CN101244187B - Suppository for treating gynaecologic disease - Google Patents
Suppository for treating gynaecologic disease Download PDFInfo
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- CN101244187B CN101244187B CN2008100580815A CN200810058081A CN101244187B CN 101244187 B CN101244187 B CN 101244187B CN 2008100580815 A CN2008100580815 A CN 2008100580815A CN 200810058081 A CN200810058081 A CN 200810058081A CN 101244187 B CN101244187 B CN 101244187B
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Abstract
The invention relates to a herbal drug for gynecologic diseases with natural plants, in particular to a pharmaceutical preparation with specific formulation, comprising certain amount of active pharmaceutical ingredient, certain amount of penetration enhancer and certain amount of pharmacyeutical adjuvant with the following weight proportion. The active pharmaceutical ingredient comprises one hundred and fifty shares of bidens tripartita, one hundred shares of smilax glabra, one hundred and fifty shares of paris, one hundred shares of phellodendron bark, one hundred shares of lightyellow sophora root, ninety-five shares of attractylodes, one hundred shares of common cnidium fruit, one hundred shares of Szechwan lovage rhizome, thirty shares of periostracum cicada, fifty shares of gleditsia spine, five shares of menthol, and twenty shares of zanthoxylum. The penetration enhancer comprises a certain amount of laurocapram and a certain amount of propanediol with the weight proportion of eighty to fifteen - thirty; the adding amount of the penetration enhancer is point zero eight to point four percent of the weight of the active pharmaceutical ingredient. The herbal drug has the advantage of being more effecient than oral drugs and external lotion due to full play of effective ingredients in specific formulation by organically combining specific penetration enhancer and the effective ingredient.
Description
Technical field
The present invention relates to a kind of is the pharmaceutical preparation of the medicine that is used for gynaecopathia, the especially particular dosage form of medicinal component with the natural plants.
Background technology
Episioitis is the common frequently-occurring disease of gynecological clinic, and simple western modern medicine treatment has bigger side effect (dysbacteriosis, allergy, drug resistance, xerosis cutis keratinization etc.).In recent years, Chinese medicine preparation is very popular on the world, domestic market, and consumption rises year by year, and for making full use of abundant herb resource, the utilization modern scientific method is developed new gynecological's preparation, further to satisfy the demand of clinical treatment.
Chinese patent application 200310116636.4 discloses a kind of " external-use lotion of gynaecopathia and the preparation method of this lotion ", and this invents described lotion is the medicament of being made by the following weight proportion raw material: Herba Bidentis Tripartitae 80-250, Rhizoma Smilacis Glabrae 50-150, Rhizoma Paridis 80-250, Cortex Phellodendri 50-150, Radix Sophorae Flavescentis 50-150, Rhizoma Atractylodis 50-150, Fructus Cnidii 50-150, Cortex Dictamni 50-150, Periostracum Cicadae 10-100, Spina Gleditsiae 10-150, Mentholum 1-20, Pericarpium Zanthoxyli 10-100, Radix Arnebiae (Radix Lithospermi) 50-250.This invents the treatment that described medicine is mainly used in gynaecopathia, is applicable to fumigation in treating.This application is disclosed to be a kind of lotion that is used for mucosa, well-known, and lotion is applicable to fumigation in treating, because wash time is of short duration, causes time that medicament contacts with mucosa seldom, and medicine can not play a role fully.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of suppository that can give full play to the treatment gynaecopathia of drug action is provided.
The suppository of treatment gynaecopathia of the present invention is the suppository of being made by following raw materials by weight proportions, penetrating agent and pharmaceutic adjuvant, and described crude drug is 150 parts of Herba Bidentis Tripartitaes, 100 parts of Rhizoma Smilacis Glabraes, 150 parts of Rhizoma Paridis, 100 parts of Cortex Phellodendris, 100 parts of Radix Sophorae Flavescentiss, 95 parts of Rhizoma Atractylodis, 100 parts of Fructus Cnidiis, 100 parts of Cortex Dictamnis, 30 parts of Periostracum Cicadaes, 50 parts of Spina Gleditsiaes, 5 parts of Mentholums, 20 parts in Pericarpium Zanthoxyli; Described penetrating agent is made up of laurocapram and propylene glycol, and its weight proportion is 80: 15-30, its addition is the 0.08-0.4% of crude drug weight.
