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Intra-uterus administered medicinal stick of danazol and preparation process thereof

A technology of danazolome and danazol, which is applied in the field of pharmaceutical preparations and preparations, can solve the problems of no case, unspecified regular quantitative drug release rate, etc., and achieve the effect of stable drug release rate

Inactive Publication Date: 2007-05-23
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the cases in this study were not pathologically diagnosed, nor did they illustrate how much appropriate regular quantitative drug release rate, and the impact of local doses on various organs throughout the body

Method used

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  • Intra-uterus administered medicinal stick of danazol and preparation process thereof
  • Intra-uterus administered medicinal stick of danazol and preparation process thereof
  • Intra-uterus administered medicinal stick of danazol and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: the preparation of danazol long-acting drug stick

[0021] Take silicone gel (hereinafter referred to as component A), and silicone gel vulcanizing agent (hereinafter referred to as component B), mix uniformly according to 1:1 (W:W); 1:1, 1:1.5, 1:2, 1:3, add components A and B that are well mixed, stir and mix. Coat the silicone gel emulsion of the drug on a polyvinyl chloride rod with a diameter of 0.15 cm, the drug amount is about 175 mg / cm, and vulcanize at room temperature for 24 hours to obtain a long-acting danazol drug rod.

[0022] Intercept 1 cm of the danazol long-acting drug stick, put it into 1000 ml of release medium (0.1% HCl:isopropanol=6:4), shake at a constant temperature of 37°C, 60 times / min, at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144h, 7 days, 8, 9, 10, 11, 12, 13, 14, 15, 20... (until more than 3 months) sampling 1ml. The sample was filtered through a 0.45 μm microporous membrane, and 20 μL of the filtrate was injected...

Embodiment 2

[0029] Embodiment 2: the preparation of danazol long-acting drug stick (silicone gel proportioning)

[0030] Take components A and B, and mix them uniformly according to 0.6:1, 0.7:1, 0.8:1, 0.9:1 (W:W); in addition, weigh an appropriate amount of danazol, and the ratio of drug to carrier is 1:3 (W:W) : W), add in the well-mixed silicone gel emulsion, stir and mix. Coat the silicone gel emulsion of the drug on a polyvinyl chloride rod with a diameter of 0.15 cm, the drug amount is about 175 mg / cm, and vulcanize at room temperature for 24 hours to obtain a long-acting danazol drug rod.

[0031] Intercept 1 cm of the danazol long-acting drug stick, put it into 1000 ml of release medium (0.1% HCl:isopropanol=6:4), shake at a constant temperature of 37°C, 60 times / min, at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144h, 7 days, 8, 9, 10, 11, 12, 13, 14, 15, 20... (until more than 3 months) sampling 1ml. The sample was filtered through a 0.45 μm microporous membrane, and 2...

Embodiment 3

[0034] Embodiment 3: the preparation of danazol long-acting drug stick (silicone gel ratio)

[0035] Take components A and B, and mix them uniformly according to 1:0.5, 0.5:1 (W:W); in addition, weigh an appropriate amount of danazol, according to the ratio of drug to carrier of 1:3 (W:W), add the mixed In the silicone gel emulsion, stir and mix well. Coat the silicone gel emulsion of the drug on a polyvinyl chloride rod with a diameter of 0.15 cm, the drug amount is about 175 mg / cm, and vulcanize at room temperature for 24 hours to obtain a long-acting danazol drug rod.

[0036] Intercept 1 cm of the danazol long-acting drug stick, put it into 1000 ml of release medium (0.1% HCl:isopropanol=6:4), shake at a constant temperature of 37°C, 60 times / min, at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 hours, 7 days, 8, 9, 10, 11, 12, 13, 14, 15, 16... (sampling the next day until 3 More than one month) sample 1ml. The sample was filtered through a 0.45 μm microporous m...

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PUM

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Abstract

The invention relates to a Danaco drug rod for feeding agent in uterus, wherein it uses silicon gel as carrier, uses polychloroethylene rod as support, and it is formed by 20.0% Danaco, 40.0% silicon gel, and 40.0% silicon gel vulcanizer. The production comprises that: mixing drug and silicon gel uniformly to be coated on support to prepare rod agent; the rod agent can release drug at 1-7% of total amount each day, to function for three months. The invention can express local drug function, to function the uterus directly. And it uses slow-release agent to release drug stably.

Description

technical field [0001] The invention belongs to a pharmaceutical preparation and a preparation method, and relates to a danazol intrauterine long-acting administration stick composition and a preparation method. Background technique [0002] Adenomyosis is a common gynecological disease that seriously affects women's physical and mental health. Since the etiology and pathogenesis of this disease are still unclear, women suffering from this disease often undergo traumatic radical hysterectomy due to menorrhagia or severe dysmenorrhea. For young women who want to have children, and women who do not require surgery for the time being, only injections of luteinizing hormone-releasing hormone agonists or oral preparations of danazol can be used to temporarily control their clinical symptoms or shrink their lesions. The final radical hysterectomy is the final treatment that cannot be avoided. [0003] Conservative treatment with oral danazol, due to the serious side effects of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61K9/00A61K47/32A61K47/04A61P15/00
Inventor 林俊张信美胡富强邓琳袁弘
Owner ZHEJIANG UNIV
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