Method for controlling quality of injection for treating tumor

A quality control method and injection technology, which can be applied to antineoplastic drugs, medical preparations containing active ingredients, measuring devices, etc., and can solve the problems of not providing fingerprints, etc.

Active Publication Date: 2008-11-26
CHANGBAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The invention patent with the application number 021533350 discloses a pharmaceutical composition for treating tumors and its preparation method. The pharmaceutical composition is made of astragalus 200-400 weight parts ginseng 60-130 weight parts matrine 6-13 weight parts However, the fingerprint of the drug composition has not been provided, so further improvement is needed to ensure the content and efficacy of the drug ingredients

Method used

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  • Method for controlling quality of injection for treating tumor
  • Method for controlling quality of injection for treating tumor
  • Method for controlling quality of injection for treating tumor

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0066] Experimental Example 1: The Inhibitory Effect of the Injection of the Invention on the Transplanted Tumor Lung Cancer Lewis Sarcoma in Mice

[0067] Take 18~22g healthy pure line C 57 Fifty white mice, half female and half male, were taken from well-grown sarcomas under aseptic conditions, ground with a grinder, diluted with sterile saline 1:2, and subcutaneously inoculated with 0.2ml / mouse under the armpit of the right forelimb. Fasting without water for 17 hours after inoculation, randomly divided into 5 groups according to body weight, 10 in each group, low-dose group, middle-dose group, high-dose group, positive control group, blank control group, the average body weight difference between groups is less than 1g, Immediately after group administration, the tail vein administration was started, once a day, and the blank control group was given the same amount of normal saline, and the administration was continued for 7 days. The animals were killed 24 hours after the...

experiment example 2

[0073] Experimental Example 2: The Inhibitory Effect of the Injection of the Invention on Transplanted Human Small Cell Lung Cancer LTEP-SML in Nude Mice

[0074] Take 50 17-18 BALB / c male nude mice, SPF grade, subcutaneously inoculate the right forelimb axilla with well-grown human lung cancer tumor tissue blocks in nude mice, remove the tumor nodules under aseptic operation in the ultra-clean bench, and take Conventional small block inoculation method, 1 block / mouse (about 1mm 3 ), the tumor inoculation of 50 animals was completed within 40 minutes. When the tumor grows and becomes palpable (1mm 3 ), the animals were randomly divided into 5 groups, 10 in each group, weighed, labeled, low-dose group, middle-dose group, high-dose group, positive control group, blank control group, and the experimental group was administered by tail vein injection every day. Once, the blank control group was given the same amount of normal saline for 15 days, and 24 hours after the last admin...

experiment example 3

[0080] Experimental Example 3: Injection of the present invention to S 180 Synergistic effect of cyclophosphamide chemotherapy on sarcoma (solid type) tumor-bearing mice

[0081] Take 60 healthy Kunming mice of 18-22g, half female and half male, and extract the well-developed S 180 Ascites, diluted with sterile normal saline 1:2, subcutaneously inoculated 0.2ml per mouse under the armpit of the right forelimb. Fasting without water for 17 hours after inoculation, randomly divided into 6 groups according to body weight, 10 rats in each group, low-dose group, middle-dose group, high-dose group, positive control group, model control group, and tumor-bearing blank control group. The average body weight difference between the groups was less than 1 g. After grouping, except the blank control group which was not injected with cyclophosphamide, which was the tumor-bearing control group, all other groups received intraperitoneal injection of cyclophosphamide 30 mg / kg chemotherapy, on...

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Abstract

A Chinese medicine in the form of injection for treating tumor is proportionally prepared from astragalus root, ginseng and flavescent sophora root. Its quality control method includes the fingerprint detection of intermediate and finished product, identification of injection and content measurement.

Description

technical field [0001] The invention relates to a quality control method of an injection, in particular to a quality control method of an injection for treating tumors. Background technique [0002] The quality control of traditional Chinese medicine is one of the key problems to be solved urgently in the process of modernization of traditional Chinese medicine. At present, fingerprint has become one of the most effective means to control the quality of traditional Chinese medicine or natural medicine recognized internationally. Through modern analysis methods, the characteristics of fingerprints can reflect the internal chemical composition and content of traditional Chinese medicine. According to the application object, it can be divided into fingerprints of traditional Chinese medicinal materials (raw materials), fingerprints of raw materials of traditional Chinese medicines (including decoction pieces and compatible granules), fingerprints of intermediates (intermediate...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N33/15A61K36/481A61K36/258A61K31/445A61P35/00
Inventor 阎志刚李安平刘立明张冬雷
Owner CHANGBAISHAN PHARMA
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