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Progesterone membrane agent and its preparing method

A ketone film and progesterone technology, which is applied to the progesterone film for external vaginal use and the field of preparation thereof, can solve the problems of difficulty in ensuring accurate drug dosage, inability to stand up immediately, and a large proportion of suppository bases, thereby avoiding metabolic burden, High progesterone concentration, rapid melt release effect

Inactive Publication Date: 2009-05-13
成都博爱医学科学技术研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, both suppositories and gels have body position restrictions. In order to prevent the medicine from falling out after use, you cannot stand and act immediately.
The matrix ratio of suppositories is relatively large, and the matrix is ​​easy to flow out after melting, so it is difficult to ensure the accuracy of drug dosage
The progesterone gel is easy to flow out after melting, which will cause inaccurate dosage and reduce the efficacy
Therefore, clinical use brings a lot of inconvenience to patients

Method used

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  • Progesterone membrane agent and its preparing method
  • Progesterone membrane agent and its preparing method
  • Progesterone membrane agent and its preparing method

Examples

Experimental program
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Effect test

Embodiment 1

[0034] Embodiment 1 Preparation of progesterone film of the present invention

[0035] 1. Raw materials: progesterone 50g, polyvinyl alcohol 165g, sodium lauryl sulfate 8.75g, ethylparaben 0.25g, water 660ml;

[0036] 2. Preparation method:

[0037] Preparation of liquid A: Weigh 165g of PVA, slowly pour it into a beaker filled with 560ml of water, stir while adding, let it stand still, after fully swelling, heat in a water bath to completely dissolve the PVA, add 5% ethylparaben ethanol Solution 5ml, mix well.

[0038] Configuration of liquid B: Weigh 50 g of the progesterone bulk drug (passed through a No. 9 sieve), add it to 100 ml of 8.75% sodium lauryl sulfate solution, and stir.

[0039] Pour liquid A into liquid B under stirring, stir for 15 minutes, and keep warm in a water bath at 60°C for 1 hour to remove air bubbles. Apply evenly, dry at 80°C until the surface of the film is not sticky, peel off the film, shape it, measure the drug content in the film per unit ar...

Embodiment 2

[0040] Embodiment 2 Preparation of progesterone film of the present invention

[0041] 1. Raw materials: progesterone 50g, polyvinyl alcohol 165g, sodium lauryl sulfate 8.75g;

[0042] 2. Preparation method:

[0043] Preparation of liquid A: Weigh 165g of PVA, slowly pour it into a beaker filled with 560ml of water, stir while adding, let it stand still, after fully swelling, heat in a water bath to completely dissolve the PVA;

[0044] Configuration of liquid B: Weigh 50 g of the progesterone bulk drug (passed through a No. 9 sieve), add it to 100 ml of 8.75% sodium lauryl sulfate solution, and stir.

[0045] Pour liquid A into liquid B under stirring, stir for 15 minutes, and keep warm in a water bath at 60°C for 1 hour to remove air bubbles. Apply evenly, dry at 80°C until the surface of the film is not sticky, peel off the film, shape it, measure the drug content in the film per unit area by high performance liquid chromatography, divide and pack according to the drug cont...

Embodiment 3

[0046] Embodiment 3 Preparation of progesterone film of the present invention

[0047] Raw materials: progesterone 75g, polyvinyl alcohol 245g, sodium lauryl sulfate 13.15g, ethylparaben 0.37g, water 990ml;

[0048] Progesterone film was prepared according to the method described in Example 1, so that its specification was 75 mg / tablet.

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Abstract

The present invention provides a kind of progesterone membrane preparation, each sheet of which contains progesterone in 25-400 mg, and its preparation process. The progesterone membrane preparation is superior to available injection preparation, suppository and gel preparation, and has less side effect, less flow out, accurate medicine content, good flexibility, great tensile strength, high safety, high stability and good controllability.

Description

technical field [0001] The invention relates to a film for external vaginal use, in particular to a progesterone film for external vaginal use and a preparation method thereof, which belongs to the field of medicines. Background technique [0002] Progesterone is a natural progesterone drug that can promote the development of the uterus and breast and prevent miscarriage [1～3] . It is clinically used to treat threatened abortion, habitual abortion, irregular menstruation, functional uterine bleeding, endometriosis, and can be used for contraception when combined with estrogen. Because some synthetic progestogens have excess androgen effects in the body, physiological progestogens are preferred in clinical application. When progesterone is taken orally, it is rapidly metabolized by the liver and fails, so it is invalid when taken orally. At present, the main route of administration of progesterone is intramuscular injection. Because progesterone injection is an oil solutio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/57A61K9/70A61P15/06
Inventor 武斌
Owner 成都博爱医学科学技术研究院
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