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Urotropin freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and urinary gonadotropin, which is applied in freeze-drying transportation, sexual diseases, powder transportation and other directions, can solve the problems of less freeze-drying time, lower titer, and high production cost, and achieves improved pre-freezing speed, Avoid the effect of reducing the content and shortening the freeze-drying time

Inactive Publication Date: 2011-12-28
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And in strong acid and strong alkali HCl or NaOH solution, the stability of polypeptide biochemical drugs will be affected, which will easily lead to a decrease in potency and a decrease in content;
[0017] 4. During the freeze-drying process, the freeze-drying time is too short to achieve complete freeze-drying. Therefore, the freeze-drying time must exceed 22 hours
However, the longer the freeze-drying time, the longer the urogonadotropin is in a non-dry state, the more unstable the product quality, the greater the energy consumption, and the higher the production cost

Method used

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  • Urotropin freeze-dried powder injection and preparation method thereof
  • Urotropin freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Embodiment 1: Urotropin freeze-dried powder injection

[0049] 1. Prescription: 60,000 units of gonadotropin, 4g of L-arginine, 30g of mannitol, and 3.0g of phosphate buffered saline (composed of sodium dihydrogen phosphate and disodium hydrogen phosphate in a weight ratio of 1:1).

[0050] 2. Production process:

[0051] 1) Preparation

[0052] Weigh 30g of mannitol, put it into a stainless steel bucket, add 500ml of water for injection to dissolve, add 1.0g of activated carbon, boil, keep warm for 15 minutes, then filter and decarbonize to obtain solution A;

[0053] Add 4g of L-arginine to solution A, stir to dissolve, and cool to 6°C to obtain solution B;

[0054]Take 3.0g of phosphate buffered saline, add 200ml of cold water for injection at 5°C to dissolve, then add 60,000 units of urogonadotropin, and dissolve to obtain solution C;

[0055] Slowly pour solution B and solution C into the batching tank, then make up the volume to a total of 1000ml with 5°C cold ...

Embodiment 2

[0070] Embodiment 2: Urotropin freeze-dried powder injection

[0071] 1. Prescription: 200,000 units of urotropin, 8 g of L-arginine, 20 g of mannitol, and 6.0 g of phosphate buffered saline (composed of sodium dihydrogen phosphate and disodium hydrogen phosphate in a weight ratio of 2:1).

[0072] 2. Production process:

[0073] 1) Preparation:

[0074] Weigh 20g of mannitol, put it into a stainless steel bucket, add 400ml of water for injection to dissolve, add 0.8g of activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain solution A;

[0075] Add 8g of L-arginine to solution A, stir to dissolve, and cool to 6°C to obtain solution B;

[0076] Weigh 6.0g of phosphate buffered saline, add 300ml of cold water for injection at 8°C to dissolve, then add 200,000 units of urotropin, and dissolve to obtain solution C;

[0077] Slowly pour solution B and solution C into the batching tank, then make up the volume with 8°C cold water for injection to a to...

Embodiment 3

[0091] Embodiment 3: Urotropin freeze-dried powder injection

[0092] 1. Prescription: 100,000 units of urotropin; 6g of L-arginine; 35g of mannitol; 4.0g of phosphate buffered saline (composed of sodium dihydrogen phosphate and disodium hydrogen phosphate in a weight ratio of 1:1).

[0093] 2. Production process:

[0094] 1) Preparation process operation process:

[0095] Weigh 35g of mannitol, put it into a stainless steel bucket, add 400ml of water for injection to dissolve, add 0.8g of activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain solution A;

[0096] Add 6g of L-arginine to solution A, stir to dissolve, and cool to 6°C to obtain solution B;

[0097] Weigh 4.0 g of phosphate buffered saline, add 200 ml of cold water for injection at 10°C to dissolve, and then add 100,000 units of gonadotropin powder to dissolve to obtain solution C;

[0098] Slowly pour solution B and solution C into the batching tank, then make up the volume with 10...

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Abstract

The invention relates to a urethrotropin freeze-dried powder injection and a preparation method thereof. In every 1 mg freeze-dried powder injection: the active ingredient is 60-200 units based on the titer of follicle-stimulating hormone, and the auxiliary materials are L-arginine, The composition of mannitol and phosphate buffer salt is 4-8:20-40:2.0-6.0 according to the weight ratio. The formula of the present invention prevents the urea gonadotropin from existing in the aqueous solution state for a long time in the preparation process, reduces the freeze-drying time, and increases the stability of the urea gonadotropin freeze-dried powder injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried powder injection of urotropin and a preparation method thereof. Background technique [0002] Urinary gonadotropins (Menotropins) are glycoprotein gonadotropins extracted and refined from the urine of menopausal women. They are composed of follicle stimulating hormone (FSH, molecular weight: 32,000) and luteinizing hormone (LH, molecular weight is about 30,000) according to the ratio of 1: Composition of the potency ratio of 1, follicle-stimulating hormone can stimulate the growth and maturation of follicles, luteinizing hormone can cause ovulation and stimulate corpus luteum development, but the amount of luteinizing hormone contained in urinary gonadotropin is not enough to make corpus luteum develop, so its main The role is to stimulate follicle development, prepare mature follicles for ovulation, and often give chorionic gonadotropin to stimulate ovul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/24A61P15/08
Inventor 尹双青刘永宏
Owner 蚌埠丰原涂山制药有限公司
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