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Preparation method of progesterone vaginal gel

A technology of vaginal gel and progesterone, which is applied in the field of drug preparation, can solve the problems of difficulty in controlling the content uniformity of raw materials, rapid swelling, etc., and achieve the effect of solving rapid polymer swelling, simple operation process, and convenient large-scale industrial production

Active Publication Date: 2021-08-24
ZHEJIANG XIANJU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the problems and deficiencies in the above-mentioned prior art, the purpose of the present invention is to solve the problems such as the rapid swelling of the polymer of the suspension gel and the difficult control of the content uniformity of the raw material drug in the preparation process of the progesterone vaginal gel. At the same time, the in vitro dissolution is consistent with that of the original drug

Method used

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  • Preparation method of progesterone vaginal gel
  • Preparation method of progesterone vaginal gel
  • Preparation method of progesterone vaginal gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Prepare raw materials according to prescription,

[0093] Prepare as follows:

[0094] a, the preparation of the premix of raw material drug and polymer, mix progesterone, carbomer, and polycarbophil in the mixing tank according to the prescription ratio, mix at a speed of 10 rpm, and take 6 minutes to obtain the premix,

[0095] b. Water phase preparation, add glycerin and sorbic acid into purified water according to the prescription ratio, stir to dissolve, stirring at a speed of 10 rpm for 1 hour;

[0096] c. Add the premix into the water phase under stirring conditions, heat and stir until a uniform gel phase is formed, stir rapidly at 1500 rpm, stir slowly at 25 rpm, and stir for 2.5 hours to obtain a hydrogel phase;

[0097] d. Preparation of oil phase, heating liquid paraffin and hydrogenated palm oil to 75°C to melt, and mixing evenly;

[0098] e. Heat the hydrogel phase to the same temperature as the oil phase, mix the two phases, stir rapidly at 1500rpm, sti...

Embodiment 2

[0109] Prepare raw materials according to prescription,

[0110] Prepare as follows:

[0111] Others are the same as in Example 1, except that: in step a, the mixing speed is 30 rpm, and the time is 5 minutes; in step d, it is heated to 55° C. to melt.

[0112] The evaluation process is the same as in Example 1.

[0113] The evaluation results of appearance and mixing uniformity are shown in Table 3. The release results are as Figure 5 shown.

Embodiment 3

[0115] Prepare raw materials according to prescription,

[0116] Prepare as follows:

[0117] Others are the same as in Example 1, except that: in step a, the mixing speed is 25 rpm, and the time is 10 minutes; in step c, the stirring speed is 1000 rpm.

[0118] The evaluation process is the same as in Example 1.

[0119] The evaluation results of appearance and mixing uniformity are shown in Table 3. The release results are as Figure 6 shown.

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Abstract

The invention belongs to the field of gynecological medicine preparation, and particularly relates to a preparation method of progesterone vaginal gel, which comprises: preparing a premix from active pharmaceutical ingredients progesterone and a polymer, adding into a water phase to obtain a hydrogel phase, adding a proper amount of a sodium hydroxide solution, and adjusting the pH value to 2.5-3.5 to obtain the progesterone vaginal gel. The progesterone vaginal gel can effectively solve the problems that in the progesterone vaginal gel preparation process, a polymer such as suspension gel swells quickly, and the content uniformity of raw material medicines is difficult to control, and meanwhile in-vitro dissolution is consistent with that of an original drug.

Description

technical field [0001] The invention belongs to the field of medicine preparation, and in particular relates to the preparation of obstetrics and gynecology medicine, and more specifically relates to a preparation method of progesterone vaginal gel. Background technique [0002] Progesterone is an important component to regulate the female reproductive system. It mainly acts on the uterus, ovary and its breasts and the central nervous system (CNS). During the luteal phase of women's menstrual cycle and pregnancy, the blood concentration of progesterone in the body is very high. Progesterone is produced in the corpus luteum during non-pregnancy and early pregnancy, and in the placenta later in pregnancy. Endogenous progesterone can transform the endometrium from the proliferative phase to the secretory phase and maintain normal physiological changes. [0003] Progesterone vaginal sustained-release gel was developed by Columbia and Pfizer, marketed by Actavis and Merck Serono...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/57A61K47/32A61K47/22A61K47/10A61K47/12A61P15/06A61P15/00
CPCA61K9/08A61K9/0034A61K31/57A61K47/32A61K47/22A61K47/10A61K47/12A61P15/06A61P15/00
Inventor 王咏魏白肖杨会
Owner ZHEJIANG XIANJU PHARMA
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