Clotrimazole vaginal tablet composition and preparation method thereof
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A composition, technology of clotrimazole, applied in the field of clotrimazole vaginal tablet composition and its preparation, can solve problems such as poor stability
Active Publication Date: 2020-10-20
DISHA PHARMA GRP
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[0007] Clotrimazole is a broad-spectrum imidazole antifungal drug, almost insoluble in water, and has poor stability in acidic environment. It is the first-line drug for candida vulvovaginitis, infection caused by yeast, and double infection caused by sensitive bacteria
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Embodiment 1
[0046] Embodiment 1: a kind of clotrimazole vaginal tablet, its preparation prescription:
[0047]
[0048] Preparation Process:
[0049] 1) Bacterial solution preparation: Boil purified water, add prescription amount of starch to prepare 3% (g / g) starch slurry, cool to room temperature below 30°C, add lactobacillus powder and mix well, then use prescription amount of lactic acid and lactic acid Calcium, the measured pH is 2.51;
[0051] Using fluidized bed bottom spray coating technology, spray the bacterial liquid prepared in the first step onto the surface of cellulose lactose C80, then dilute Eudragit® RL30D to 10% concentration for coating, the coating weight increases by 10%, and dry , the particles are sieved through a 30-mesh sieve, and set aside;
[0052] Process parameters: The air inlet temperature of the fluidized bed coating agent is 40°C; the air flow rate is 25Hz, the atomization pressure is 0.4mpa, t...
Embodiment 2
[0056] Embodiment 2: a kind of clotrimazole vaginal tablet, its preparation prescription:
[0057]
[0058] Preparation process: The preparation process is the same as in Example 1, the starch slurry concentration is 4%, and the pH value is 3.01.
Embodiment 3
[0059] Embodiment 3: a kind of clotrimazole vaginal tablet, its preparation prescription:
[0060]
[0061] Preparation process: the preparation process is the same as in Example 1, the starch slurry concentration is 6%, and the pH value is 2.72.
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Abstract
The invention relates to a clotrimazole live lactobacillus composition and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The clotrimazole live lactobacillus vaginal tablet disclosed by the invention comprises 500mg of clotrimazole; 1mg of lactobacillus powder; 20mg to 30mg of lactic acid; 8-12mg of calcium lactate; 6-12mg of starch; 200-300mg of cellulose lactose C80; 66mg to 180mg of eudragit-RL30D; 225mg to 314mg of lactose; 170mg to 225mg of microcrystalline cellulose; 70mg of crospovidone; 20mg of colloidal silicon dioxide; and 10 mg of magnesium stearate. The invention provides the clotrimazole live lactobacillus vaginal tablet.
Description
technical field [0001] A clotrimazole vaginal tablet composition and a preparation method thereof. Background technique [0002] Candida vaginitis is a common gynecological disease, which is caused by Candida infection. The clinical manifestations are extrinsic itching and leucorrhea, which seriously affects the quality of life of women. [0003] Candida, also known as Candida albicans, is most suitable for the pH value of the breeding environment to be 5.5 to 6.5. It adheres to body tissues, secretes adenosine to block neutrophils from releasing oxygen free radicals, and produces aspartase to degrade cells. Extracellular matrix, and increase the glycogen and acidity in the vagina, causing tissue damage and inflammation. [0004] Under normal circumstances, the pH value of the female vagina is maintained at 3.8 to 4.4, which inhabits microorganisms that are not harmful to the human body, commonly known as normal microflora or normal flora; under this condition, the relation...
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