CN102302443B - Misoprostol vaginal sustained-release suppository and preparation method thereof - Google Patents
Misoprostol vaginal sustained-release suppository and preparation method thereof Download PDFInfo
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- CN102302443B CN102302443B CN201110278270.5A CN201110278270A CN102302443B CN 102302443 B CN102302443 B CN 102302443B CN 201110278270 A CN201110278270 A CN 201110278270A CN 102302443 B CN102302443 B CN 102302443B
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Abstract
The invention discloses a misoprostol vaginal sustained-release suppository and a preparation method thereof. Medical sponge is used as a medicament carrier in the misoprostol vaginal sustained-release suppository; and the misoprostol vaginal sustained-release suppository comprises misoprostol, solvent, plasticizer, retarder and a termination rope. According to the preparation method, the traditional preparation concept is broken, a medicament sustained-release technology is combined with a medical macromolecular material, the defect of normal temperature instability of the raw misoprostol medicament is overcome by an optimized process, the production cost is reduced, and defects of similar medicaments in clinic are overcome.
Description
Technical field
The invention provides one administering mode safely and effectively, take medical sponge as carrier, the slow-release suppository that contains misoprostol, and preparation technology is provided.
Background technology
Misoprostol is a kind of synthetic PGE1 analog, be in the natural PGE1 chemical constitution after twice transformation synthetic, its chemical constitution has increased 35 times than parent, thereby has overcome short, the shortcoming such as side reaction is many natural PGE1 action time.Its mechanism of action is as follows:
Bring out uterine contraction effect: mainly by excited myometrium, stimulon palace endogenous PG continues to increase, altofrequency, high-amplitude and rhythmic uterine contraction while causing similar normal labor, discharge pregnant thing, reaches the object of miscarriage or induced labor.Misoprostol all has contraction to each phase gravid uterus, and constantly increases with dosage increase intrauterine pressure.Within 30 minutes, peak, within 2 hours, intrauterine pressure is still significantly higher than matched group.The sensitivity difference of each phase uterus to misoprostol, during full-term pregnancy, uterine smooth muscle obviously strengthens than early stage and midtrimester of pregnancy the irritability of misoprostol.Misoprostol is when the term induced labor, and the amplitude of uterine contraction, intensity, persistent period are all similar to spontaneous labor.
Promote cervix maturation: misoprostol promotes that cervix maturation relates generally to two processes, the dissolving of collagen fiber and the variation of substrate, misoprostol acts on cervix uteri fibrocyte, activate collagenolysis enzyme, collagen fiber rupture, dissolve and cause content to reduce under the effect of lyase, make cervix uteri deliquescing; Make the poly-polysaccharide component in Portugal that forms substrate change simultaneously, from chondroitin sulfate, change more hydrophilic hyaluronic acid into, cervix uteri softens because moisture increases.
Misoprostol the earliest indication is treatment gastric ulcer.Effectively induced parturition of clinical confirmation misoprostol afterwards, owing to not meeting the dosage form product of this indication, some hospitals get used to import drugs " happiness gram feedback " to do drug inducing labor use for many years, but have exceeded the approved indication of this medicine, exist potential safety hazard and illegal property.Advantages such as being made into slow release vaginal suppository and having that determined curative effect, success rate are high, convenient drug administration, untoward reaction are few.
The domestic patent No. 200580026190.3 is described the Misoprostol vaginal sustained-release suppository of making take polyurethanes aqueous polyurethane gel as carrier, it is the vagina slowly-releasing suppository of the composition take polyurethane polymer as carrier, but technique is more complicated, cost is higher.
Due at room temperature extremely unsettled character of misoprostol crude drug itself, unsuitable high temperature preparation, this product is through test of many times, employing medical sponge is carrier, add a certain proportion of blocker, directly adsorb the preparation technology of medicine, medicine can evenly slowly discharge, it is swelling but do not dissolve that this carrier is met water environment, and medicine can effectively be discharged lastingly.This dosage form is easy to use, steady quality, determined curative effect, and preparation technology is easy and cost is lower, is easy to suitability for industrialized production.
