Gonadorelin for injection for veterinary use and preparation method of gonadorelin for injection

A technology of freeze-dried powder injection and chorionic gonadotropin, which is applied in freeze-dried delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Collapse, chorionic gonadotropin damage, etc., to prevent the destruction of the vitrified state, improve the stability of the drug, and ensure the quality of the product

Pending Publication Date: 2021-11-23
苏州素仕生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] For chorionic gonadotropin freeze-dried powder injection, the existing preparation method has certain disadvantages; for example, the freeze-drying time is longer, so that the chorionic gonadotropin is in a non-dried state for a long time, which makes the product quality unstable. Moreover, the energy consumption of the preparation process is large, and the production cost is high; the preparation process is likely to cause damage to chorionic gonadotropins; in addition, the existing preparation methods generally use activated carbon to adso

Method used

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  • Gonadorelin for injection for veterinary use and preparation method of gonadorelin for injection
  • Gonadorelin for injection for veterinary use and preparation method of gonadorelin for injection
  • Gonadorelin for injection for veterinary use and preparation method of gonadorelin for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035]

[0036] Wherein, the concentration of the gelatin solution is 4%, and the coagulation agent is a sodium sulfate solution with a concentration of 60%.

[0037] (1) Add 8000 units of chorionic gonadotropin, 650g lactose, 150g dextrin, 16g trehalose, 80g sodium dihydrogen phosphate, 4g L-cysteine ​​hydrochloride to the water for injection, and process through macroporous adsorption resin after dissolving, Add 16g of gelatin solution and 16g of coagulant, and then stir at 350rpm for 30 minutes; adjust the pH to 4.5-6.5 with a pH regulator, add 2g of genipin, continue to stir, and then filter and sterilize through a 0.22μm sterile filter to prepare into microcapsule liquid;

[0038] (2) Reduce the temperature of the condenser of the lyophilizer to below -45°C in advance; the liquid medicine is filled into ampoules under the protection of nitrogen, and fed to the lyophilizer;

[0039] (3) Reduce the temperature of the plate layer to below -40°C within 1h, freeze for 2h; ...

Embodiment 2

[0047]

[0048] Wherein, the concentration of the gelatin solution is 4%, and the coagulation agent is a sodium sulfate solution with a concentration of 60%.

[0049](1) Add 8000 units of chorionic gonadotropin, 1000g lactose, 200g dextrin, 24g trehalose, 120g sodium dihydrogen phosphate, 6g L-cysteine ​​hydrochloride to the water for injection, and process through macroporous adsorption resin after dissolving, Add 24g of gelatin solution and 8g of coagulant, and then stir at a speed of 350rpm for 30min; adjust the pH to 4.5-6.5 with a pH regulator, add 3g of genipin, continue to stir, and then filter and sterilize through a 0.22μm sterile filter to prepare into microcapsule liquid;

[0050] (2) Reduce the temperature of the condenser of the lyophilizer to below -45°C in advance; the liquid medicine is filled into ampoules under the protection of nitrogen, and fed to the lyophilizer;

[0051] (3) Reduce the temperature of the plate layer to below -40°C within 1h, freeze fo...

Embodiment 3

[0058]

[0059]

[0060] Wherein, the concentration of the gelatin solution is 4%, and the coagulation agent is a sodium sulfate solution with a concentration of 60%.

[0061] (1) Add 8000 units of chorionic gonadotropin, 1200g of lactose, 400g of dextrin, 32g of trehalose, 160g of sodium dihydrogen phosphate, 8g of L-cysteine ​​hydrochloride to 80L of water for injection, and process it through macroporous adsorption resin after dissolving , add 48g of gelatin solution and 12g of coagulant, and then stir at a speed of 350rpm for 30min; adjust the pH to 4.5 to 6.5 with a pH regulator, add 4g of genipin, continue to stir, and then filter and sterilize through a 0.22μm sterile filter. Formulated into microcapsule liquid medicine;

[0062] (2) Reduce the temperature of the condenser of the lyophilizer to below -45°C in advance; the liquid medicine is filled into ampoules under the protection of nitrogen, and fed to the lyophilizer;

[0063] (3) Reduce the temperature of th...

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PUM

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Abstract

The invention discloses a preparation method of gonadorelin for injection for veterinary use. The method comprises the following steps: adding gonadorelin, a composite protective agent, trehalose, sodium dihydrogen phosphate and L-cysteine hydrochloride into water for injection, performing dissolving, performing treating with macroporous adsorption resin, adding gelatin liquid and a coagulant, and performing stirring for 30 minutes; adjusting the pH value, adding a biological cross-linking agent, continuing to perform stirring, and performing filtering and sterilizing to prepare a micro-capsule liquid medicine; reducing the temperature of a condenser of a freeze dryer to minus 45 DEG C or below; filling the liquid medicine into an ampoule bottle, and performing feeding into the freeze dryer; cooling a plate layer to minus 40 DEG C or below, and performing freezing for 2 hours; adjusting the vacuum degree to 10 Pa or below, after the temperature is increased to 0 DEG C, adjusting the vacuum degree to 20 Pa, and performing heat preservation for 8 h; and raising the temperature to 35 DEG C, and keeping the temperature for 3-5 hours to obtain the gonadorelin for injection for veterinary use. According to the method, the freeze-drying time is shortened, the production cost is low, and the prepared freeze-dried powder injection is high in active ingredient content and stable in product quality.

Description

technical field [0001] The invention belongs to the technical field of veterinary medicine, in particular to a veterinary chorionic gonadotropin freeze-dried powder injection and a preparation method. Background technique [0002] Chorionic gonadotropin is a glycoprotein hormone produced by the placenta and extracted from the urine of pregnant women. Can stimulate gonadal activity, chorionic gonadotropin and luteinizing hormone (LH) have the same α subunit structure. It has biological activity and immune activity similar to that of LH. When it is used to stimulate follicle maturation, it needs to be injected in large doses to simulate the LH peak before ovulation, thereby accelerating follicle maturation and inducing ovulation. [0003] Chorionic gonadotropin is a gonadotropin secreted by placental trophoblast cells. Similar to luteinizing hormone (LH), while follicle-stimulating hormone (FSH) has little effect. For females, it can promote follicle maturation and ovulatio...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K9/19A61K38/24A61K47/18A61K47/26A61K47/36A61K47/42A61P15/08
CPCA61K38/24A61K9/19A61K47/26A61K47/183A61K47/36A61K9/5057A61K9/5089A61P15/08
Inventor 陆宏汪华王远兵王金
Owner 苏州素仕生物科技有限公司
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