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Danazol vaginal tablet process and quality control method

A quality control method, the technology of danazol, is applied in the direction of pharmaceutical formula, medical preparations containing active ingredients, pill delivery, etc. It can solve the problems of affecting vaginal physiological pH value, body temperature melting loss, storage deformation, etc., and achieve reduction Effects of adverse reactions, promotion of disease recovery, and convenience of use

Inactive Publication Date: 2008-10-15
王世锋
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although there are many kinds of gynecological drugs, there are certain problems in use and treatment; in addition, there are danazol suppositories on the market, which have problems of storage deformation, melting and loss when encountering body temperature, and contamination of clothes; problems affecting the physiological pH value of the vagina question

Method used

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

Examples

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Embodiment

[0020] Example: (1) Prescription danazol 50g, lactose 65g, starch 180.0g, calcium lactate 60g, lactic acid 82g, hypromellose 3.0g, silicon dioxide 15.0g, microcrystalline cellulose 90.0g crospovin Ketone 60g (plus 20g), magnesium stearate 2.0g.

[0021] (2) Method

[0022] A pretreatment: In addition to lactic acid, danazol, lactose, starch, calcium lactate, silicon dioxide, crospovidone, microcrystalline cellulose, and magnesium stearate were passed through a No. 7 sieve.

[0023] Preparation of B danazol vaginal tablet granules: take by weighing 40 g of danazol and lactose, starch, calcium lactate, lactic acid, microcrystalline cellulose, and crospovidone of the prescribed amount, and use 2% hypromellose aqueous solution as a bonding agent. 16-mesh granulation, drying at 60-70°C, sizing with a 16-mesh sieve, adding prescription amount of magnesium stearate, silicon dioxide, and 20 g of additional crospovidone, and mixing. Measure the drug content of the granules and calcul...

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Abstract

The invention relates to a preparation method and a quality control method of a new drug, Danazol Vaginal Tablets, for treating endometriosis with clear dysmenorrhea symptom but light physical sign. The drug can be delivered via cavitary mucosa, so as to prevent or relieve the possible adverse reactions due to systemic drug delivery; the effective drug concentration at lesion site is high, so as to be in favor of exert curative action; and the added lactic acid-calcium lactate buffer system results in the drug with pH of 3.5-4.0 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.

Description

technical field [0001] The invention relates to a preparation method and quality control method of danazol vaginal tablets, a new drug for endometriosis with obvious symptoms of gynecological dysmenorrhea but relatively mild signs. Background technique [0002] At present, dysmenorrhea and endometriosis seriously threaten women's health. Although there are many kinds of gynecological drugs, there are certain problems in use and treatment; in addition, there are danazol suppositories on the market, which have problems of storage deformation, melting and loss when encountering body temperature, and contamination of clothes; problems 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. Contents of the invention [0...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/58A61P15/02
Inventor 王世锋
Owner 王世锋
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