Summary of the invention
The object of the present invention is to provide a kind of Misoprostol vaginal sustained-release suppository take medical sponge as carrier, for term induced labor, this dosage form is easy to use, steady quality, determined curative effect.
Another object of the present invention is to provide the preparation method of said preparation.
Misoprostol vaginal sustained-release suppository of the present invention is comprised of medical sponge, termination rope, misoprostol and suitable adjuvant.
Misoprostol in Misoprostol vaginal sustained-release suppository of the present invention, can be used misoprostol sterling or 1% misoprostol hypromellose powder.
Amount containing misoprostol in Misoprostol vaginal sustained-release suppository of the present invention is 50 μ g～200 μ g, preferably 100 μ g.
In Misoprostol vaginal sustained-release suppository of the present invention, except medical sponge carrier, also comprise solvent, plasticizer, blocker and termination rope.
The present invention's solvent used can be dehydrated alcohol, 95% ethanol.
The plasticizer of Misoprostol vaginal sustained-release bolt of the present invention can be one or more in Polyethylene Glycol, glycerol, propylene glycol; Wherein preferred Polyethylene Glycol; Described Polyethylene Glycol, can be Macrogol 200, PEG400, Macrogol 600, cetomacrogol 1000, preferably PEG400.
The blocker of Misoprostol vaginal sustained-release bolt of the present invention can be one or more in ethyl cellulose, acrylic resin IV, polyvidone, Hydroxypropylcelliloxe, hydroxypropyl methylcellulose.
Medical sponge in Misoprostol vaginal sustained-release suppository of the present invention can be finished-product material, also can be by preparing.
Termination rope and medical sponge described in Misoprostol vaginal sustained-release suppository of the present invention are fixed, and at any time suppository being taken out, thereby stop in time administration.
In the present invention, the preparation method of Misoprostol vaginal sustained-release suppository is:
A. medical sponge is cut into suitable size;
B. misoprostol, plasticizer and blocker are made to solution with appropriate solvent;
C. above-mentioned solution is quantitatively added on medical sponge to drying under reduced pressure, packing.
The innovation point of Misoprostol vaginal sustained-release bolt of the present invention
Misoprostol slow-release suppository has been broken through traditional preparation theory, and medicament slow release technology and medical macromolecular materials are combined, and by Optimization Technology, has reduced production cost, has solved the weak point of similar drugs clinically.
Misoprostol slow-release suppository has avoided clinicist to use ordinary preparation to need the inconvenience of multiple dosing, and ordinary preparation cannot stop rapidly the danger of administration; The present invention adopts unique termination administering mode to make pharmaceutical applications safer, and the formulation and technology of optimizing screening has reduced the requirement of medicine to condition of storage, more tallies with the national condition; In the present invention, the preparation technology of said preparation is simple, and cost is low, easily realizes suitability for industrialized production.
Accompanying drawing explanation
Accompanying drawing is three groups of external average release percentage curves figure of prescription misoprostol slow-release suppository.
By the Misoprostol vaginal sustained-release bolt of the known embodiment 1 of accompanying drawing, embodiment 2 and embodiment 3 at the release rate of 2 hours all lower than 30%, therefore there is no burst effect, be slow release characteristics, there is slow releasing function.
The specific embodiment
Below by specific embodiment, the present invention is described in further detail, but be not limited to following embodiment.
Embodiment 1:
Preparation technology:
1. get polyvidone (K90) 20g, be dissolved in 200mL95% ethanol standby;
2. take misoprostol hypromellose powder 10g (containing misoprostol 0.1g) and be dissolved in the solution of 1. preparation, add Polyethylene Glycol 4001g, stir standby;
3. each medical sponge drips 2. solution of 0.2mL, room temperature vacuum drying, and packing.
Embodiment 2:
Preparation technology:
1. get polyvidone (K30) 10g, ethyl cellulose 2g, is dissolved in 200mL95% ethanol standby;
2. take misoprostol hypromellose powder 10g (containing misoprostol 0.1g) and be dissolved in the solution of 1. preparation, add 2g PEG400, stir standby;
3. each medical sponge drips 2. solution of 0.2mL, room temperature vacuum drying, and packing.
