A kind of live bacteria preparation for vagina which can be preserved at room temperature and its preparation method

A technology for preservation at room temperature and bacterial preparation, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, antibacterial drugs, etc. Short time and other problems, to achieve the effect of suitable large-scale production, simple and reasonable steps, and good product stability

Active Publication Date: 2019-05-03
内蒙古双奇药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because probiotics themselves are relatively fragile and easily affected by surrounding environmental factors, especially when micro-ecological live bacteria products are placed at room temperature for a long time, the survival period of probiotics in the product is short, and when they enter the body, the probiotics Decreased quantity and unable to effectively exert its prebiotic effect

Method used

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  • A kind of live bacteria preparation for vagina which can be preserved at room temperature and its preparation method
  • A kind of live bacteria preparation for vagina which can be preserved at room temperature and its preparation method
  • A kind of live bacteria preparation for vagina which can be preserved at room temperature and its preparation method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1. The preparation of the vaginal live bacteria preparation that can be stored at room temperature

[0024] (1) Preparation of microcapsules of Lactobacillus delbrueckii

[0025] The bacterial powder of Lactobacillus delbrueckii DM8909 was placed on a fluidized bed, and the maltodextrin was side-sprayed onto the bacterial powder to make primary microcapsules with stable structure. Among them, the air inlet temperature of the fluidized bed coating machine is 35-65°C, and the air flow rate is 25-65m 3 / h, atomization pressure 0.5-4.0bar, material temperature 30-55℃, spray rate 1-25ml / min, turntable speed 300-600r / min.

[0026] The prepared Lactobacillus delbrueckii microcapsules were observed under a 40-fold microscope to have uniform microcapsule size and less adhesion between microcapsules, and the median diameter of the microcapsule particles was D 50 =157.6um, the flow velocity is 27.4s, the degree of compression is 17.7%, and the angle of repose is 26.3°...

Embodiment 2

[0034] Embodiment 2. Stability test of vaginal live bacteria capsules that can be stored at room temperature

[0035] This stability test is carried out under the conditions of temperature 25°C±2°C and relative humidity 60%±10%, and the time is 12 months. The experimental results are as follows:

[0036] Table 2 Stability test results

[0037]

Embodiment 3

[0038] Example 3. The animal experiment verification of the vaginal live bacteria capsule that can be stored at room temperature

[0039] Five female mice weighing 24-26 g were taken, and 10 mg of vaginal live bacteria capsules were inserted into the vagina of each mouse, once a day, for three consecutive days. From the first day of administration, the health status of the mice and the presence or absence of redness, swelling and secretions at the vaginal opening were observed. By the seventh day, the mice should be healthy, with no symptoms in the vaginal area, and should gain weight. If the mice are unhealthy, lose weight or have the above symptoms, the batch of products should be judged as unqualified.

[0040] The experimental results are:

[0041] Table 3 Safety test results

[0042]

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PUM

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Abstract

The present invention discloses a vaginal living bacteria preparation capable of being preserved at normal temperature and a preparation method thereof, lactobacillus delbrueckii microcapsules can be prepared from lactobacillus delbrueckii powder in the manner of side spraying by use of a fluidized bed coater, the lactobacillus delbrueckii microcapsules are mixed with modified starch processed by microwave drying technology to prepare capsules, the vaginal living bacteria capsules can be preserved at normal temperature for 12 months. The preparation method of the vaginal living bacteria preparation has the advantages of being strongly practical, simple in operation, short in cycle, reasonable and simple in step, low in cost, high in yield, and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a vaginal live bacteria preparation capable of treating bacterial vaginosis and a preparation method thereof. The live bacteria preparation has strong storage stability under normal temperature conditions. Background technique [0002] The vaginal micro-ecosystem is one of the important micro-ecosystems of the human body. There are a variety of microorganisms in the vagina of healthy women, the most common are Lactobacillus, Staphylococcus, Streptococcus, Enterobacter, Enterococcus, Corynebacterium, Bacteroides, Candida albicans, Mycoplasma, viruses, etc. normal flora. Currently recognized as the most important member of the normal vaginal flora is Lactobacillus, which is a resident bacterium of the normal vagina. In vaginal discharge specimens, the separation rate is 80% to 100%, and the number can reach 8×10 7 CFU / mL, other bacteria are non-physiologic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/50A61K35/747A61K47/36A61P15/02A61P31/04
CPCA61K9/5036A61K35/747
Inventor 黄少磊刘彦民夏少明李林泉刘云辉张春霞李康宁王春颖冯谦韩至马征途马晓娟金海英杨飞雁李晓军龚虹马晓红程超马跃英王海霞邢会霞王潇焦志军冯锐成
Owner 内蒙古双奇药业股份有限公司
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