CN100525771C - Medicine possessing menacme accerant contraception action - Google Patents

Medicine possessing menacme accerant contraception action Download PDF

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Publication number
CN100525771C
CN100525771C CNB031212786A CN03121278A CN100525771C CN 100525771 C CN100525771 C CN 100525771C CN B031212786 A CNB031212786 A CN B031212786A CN 03121278 A CN03121278 A CN 03121278A CN 100525771 C CN100525771 C CN 100525771C
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CN
China
Prior art keywords
tablet
medicine
contraception
menacme
accerant
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Expired - Fee Related
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CNB031212786A
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Chinese (zh)
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CN1533771A (en
Inventor
肖碧莲
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NATIONAL POPULATION AND FAMILY PLANNING COMMISSION OF CHINA
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NATIONAL POPULATION AND FAMILY PLANNING COMMISSION OF CHINA
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Priority to CNB031212786A priority Critical patent/CN100525771C/en
Publication of CN1533771A publication Critical patent/CN1533771A/en
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Abstract

A medicine with mensis inducing and contraception functions contains mifepristone and misoprostol applied to vagina after 36-48 hr. Its advantages are low dosage, high effect and short bleeding time.

Description

A kind of have a medicament of urging through contraceptive efficacy
Invention field
The present invention relates to a kind of medicament, particularly have the kit of urging through contraceptive efficacy.
Background technology
Menstrual regulation is meant that the women to opsomenorrhea induces hemorrhage with the method for medicine or apparatus.Its use majority is limited to opsomenorrhea within one week, brings out menstruation and can solve the women to unwillingly pregnant worry, although she not necessarily may be conceived.In fact " urge through " of opsomenorrhea simultaneously, also make many women avoid seeking miscarriage more a little later, particularly, make the women avoid the danger of dangerous miscarriage in the illegal country of some miscarriages.In the most frequently used " the urge through " method of many countries is to adopt a kind of negative pressure extractor of special suction tube formula, belongs to though this method is safe and effective " invasive ", because of need insert conduit in the official jargon, may cause damage, causes infecting.And with the extractive method of suction tube negative pressure, mortality is higher than traditional vacuum aspiration.Therefore, must a kind of simple and effective method of invention.
Summary of the invention
The objective of the invention is to a kind of medicament of urging that has through contraceptive efficacy.
Medicament of the present invention, for the mifepristone of sequential first oral dosage units and after 36-48 hours in the misoprostol of vagina using dosage unit.
Described mifepristone sheet chemical name: 17 β hydroxyl-11 β-(4-dimethylaminophenyl)-17 α-(1-propinyl) female steroid-4,9-diene-3-ketone; Described misoprostol sheet chemical name: ± (11 α, 13E)-11,16-dihydroxy-16 methyl prostatitis-9-ketone 13 alkene-1-acid-formicester.
Described dosage unit typically refers to and is suitable for the unit of human body as single dose, and they contain the active substance that expectation can produce the specified amount of required effect, and these units for example are tablet, pill, powder agent, capsule etc.The mifepristone dosage unit is 140-160 milligrams, and the misoprostol dosage unit is the 350-450 microgram; The mifepristone dosage unit is preferably 150 milligrams, and the misoprostol dosage unit is 400 micrograms.
When preparing this type of dosage unit, can consider to use conventional additive, for example filler, coloring agent, polymeric binding agent etc.Anyly do not cause interferential pharmaceutically acceptable additive in one or more compositionss, to use to the effect of reactive compound.
The present invention is convenient to be used, and adopt oral, vagina medicinal, and dosage is less, effective, and hemorrhage time ratio conventional medicine miscarriage is short, can remove worry and misery, and without any complication.To miscarrying illegal or not possess the country of safe miscarriage condition more favourable.
Experimental example 1
Materials and methods: received 720 women in the whole nation altogether, prolonged 4.9 days (± 1.7) after their the average expectancy menstruation.Admitted gave 150 milligrams of mifepristones the same day, after 36-48 hour, the women comes the outpatient service vagina to place 400 microgram misoprostols, and remains in a hospital under observation one hour.Advising takes medicine examines in back 10 days and follows up a case by regular visits to.Observation index is mainly gestation, menstrual onset.Cyesiognosis is according to the discharge that is blood and urine hCG test, ultrasound investigation or embryonal tissue.Measure serum estradiol and serum progesterone simultaneously, phase during cycle when purpose is to analyze opsomenorrhea, or early pregnancy.
The result: only 1 example is lost visit in 720 examples.In 719 examples, pregnant when 492 examples are gone to a doctor, 467 examples of wherein miscarrying (95.0%) comprise fully and incomplete abortion.Gestation continues 24 examples (4.9%), and ectopic pregnancy 1 example is for further processing.227 examples are opsomenorrhea.222 examples (97.8%) menstrual onset wherein; Menstrual onset〉45 days or menolipsis person's 5 examples (2.2%).Taking medicine, 9% women has nauseatingly in the side reaction of back, and 5% has vomiting.These symptoms are due to the already present gestation, rather than owing to the reason of taking medicine.Gestation person is hemorrhage more, and the time is longer, but compares with non-gestation, and statistical analysis difference does not have significance.Serum estradiol and serum progesterone show, the women of opsomenorrhea has 60% level that still is in follicular phase, and only 30% is in luteal phase.In gestation group, being on close level in level luteal phase of 60% serum progesterone and estradiol illustrates their existing phase gestation very early.
Conclusion: the medicament of being made up of mifepristone and misoprostol was effective and safe to reinstating menstruation and terminating pregnancy in 7 days delayed menstruaions.Unwillingly pregnant favourable to solving women's worry, can exempt 95% women and seek miscarriage afterwards.
Following examples can realize above-mentioned experimental example effect.
Embodiment 1: tablet
Tablet I: chemical compound mifepristone 150g, corn starch 1000g, polyvidone 200g, stearic 100g, make 1000.Tablet II: chemical compound misoprostol 400mg, corn starch 1000g, polyvidone 200g, stearic 100g, make 1000.Be divided in the push-in type packing, make 1000 kits, each kit contains each one of tablet I, tablet II.
Usage and dosage: in the opsomenorrhea 7 days or 7 days, the women who meets the medication standard, empty stomach decoction being taken at a draught tablet I, the back fasting 2 hours of taking medicine is after 36-48 hours, place tablet II in posterior fornix of vagina, the flat bed half an hour guarantees drug absorption, and clinical observation is more than at least 1 hour, observe hemorrhage rate, in case contingent side reaction.
Untoward reaction: side reactions such as some women may feel sick in therapeutic process, vomiting, uteralgia can give necessary treatment to the ill.
Contraindication:
The adrenal cortex disease, diabetes, the endocrinopathy patient, hepatic and renal function is unusual, trimester of pregnancy the skin itching history, hematologic disease and thromboembolism medical history, the tumor relevant with steroidal.
Cardiovascular system diseases, glaucoma, functional gastrointestinal disorder, hypotension (80/50mmHg), asthma, epilepsy etc.
Allergic constitution.Pregnancy with IUD in situ.Ectopic pregnancy or ectopic pregnancy are suspicious.When gestation in past the hyperemesis person that feels sick, may produce hyperemesis after taking medicine and cause dosage to affect the treatment inadequately.Take following medicine for a long time: Rimactazid, antuepileptic, antidepressants, cimetidine, aspirin, indometacin, barbiturate, above medicine can weaken the pharmacological action of mifepristone.Smoking surpasses 10/day or be addicted to drink, and note potential cardiovascular disease.Vagina has infusorian and fungal infection person, can cause superinverse to infect during reinstating menstruation and terminating pregnancy.