Described pharmaceutic adjuvant is No. 36, mixing-in fat acid glyceride.
The design of prescription of the present invention is to combine with clinical practice according to medication experience among the people, aims at gynecological's pudendum illness and establishes, and Herba Bidentis Tripartitae has another name called three and splits Herba Bidentis Bipinnatae in the side, function heat-clearing and toxic substances removing, dissipating blood stasis for subsidence of swelling, and it is rather good that the skin infection effect is controlled in external; Skin or mucosa skin infection that Rhizoma Smilacis Glabrae energy blood-cleaning detoxifying, dampness removing are dispelled heat, be can be used for the carbuncle skin infection or show effect repeatedly are with the compatible effect of receiving Synergistic of Herba Bidentis Bipinnatae, so the two is all it " monarch drug " among the we.Rhizoma Paridis energy heat-clearing and toxic substances removing, mass dissipating and swelling eliminating; Skin ulcer is treated in the detoxifcation of Cortex Phellodendri clearing away heat-fire, dampness, and kind to control the foul Huang of women's damp-heat vaginal discharge thick, 5 practises titles " two is wonderful " (Dan Xi side) and controls damp and hot good especially mutually with the Rhizoma Atractylodis of dispeiling pathogenic wind and removing dampness; But Radix Sophorae Flavescentis heat clearing away, dampness, dispel the wind, parasite killing, antipruritic, can control the disease of damp and hot sore or damp invasion of lower energizer; Fructus Cnidii dampness, parasite killing, dispelling wind for relieving itching, the kind pruritus due to damp pathogen of controlling all diseases of cysthus; The Cortex Dictamni bitter cold, can heat clearing and damp drying dispelling wind for relieving itching, kindly control damp and hot sore skin pruritus, with Radix Sophorae Flavescentis, Fructus Cnidii, two wonderful mutual compatibilities control the damp and hot skin infection of woman's pudendum and pruritus imitate good, so be all it " ministerial drug " among the we.It is stronger that Spina Gleditsiae is attacked diffusing power, the merit that the subduing swelling and detoxicating evacuation of pus is arranged, all swollen ulcer drugs be disappearing of using of the person of one-tenth, can bursting of executing of one-tenth person, and the wind dispelling insecticide effect is arranged, be the product that external treatment with Chinese medicine is commonly used, with assist " adjuvant drug " in the antipruritic Periostracum Cicadae side of being all of wind-dispelling heat-dissipating, rash; But Fructus Zanthoxyli cold expelling, dampness, expelling insect and relieving itching; The hot cool heat radiation of Mentholum is warded off dirty antipruriticly, and the two is altogether in the side it " messenger drug ".Behind the common compatibility of above Chinese medicine, can gather heat-clearing and toxic substances removing, damp eliminating removes wind, and killing parasites for relieving itching has better effect.Other has laurocapram and propylene glycol coordination compound, can increase medicinal component and better absorb.Especially, when laurocapram and propylene glycol coordination compound ratio when being aforementioned, its transdermal penetration rate can improve 46% (skin), 52% (mucosa) on other ratio basis.After being developed into suppository, enlarged the drug effect position, the fat-soluble substrate of suppository makes drug release steadily quicken.Simultaneously, the suppository consumption is accurate, and is easy to carry.
