Pharmaceutical composition contg .bifidobacterium, prepn. method and medical use thereof

Abstract

A composite medicine for treating vaginitis is prepared from the bifidobacterium No. 47757732, the mixture of acid and alkali for making its pH=3.75-5.3, and the pharmacologically acceptable carrier. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a bifidobacterium-containing pharmaceutical composition for treating vaginal flora imbalance and vaginitis, a preparation method and application in medicine. Background technique [0002] The destruction of vaginal micro-ecological balance is the cause of various gynecological inflammations and the result of various gynecological diseases. The treatment of vaginal inflammation mainly includes two aspects of fungicides and probiotics. Fungicides have strong therapeutic specificity and remarkable effect, but have a broad antibacterial spectrum and low selectivity, so they have many side effects and a high recurrence rate. The existing single-species probiotics all use bacterial vaginosis as the therapeutic target, and the scope of application is limited. At the same time, the distribution of normal flora in different sections of the vagina has a certain pattern, that is, the deep p...

AI Technical Summary

Problems solved by technology

But there are still the following deficiencies: 1. The anti-inflammatory, anti-infection, bacteriostasis, anti-tumor and immunomodulatory effects described in the instructions are inferred from bifidobacteria in vitro test literature reports, and there is no specific experimental data to support them.

For example, it has been proven that Lactobacillus gasseri and Lactobacillus crispatus have no effect on Escherichia coli and Neisseria gonorrhoeae, not only have no anti-tumor and immune regulation effects, but also cause opportunistic infections to the human body

Therefore, this inference is not objective and there are considerable uncertainties

2. In terms of indications for treatment, the invention only mentioned "good anti-inflammation, anti-infection, and antibacterial effects", without a specific range of suitable treatments, and no specific experimental results to support it. inference

3. The influence of the pH of the drug on the survival and growth conditions of live bacteria of Lactobacillus and Bifidobacteria, the influence on the conditions for inhibiting the growth of pathogenic bacteria, and the influence on the suitable conditions for the acidity of the local (vaginal) drug environment are not considered.

4. When in use, because it is mixed and dissolved in vitro with a balanced solution, it is difficult to avoid the contamination of bacteria, and the aerobic environment will reduce the number of viable bacteria in the drug

Moreover, the invention does not involve the course of treatment, so the curative effect is difficult to judge by certain standards

5. The glycerin excipient added in the preparation process will affect the number of viable bacteria

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