Studies On Quality Control Of Danshen Injection And Tanreqing Injection

Traditional Chinese Medicine Injection (TCMI) should be secure, valid, stable and controllable, while quality controllability is the precondition and guarantee of TCMI's security and validity. There are many aspects in the quality control of TCMI which includes medicinal material, production engineering, quality standard and so on. Analytic techniques such as Spectrophotometry, High performance liquid chromatography (HPLC), Gas chromatography-mass spectrometry (GC-MS) can be used in the reserach. Taking Danshen Injection and Tanreqing Injection as analytical samples, which are widely used in clinic, we have developed a series of methods for quality control which are consistent with manufacture practice to improve production engineering and quality standard, so that safety problems origined from quality of TCMI will be reduced. The main content of this paper is described as follows:1. Spectroscopic method with phosphomolybdium tungstic acid - casein was established for determination of tannins in Radix Salvia miltiorrhiza and could be applied to detect the content of tannins in Radix Salvia miltiorrhiza from different origins effectively. This validated method has the advantage of simplicity and precision, allowing its application in determination of tannins in Radix Salvia miltiorrhiza and Danshen injection during the manufacture period, and ensuring the security of Danshen injection in clinic.2. An HPLC-UV method was established for determination of seven phenolic acids including danshensu, protocatechuic aldehyde, caffeic acid, salvianolic acid D, rosmarinic acid, salvianolic acid B and salvianolic acid A in Danshen Injection. Three detective wavelengths were selected as follows: 280, 326 and 286 nm, so that high sensitivity was gained with LOD values ranged from 0.008 to 0.16μg/mL. This method is simple and accurate for quality analysis of Danshen Injection and its production engineering.3. Cornu caprae hircus which is ministerial drug in recipe of Tanreqing Injection was analysed, and a GC-MS method was established to detect twelve amino acids simultaneously in Cornu caprae hircus extract. Sealed amino acids were identified rapidly, and each amino acid was quantified accurately, so the quality standard was optimized obviously. Furthermore, the derivatization conditions of amino acids were optimized in order to guarantee the validity of methodology. This method can be used in the quality control of Cornu caprae hircus extract, improving the quality control of intermediate in the manufacturing process of Tanreqing Injection.4. Taking Lonicera japonica and Forsythia suspense as samples, we discussed several key points of quality control in production of Tanreqing Injection. Both regulation of pH and activated carbon adsorption affected the content of components obviously, but soaking time of water for injection had no influence on it. This research meets the requirement of manufacture practice and could be applied in the quality control of Tanreqing Injection.