Method for preparing gonadorelin freeze-dried powder injection

The technology of freeze-dried powder injection and freeze-drying machine, which is applied in the field of medicine, can solve the problems of large difference in pH value, unstable product quality, and reduced product content, and achieves improved stability, shortened freeze-drying time, and stable product quality. Effect

Active Publication Date: 2010-05-05
MAANSHAN BBCA PHARMA
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  • Abstract
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  • Claims
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Problems solved by technology

[0009] The disadvantages of this method are: (1) in the process of preparing the liquid medicine, since the active carbon is added after the raw materials and auxiliary materials are completely dissolved, part of the gonadorelin will also be absorbed by the active carbon, thereby reducing the product content; (2) due to Use 5% NaOH solution or 5% hydrochloric acid to adjust the pH, so the pH value of the medicinal solution is quite different from the pH value of reconstitution after freeze-drying of the product; (3) Gonadorelin is a polypeptide biochemical drug, which is stable in aqueous solution Poor, since the gonadorelin freeze-dried preparation is first formulated into an aqueous solution during the production process, so the gonadorelin is in a non-dried state until the end of the freeze-drying, while the freeze-drying time of the existing method exceeds 20 hours , the freeze-drying time is long, so that gonadorelin is in a non-dry state for a long time, the product quality is unstable, and the energy consumption is large, and the production cost is high

Method used

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  • Method for preparing gonadorelin freeze-dried powder injection
  • Method for preparing gonadorelin freeze-dried powder injection

Examples

Experimental program
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Effect test

Embodiment 1

[0027] Gonadorelin 1.00g

[0028] Mannitol 200g

[0029] Phosphate buffered saline 30g

[0030] Add water for injection to 10L

[0031] (1) Preparation of medicinal solution: Weigh 200g of mannitol and add it to 5L of water for injection, stir until completely dissolved to obtain a mannitol solution; weigh 30g of phosphate buffered saline (wherein 26g of sodium dihydrogen phosphate and 4g of disodium hydrogen phosphate) are dissolved in Add 1L water for injection, then add to the above mannitol solution, mix well; add 1.0g / L activated carbon according to the full volume, boil for 15min, filter to remove carbon, cool to room temperature, add 1.00g gonadorelin, after completely dissolving, Add water for injection to 10 L, measure its pH to 5.8, filter through a 0.22 μm microporous membrane filter to a storage tank, prepare a medicinal solution, and set aside.

[0032] (2) Freeze-drying: Pre-lower the temperature of the condenser of the freeze-dryer (FCM50D type) to below -40°...

Embodiment 2

[0039] Gonadorelin 0.25g

[0040] Mannitol 800g

[0041] Phosphate buffered saline 30g

[0042] Add water for injection to 10L

[0043](1) Preparation of medicinal solution: Weigh 800g of mannitol and add it to 6L of water for injection, stir until completely dissolved to obtain a mannitol solution; weigh 30g of phosphate buffered saline (including 25g of sodium dihydrogen phosphate and 5g of disodium hydrogen phosphate) in Add 1L of water for injection, then add to the above-mentioned mannitol solution, mix well; add 2.0g / L activated carbon according to the full volume, boil for 30min, filter to remove charcoal, cool to room temperature, add 0.25g of gonadorelin, after completely dissolving, Add water for injection to 10 L, measure its pH to 5.8, filter through a 0.22 μm microporous membrane filter to a storage tank, prepare a medicinal solution, and set aside.

[0044] (2) Freeze-drying: Pre-lower the temperature of the condenser of the freeze-dryer (FCM50D type) to below...

Embodiment 3

[0050] Gonadorelin 1.00g

[0051] Mannitol 400g

[0052] Phosphate buffered saline 30g

[0053] Add water for injection to 10L

[0054] (1) Preparation of medicinal solution: Weigh 400g of mannitol and add it to 5L of water for injection, stir until completely dissolved to obtain a mannitol solution; weigh 30g of phosphate buffered saline (wherein 25g of sodium dihydrogen phosphate and 5g of disodium hydrogen phosphate) are dissolved in 1L of water for injection, then added to the above-mentioned mannitol solution, and mixed evenly; added activated carbon with a volume of 2.0g / L in full volume, boiled for 20min, filtered to remove charcoal, cooled to room temperature, added 1.00g of gonadorelin, after completely dissolving, supplemented Add water for injection to 10L, measure its pH value to 5.9, filter through a 0.22μm microporous membrane filter to a storage tank, prepare a medicinal solution, and set aside.

[0055] (2) Freeze-drying: Pre-lower the temperature of the con...

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Abstract

The invention provides a method for preparing a gonadorelin freeze-dried powder injection, which comprises the following steps: dissolving mannitol and phosphate buffer salt, adding activated carbon, filtering after boiling, adding gonadorelin and preparing liquid medicine; pre-regulating the temperature of a condenser to below minus 40 DEG C, packing the liquid medicine into tube-type bottles, placing into a freeze-drying machine, reducing the temperature for 1h till the temperature of a plate layer is lower than minus 35 DEG C, and freeze-drying for 2h; then regulating the vacuum degree to below 20Pa, increasing the temperature within 1h till the temperature of the plate layer is 2-3 DEG C, and keeping the temperature for 3-4h; and regulating the vacuum degree to be 10-20Pa, increasing the temperature within 1h till the temperature of the plate layer is 12-14 DEG C, keeping the temperature for 2h, then continuously increasing the temperature within 1h to 36-38 DEG C and keeping the temperature for 3-4h. The method has the advantages that the method improves the technological steps of preparing the liquid medicine and freeze-drying, does not affect the content of the gonadorelin, simultaneously shortens freeze-drying time, further improves product stability, saves energy, increases production and reduces production cost.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of gonadorelin freeze-dried powder injection. Background technique [0002] Gonadorelin, whose chemical name is 5'-oxoprolyl-L-histidyl-L-tryptophanyl-L-seryl-L-tyrosyl-glycyl-L-leucine Acyl-L-arginyl-L-prolyl-glycylamide with the formula C 55 h 75 N 17 o 13 ; The molecular weight is 1182.33. [0003] Gonadorelin can stimulate the synthesis and release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the anterior pituitary gland, thereby detecting the function of pituitary gonadotropin reserve. After injection of gonadorelin in normal people, the increase of LH is significantly higher than that of FSH, and the response of FSH in prepubertal women is higher than that of LH; those with insufficient gonadotropin-releasing hormone may have a delayed reaction after injection, and sometimes need to intravenously infuse this product for se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/24A61P5/24A61P15/08
Inventor 尹双青刘永宏
Owner MAANSHAN BBCA PHARMA
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