CN102614192A - Medical composition for emergency contraception - Google Patents
Medical composition for emergency contraception Download PDFInfo
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- CN102614192A CN102614192A CN2011100329477A CN201110032947A CN102614192A CN 102614192 A CN102614192 A CN 102614192A CN 2011100329477 A CN2011100329477 A CN 2011100329477A CN 201110032947 A CN201110032947 A CN 201110032947A CN 102614192 A CN102614192 A CN 102614192A
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- hours
- emergency contraception
- mifepristone
- sexual intercourse
- contraception
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Abstract
The invention relates to a dosage regimen for emergency contraception and a medical composition for the dosage regimen. In the dosage regimen for emergency contraception existing in the prior art, a single dose of 10 mg of mifepristone is taken within 120 hours of sexual intercourse, especially within 72 hours, the contraceptive effect is not good. The dosage regimen for emergency contraception with good contraceptive effect provided by the invention is characterized in that 5 mg +/- 0.5 mg of mifepristone dose unit is taken within 120 hours of sexual intercourse, and 5 mg +/- 0.5 mg of mifepristone dose unit is taken again within 12 hours of sexual intercourse. The technical scheme of the invention can effectively prevent pregnant, and especially has better contraceptive effect of taking medicine within 72-120 hours than the single dose, and the side effect is little.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for emergency contraception.
Background technology
Mifepristone be phase early 1980s by the synthetic gestation of French Roussel ucalf company, only be used for antiearly pregnancy at first.It is through the blocking-up progesterone receptor, and the direct or indirect HPO-endometrium axle that acts on disturbs each stage of pregnant incidence and development, and it is also different in the mechanism of the different times effect of menstruation that mifepristone is used for emergency contraception.The preovulatory phase medication can suppress ovarian follicular growth and grow, suppress ovulation or prolong ovulation; Ovulation back medication mainly acts on endometrium, disturbs implantation of ovum.Ideal emergency contraception should be efficiently, have no side effect, and does not disturb menstrual cycle, and can act on each period of menstrual cycle.
Mifepristone is used for the clinical general dosage of emergency contraception from 600mg, is reduced to 25mg and 10mg gradually, disposable taking in 72 hours especially in 120 hours after sexual intercourse.Present clinical common method be after the sexual intercourse in 120 hours especially in 72 hours single give 25mg and 10mg mifepristone, but the contraceptive effect between 72 hours-120 hours is unsatisfactory.
" it is close that " take low dose mifepristone administration at twice and be used for emergency contraception " of 1999 the 10th phase Tan Kunlun of Chinese oligogenics journal etc. discloses the contraceptive rate that same drug dose single that method that 25mg and 50mg mifepristone take at twice is used for effective percentage and the domestic report of emergency contraception takes.
Summary of the invention
The object of the invention is to provide after a kind of sexual intercourse to take effective pharmaceutical composition in 120 hours.
The dosage regimen that realizes above-mentioned purpose is:
A kind of compositions that is used for emergency contraception, said composition comprise 2 dosage units, and each dosage unit comprises mifepristone and the pharmacy acceptable auxiliary of 5mg ± 0.5mg.
Also comprise in the compositions of the present invention and test pregnant reagent paper.
Compositions of the present invention is used for the emergency contraception of unprotect sexual life in 120 hours, is particularly useful for 72-120 hour unprotect sexual life.
Each dosage unit is a solid preparation, like tablet, capsule, granule, powder, drop pill, membrane etc.Wherein tablet and capsule are preferred dosage form.
The pharmacy acceptable auxiliary comprises excipient, diluent, disintegrating agent and lubricant etc.
Beneficial effect of the present invention is:
1, composition for contraception of the present invention is taken 2 dosage units that contain 5mg ± 0.5mg mifepristone in 120 hours after sexual intercourse, has increased contraceptive effect, can prevent the generation of gestation effectively.
2, pharmacy test and clinical trial all prove composition for contraception of the present invention after sexual intercourse in 72-120 hour at twice the contraceptive effect of administration obviously be superior to the contraceptive effect of single-dose, and side effect is little.
Pharmacodynamics test:
1, test method: get the sexual maturity rat; Adaptability is raised a week, in afternoon 5 male and female mate at 2: 1, second day morning, 8:00-9:00 carried out vaginal smear examination; See that like vagina internal medicine a large amount of sperms occur; Show the copulation success, copulation winner sub-cage rearing, and with being decided to be first day (d1) of gestation this day.The rat random packet that copulation is successful, respectively at d1, d2, d3, d4, d5 gastric infusion, wherein MF1 organizes single-dose; Dosage is 25mg/kg (the 10mg mifepristone that is equivalent to the phase human), twice administration of MF2 component, two minor tick 12h; Each dosage is 12.5mg/kg; Put to death animal in d12 days dislocation methods, dissect, inspection.
2, result of the test:
Pregnant Mus number, pregnancy rate (%), pregnant suppression ratio (%)
# compares P＜0.05 with the blank group, and * * compares P＜0.001 with the blank group
Can find out that from above result of the test the MF2 group all can effectively suppress gestation in 120 hours after sexual intercourse, and the MF2 group there is significance to improve than MF1 group inhibition pregnancy rate between 72-120 after the sexual intercourse hour.