The suppository of this preparation medicine cooperates with suitable substrate, and the effect of suppository administration comprises two aspects: one suppository plays local action in tract, and the medicine in its two suppository enters blood and brings into play general action via the tract absorption.Local action: be mainly lubricated, antibiotic, antiinflammatory, convergence, antipruritic, pain relieving etc.Medicine directly can be sent to disease institute because of it, so evident in efficacy, side effect is little.General action: suppository still can be brought into play the whole body therapeutic effect except bringing into play the local action.Suppository is used for whole body therapeutic and has following advantage: (1) medicine per rectum absorbs, and can avoid the destruction of the liver " first pass effect " that oral drugs subject to; (2) interference factor of rectum absorption lacks than oral administration; (3) medicine can be avoided losing activity because of the effect that is subjected to gastrointestinal tract PH environment or digestive enzyme; (4) gastric mucosa medicine excitatory is used instead can be made behind the suppository stomach avoid stimulating; (5) to the patient of can not or be reluctant to swallow sheet, ball, capsule, the suppository administration alternative route preferably of can yet be regarded as; (6) medicine per rectum absorptance oral absorption has bigger bioavailability.
The present invention organically combines with specific penetrating agent and active ingredient in special formulation, under the support of particular dosage form, makes active ingredient give full play to drug action, and its effect is better than oral drugs and external-use lotion greatly.The described dosage form of the application still helps drug distribution and penetrates within the pleat of mucosa, is particularly useful for treating the preparation of gynaecopathia vaginal suppository.In local application of gynecological, have disintegration rate fast, rapid-action, absorb and fully, not hinder characteristics such as mucosa, clean hygiene, storage be easy, overcome other preparation weak point.
Medicine of the present invention is mainly used in the treatment of gynaecopathia, and drug price of the present invention is cheap, and determined curative effect is rendered on the market, and the good social economic benefit is not only arranged, and also can be the abundant herb resource contribution society of exploitation simultaneously.
Pharmacodynamics test of the present invention:
One, the antiinflammatory action of this preparation
1, experiment material
1.1 medicine: this preparation; JIEERYIN: Chinese-foreign joint Chengdu grace prestige generation is enjoyed pharmaceutical Co. Ltd and is produced; Dimethylbenzene: Beijing Hua Wuchang produces.
1.2 animal: Kunming kind rabbit is provided by animal section of unming Medical College.
2, experimental technique
Get 38 of healthy male kind of rabbits, body weight 700-800g is divided into 3 groups at random: normal saline group, JIEERYIN group, this preparation group.
With dimethylbenzene 0.03ml/ only, the two sides causes inflammation before and after being applied to kind of rabbit auris dextra shell, the auris dextra shell is coated with respectively with normal saline, JIEERYIN and this preparation (3ml/kg) again after 30 minutes, took off cervical vertebra and put to death two auricles about every Mus is cut after 2 hours, take off two auricles with diameter 7mm card punch at ears symmetry place, weigh with analytical balance, deducting left auricle with the auris dextra sheet heavily is auris dextra swelling severe, and calculates inhibitory rate of intumesce respectively, each medicine group and matched group relatively the results are shown in following table:
| Dosage ml/kg | Number of animals (only) | Inflammation swelling degree (X ± SD) (mg) | The P value | Suppression ratio (%) | |
| Normal saline | 3 | 12 | 7.5±3.7 | ||
| JIEERYIN | 3 | 12 | 4.8±2.5 | ＜0.05 | 36 |
| This preparation | 3 | 14 | 4.2±1.5 | ＜0.05 | 44 |
3, experimental result
This preparation group, positive drug JIEERYIN matched group, xylol lead to kind of a rabbit ease auricle swelling that obvious inhibitory action is arranged, and with the matched group comparing difference significance (P＜0.05) are arranged.
Two, the bacteriostasis of this preparation experiment
(1) medicine
Sample: this preparation No. 1, No. 2, No. 3, No. 4, No. 5, JIEERYIN (contrast is used).Above medicine is all made bacteriostatic experiment with original content.
(2) experimental strain
Totally five kinds of the staphylococcus aureus of gonococcus niikita bacteria strain P-528-1 and the preservation of this teaching and research room, colibacillus, Candida albicans, microsporon gypseum.
