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Preparation method of hexadecadrol sodium phosphate freeze-dried powder injection

A technology of dexamethasone sodium phosphate and freeze-dried powder injection, which is applied in the field of medicine, can solve problems such as unstable product quality, high production cost, and poor stability, and achieve the effects of increasing single batch output, saving energy consumption, and ensuring quality

Active Publication Date: 2010-05-12
MAANSHAN BBCA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] But the shortcoming of above-mentioned two kinds of methods is: (1) in the preparation liquid process, owing to adding gac after raw material and adjuvant are all dissolved, therefore when gac removes endotoxin, also can absorb a small amount of dexamethasone sodium phosphate , so that the content of dexamethasone sodium phosphate is reduced by about 5.0% to 8.0%; (2) when the liquid medicine is divided into control bottles, because the bottom area of ​​the 7mL or 10mL control bottles usually selected is relatively large, when using the same During freeze-drying machine, single batch output is less, and production cost is high; (3) the aqueous solution of dexamethasone sodium phosphate is poorer than the stability of dry powder, because dexamethasone sodium phosphate freeze-dried powder injection needs to be dissolved earlier into Therefore, the longer the freeze-drying time, the longer the dexamethasone sodium phosphate is in the non-dry state, and the more unstable the product quality is, while the existing method freeze-drying time exceeds 25h, and the energy consumption is large, and the production cost is high.

Method used

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  • Preparation method of hexadecadrol sodium phosphate freeze-dried powder injection
  • Preparation method of hexadecadrol sodium phosphate freeze-dried powder injection

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Effect test

Embodiment 1

[0026] Dexamethasone Sodium Phosphate 20g

[0027] Mannitol 800g

[0028] Add water for injection to 10L

[0029] (1) Preparation of medicinal solution: Weigh 800g of mannitol quantitatively, add 6L of water for injection, stir until completely dissolved, add 2.0g / L of activated carbon according to the full volume, boil for 30min, filter to remove carbon; add 2L of water for injection, 20g of ground Sodium dexamethasone phosphate was dissolved completely, and the pH value of the medicinal solution was measured to be 8.12, and water for injection was added to 10 L, filtered through a 0.22 μm microporous membrane filter to a storage tank, prepared into a medicinal solution, and set aside;

[0030] (2) Freeze-drying: Pre-lower the temperature of the condenser of the freeze-drying machine (FCM50D type) to below -40°C, divide the above-mentioned medicinal solution into 2mL vials of 1mL (2mg specification) per bottle, and put them into freeze-drying For the plate layer in the mach...

Embodiment 2

[0036] Dexamethasone Sodium Phosphate 50g

[0037] Mannitol 200g

[0038] Add water for injection to 10L

[0039] (1) Preparation of medicinal solution: Weigh 200g of mannitol quantitatively, add 3L of water for injection, stir until completely dissolved, add 1.0g / L of activated carbon according to the full volume, boil for 15min, filter to remove carbon; add 5L of water for injection, 50g of ground Sodium dexamethasone phosphate was dissolved completely, and the pH value of the medicinal solution was measured to be 8.02, and water for injection was added to 10 L, filtered through a 0.22 μm microporous membrane filter to a storage tank, prepared into a medicinal solution, and set aside;

[0040] (2) Freeze-drying: Pre-lower the temperature of the condenser of the freeze-drying machine (FCM50D type) to below -40°C, divide the above-mentioned medicinal solution into 2mL vials of 1mL (5mg specification) per bottle, and put them into freeze-drying For the plate layer in the mach...

Embodiment 3

[0046] Dexamethasone Sodium Phosphate 20g

[0047] Mannitol 600g

[0048] Add water for injection to 10L

[0049] (1) Preparation of medicinal solution: Weigh 600g of mannitol quantitatively, add 5L of water for injection, stir until completely dissolved, add 2.0g / L of activated carbon according to the full volume, boil for 20min, filter to remove carbon; add 3L of water for injection, 50g of ground Sodium dexamethasone phosphate was dissolved completely, and the pH value of the medicinal solution was measured to be 8.06, and water for injection was added to 10 L, filtered through a 0.22 μm microporous membrane filter to a storage tank, prepared into a medicinal solution, and set aside;

[0050] (2) Freeze-drying: Pre-lower the temperature of the condenser of the freeze-drying machine (FCM50D type) to below -40°C, divide the above-mentioned medicinal solution into 2mL vials of 1mL (2mg specification) per bottle, and put them into freeze-drying For the plate layer in the mach...

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Abstract

The invention provides a preparation method of hexadecadrol sodium phosphate freeze-dried powder injection, which comprises the following steps: mannitol is dissolved, added with active carbon, boiled and filtered, added with the hexadecadrol sodium phosphate and prepared to a liquid medicine; the liquid medicine is treated by prefreezing, primary freeze drying and secondary freeze drying; and then hydraulic pressure adding stopper, rolling cap and packaging are carried out. The method has the advantages that the method improves the liquid medicine preparation and freeze-drying technology, does not affect the content of the hexadecadrol sodium phosphate, can increase the single batch output, simultaneously shortens the freeze-drying time, increases the product stability, saves the energy, increases the production and reduces the production cost.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of dexamethasone sodium phosphate freeze-dried powder injection. Background technique [0002] Dexamethasone sodium phosphate is an adrenocortical hormone drug, mainly used for allergic and autoimmune inflammatory diseases, mostly for connective tissue diseases, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe Dermatitis, ulcerative colitis, acute leukemia, etc., are also used in the comprehensive treatment of certain severe infections, poisoning, and malignant lymphoma. The chemical name of dexamethasone sodium phosphate is 16α-methyl-11β,17α,21-trihydroxy-9α-flupregna-1,4-diene-3,20-diketo-21-phosphate disodium salt , the molecular formula is C 22 h 28 FNa 2 o 8 P, the molecular weight is 516.41. [0003] Dexamethasone sodium phosphate freeze-dried powder injection is a sterile freeze-dried product made by...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/661A61P37/08A61P35/02A61P35/00A61P31/00A61P29/00A61P19/02A61P19/04A61P17/00A61P11/06A61P1/04
Inventor 尹双青刘永宏
Owner MAANSHAN BBCA PHARMA
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