Method for detecting cerebroprotein hydrolysate tablets

A cerebroprotein hydrolysate and detection method technology, which is applied in the detection field of biological preparations, can solve the problems of lack of scientific methods and indicators for the efficacy of cerebroprotein hydrolysate tablets and product quality control, and achieve great application value and improve quality. Controllable and guaranteed curative effect

Active Publication Date: 2012-01-04
SHANGHAI ZHONGHUA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the current quality standards, only free amino acids (amino nitrogen) are controlled, and the content of small molecule peptides is not controlled. Therefore, there is a lack of scientific methods for the efficacy and product quality control of cerebroprotein hydrolyzate tablets. and indicators

Method used

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  • Method for detecting cerebroprotein hydrolysate tablets
  • Method for detecting cerebroprotein hydrolysate tablets
  • Method for detecting cerebroprotein hydrolysate tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1, cerebroprotein hydrolyzate sheet (manufacturer: Great Wall Pharmaceutical of Shanghai Industrial United Group, specification: 36 pieces / box)

[0023] 1. Identification of peptides

[0024] (1) method

[0025] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix V D).

[0026] (2) Instruments and reagents

[0027] Instrument: Agilent 1100 liquid chromatograph

[0028] Reagents: dipotassium hydrogen phosphate, potassium dihydrogen phosphate, phosphoric acid, all of analytical grade. Isopropanol (chromatographically pure). water (double distilled, homemade)

[0029] Reference substance: cerebroprotein hydrolyzate reference substance solution (China Institute for the Control of Biological Products, batch number: 140697-200602).

[0030] Mobile phase: Phosphate buffer (take 10.63g of dipotassium hydrogen phosphate and 5.31g of potassium dihydrogen phosphate, add 50ml of isopropanol, add water to ab...

Embodiment 2

[0064] Embodiment 2, the specificity of the identification method of peptides

[0065] (1) method

[0066] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix V D).

[0067] (2) Instruments and reagents

[0068] Instrument: Agilent 1100 liquid chromatograph

[0069] Reagents: dipotassium hydrogen phosphate, potassium dihydrogen phosphate, phosphoric acid, all of analytical grade. Isopropanol (chromatographically pure). water (double distilled, homemade)

[0070] Reference substance: cerebroprotein hydrolyzate reference substance solution (batch number: 140697-200602).

[0071] Mobile phase: Phosphate buffer (take 10.63g of dipotassium hydrogen phosphate and 5.31g of potassium dihydrogen phosphate, add 50ml of isopropanol, add water to about 800ml, adjust pH to 7.0 with phosphoric acid, add water to dilute to 1000ml). Flow rate 0.6ml / min.

[0072] Detection wavelength: 280nm.

[0073] Chromatographic column: TSK...

Embodiment 3

[0081] Embodiment 3, methodological research on the determination item of polypeptide content

[0082] (1) method

[0083] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix V D).

[0084] (2) Instruments and reagents

[0085] Instrument: Waters 2695 / 2487 liquid chromatograph

[0086] Reagents: Sodium acetate and phosphoric acid are of analytical grade. Acetonitrile (chromatographically pure). Water (double distilled, homemade). WatersAccQ-Fluor kit (Waters, USA, for amino acid derivatization).

[0087] Reference substance: 16 kinds of amino acid reference substances (batch number of China Inspection Institute: 624-200104). D-norleucine (batch number: 140687-200401).

[0088] mobile phase:

[0089] Mobile phase A: Take 19.05g of sodium acetate, add 1000ml of water to dissolve, adjust the pH to 5.00 with phosphoric acid.

[0090] Mobile phase B: 60% acetonitrile solution.

[0091] Flow rate: 1.4ml / min, gradie...

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Abstract

The invention provides a method for detecting cerebroprotein hydrolysate tablets. The method comprises the following steps of identifying the micromolecule peptides in the cerebroprotein hydrolysate tablets, determining the content and the like. The total amount of amino acid in the cerebroprotein hydrolysate tablets is determined by performing complete acid hydrolysis on a sample, the content ofthe free amino acid contained in the cerebroprotein hydrolysate tablets is determined, the reasonable quality control index aiming at micromolecule peptides is set, the method for detecting the cerebroprotein hydrolysate tablets is improved, and a complete and accurate quality control method is provided from the cerebroprotein hydrolysate tablets. The content controllability of active ingredientsin a product is guaranteed, and components of a preparation reach the effective dose range, so that the curative effect is guaranteed. The method is suitable for the quality control of industrial production and has great application value.

Description

technical field [0001] The invention relates to a detection method of a biological agent, in particular to a detection method of a cerebroprotein hydrolyzate sheet. Background technique [0002] Brain protein hydrolyzate tablet is an active peptide hydrolyzate extracted from fresh brain tissue of healthy pigs, which contains a variety of amino acids, cephalin, lecithin, and peptide nerve growth factors. It is widely used clinically to improve symptoms such as insomnia, headache, memory loss, dizziness and irritability, and can promote the rehabilitation of sequelae of brain trauma, sequelae of cerebrovascular diseases, sequelae of encephalitis, acute cerebral infarction and acute brain trauma. The results of pharmacological experiments show that cerebroprotein hydrolyzate is a kind of peptide energy neurotrophic substance unique to the brain. It can act on the central nervous system in various ways, regulate and improve the metabolism of neurons, promote the formation of sy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 汤晓枢刘春生陆志英陆臻蔡燕沈庆庆
Owner SHANGHAI ZHONGHUA PHARMA
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