(3) experimental technique
Adopt cup-plate method, paper disk method carries out simultaneously.Be about to the intensive streak inoculation of above-mentioned five kinds of antibacterials difference to corresponding plating medium, on each culture plate, put two aseptic steel Oxford cups then, add said medicine suspension 0.2ml respectively and use the scraps of paper (standby behind the diameter 6mm autoclaving) to soak into same concentration liquid simultaneously to be affixed on the flat board in the cup of Oxford, antibacterial culturing is put 37 ℃ of 24-48 hour observed results; Fungal culture is put 25 ℃ of one all observed result.
(4) result
Measure the Oxford cup and scraps of paper medicine bacteriostatic diameter (mm) on every side, the results are shown in subordinate list.
(5) conclusion
Through the discriminatory analysis of experimental result, this preparation 1-5 sample is similar to the reference substance JIEERYIN to the effect of common microsporon gypseum and Candida albicans.The bacteriostasis of gonococcus, staphylococcus aureus, colibacillus except that No. 2 samples, all is better than JIEERYIN.
Three, the comparison of the release rate of lotion and suppository and action time
1, experiment material
1.1 medicine: this suppository; 200310116636.4 the washing liquid of application: Yunnan Mingyang Pharmaceutical Co., Ltd. produces.
2, experimental technique
Adopt the zoopery of mice mucosa, measure the adhesion drug level by 0.5min, 1min, 1.5min, 2min, 8min, 10min, 15min, 20min, 30min, 40min, 50min respectively.
The results are shown in Figure 1.
3, experimental result
Lotion: act on vagina and mucosa, active drug concentration and time are short.(with the dipping bath time correlation, by ten minutes).
Suppository: sustainable vagina and the mucosa of acting on of medicine, the utilization ratio of drug height can reach more than 120 minutes the raising that utilization ratio of drug improves action time.
The clinical trial observation of curative effect:
1, experiment material
1.1 medicine: this preparation suppository: Yunnan Mingyang Pharmaceutical Co., Ltd. provides; 200310116636.4 the application lotion: Yunnan Mingyang Pharmaceutical Co., Ltd. provides.
2, experimental technique:
Get this preparation suppository (1.61g/ grain), directly fill in the affected part, every day secondary, continuous seven days is a course of treatment.
The contrast medication: this preparation lotion, get 20ml at every turn, use by the usage of this medicine operation instruction, continuous seven days is a course of treatment.The results are shown in following table:
The comparison of suppository and lotion
| Medicine | The example number | Clinic control | Basic controlling | Effectively | Invalid | Total effective rate (%) |
| This suppository | 30 | 2(6.6) | 6(20) | 20(66.7) | 2(6.6) | 93.4 |
| 200310116636.4 |
30 | 1(3.3) | 4(13.3) | 19(63.3) | 6(20) | 80 |
3, result:
Through experimental observation, the suppository group total effective rate of this preparation is that the lotion group total effective rate of 93.4%, 200310116636.4 application is 80%.
Description of drawings
Fig. 1 is the release rate of pharmaceutical preparation of the present invention and the graph of a relation of action time.
The specific embodiment
Claims (2)
1. suppository for the treatment of gynaecopathia, it is characterized in that it being the suppository of being made by following raw materials by weight proportions, penetrating agent and pharmaceutic adjuvant, described crude drug is 150 parts of Herba Bidentis Tripartitaes, 100 parts of Rhizoma Smilacis Glabraes, 150 parts of Rhizoma Paridis, 100 parts of Cortex Phellodendris, 100 parts of Radix Sophorae Flavescentiss, 95 parts of Rhizoma Atractylodis, 100 parts of Fructus Cnidiis, 100 parts of Cortex Dictamnis, 30 parts of Periostracum Cicadaes, 50 parts of Spina Gleditsiaes, 5 parts of Mentholums, 20 parts in Pericarpium Zanthoxyli; Described penetrating agent is made up of laurocapram and propylene glycol, and its weight proportion is 80: 15-30, its addition is the 0.08-0.4% of crude drug weight.
