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

Abstract

The invention relates to a Fukang expandable vaginal suppository, and a preparation method and a detection method thereof. The expandable suppository comprises active ingredients, a matrix and an expansion carrier. The active ingredients and the matrix form a drug-containing matrix, which is coated on the surface of the carrier. The active ingredients include walnut oil and further include motherwort and radix polygonati officinalis. The additional motherwort and radix polygonati officinalis can improve the curative effect of the Fukang expandable vaginal suppository on symptoms of leukorrhea with reddish discharge and bearing-down pain in lower abdomen; the starch sodium glycolate and walnut oil are prepared into a solid dispersion to improve the solubility of walnut oil and reduce volatilization of walnut oil; the stearic acid palmitic acid glycol ester improve the stability of the suppository; and the dextrin increases cohesiveness of the expandable suppository and is beneficial to forming the expandable suppository. The Fukang expandable vaginal suppository employs six 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 Fukang vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Fukang suppository is a classic Chinese patent medicine, which is recorded in the seventeenth volume of "Ministry of Health's Drug Standards for Traditional Chinese Medicine Prescriptions". , has the effects of clearing heat and detoxifying, astringent and astringent, and is clinically used for red and white vaginal discharge, lower abdominal pain, and cervical erosion. [0003] The curative effect of Fukang Suppository has been clinically confirmed for many years, but the walnut distilled oil in traditional Fukang Suppository is volatile and has low solubility, which leads to low content of active ingredients in the suppository and affects the bioavailability of the suppository; and the walnut distilled oil The suppository made of oil and glycerin gela...

AI Technical Summary

Problems solved by technology

[0003] The curative effect of Fukang Suppository has been clinically confirmed for many years, but the walnut distilled oil in traditional Fukang Suppository is volatile and has low solubility, which leads to low content of active ingredients in the suppository and affects the bioavailability of the suppository; and the walnut distilled oil The suppository made of oil and glycerin gelatin is irritating to mucous membrane; To improve the odor and solubility of walnut distilled oil, the adopted technical solutions include: CN103238680 discloses that walnut distilled oil is made into microcapsules, CN1362107 discloses that walnut oil is nanometerized, and CN102178240 discloses that walnut distilled oil is made into microemulsions After walnut distillate oil is carried out microcapsule or microemulsion etc. to handle, can significantly increase the solubility of walnut distillate oil, can improve the bioavailability of preparation after making oral preparation, but the walnut distillate oil of described microcapsule and microemulsion and After the matrix is ​​made into a suppository, there are still technical problems such as poor cohesion and poor stability; and the sliver in the traditional Fukang suppository has no swelling effect, or the expansion is disordered, which greatly reduces the clinical application; the suppository is easy to contaminate clothes , not easy to clean; 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

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