Matrine diatomic alcohol plastid temperature-sensitive gel and preparation method thereof

Abstract

The invention relates to a matrine diatomic alcohol plastid temperature-sensitive gel and a preparation method thereof, and aims to overcome the defects of vaginal dosage forms in the prior art. By adopting the matrine diatomic alcohol plastid temperature-sensitive gel, the medicine can be conveniently used, a patient does not have foreign body sensation, a medicine storage is formed in a vagina at the same time, the acting time of the medicine is long, and the bioavailability of matrine can be fully improved. The matrine diatomic alcohol plastid temperature-sensitive gel is prepared from the following raw materials in percentage by weight: 0.25-1.5% of matrine, 0.25-1.5% of lecithin, 0.5-1% of chitosan, 13-30% of low-molecular-weight alcohol, 38-55% of a phosphate buffer solution, 15-35% of poloxamer and 5-10% of glycerol. The diatomic alcohol plastid using ethanol and propanediol as softening agents has high encapsulation efficiency and stability, is stable in structure, can increase the in vivo and in vitro pereutaoeous permeation to ensure that the medicine can be slowly released, thereby improving the therapeutical effect; in addition, the gel does not have obvious toxicity.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to a matrine glycol-based temperature-sensitive gel for vagina and a preparation method thereof. Background technique [0002] Gynecological diseases, such as trichomonas, rosary vaginitis, chronic cervicitis, senile vaginitis, pelvic inflammatory disease, etc., are common gynecological diseases, which have the characteristics of recurring and difficult to heal. Gynecological diseases are often caused by trichomoniasis, mold and bacterial infections, and can also be caused by mixed infections. The treatment of these diseases is mainly by topical vaginal application of antibiotics. Due to the wide incidence, long course and recurrence of these diseases, as well as the decreased sensitivity of pathogenic bacteria to drugs in recent years, the majority of patients around the world are suffering. Therefore, clinical development of such new drugs is very import...

AI Technical Summary

Problems solved by technology

[0004] When clinically used to treat gynecological diseases, matrine preparations are usually made into vaginal suppositories, effervescent tablets, films and gels. These traditional dosage forms have certain defects in actual use: suppositories are made of solid The form of administration has foreign body sensation, poor patient compliance, inconvenient use, and the problem of medication dead ends; although the effervescent tablet (patent CN1439370A) is uniformly administered, the local action time is short, and a large amount of water-soluble substrate discharge pollutes the clothes; membrane Matrine gel (patent CN1593408A) has slow-release characteristics, which can solve the problem of short drug action time, but there are dead ends and foreign body sensation, and the patient's compliance is poor during administration; matrine gel (patent CN1410060A) is New drugs approved by the State Food and Drug Administration in 2005

[0006] Poloxamer polymers are one of the most researched and used gel materials. The published patent: a heat-sensitive gel containing matrine alkaloids and its preparation method (Patent No.: CN1850076A ), the temperature-sensitive gel is administered in liquid form, which is convenient for medication and has good patient compliance. At the same time, the drug is in close contact with the mucous membrane of the administration site, which has obvious advantages compared with previous dosage forms. However, studies have shown that hypromellose Addition of the element has little delaying effect on gel dissolution and drug release

Therefore, the gel dissolves too fast, and the problem of drug loss with the gel solution limits the clinical application of the sophora alkaloid thermosensitive gel.

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