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A kind of steroid hormone coating agent and preparation method thereof

A technology of steroid hormones and film-coating agents, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as difficult cleaning, drug loss, and cumbersome preparation process , achieve the effects of reducing skin irritation, promoting hydration, and simple preparation process

Active Publication Date: 2011-11-30
上海市生物医药技术研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In transdermal preparations, such as sprays, solutions, lotions, ointments, films, gels, etc., there are certain disadvantages: that is, it may cause drug loss when the patient rubs, and it is easy to contaminate the patient's clothing , or pollute the exposed population, it is not easy to clean up; the patch may cause adverse reactions such as allergies or even ulcers due to poor air permeability; the preparation process is cumbersome and requires high preparation equipment, such as vacuum mixer or coating machine, etc.
The reason is that: firstly, it is quite difficult to screen out a matrix (film-forming material, etc.) that can be well compatible with the main active ingredient-steroid hormone drugs, such as severe precipitation of such drugs or poor film properties; secondly, the preparation The poor air permeability or irritation brought by the ingredients makes it poorly tolerated, and adjusting the ingredients may lead to reduced adhesion and drug efficacy

Method used

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  • A kind of steroid hormone coating agent and preparation method thereof
  • A kind of steroid hormone coating agent and preparation method thereof
  • A kind of steroid hormone coating agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] 20g film formulation:

[0047] Testosterone (Zhejiang Xianju Pharmaceutical Factory) 100mg

[0048] PVA 05-88 (China Pharmaceutical (Group) Shanghai Chemical Reagent Company) 300mg

[0049] CMC-Na (China Pharmaceutical (Group) Shanghai Chemical Reagent Company) 100mg

[0050] Glycerin (Shanghai Chemical Reagent Co., Ltd.) 200mg

[0051] Lauryl alcohol (Sinopharm Chemical Reagent Co., Ltd.) 1000μL

[0052] Ethanol (Shanghai Zhenxing Chemical Plant No. 1) up to 20g

[0053] Add water to swell 300mg of PVA, let it stand overnight, and then heat and dissolve in an upper water bath to obtain substance A.

[0054] Add water to 100 mg of CMC-Na to swell and leave overnight to make gel B.

[0055] Add 200mg of glycerin and gel B to substance A respectively, stir well to obtain transparent colloid C.

[0056] Finally, weigh 100 mg of testosterone and add it to 12.2 grams of ethanol, stir to dissolve and immediately add 1000 microliters of lauryl alcohol, slowly add it to t...

Embodiment 2

[0059] 20g film formulation:

[0060] Testosterone (Zhejiang Xianju Pharmaceutical Factory) 100mg

[0061] PVA 17-88 (China Pharmaceutical (Group) Shanghai Chemical Reagent Company) 360mg

[0062] CMC-Na (China Pharmaceutical (Group) Shanghai Chemical Reagent Company) 100mg

[0063] Carbomer (Langfang Jutong Chemical Co., Ltd.) 100mg

[0064] Glycerin (Shanghai Chemical Reagent Co., Ltd.) 200mg

[0065] Transcutol p (GATTEFOS SE) 600μL

[0066] Ethanol (Shanghai Zhenxing Chemical Plant No. 1) up to 20g

[0067] Add water to swell 360mg of PVA, let stand overnight, and then heat and dissolve in an upper water bath to obtain substance A.

[0068] Add water to 100 mg of CMC-Na to swell and leave overnight to make gel B.

[0069] Add 4.8 ml of ethanol to 100 mg of carbomer to dissolve and leave overnight to make gel B.

[0070] Add 200mg of glycerin and gel B to substance A respectively, stir well to obtain transparent colloid C.

[0071] Finally, 100 mg of testosterone wa...

Embodiment 3

[0074] 20g film formulation:

[0075] Testosterone (Zhejiang Xianju Pharmaceutical Factory) 100mg

[0076] PVA 124 (Japan Kuraray) 400mg

[0077] CMC-Na (China Pharmaceutical (Group) Shanghai Chemical Reagent Company) 100mg

[0078] Carbomer (Langfang Jutong Chemical Co., Ltd.) 100mg

[0079] Propylene glycol (Sinopharm Chemical Reagent Co., Ltd.) 150mg

[0080] IPM (Sinopharm Group Chemical Reagent Co., Ltd.) 1600μL

[0081] Ethanol (Shanghai Zhenxing Chemical Plant No. 1) up to 20g

[0082] Add water to swell 400mg of PVA, let stand overnight, and then heat and dissolve in an upper water bath to obtain substance A.

[0083] Add water to 100 mg of CMC-Na to swell and leave overnight to make gel B.

[0084] Add 4 ml of ethanol to 100 mg of carbomer to dissolve and leave overnight to make gel B.

[0085] Add 150 mg of propylene glycol and gel B to substance A respectively, stir evenly, and obtain transparent colloid C.

[0086] Finally, weigh 100 mg of testosterone and ...

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Abstract

The invention relates to a film coating agent containing steroid hormone, which comprises 1 part of steroid hormone medicament, 1-50 parts of film forming materials, 0.5-10 parts of plasticizer, 0.5-10 parts of biological adhesive materials and 1-50 volumes of transdermal enhancer. The preparation of the present invention is capable of raising the efficiency of conveying steroid hormone medicament into the body by permeating skin and improving the irritation to the skin, and has good survivability. The invention also relates to a preparation method of the film coating agent, and the preparation method has the advantages of simple process, convenient operation and less energy consumption.

Description

(1) Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a coating agent containing steroid hormone drugs and a preparation method thereof. (2) Background technology [0002] Steroid hormones play a definite role in maintaining life, regulating sexual function, developing the body, regulating immunity, treating skin diseases and birth control. When the level of steroid hormones in the body is low or lacking, it will produce very painful syndromes, loss of fertility, serious and even life-threatening. For example, studies have shown that one of the reasons for male hypogonadism or postmenopausal female sexual disorder (HSDD) is due to the lack of androgen. Steroid hormones are often used in hormone replacement therapy or to supplement deficient hormone levels in the body. However, most natural steroid hormones, such as testosterone, are hardly absorbed in the gastrointestinal tract, and oral administration is ineffective...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/56A61K47/32A61K47/38A61K47/36A61K47/42A61K47/34A61P15/00A61P37/02A61P17/00A61P15/08A61P5/24
Inventor 俸灵林谢谭芳郑昕陈良康陈建兴陈海林黄婷李芳
Owner 上海市生物医药技术研究院
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