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HerbOshieldTM 阴道凝胶在大鼠中的避孕效果和安全性。

Contraceptive efficacy and safety of HerbOshield™ vaginal gel in rats.

机构信息

C.U. Shah College of Pharmacy, Shreemati Nathibai Damodar Thakersey Women's University, Santacruz (West), Mumbai-400049, India.

出版信息

Contraception. 2012 Jan;85(1):122-7. doi: 10.1016/j.contraception.2011.04.013. Epub 2011 Aug 26.

DOI:10.1016/j.contraception.2011.04.013
PMID:22067802
Abstract

BACKGROUND

Spermicides represent one of the methods of contraception. The synthetic agents available as spermicides produce severe side effects. Hence, there is a need to replace these agents with safe and effective agents such as plant-based contraceptive agents.

STUDY DESIGN

The objective of the present study was to develop and evaluate a stable, safe, effective and easily acceptable contraceptive delivery system containing herbal drug. Efforts were made to evaluate the contraceptive potential of the hydroalcoholic extract from the seeds of Annona squamosa Linn. and the vaginal gel HerbOshield™ containing the extract.

RESULTS

Spermicidal effect was evaluated in vitro using healthy human spermatozoa and in vivo in rats. The in vitro results demonstrated that HerbOshield™ vaginal gel is an effective spermicide. At a 100-mg/mL dose, complete immobilization of human spermatozoa was observed within 20 s. None of the treated animals conceived, indicating 100% contraceptive effect as compared to Gynol II, a nonoxynol-9-containing marketed formulation, which showed only 67% contraceptive effect in vivo. HerbOshield™ vaginal gel was found to be safe in animals during a 14-day toxicity study.

CONCLUSIONS

HerbOshield™ vaginal gel was found to be safe and effective in rats and could be developed as a potential vaginal contraceptive for future use in humans.

摘要

背景

杀精剂是避孕方法之一。现有的合成杀精剂会产生严重的副作用。因此,需要用安全有效的植物性避孕剂代替这些杀精剂。

研究设计

本研究的目的是开发和评估一种含有草药的稳定、安全、有效且易于接受的避孕药物传递系统。努力评估从 Annona squamosa Linn. 种子的水醇提取物和含有该提取物的阴道凝胶 HerbOshield™ 的避孕潜力。

结果

在体外使用健康的人精子和体内在大鼠中评估了杀精效果。体外结果表明 HerbOshield™ 阴道凝胶是一种有效的杀精剂。在 100mg/mL 剂量下,人精子在 20 秒内完全被固定。与含有非诺孕醇-9 的市售制剂 Gynol II 相比,没有一只处理过的动物怀孕,表明避孕效果达到 100%,而后者在体内的避孕效果仅为 67%。在为期 14 天的毒性研究中,发现 HerbOshield™ 阴道凝胶在动物中是安全的。

结论

在大鼠中发现 HerbOshield™ 阴道凝胶安全有效,可开发为未来人类使用的潜在阴道避孕药。

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Contraceptive efficacy and safety of HerbOshield™ vaginal gel in rats. HerbOshieldTM 阴道凝胶在大鼠中的避孕效果和安全性。
Contraception. 2012 Jan;85(1):122-7. doi: 10.1016/j.contraception.2011.04.013. Epub 2011 Aug 26.
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