Metronidazole vaginal tablet process and quality control method

A quality control method and technology for vaginal tablets, which are applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc., can solve the problems of affecting the physiological pH value of the vagina, moisture absorption and gas production during storage, and irritation caused by acidic ingredients, etc. To achieve the effect of reducing adverse reactions, convenient use, and promoting disease recovery

Inactive Publication Date: 2008-10-15
何文健
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  • Claims
  • Application Information

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Problems solved by technology

Although there are many varieties of gynecological medicines, there are certain problems in their use and treatment; in addition, Shuangzotai vaginal effervescent tablets are currently on ...

Method used

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  • Metronidazole vaginal tablet process and quality control method
  • Metronidazole vaginal tablet process and quality control method
  • Metronidazole vaginal tablet process and quality control method

Examples

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Embodiment

[0019] Example: (1) prescription metronidazole 200g, clotrimazole 160g, chlorhexidine acetate 8g, lactose 40g, starch 20.0g, calcium lactate 60g, lactic acid 82g, hypromellose 6.0g, silicon dioxide 30.0g , microcrystalline cellulose 182.0g crospovidone 120g (additional 40g), magnesium stearate 4.0g.

[0020] (2) Method

[0021] A pretreatment: In addition to lactic acid, metronidazole, clotrimazole, chlorhexidine acetate, lactose, starch, calcium lactate, lactic acid, silicon dioxide, crospovidone, microcrystalline cellulose, magnesium stearate Pass through a No. 7 sieve.

[0022] B Shuangzotai vaginal tablet granule preparation: take metronidazole, clotrimazole, chlorhexidine acetate and lactose, starch, calcium lactate, lactic acid, crospovidone 80g of prescription quantity, use 2% hypromellose The plain aqueous solution is used as a binder, granulated with 16 mesh, dried at 60-70°C, granulated with a 16 mesh sieve, and 40 g of magnesium stearate, silicon dioxide, microcry...

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Abstract

The invention relates to a preparation method and a quality control method of a new gynecologic drug, Metronidazole, Clotrimazole and Chlorhexidine Acetate Vaginal Tablets, with antibacterial and anti-inflammatory effects. The added lactic acid-calcium lactate buffer system results in a drug with pH of 3.5-4.0 t that is similar to the physiological pH in vagina, so as to effectively retain physiological environment in vagina, provide existing conditions suitable for vaginal beneficial bacteria, and promote rehabilitation. The main preparation method comprises the steps of compounding, granulating, grading, mixing, and tabletting. The quality control method comprises the steps of collecting one dosage unit of the product, grinding, adding 100mL water, shaking for 10min, and testing pH (should be 3.5-4.0); testing melting time limit (should be 30min); and measuring the nominal content of the three components by high performance liquid chromatography (should be both in the range of 90.0-110.0%).

Description

technical field [0001] The invention relates to a preparation method and a quality control method of a new gynecological antibacterial and anti-inflammatory drug Shuangzotai vaginal tablet. Background technique [0002] At present, trichomonas, anaerobes, molds and other bacterial infectious gynecological diseases seriously threaten women's health. Although there are many varieties of gynecological medicines, there are certain problems in their use and treatment; in addition, Shuangzotai vaginal effervescent tablets are currently on the market, which have problems of absorbing moisture and producing gas during storage, and stimulating pain with acidic components; affecting the physiological pH value of the vagina. question. [0003] The purpose of the present invention is to overcome the shortcomings of the existing varieties, provide a novel preparation with spectrum, high efficiency, quick effect, stability and good patient compliance and provide a quality control method....

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4164A61K31/155A61P15/02
Inventor 王世锋
Owner 何文健
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