Claims (1)

1, a kind of kit has the application of urging in the medicine of effect in preparation, it is characterized in that this kit is made up of tablet I, tablet II:
Tablet I: chemical compound mifepristone 150g, corn starch 1000g, polyvidone 200g, stearic 100g, make 1000; Tablet II: chemical compound misoprostol 400mg, corn starch 1000g, polyvidone 200g, stearic 100g, make 1000; Be divided in the push-in type packing, make 1000 kits, each kit contains each one of tablet I, tablet II; Described have urge through effect be meant to nogestational menstruation delay having urge through the effect.
CNB031212786A 2003-04-01 2003-04-01 Medicine possessing menacme accerant contraception action Expired - Fee Related CN100525771C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CNB031212786A CN100525771C (en) 2003-04-01 2003-04-01 Medicine possessing menacme accerant contraception action

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CNB031212786A CN100525771C (en) 2003-04-01 2003-04-01 Medicine possessing menacme accerant contraception action

Publications (2)

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CN1533771A CN1533771A (en) 2004-10-06
CN100525771C true CN100525771C (en) 2009-08-12

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CNB031212786A Expired - Fee Related CN100525771C (en) 2003-04-01 2003-04-01 Medicine possessing menacme accerant contraception action

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2197415B1 (en) * 2007-09-20 2014-03-05 Lapidot Medical Import And Marketing Ltd Compositions and means for treating uterine leiomyomata, leiomyoma, myoma, uterine fibroids, endrometriosis, adenomyosis and related disorders by mifepristone
CN106667900A (en) * 2017-01-24 2017-05-17 楚雄医药高等专科学校 Gel matrix having bioadhesion and favorable biocompatibility, and preparation method and application thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
《RU486合并索前列醇抗早孕的临床观察》《广西医学》1994.16(4,5)P370-371. 林国丽等.药学文摘95019389. 1995
《RU486合并索前列醇抗早孕的临床观察》《广西医学》1994.16(4,5)P370-371. 林国丽等.药学文摘95019389. 1995 *

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