The Preparation Process And Quality Control Of Refined Xingnaojing Injection

Xingnaojing Injection(XNJI) was made from steam distillation process, which was formed by the four flavor herbs-radix curcumae、musk、borneol and gardenia.This prescription apply widely in clinic、it can remove pathogenic heat from blood and promote blood circulation detoxification,as well as activite brain and regain consciousness.Due to treating stroke definitely, the health ministry has been identified as one of the drugs commonly used where clinical first aid at present. All kinds of Xingnaojing Injections came from three manufacturers。But different manufacturers have different sources of borneol, which including borneol、mechanism of borneol and synthetic borneol.Musk ranges over natural musk and artificial musk. Because of the differences of raw materials from various manufacturers caused its effective components difference, affected its clinical curative effect.In modern research, there are many reports about non-chiral gas chromatography determining borneol. isoborneol and muscone of XNJI。Trying to invent a kind of traditional Chinese medicine injection with the prescription on the basis of pharmacological research before. The quality of the injection should be stable and most of the components of the injection should be clear.The quality of the injection should be stable and the most components of the injection should be clear-Refined Xingnaojing Injection(RXNJI).Objective(1) To analyze the xolatile chemical compositions and their contents in Xingnaojing Injection(XNJI) manufactured by different factories by chiral gapillary gas chromatography.(2) Though the protective effect of PC12cells and the model of middle cerebral artery occlusion(MCAO),to screen active monomer.With uniform design and preferred complexes of Group8experiment to evaluate the efficacy in vitro and in vivo.Then to determine the ratio and dose of L-camphor,D-borneol and muscone. (3) To establish the preparation process of RXNJI.(4) To establish the quality control method of RXNJI.The quality of the injection should be stable and most of the component of the components of the injection should be clear-Refined Xingnaojing Injection.Methods(1)By Chiral Capillary gas Chromatography,to analyze the chemical compositions and their contents of Xinnaojing Injection (XNJI).Establishment of the GC method for the determination of the relative large content of three components.(2)The treatment of ischemic stroke in vitro model of PC12cells hypoxia and glucose deprivation model of L-camphor, D-camphor, L-borneol, D-Borneol,and muscone and the onset concentration Filter.(3) with uniform design, commercial refreshing static control, the protective effect of PC12cells and preliminary focal cerebral ischemic injury in rats overall model experiments, further screening of active ingredients derived from group screening of L-camphor, the right spin borneol, musk ketone ratio and dose.(3)To examine the varieties and their dose of the additives and and then design the preparing progress of RXNJI.Investigated the preparation of the transfer rate of each component in the process.(4)Gas chromatography was used to establish method of analysising of XNJI containing the L-camphor、D-borneol and muscone content.To finished the quality criatia of RXNJI sush as the regular injection of sterility test, pyrogen test, clarity test, permeability, PH, etc.Results(1) Obvious difference was found in the compoments of the mainstream products of XNJI from Shanhe of Wuxi city and from Tiandi of Henan province.Both of the tow products contain muscone.But the components of borneol varied greatly in the two products.The main contents of XNJI(Wuxi ShanHe) were L-borneol. L-camphor and muscone,while XNJI (Henan TianDi) were D-borneol, D-camphor and muscone. The average levels of L-borneol were0.1158mg·mL-1, L-camphor were0.8571mg·mL-1, and the muscone were0.2067mg·mL-1. in XNJI(Wuxi ShanHe);The average levels of D-borneol were0.0091mg·mL-1, D-camphor were0.8967mg·mL-1and the muscone were0.1284mg·mL-1. in XNJI(Henan TianDi);The average levels of borneol were0.0178mg·mL-1, camphor were0.9254mg·mL-1and the muscone were0.0524mg·mL-1. in XNJI(DaLi). (2) Screening active monomer,active ingredients were L-camphor, D-borneol and muscone.With uniform design and preferred complexes of Group8experiment to evaluate the efficacy in vitro and in vivo.To determine the prescription of RXNJI:L-camphor: D-borneol: muscone=8:7:1.(3) Determining the solubilizing agent, the isotonia conditioner and their dosage. Reduce the dosage of Tween-80was0.7%so as to reduce the risk hematolysis.(4) The average levels of L-camphor were0.4463mg·mL-1,D-borneol were0.4489mg·mL-1, and the muscone were0.0597mg·mL-1. in RXNJI;To establish the quality control method of RXNJI.The quality standard of RXNJI included the test for clarity,PH,undue toxicity, pyrogens, hemolysis and cohesion.These conformed to the "Pharmacopoeia of the People’s Republic of China"Conclusion(1)By chiral capillary gas chromatography,to analyze the volatile chemical compositions and their contents in XNJI manufactured by different factories.(2) Controllable elements more than90%It can control the quality of injection well.(3)Trying to invent a kind of traditional chinese medicine injection with the Prescription on the basis of pharmacological research before. The quality of the injection should be Stable and most of the components of the injection should be clear.(4) Tentatively setting the preparation process and quality evaluation system of the Refined Xingnaojing Injection(RXNJI) was feasible,but also need more in-depth study and improve their quality standards.