Compound zedoary oil expandable vaginal suppository, and preparation method and detection method thereof

Abstract

The invention relates to a compound zedoary oil expandable vaginal suppository, and a preparation method and a detection method thereof. The expandable vaginal suppository comprises active ingredients, a matrix and an expansion carrier. The active ingredients include an imidazole antimicrobial drug and zedoary oil; the drug-containing matrix of the expandable vaginal suppository contains povidone to increase solubility and stability of the zedoary oil; and the menthol can promote the absorption of the active ingredients. The compound zedoary oil expandable vaginal suppository is a hollow double-layer expandable suppository, and the suppository separates the matrix and the active components to further improve the stability of the active ingredients and prevent volatilization of zedoary oil, so as to improve the curative effect of the suppository. The compound zedoary oil expandable vaginal suppository employs six originally created leading technologies and has beneficial effects of prevention of liquid outflow, high stability and significant curative effect.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a vaginal expansion suppository with compound curcuma oil and a preparation method and detection method thereof. Background technique [0002] Imidazole antibacterial drugs are synthetic antibacterial drugs, which mainly exert antibacterial effects by inhibiting the biosynthesis of ergosterol in fungal cell membranes. The imidazole antibacterial drugs mainly include econazole, metronidazole, clotrimazole or miconazole. At present, the clinical preparations of imidazole antibiotics include oral (tablets), injections and suppositories, etc. The oral and injections generally have adverse reactions such as digestive tract, but the suppositories can overcome the above adverse reactions, and The first pass effect of the liver can be avoided. [0003] In order to further enhance the antibacterial effect of imidazole antibacterial drugs, in the prior art, imidazole antibacterial dru...

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Problems solved by technology

The 16th volume of "Chemical Drug Local Standard Rise National Standard" has disclosed the compound curcuma oil suppository made from econazole nitrate 50g, curcuma oil 210ml and auxiliary materials; prior art also has some documents disclosing the suppository of compound curcuma oil, For example, CN1449784 discloses three kinds of suppositories of compound curcuma oil, including the common suppository made of curcuma oil, econazole nitrate, borneol and water-soluble matrix, and the gelatin shell made of gelatin, glycerin, etc. Capsule suppositories made of β-cyclodextrin, sorbitol monolaurate and active ingredients; the above-mentioned suppositories solve the volatile characteristics of zedoary oil, but due to the inherent nature of the oil Stability, whether it is mixed with the matrix or directly mixed with the matrix, it will affect the stability of zedoary oil

[0004] Yet prior art is not much to the research of compound curcuma oil suppository, and following problem still needs to be solved: 1. the tampon in the suppository of traditional compound curcuma oil has no expansion effect, or expansion disorder, greatly reduces clinical 2. The drug release is fast, and there is a "peak and valley" phenomenon; 3. The quality control method is unreliable, which leads to great changes in the content, stability, and melting time limit between batches in the actual production process; 4. Active ingredients and Simple mixing of excipients cannot give full play to the curative effect of active ingredients, etc.

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