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Clomiphene citrate capsule and preparation method thereof

A technology of clomiphene citrate and capsules, which is applied in the directions of capsule delivery, pharmaceutical formulations, and medical preparations containing active ingredients, etc., can solve the problem that the effect cannot be fully utilized, and the slow-release effect of clomiphene citrate capsules Poor, short stay time and other problems, to achieve the effect of promoting follicle development, prolonging the slow release effect, and promoting endometrial thickening

Inactive Publication Date: 2018-02-02
广州市桐晖药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The existing clomiphene citrate capsules have poor slow-release effect, and the residence time in the human body is short, and its effect cannot be fully utilized

Method used

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  • Clomiphene citrate capsule and preparation method thereof

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preparation example Construction

[0035] A preparation method of clomiphene citrate capsules, comprising the following steps:

[0036] a, according to the formula, the clomiphene citrate, letrozole, estradiol valerate, human chorionic gonadotropin, progesterone, levodopa, vitamin B6, ginsenoside Rh2, mannan Glycopeptides, traditional Chinese medicine extracts, fillers, lubricants, and adhesives are ground and passed through a 120-mesh sieve, sieved, placed in a stirring mixer, and mixed evenly, and then prepared into soft materials according to conventional methods;

[0037] b. Turn on the low-temperature refrigerator, control the temperature at 3-15°C, put the soft material prepared in step a into the extrusion spheronizer, select a sieve plate with a sieve hole of 0.5-1.5mm, and extrude and spheronize in the extrusion spheronizer , form drug-loaded pellets with uniform particle size, place them in an oven and dry until the water content is <3.0%, and then obtain the product clomiphene citrate sustained-relea...

Embodiment 1

[0045] A clomiphene citrate capsule, which is composed of a capsule and a core material wrapped inside the capsule,

[0046]The core material comprises the following components in mass percentage: 30 parts of clomiphene citrate; 30 parts of letrozole; 15 parts of estradiol valerate; 8 parts of human chorionic gonadotropin; 3 parts of progesterone 1 part of levodopa; 30 parts of vitamin B6; 234 parts of ginsenoside Rh; 28 parts of mannan peptide; 15 parts of Chinese medicine extract; 200 parts of filler; 10 parts of lubricant; 8 parts of adhesive;

[0047] Its preparation method is as follows:

[0048] A. Preparation of traditional Chinese medicine extract

[0049] Crush steps: use 5 parts of Angelica, 10 parts of Chishao, 12 parts of Eupatorium, 15 parts of Rhizoma Chuanxiong, 12 parts of Rehmannia glutinosa, 12 parts of Dipsacus, 8 parts of Rhizoma Cyperi, 12 parts of Salvia, 12 parts of motherwort, and 8 parts of safflower. The pulverizer is crushed into fine-grained raw m...

Embodiment 2

[0055] A clomiphene citrate capsule, which is composed of a capsule and a core material wrapped inside the capsule,

[0056] The core material comprises the following components in mass percentage: 40 parts of clomiphene citrate; 25 parts of letrozole; 180 parts of estradiol valerate; 6 parts of human chorionic gonadotropin; 5 parts of progesterone 2 parts of levodopa; 40 parts of vitamin B6; 28 parts of ginsenoside Rh; 25 parts of mannan peptide; 22 parts of Chinese medicine extract; 250 parts of filler; 15 parts of lubricant; 12 parts of adhesive;

[0057] Its preparation method is as follows:

[0058] A. Preparation of traditional Chinese medicine extract

[0059] Crush steps: 8 parts of Angelica, 8 parts of Chishao, 15 parts of Eupatorium, 18 parts of Rhizoma Chuanxiong, 15 parts of Rehmannia glutinosa, 13 parts of Dipsacus, 16 parts of Cyperus cyperi, 15 parts of Salvia, 15 parts of motherwort, and 12 parts of safflower The pulverizer is crushed into fine-grained raw ma...

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Abstract

The invention discloses a clomiphene citrate capsule. The clomiphene citrate capsule consists of a capsule and a core material wrapped inside the capsule, wherein the core material is prepared from the following components in parts by weight: 30 to 50 parts of clomiphene citrate, 20 to 30 parts of letrozole, 15 to 20 parts of estradiol valerate, 5 to 8 parts of human chorionic gonadotropin, 3 to 8parts of progestin, 1 to 2 parts of levodopa, 30 to 50 parts of vitamin B6, 25 to 34 parts of ginsenoside Rh2, 20 to 28 parts of mannatide, 15 to 28 parts of traditional Chinese medicine extract, 200to 280 parts of filling agent, 10 to 20 parts of lubricant and 8 to 15 parts of adhesive. The invention also discloses a preparation method of the clomiphene citrate capsule. By adopting the clomiphene citrate capsule and the preparation method thereof, the sustained release effect can be effectively prolonged, and the capsule is ensured to be stably and uniformly released in the human body.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a clomiphene citrate capsule and a preparation method thereof. Background technique [0002] Clomiphene citrate, its chemical name is: N,N~diethyl~2~[4~(1,2~diphenyl~2~chlorovinyl)~phenoxy]ethylamine cis trans iso Citrate salt of a mixture of conformers. Clomiphene citrate (Clomiphene citrate, CC) is so far the first-line drug for ovulation induction in infertile patients with PCOS, because it has a weak estrogenic effect of non-steroidal anti-estrogen preparations, which can competitively bind to hypothalamic cells It reduces the negative feedback of estrogen to the hypothalamus, thereby stimulating the release of GnRH in the hypothalamus, promoting the increase of FSH and LH levels, and promoting follicle development. CC has anti-estrogen activity, and the study found that it has no important clinical significance on the development of endometrium. For PCOS pati...

Claims

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Application Information

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IPC IPC(8): A61K38/24A61K9/48A61P15/08A61K36/8905A61K31/138A61K31/4196A61K31/565A61K31/57A61K31/198A61K31/4415A61K31/704
CPCA61K9/0002A61K9/1652A61K31/138A61K31/198A61K31/4196A61K31/4415A61K31/565A61K31/57A61K31/704A61K36/185A61K36/232A61K36/236A61K36/286A61K36/53A61K36/533A61K36/537A61K36/65A61K36/71A61K36/804A61K36/8905A61K38/24A61K2300/00
Inventor 张彤丽
Owner 广州市桐晖药业有限公司
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