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Mecobalamine freeze-drying composition and preparation method thereof

A composition, the technology of methylcobalamin, which is applied in the field of methylcobalamin freeze-dried composition and its preparation, can solve the problems of inconvenient production and use, poor light stability, and easy increase of substances, and achieve good quality and resolubility Good, the effect of enhancing stability

Active Publication Date: 2013-01-30
HUBEI RENMIN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The prior art shows that methylcobalamin freeze-dried powder injection has poor photostability, and related substances tend to increase during storage; in order to reduce the growth of related substances, it is necessary to add antioxidants and other excipients that may cause injection safety; Commercially available packaging needs to adopt special light-proof measures, which brings inconvenience to production and use and other defects

Method used

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  • Mecobalamine freeze-drying composition and preparation method thereof
  • Mecobalamine freeze-drying composition and preparation method thereof
  • Mecobalamine freeze-drying composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] prescription:

[0032]

[0033] Add 100g of dextran to 500ml of water for injection, heat and stir until it dissolves completely, then add 0.5g of methylcobalamin, stir and dissolve, add water for injection to 1000ml, then add activated carbon for needles with a weight of 0.05% of the liquid medicine, and absorb for 30min. Filter and remove carbon to obtain the crude filtrate. The crude filtrate is sterilized and filtered with a 0.22 μm microporous membrane to obtain a sterile medicinal solution. Then put 1ml of the sterile solution into 10ml freeze-drying bottles, half-stoppered, put into a freeze-drying box, and finally freeze-dry: firstly, lower the temperature of the product from normal temperature to below -30°C, and keep it warm for 2 hours; then carry out For primary drying, raise the shelf temperature to -20°C within 4 hours under reduced pressure drying conditions, keep warm for 4 hours after the ice crystals or water lines disappear completely; finally per...

Embodiment 2

[0035] prescription:

[0036]

[0037] Add 150g of dextran to 500ml of water for injection, heat and stir until completely dissolved, then add water for injection to 1000ml, then add activated carbon for needles with a weight of 0.1% of the liquid medicine, absorb for 30min, filter and decarbonize, and obtain a matrix solution. Add 1 g of methylcobalamin to the matrix solution, stir to dissolve, and perform sterile filtration with a 0.22 μm microporous membrane to obtain a sterile medicinal solution. Then the aseptic solution is divided into 7ml freeze-drying bottles by 1ml per bottle, half stoppered, sent into a freeze-drying box, and finally freeze-dried according to the freeze-drying curve in Example 1 to obtain the finished product.

Embodiment 3

[0039] prescription:

[0040]

[0041]Add 100g of PVP K90 to 500ml of water for injection, heat and stir until completely dissolved, then add 0.5g of methylcobalamin, stir and dissolve, add water for injection to 1000ml, then add activated carbon for needles with a weight of 0.05% of the liquid medicine, absorb for 30min, filter Decarbonization, the crude filtrate was obtained. The crude filtrate is sterilized and filtered with a 0.22 μm microporous membrane to obtain a sterile medicinal solution. Then put 1ml of the sterile solution into 10ml freeze-drying bottles, half-stoppered, put into the freeze-drying box, and finally freeze-dry: first lower the temperature of the product from normal temperature to below -35°C, and keep it warm for 2 hours; then carry out For primary drying, raise the shelf temperature to -22°C within 4 hours under reduced pressure drying conditions, keep warm until the ice crystals or water lines disappear completely, and then continue to keep warm...

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Abstract

The invention discloses a mecobalamine freeze-drying composition and a preparation method thereof. The freeze-drying composition contains mecobalamine and a water-soluble polymer, wherein the water-soluble polymer is one or more of water-soluble glycans, water-soluble polyvinylpyrrolidone, polyethylene glycol, gelatin, Arabic gum and albumin. Compared with an injection preparation sold on the market, the freeze-drying composition has the advantages that the light stability and storage stability of the freeze-drying composition are remarkably superior to those of the injection preparation, and the product is not required to be specially preserved in a dark place.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a methylcobalamin freeze-dried composition and a preparation method thereof. Background technique [0002] Methylcobalamin, also known as methylcobalamin 12 , and its chemical name is: Coα-[α-(5,6)-dimethylbenzimidazolyl]-Coβ-methylcobalamide. [0003] [0004] Methylcobalamin is an endogenous coenzyme B 12 , participate in the one-carbon unit cycle, and play an important role in the transmethylation reaction process of synthesizing methionine from homocysteine. Clinically used for peripheral neuropathy and vitamin B deficiency 12 Treatment of megaloblastic anemia. The currently clinically used dosage forms of methylcobalamin include injection, freeze-dried powder injection, tablet, and capsule. Because the dosage of methylcobalamin is very small (the current specification is 0.5mg / tablet or granule), it is difficult to solve the problem of...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/714A61P7/06A61P25/02
Inventor 孙永平赵砥朱胜节余记川李爱菊毛书平
Owner HUBEI RENMIN PHARMACEUTICAL CO LTD
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