Zhimikang expandable vaginal suppository, and preparation method and detection method thereof

Abstract

The invention relates to a Zhimikang expandable vaginal suppository. The expandable suppository comprises a traditional Chinese medicine composition, a matrix and an expansion carrier. The traditional Chinese medicine composition and the matrix form a drug-containing matrix, which is coated on the surface of the carrier. The traditional Chinese medicine composition is prepared from golden cypress, sophora flavescens, catechu, dried alum and borneol. bulk drugs including cortex lycii and gentian are further required for preparation of the traditional Chinese medicine composition, and can improve treatment effect of the expandable vaginal suppository on cervical erosion and vulvovaginal candidiasis; and the traditional Chinese medicine composition is prepared into microcapsules to increase the solubility and stability of the traditional Chinese medicine composition and increase bioavailability of the suppository. The Zhimikang expandable vaginal suppository employs seven unique technologies, and has beneficial effects of prevention of outflow liquid, high stability, lasting curative effect and prevention of secondary infection.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a Zhimikang vaginal expansion suppository and a preparation method and a detection method thereof. Background technique [0002] Zhimikang Suppository, known as Zhimiling Suppository before 2010, is recorded in Volume 11 and Volume 18 of "Ministry of Health's Drug Standards for Traditional Chinese Medicine Prescriptions". Made of 20g, borneol 5g and appropriate amount of polyoxyethylene monostearate and glycerin; it was renamed as Zhimikang Suppository at the end of 2010, and it was recorded in Part One of the Chinese Pharmacopoeia 2010 Edition. It is made from 400g of dry alum, 100g of borneol, 2000-2060g of polyoxyethylene monostearate and 20ml of glycerin. The efficacy of Zhimikang Suppository has been clinically proven for many years, and it is widely used for cervical erosion, infectious vaginitis, trichomonal vaginitis and other gynecological diseases. Zhimikang suppo...

AI Technical Summary

Problems solved by technology

Zhimikang suppository is a classic Chinese patent medicine, but the water solubility of the active ingredients in the suppository is poor. In order to solve this technical problem, CN1368325 discloses a nano-Zhimikang suppository. The bioavailability of suppositories, and then obtained suppositories with good dispersibility and complete absorption, but because the particle size of each raw material medicine in the suppository is too fine after nano-processing, it is not conducive to mixing, and it is easy to aggregate into blocks, resulting in active ingredients. It has strong hygroscopicity and affects the stability of the preparation; Tian Zhenkun et al. (Tian Zhenkun, Ma Yingli, Wang Wenyi. Zhimiling Effervescent Capsule Suppository is the most useful in the treatment of phenol-induced cervical erosion model in rats[J], Journal of China Yaoxue, 2011 ,39(4):44-45) discloses a Zhimiling effervescent capsule suppository, but does not disclose the specific prescription of the suppository, pointing out that the suppository can overcome the stability problem of ordinary Zhimikang suppositories, but the suppository The medicines in it take effect quickly, the effective administration time is short, and there are "peaks and valleys"; in addition, in the prior art, the tampon in the traditional Zhimikang suppository still has no swelling effect, or the swelling is disordered, which greatly reduces the clinical efficacy. Application; Difficult to clean, easy to contaminate clothes; Unreliable quality control methods, leading to technical problems such as large variations in batch-to-batch content, stability, and melting time limit in the actual production process

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