) * | 2020-03-21 | 2020-06-05 | 武汉天天健康生物工程有限公司 | Health-preserving health-care foot bath bag and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100370969C (en) | 2008-02-27 |
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