2. the suppository of treatment gynaecopathia as claimed in claim 1 is characterized in that described penetrating agent is made up of laurocapram and propylene glycol, and its weight proportion is 80: 20.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100580815A CN101244187B (en) | 2008-02-02 | 2008-02-02 | Suppository for treating gynaecologic disease |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100580815A CN101244187B (en) | 2008-02-02 | 2008-02-02 | Suppository for treating gynaecologic disease |
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| Publication Number | Publication Date |
|---|---|
| CN101244187A CN101244187A (en) | 2008-08-20 |
| CN101244187B true CN101244187B (en) | 2010-06-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2008100580815A Active CN101244187B (en) | 2008-02-02 | 2008-02-02 | Suppository for treating gynaecologic disease |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101856475B (en) * | 2010-06-28 | 2011-07-20 | 蔡伦 | Chinese medicinal composition for treating gynecological inflammation and preparation method thereof |
| CN102793828B (en) * | 2012-08-09 | 2014-04-16 | 西安太极药业有限公司 | Externally-used washing lotion for treating female vulvitis and colpitis and preparation method thereof |
| CN104274666A (en) * | 2014-10-11 | 2015-01-14 | 中山百鸥医药科技有限公司 | Effervescent tablet for treating gynecological diseases |
| CN104274665A (en) * | 2014-10-11 | 2015-01-14 | 中山百鸥医药科技有限公司 | Suppository used for treating gynecological diseases |
| CN107349421A (en) * | 2017-06-22 | 2017-11-17 | 杨利国 | A kind of biological complex enzyme composition lotion and its application |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1218682A (en) * | 1998-10-12 | 1999-06-09 | 范永昌 | Bathing medicine for preventing and curing vulva disease |
| CN1546126A (en) * | 2003-11-28 | 2004-11-17 | 温先敏 | Externally applied medical lotion for treating gynecopathy and its preparing process |
| CN1679754A (en) * | 2005-01-20 | 2005-10-12 | 李木林 | Strong-effect external-applied preparation for treating multiple skin diseases |
| CN1943666A (en) * | 2005-10-08 | 2007-04-11 | 曾雄辉 | A Chinese/western compound medicine for treatment of and preventing women's colpitis |
| CN100998809A (en) * | 2006-12-28 | 2007-07-18 | 西安仁仁药业有限公司 | Chinese medicine external use lotion for treating woman reproduction system inflammation |
-
2008
- 2008-02-02 CN CN2008100580815A patent/CN101244187B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1218682A (en) * | 1998-10-12 | 1999-06-09 | 范永昌 | Bathing medicine for preventing and curing vulva disease |
| CN1546126A (en) * | 2003-11-28 | 2004-11-17 | 温先敏 | Externally applied medical lotion for treating gynecopathy and its preparing process |
| CN1679754A (en) * | 2005-01-20 | 2005-10-12 | 李木林 | Strong-effect external-applied preparation for treating multiple skin diseases |
| CN1943666A (en) * | 2005-10-08 | 2007-04-11 | 曾雄辉 | A Chinese/western compound medicine for treatment of and preventing women's colpitis |
| CN100998809A (en) * | 2006-12-28 | 2007-07-18 | 西安仁仁药业有限公司 | Chinese medicine external use lotion for treating woman reproduction system inflammation |
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| CN101244187A (en) | 2008-08-20 |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
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| C14 | Grant of patent or utility model | ||
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Assignee: Yunnan Mingyang Pharmaceutical Co., Ltd. Assignor: Wen Xianmin Contract record no.: 2011530000036 Denomination of invention: Suppository for treating gynecopathy and its preparation technology Granted publication date: 20100609 License type: Exclusive License Open date: 20080820 Record date: 20110628 |