Preparation method of progestin sustained-release gel for treating threatened abortion

A technology for slow-release gel and progesterone, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, sexual diseases, etc., and can solve problems such as drug loss, reduction, and inconvenience of medication that are not considered.

Inactive Publication Date: 2013-08-14
SHANGHAI ZHAOHUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Since the gel is a relatively thin semi-solid with a certain degree of viscosity and fluidity, it will flow out with vaginal secretions after administration, which will cause inconvenience and loss of medication and reduce the curative effect.
In the progesterone vaginal gel preparations reported so far, none of the medicines will be lost at the administration site and affect the efficacy of the medicine.

Method used

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  • Preparation method of progestin sustained-release gel for treating threatened abortion
  • Preparation method of progestin sustained-release gel for treating threatened abortion
  • Preparation method of progestin sustained-release gel for treating threatened abortion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025]

[0026] Process:

[0027] Preparation of progesterone emulsion: oil phase, heating and melting liquid paraffin and Span-80, after reaching 70°C, add micronized progesterone and stir. For the water phase, mix polyethylene glycol 400, purified water and glycerin, and heat to 60°C. Add the oil phase to the water phase while stirring continuously and cooling down. Homogenize and form an emulsion.

[0028] Preparation of temperature-sensitive gel: Add Poloxamer 407 to fully swollen Carbomer 974 aqueous solution, stir evenly, add progesterone emulsion into the temperature-sensitive gel matrix, stir continuously, cool down, and adjust with sodium hydroxide solution pH to 4.5, that's it.

Embodiment 2

[0030]

[0031]

[0032] Process:

[0033] Preparation of progesterone emulsion: In the oil phase, liquid paraffin and Tween-80 are heated and melted, and after reaching 70°C, micronized progesterone is added and stirred. For the aqueous phase, mix and dissolve purified water, polyethylene glycol 400, sorbic acid, and glycerin, and heat to 60°C. Add the oil phase to the water phase while stirring continuously to homogenize and form an emulsion.

[0034] Preparation of temperature-sensitive gel: Add poloxamer 407 to fully swollen carbomer 974 aqueous solution, adjust the pH to 4.1 with sodium hydroxide solution, stir evenly, add the emulsion of progesterone into the temperature-sensitive gel matrix, and continuously Stir, cool down, and serve.

Embodiment 3

[0036]

[0037] Process:

[0038] Preparation of progesterone emulsion: In the oil phase, liquid paraffin, hydrogenated palm oil glyceride, and glyceryl monostearate are heated and melted, and after reaching 70°C, micronized progesterone is added and stirred. For the water phase, mix and dissolve polyethylene glycol 400, purified water, and disodium EDTA, and heat to 60°C. The oil phase is added to the water phase while stirring continuously to homogenize and form an emulsion, and the pH is adjusted to 3.5 with sodium hydroxide.

[0039]Preparation of temperature-sensitive gel: Add poloxamer 407 into fully swollen carbomer aqueous solution, stir evenly, add progesterone emulsion into the temperature-sensitive gel matrix, stir continuously, and cool down.

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Abstract

The invention relates to a progestin sustained-release gel for treating threatened abortion. The progestin sustained-release gel is prepared by the following steps: preparing micronized progestin emulsion; and dispersing the emulsion in a temperature-sensitive body gel matrix to form the progestin temperature-sensitive sustained-release gel.

Description

Technical field: [0001] The invention belongs to the field of preparations, and relates to progesterone sustained-release gel for treating threatened abortion. Firstly, micronized progesterone emulsion is prepared, and then the emulsion is dispersed into a temperature-sensitive in-body gel matrix to form a Progesterone thermosensitive slow-release gel. Background technique: [0002] Progesterone is a natural progestin secreted by the corpus luteum of the ovary. It has a significant morphological effect on the estrogen-stimulated endometrium in vivo and is necessary to maintain pregnancy. Progesterone is clinically used in the reactive diagnosis of threatened abortion, habitual abortion and other amenorrhea or the cause of amenorrhea. [0003] Progesterone is a steroid hormone secreted by the ovary, placenta and adrenal gland. In the presence of sufficient estrogen, progesterone can change the endometrium from the proliferative phase to the secretory phase, providing favorab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/57A61K47/34A61P15/00
Inventor 张自强郑一美谢晓燕戴青徐张展
Owner SHANGHAI ZHAOHUI PHARMA
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