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Calf serum protein-removing extract for injection and its preparation method

A calf serum and protein removal technology, which is applied in the directions of non-active ingredients medical preparations, drug combinations, and pharmaceutical formulations, can solve the problems of unstable water injection, short product quality, and precipitation, and achieves fine appearance and product quality. The effect of stable quality and extended validity period

Active Publication Date: 2009-08-26
JINZHOU AHON PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The water needle is unstable, and it is easy to undergo polymerization, photolysis and other reactions to change the composition or even precipitate when placed at room temperature, and the product has a short shelf life

Method used

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  • Calf serum protein-removing extract for injection and its preparation method
  • Calf serum protein-removing extract for injection and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1. Screening of component content of deproteinized extract of calf serum for injection

[0024] 1. Preparation of deproteinized calf serum extract for injection (freeze-dried powder injection of deproteinized calf serum extract)

[0025] The venous blood of 1-6 months old calves was collected aseptically, and the serum was separated according to the method described in Example 1 of the invention patent (Patent No. ZL96120777.9), and the pH value, total serum protein, and serum of the calf serum were detected. For albumin content, select calf serum that meets the following conditions:

[0026] 1) pH value: The pH value of calf serum should be 6.5-7.5.

[0027] 2) Serum total protein: calf serum is diluted 500 times, and the total serum protein content should be greater than 4.0g / 100ml in accordance with the 35-page method of "Chinese Biological Products Regulations".

[0028] 3) Serum albumin content: Take 0.02ml of calf serum, and determine the serum albumin content...

Embodiment 2

[0063] Example 2. Preparation and stability test of freeze-dried powder injection of deproteinized calf serum extract

[0064] 1. Preparation of lyophilized powder injection and injection of deproteinized calf serum extract

[0065] The venous blood of 1-6 months old calves was collected aseptically, and the serum was separated according to the method in Example 1 of the invention patent (Patent No. ZL 96120777.9), and the pH value, total serum protein, and serum albumin content of the calf serum were detected. , Select calf serum that meets the following conditions:

[0066] 1) pH value: The pH value of calf serum should be 6.5-7.5.

[0067] 2) Serum total protein: calf serum is diluted 500 times, and the total serum protein content should be greater than 4.0g / 100ml in accordance with the 35-page method of "Chinese Biological Products Regulations".

[0068] 3) Serum albumin content: Take 0.02ml of calf serum, and determine the serum albumin content according to the 644 page metho...

Embodiment 3

[0105] Example 3. The effect of lyophilized powder injection of deproteinized calf serum extract on the ability of mice to withstand hypoxia under normal pressure

[0106] Choose healthy Kunming first-class mice (purchased from SPF Experimental Animal Center of Liaoning Medical College), weighing 18-22g, male and female, divided into four groups, sample 2 prepared in Example 2 (calf serum deproteinized Extract freeze-dried powder injection), 3 groups of samples prepared in Example 2, 4 groups of samples prepared in Example 2, and a normal saline control group.

[0107] The sample 2 groups prepared in Example 2 (calf serum deproteinized extract freeze-dried powder injection), the sample 3 groups prepared in Example 2, and the sample 4 groups prepared in Example 2 were extracted with 1.5 mg calf serum deproteinized respectively The dry matter / kg body weight was injected with the sample 2, the sample 3 prepared in the embodiment 2, and the sample 4 prepared in the embodiment 2, once ...

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Abstract

The invention discloses a calf serum deproteinized extract freeze-dried powder injection and a preparation method thereof. The calf serum deproteinized extract freeze-dried powder injection contains the following components by weight and ratio: 1 part of dry matter of calf serum deproteinized extract; 9-11 parts of mannitol; and 4.5 parts of small molecule dextran -5.5 parts. The deproteinized calf serum extract freeze-dried powder injection of the present invention overcomes the defects of unstable water injection and infusion quality, prolongs the valid period of the product, expands clinical application, and reduces the probability of adverse reactions.

Description

Technical field [0001] The invention relates to a deproteinized calf serum extract for injection and a preparation method thereof, in particular to a freeze-dried powder injection of deproteinized calf serum extract and a preparation method thereof. Background technique [0002] Calf serum deproteinized extract (also known as calf blood deproteinized extract) is mainly used to treat cerebrovascular diseases. At present, the extraction process of calf blood deproteinized extract is generally to use calf serum as raw material and heat to remove protein to obtain calf blood deproteinized extract (see Chinese Patent ZL200410013643.6). The patent document with the patent number ZL96120777.9 discloses a method for extracting deproteinized calf blood extract by using ethanol to remove the protein; the molecular weight of deproteinized calf blood extract is less than 5000 Daltons because of its small molecular weight and no antigen , Does not cause allergic reactions. [0003] The deprot...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K35/14A61K47/26A61K47/10A61P9/00A61P9/10A61K35/16
Inventor 于洪儒王洪新张敬国杨菁
Owner JINZHOU AHON PHARM CO LTD
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