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
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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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