Clinical trial:
1, subjects: the healthy women of child-bearing age, nearly 3 months menstruation fundamental rules, sexual life once in this menstrual cycle; Because of not taking contraceptives; Or the contraceptives failure, require emergency contraception person after the sexual intercourse in 120 hours voluntarily, instruct its back of taking medicine to use the barrier contraception to next menstrual onset.
2, test method: eligible, be divided into two groups at random, MF1 group single gives 10mg mifepristone capsule, and the MF2 component is taken for twice, each 5mg mifepristone capsule, 12 hours at interval, tracing object was to menstrual onset.
3, result of the test:
* compare P＜0.05 with the MF1 group
Above result of the test shows, the MF2 group equal 100% effectively suppresses gestation in 120 hours after sexual intercourse, and the MF2 group has significant difference than MF1 between 72-120 after the sexual intercourse hour.
According to patient's feedback, this clinical trial MF2 group is little to the influence of menstruation than the MF1 group, and side effect is little.
The specific embodiment
Embodiment 1: tablet
Prescription: mifepristone 5mg
Starch 25mg
Microcrystalline Cellulose 65mg
30 POVIDONE K 30 BP/USP 30 4mg
Purified water is an amount of
Magnesium stearate 0.5mg
Micropowder silica gel 0.5mg
Above formulation is become tablet, 2 mifepristone sheets are packaged into an independent packaging, also comprise in the independent packaging and test pregnant reagent paper.
Embodiment 2: capsule
Prescription: mifepristone 5mg
Lactose 100mg
Pregelatinized Starch 10mg
Microcrystalline Cellulose 20mg
Pulvis Talci 1mg
Magnesium stearate 1mg
Micropowder silica gel 1mg
Above formulation is become capsule, 2 mifepristone capsulations are become an independent packaging.
Claims (7)
1. compositions that is used for emergency contraception, it is characterized by: said composition comprises 2 dosage units, and each dosage unit comprises mifepristone and the pharmacy acceptable auxiliary of 5mg ± 0.5mg.
2. compositions according to claim 1 is characterized by: also comprise and test pregnant reagent paper.
3. compositions according to claim 1 and 2 is characterized by: dosage unit is a solid preparation.
4. compositions according to claim 3 is characterized by: dosage unit is tablet or capsule.
5. compositions according to claim 4 is characterized by: the pharmacy acceptable auxiliary comprises excipient, diluent, disintegrating agent and lubricant.
6. any described compositions of claim of claim 1-5 is used for the emergency contraception of unprotect sexual life in 120 hours.
7. any described compositions of claim of claim 1-5 is used for the emergency contraception of unprotect sexual life in 72-120 hour.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011100329477A CN102614192A (en) | 2011-01-31 | 2011-01-31 | Medical composition for emergency contraception |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011100329477A CN102614192A (en) | 2011-01-31 | 2011-01-31 | Medical composition for emergency contraception |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102614192A true CN102614192A (en) | 2012-08-01 |
Family
ID=46554644
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011100329477A Pending CN102614192A (en) | 2011-01-31 | 2011-01-31 | Medical composition for emergency contraception |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102614192A (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1125097A (en) * | 1994-12-23 | 1996-06-26 | 上海第一妇婴保健院 | Contraceptive medicine box |
| CN101455671A (en) * | 2009-01-08 | 2009-06-17 | 湖北葛店人福药业有限责任公司 | Mifepristone medicinal preparation and preparation method thereof |
-
2011
- 2011-01-31 CN CN2011100329477A patent/CN102614192A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1125097A (en) * | 1994-12-23 | 1996-06-26 | 上海第一妇婴保健院 | Contraceptive medicine box |
| CN101455671A (en) * | 2009-01-08 | 2009-06-17 | 湖北葛店人福药业有限责任公司 | Mifepristone medicinal preparation and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| 《中原医刊》 20050331 王希华等 米非司酮用于紧急避孕200例临床观察 第32卷, 第06期 * |
| 梁兢妮: "不同剂量米非司酮单次口服用于紧急避孕的研究", 《中国医药导报》, vol. 3, no. 15, 31 May 2006 (2006-05-31) * |
| 王希华等: "米非司酮用于紧急避孕200例临床观察", 《中原医刊》, vol. 32, no. 06, 31 March 2005 (2005-03-31) * |
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| C53 | Correction of patent of invention or patent application | ||
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Address after: 100024 No. 27 Chaoyang North Road, Beijing, Chaoyang District Applicant after: CHINA?RESOURCES?ZIZHU?PHARMACEUTICAL?CO., LTD. Address before: 100024 No. 27 Chaoyang North Road, Beijing, Chaoyang District Applicant before: Zizhu Pharmaceutical Co., Ltd., Beijing |
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Free format text: CORRECT: APPLICANT; FROM: ZIZHU PHARMACEUTICAL CO., LTD., BEIJING TO: HUARUN ZIZHU PHARMACEUTICAL CO., LTD. |
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Application publication date: 20120801 |