Study On The Quality Standard Of Herba Lanceae

Objective:Herba Lanceae which belongs to the Scrophulariaceae family is the dried whole plant of Lancea tibetica Hook.f.et Thorns, it is commonly used in traditional Tibetan medicine. Its efficacy include heal the wound, stanch bleeding, eliminate sore muscles; Its roots can eliminate lung abscess; Its leaves can treat suppurative disease; Its seeds also have curative effect on heart disease, cancer, intestinal disease and gynecological disease. It is in the top grade of Tibetan medicine. The quality control method of Herba Lanceae in the Health Department of the People’s Republic of China drug standards · Tibetan Book 1 is too simple, can not carry the quality control, this study attempts to improve the quality standard of Herba Lanceae, to provide the basis for the comprehensive and effective quality control of it.Method:To complete a herbal textual research on Lancea tibetica Hook.f.et Thorns, then accomplish a systematic identification of Pharmacognosy for Herba Lanceae from the macro morphology, the micro tissue structure of plant stem and leaf and the micro characteristics of powder. To establish TLC methods for the identification of Herba Lanceae with catalpol, acteoside and ursolic acid as the reference substances. Then determine the moisture content, the total ash content, the acid insoluble ash content and the extract in Herba Lanceae. To determine content of catalpol by high performance liquid chromatography method, and the chromatographic condition be validated. Determine the contents of catalpol in Herba Lanceae which from different areas by the established chromatographic method.To determine four different types bioactive components in Herba Lanceae synchronously by a new method of quantitative analysis of multi-components by single marker(QAMS). Chose acteoside as the index, and then calculate relative correction factors (RCFs) of catalpol, phillyrin and phillygenol. And the contents of the four constituents be calculated according to the RCFs. Evaluate this method of durability and adaptability evaluation of system. The position of the catalpol, phillyrin and phillygenol chromatographic peaks be comfirmed by comparing the Retention time difference method and the Relative retention time method. To determine contents of the four constitunes in Herba Lanceae by external standard method. Investigate difference of QAMS and external standard method to validate the accuracy and feasibility of the QAMS method.Result:Described the macro morphology of the plant, the micro tissue structure of plant stem and leaf and the micro characteristics of powder accurately. Established the method for Herba Lanceae identification of Pharmacognosy, include the exterior characteristics identification, micro tissue structure identification and powder characteristics identification. The TLC identification methods with catalpol, acteoside and ursolic acid as the reference are simple and feasible. Under the same chromatographic conditions herbs tested and the corresponding control products were in the same position with the same color spots, the spots were clear and round, had good separation and moderate Rf value. The contents of Catalpol were determined by HPLC, the linear regression equation was Y=2039418.8618x-11096.3415, the correlation coefficient r was 0.9996, In the range of 0.075mg/mL-0.60mg/mL linear relationship was good, the average recovery was 99.45% and RSD was 1.33%(n=6), catalpol content of the 9 batch of Herba Lanceae which from different areas were 0.51%-2.48%.Determined the contents of four compositions in Herba Lanceae by QAMS at the same time. RCFs of catalpol, phillyrin and phillygenol were 7.0449,2.1350 and 0.9647 respectively. Repeatability was good on different chromatographic columns and instruments (RSDs were 2.57%,2.23% and 1.19% respectively). RDs of QAMS method and external standard method were less than 5%, which indicated that no siginificant differences between the quantitative results of QAMS method and external standard method were observed. Positioning chromatographic peak of Catalpol through Retention time difference method, The difference of retention time for Catalpol was-45.626, and RSD was 3.60% respectively. Positioning chromatographic peaks of phillyrin and phillygenol through Relative retention time method, and different instruments and chromatographic columns of the relative retention value for them were 1.271,1.518, and RSD were 4.62%,3.17%, respectively.Conclusion:The research indicates that the proposed quality standard can control the quality of Herba Lanceae effectively. And when in the control products shortage, it is accurate and feasible to evaluate the quality of Herba Lanceae by QAMS. Therefore,this method is suited to determine different types of components, and can provide a new reference for the quality assess of Tibetan herb-medicine.