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Misoprostol vaginal sustained-release suppository and preparation method thereof
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A technology of misoprostol and misoprostol hypromellone, which is applied in the field of sustained-release suppositories, can solve the problems of complicated process and high cost, and achieve the effects of simple preparation process, low cost and reduced production cost
Inactive Publication Date: 2014-04-23
天津市聚星康华医药科技有限公司
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[0006] Domestic Patent No. 200580026190.3 describes a misoprostol vaginal sustained-release suppository made of polyurethane hydrogel as a carrier, which is a vaginal sustained-release suppository composed of a polyurethanepolymer as a carrier. Suppository, but the process is more complicated and the cost is higher
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Embodiment 1
[0030]
[0031] Preparation Process:
[0032] ① Take 20g of povidone (K90), dissolve it in 200mL of 95% ethanol for later use;
[0033] ② Weigh 10 g of misoprostol hypromellosepowder (containing 0.1 g of misoprostol) and dissolve it in the solution prepared in ①, add 4001 g of polyethylene glycol, stir well and set aside;
[0034] ③ Add 0.2mL of ② solution dropwise to each medical sponge, dry it in vacuum at room temperature, and pack it.
Embodiment 2
[0036]
[0037] Preparation Process:
[0038] ①Take 10g of povidone (K30), 2g of ethyl cellulose, dissolve in 200mL of 95% ethanol for later use;
[0039] ② Weigh 10 g of misoprostol hypromellosepowder (containing 0.1 g of misoprostol) and dissolve it in the solution prepared in ①, add 2 g of polyethylene glycol 400, stir well and set aside;
[0040] ③ Add 0.2mL of ② solution dropwise to each medical sponge, dry it in vacuum at room temperature, and pack it.
[0045] ② Weigh 10 g of misoprostol hypromellosepowder (containing 0.1 g of misoprostol) and dissolve it in the solution prepared in ①, add 1 g of polyethylene glycol 400, stir well and set aside;
[0046] ③ Add 0.2mL of ② solution dropwise to each medical sponge, dry it in vacuum at room temperature, and pack it.
[0048] Carried out with reference to the in vitrodrug release test method in the 2010 edition of "Chinese Pharmacopoeia" Appendix XIXD Sustained Release, Controlled Release and Delayed Release Preparation Guidelines.
[0049] Get the misoprostol vaginal sustained-release suppository of above embodiment 1, embodiment 2 and embodiment 3 respectively, put in drugdissolution apparatus, in 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h respectively Sampling 5ml, and timely rehydration 5ml, check the dissolu...
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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 [0001] The invention provides a safe and effective drug delivery method, a slow-release suppository containing misoprostol with medical sponge as a carrier, and a preparation process. Background technique [0002] Misoprostol is a synthetic prostaglandin E1 analog, which is artificially synthesized after two modifications on the natural PGE1 chemical structure, and its chemical structure is 35 times larger than that of the parent, thereby overcoming the natural PGE1 action time Short, many side effects and other shortcomings. Its mechanism of action is as follows: [0003] Uterine contraction induction: mainly by exciting the myometrium, stimulating the continuous increase of endogenous PG in the uterus, causing high-frequency, high-amplitude and rhythmic uterine contractions similar to normal childbirth, so as to discharge the pregnancy product and achieve the purpose of miscarriage or induction of labor. Misoprostol has a contraction effect on the uterus ...
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