| Naoxuening injection is a compound preparation made by extraction and purification of injection processing,which is compsed of cornu saiga tataricae, cortex moutan, fructus gardeniae and rhizome acori tatarinowii. It is used in the treatment of the apoplexy caused by hypertension for its efficacy of balancing the liver and extinguish wind,activating blood,absorbing clots,eliminating phlegm and resuscitation. To conform with the requirements for State Drug Administration's technical regulation on the injection of TCM,this research focused on the fundament of quality control of crude Acorus tatarinowii Schott in manufaturing processsing of naoxuening injection. Study on quality contral of fingerprinting chromatogram of volatile oil section and water extracted section in crude Acorus tatarinowii Schott of manufaturing processing after determining the content of a-asarone in four origins by GC and HPLC. In the entire manufaturing processing of crude Acorus tatarinowii Schott of Naoxuening injection,the study tend to use fingerprinting chromatogram technology to detect and monitor the quality of productions.The dissertation is summarized as followed:1. Study on quality contrast in four origins of crude Acorus tatarinowii Schott Pharmaceutical enterprise requires to make sure the medical materias are stable supply and controllable cost,so that crude Acorus tatarinowii Schott from Hunan, Hubei,Anhui,Jiangxi is chosen to do the contrast in identification, physicochemical property,assay of content of volatile oil and a-asarone. After the contrast,the origin with high content of a-asarone of crude Acorus tatarinowii Schott would be chosen as the most suitable supply place and carry out the study on quality contral of fingerprinting chromatogram of volatile oil section and water extracted section of its crude Acorus tatarinowii Schott.The known components of volatile oil in Acorus tatarinowii Schott are almost 60s. In these components,a-asarone and P-asarone are depth study relatively. but it is reported by foreign literature,β-asarone was a kind of carcinogenic substance so that it was not selected as reseach parameter. To conform with manufaturing processing of Acorus tatarinowii Schott in Naoxuening injection,using steam distillation to extract the volatile oil and determine its content of a-asarone. chromatographic conditions:GC condition consists of 100% DPS column (18mx0.32mmx0.25μm), the temperatures of injector and detector with 200℃and 260℃respectively, sample size with 1μl,flow in 1.51m/min,split ratio of 40:1,acetic ether as solvent, highly pure nitrogen as carrier gas and n-octadecane as internal standard.2. Study on fingerprinting chromatogram of volatile oil section of Hunan Acorus tatarinowii SchottTo conform with manufaturing processing of Acorus tatarinowii Schott in Naoxuening injection,using steam distillation to extract the volatile oil and establish fingerprinting chromatogram of volatile oil section of Hunan Acorus tatarinowii Schott.chromatographic conditions:GC condition consists of 100% DPS column (18mx0.32mmx0.25μm):the temperatures of injector and detector with 200℃and 260℃respectively,sample size with lμl,flow in 1.51m/min,split ratio of 40:1,acetic ether as solvent,highly pure nitrogen as carrier gas.3.Study on fingerprinting chromatogram of water extracted section of Hunan Acorus tatarinowii SchottTo conform with manufaturing processing of Acorus tatarinowii Schott in Naoxuening injection,using steam distillation to extract the water extraction and establish fingerprinting chromatogram of water extracted section of Hunan Acorus tatarinowii Schott.chromatographic conditions:HPLC condition consists of Waters Cosmosil C18 column (4.6mmx250mm,5μm), methanol3% triethylamine(Ph4.0 made by phosphoric acid)=56:44 as mobile phase,detective wavelength at 245nm,flow in 1.0lm/min, column temperature at 28℃.Assay of a-asarone showed the crude Acorus tatarinowii from ShaoDong of HuNan contains relative high and stable levels of a-asarone.Study of chromatographic fingerprint of volatile oil intermediate and water extra intermediate illustrated peaks in 10 batches of crude Acorus tatarinowii from HuNan were separated.As the result, similarities of the peaks were uper 0.90 except one batch of volatile oil intermediate. This datas provided supports effectly in controling the quality of crude Acorus tatarinowii in naoxuening injection.The research has preliminarily established quality control guidance system of crude Acorus tatarinowii chromatographic fingerprint from purchasing to intermediate in manufaturing processsing.In conclusion,the powerful technical supports for naoxuening injection in safty,effectiveness,stability and control had been provided.At the same time,it is reference for orther studies on the fingerprinting standardization of TCM injections. |