Embodiment 3:
Preparation technology:
1. getting acrylic resin IV4g is dissolved in 200mL95% ethanol standby;
2. take misoprostol hypromellose powder 10g (containing misoprostol 0.1g) and be dissolved in the solution of 1. preparation, add 1g PEG400, stir standby;
3. each medical sponge drips 2. solution of 0.2mL, room temperature vacuum drying, and packing.
The drug release rate inspection of suppository
With reference to the vitro drug release degree test method in 2010 editions < < Chinese Pharmacopoeia > > appendix XIXD slow release, controlled release and slowbreak preparation guidelines, carry out.
Get respectively the Misoprostol vaginal sustained-release bolt of above embodiment 1, embodiment 2 and embodiment 3, put in medicament dissolution instrument, in 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h samples respectively 5ml, and timely fluid infusion 5ml, with high performance liquid chromatography inspection stripping percentage rate.
Claims (3)
1. a Misoprostol vaginal sustained-release suppository, is characterized in that preparation method is:
1. get polyvidone k90 20g, be dissolved in 200ml 95% alcoholic solution standby;
2. take the misoprostol hypromellose powder 10g containing misoprostol 0.1g, be dissolved in the solution of 1. preparation, add PEG400 1g, stir standby;
3. each medical sponge drips 2. solution of 0.2ml, room temperature vacuum drying, and packing, makes 1000 pieces altogether.
2. a Misoprostol vaginal sustained-release suppository, is characterized in that preparation method is:
1. get polyvidone k30 10g, ethyl cellulose 2g, be dissolved in 200ml 95% alcoholic solution standby;
2. take the misoprostol hypromellose powder 10g containing misoprostol 0.1g, be dissolved in the solution of 1. preparation, add PEG400 2g, stir standby;
3. each medical sponge drips 2. solution of 0.2ml, room temperature vacuum drying, and packing, makes 1000 pieces altogether.
3. a Misoprostol vaginal sustained-release suppository, is characterized in that preparation method is:
1. getting acrylic acid IV resin 4g is dissolved in 200ml 95% alcoholic solution standby;
2. take the misoprostol hypromellose powder 10g containing misoprostol 0.1g, be dissolved in the solution of 1. preparation, add PEG400 1g, stir standby;
3. each medical sponge drips 2. solution of 0.2ml, room temperature vacuum drying, and packing, makes 1000 pieces altogether.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110278270.5A CN102302443B (en) | 2011-09-21 | 2011-09-21 | Misoprostol vaginal sustained-release suppository and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110278270.5A CN102302443B (en) | 2011-09-21 | 2011-09-21 | Misoprostol vaginal sustained-release suppository and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102302443A CN102302443A (en) | 2012-01-04 |
| CN102302443B true CN102302443B (en) | 2014-04-23 |
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|---|---|---|---|
| CN201110278270.5A Expired - Fee Related CN102302443B (en) | 2011-09-21 | 2011-09-21 | Misoprostol vaginal sustained-release suppository and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20160008310A1 (en) | 2014-07-11 | 2016-01-14 | Azanta A/S | Misoprostol dispersible tablet |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1281689A (en) * | 2000-09-04 | 2001-01-31 | 南京农业大学 | Vaginal spongy suppository for iducing ewe estrus |
| CN101010066A (en) * | 2004-08-05 | 2007-08-01 | 控制治疗（苏格兰）有限公司 | Stabilised prostaglandin composition |
| CN102939085A (en) * | 2010-06-11 | 2013-02-20 | 辉凌公司 | Intravaginal administration of misoprostol |
-
2011
- 2011-09-21 CN CN201110278270.5A patent/CN102302443B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1281689A (en) * | 2000-09-04 | 2001-01-31 | 南京农业大学 | Vaginal spongy suppository for iducing ewe estrus |
| CN101010066A (en) * | 2004-08-05 | 2007-08-01 | 控制治疗（苏格兰）有限公司 | Stabilised prostaglandin composition |
| CN102939085A (en) * | 2010-06-11 | 2013-02-20 | 辉凌公司 | Intravaginal administration of misoprostol |
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| CN102302443A (en) | 2012-01-04 |
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