Ciclopirox olamine vaginal expansive suppository, preparation method and detection method thereof

Abstract

The invention relates to a ciclopirox olamine vaginal dilation suppository as well as a preparation method and a detection method thereof. The dilation suppository comprises a medicine-containing matrix formed by ciclopirox olamine and a matrix, and a dilation carrier. An organic acid and the ciclopirox olamine in the medicine-containing matrix are prepared into a solid dispersion and form a complex salt, so that the absorption of the ciclopirox olamine can be promoted, the bioavailability of the dilation suppository can be improved, and an acidic environment in the vagina can be kept; according to the hollow effervescent vaginal dilation suppository, the peak valley phenomenon generated during medicine release can be overcome, the stability of the dilation suppository is further improved and the curative effect can reach the depth and wrinkles of the vagina. As few types of excipients exist in the dilation suppository, the release of the ciclopirox olamine and the formation of the suppository are facilitated; in addition, the ciclopirox olamine vaginal dilation suppository provided by the invention adopts six unique leading technologies and has the beneficial effects of preventing outflow of medicine liquor and preventing secondary infection, and is high in stability, durable in curative effect and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a ciclopirox olamine vaginal expansion suppository and a preparation method and a detection method thereof. Background technique [0002] Ciclopirox amine, the chemical name is 4-methyl-6-cyclohexyl-1-hydroxy-2(1H)-pyridone-2-aminoethanol salt, its structure is as follows: [0003] [0004] Ciclopirox olamine [0005] Ciclopirox olamine is a white crystalline powder, easily soluble in methanol and ethanol, and slightly soluble in water. It is a new generation of non-imidazole broad-spectrum antifungal drug. Strong antibacterial and bactericidal effects, strong permeability, and certain inhibitory effects on various actinomycetes, gram-positive and gram-negative bacteria, mycoplasma, chlamydia, trichomonas, etc., is currently an ideal topical antibacterial fungal medicine. [0006] Currently, the dosage forms of ciclopirox olamine mainly include cream, gel, suppository a...

AI Technical Summary

Problems solved by technology

As CN101116656 and CN101049286 disclose the gel of ciclopirox olamine, and CN102657603 discloses the cream of ciclopirox olamine, because there is a large amount of moisture in the gel, which affects the stability of ciclopirox olamine, which is easy to deteriorate. Special tools are required for smearing, which is very inconvenient and likely to cause secondary infection, which affects its clinical application

[0007] In the treatment of candida vulvovaginal disease, the characteristics of the suppository itself make it accepted by the majority of patients. In order to overcome the technical problems of poor water stability and poor water solubility of ciclopirox olamine in the prior art, CN101579306 discloses a kind of suppository composed of cyclic The ciclopirox olamine vaginal suppository made of piroxolamine, substrate, stearic acid, hydrogenated castor oil and sodium benzoate, the sodium benzoate in the suppository has promoted the absorption of ciclopirox olamine in the suppository, and the stability of the suppository has Certain improvement, but after long-term placement, the stability of suppository still has problem; And the adding of described sodium benzoate also can influence the property of matrix, is unfavorable for the release of ciclopirox olamine; Common ciclopirox olamine suppository still exists It is not easy to clean, and it is easy to contaminate clothes; the contact surface between active ingredients and human body is small, resulting in insufficient absorption, and technical problems such as not exerting the best curative effect of the formula

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