Fuyanling vaginal expansion suppository and its preparation method and detection method

Abstract

The invention relates to a Fuyanling vaginal expansion suppository and a preparation method and a detection method thereof. The expansion suppository includes a Chinese medicine composition, benzalkonium bromide, a matrix and an expansion carrier. The Chinese medicine composition is composed of purple pearl leaves, boric acid, etc. Prepared from 9 raw materials; the traditional Chinese medicine composition forms microcapsules with methyl cellulose, polyvinyl alcohol and sodium lauryl sulfate, which improves the stability and absorption of the traditional Chinese medicine composition and prolongs the curative effect of the expansive suppository ; The sorbitan monostearate has improved the stability of Fuyanling vaginal expansion suppository, and described lauromacrogol 400 has promoted the absorption of benzalkonium bromide; Fuyanling vaginal expansion suppository of the present invention has immediate release And the characteristics of slow-release drug release; and the Fuyanling vaginal expansion suppository adopts seven unique technologies, which has beneficial effects such as preventing the outflow of medicinal liquid, high stability, long-lasting curative effect, and preventing secondary infection.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a Fuyanling vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Fuyanling preparation, which is prepared from 9 traditional Chinese medicines of purple pearl leaves, boric acid, flavescens, camphor, agrimony, alum, babu, borneol, cnidium, and benzalkonium bromide, has the functions of clearing away heat and dampness, killing insects and relieving itching. Efficacy; the currently marketed preparations are Fuyanling Capsules (recorded in the seventeenth volume of "Ministry of Health Drug Standard Traditional Chinese Medicine Prescriptions"), Fuyanling Effervescent Tablets and Fuyanling Suppositories; due to the existence of Fuyanling Capsules The first-pass effect of the liver, its bioavailability is low, which affects its clinical application; Fuyanling effervescent tablets can increase the contact between the drug...

AI Technical Summary

Problems solved by technology

[0002] Fuyanling preparation, which is prepared from 9 traditional Chinese medicines of purple pearl leaves, boric acid, flavescens, camphor, agrimony, alum, babu, borneol, cnidium, and benzalkonium bromide, has the functions of clearing away heat and dampness, killing insects and relieving itching. Efficacy; the currently marketed preparations are Fuyanling Capsules (recorded in the seventeenth volume of "Ministry of Health Drug Standard Traditional Chinese Medicine Prescriptions"), Fuyanling Effervescent Tablets and Fuyanling Suppositories; due to the existence of Fuyanling Capsules The first-pass effect of the liver, its bioavailability is low, which affects its clinical application; Fuyanling effervescent tablets can increase the contact between the drug and the medication site due to the generation of foam, but the acid-base effervescent agent can irritate the mucous membrane , its clinical application is also limited; therefore, Fuyanling suppositories are commonly used clinically to treat genital itching, burning pain, red and white vaginal discharge caused by damp-heat injections, frequent urination, urgency, dysuria and other symptoms, as well as fungal, Trichomonas, bacterial vaginosis see the above symptoms

[0003] The curative effect of Fuyanling suppository has been clinically confirmed for many years, but there are still some technical problems in itself, such as the traditional Fuyanling suppository has low bioavailability and unstable properties; CN1742966 discloses a Fuyanling soft capsule suppository , after the active ingredient is mixed with liquid paraffin, soft capsules are made with vaseline and lecithin, and the soft capsules improve the stability of suppositories in high-temperature and high-humidity environments; CN1742966 also discloses an effervescent suppository, the The effervescent suppository increases the contact between the active ingredient and the medication part, which improves the curative effect of the suppository; but there are still uneven releases of the active ingredient in the above preparations, resulting in the technical problem of the concentration of the medication site fluctuating; and the above-mentioned disclosed The sliver in the Fuyanling suppository has no swelling effect, or the swelling is disordered, which greatly reduces the clinical application; the suppository is easy to contaminate the clothes and is not easy to clean; the quality control method is unreliable, resulting in the actual production process. , stability, and time limit for melting change vary greatly

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