| With the traditional Chinese medicine widely used in the international arena, the security issues caused widespread concern. The bottleneck problem is Quality control of TCM in Chinese medicine modernization and internationalization. Establish quality standards for high quality in order to ensure the safety of the drug、the effectiveness is a long-term and arduous task. Chinese medicine quality standard system can be divided in four parts into content:medicinal quality standards, process standards and product quality standards and technical standards. For the overall quality control system, herbs’ quality standards are a good source of quality, process and technical standards is a guarantee of good quality, product quality standards is the ultimate expression of good quality standards.The early Chinese medicine quality inspection method is very simple, has the morphology of the experience of identification methods, in1963, using the gravimetric method^volumetric method et. laboratory means to assist in the identification.1985, manual analysis of laboratory identification methods was used. Until1990, the real beginning of modern instruments of the gas/liquid chromatography analysis of the detection method identification.Evaluate the quality of Salvia miltiorrhiza, commercial grade division have two kinds methods:follow the traditional evaluation method-based on place of origin, appearance, color, or index components for Salvia (salvianolic acid B, tanshinone Ⅱ)TLC qualitative identification or quantitative analysis using high performance liquid chromatography. Although these methods can in some ways reflect the quality of Salvia, but the control of the index components is difficult to really control the effectiveness of Chinese medicine, can not fully reflect the intrinsic quality of the Salvia. Today, fingerprints have become increasingly effective means of control of traditional Chinese medicine(TCM) or natural medicine quality. TCM fingerprint detection techniques using modern analytical instrumentation and chemical information processing means of the quality of Chinese medicine products were characterized by breakthrough of traditional Chinese medicine quality control techniques are many defects. Fingerprinting can be more fully reflect the type and quantity of chemical constituents in traditional Chinese medicine, in particular, the intrinsic quality is in this stage, the vast majority of the active ingredient is no clear case, to better reflect the traditional Chinese medicine. Fingerprinting has the overall, macro and fuzzy analysis, especially for the needs of the research in traditional Chinese medicine theory.Fingerprint refers to a Chinese herbal medicine or proprietary Chinese medicine being treated properly using analytical tools to map marked characteristics of the traditional Chinese medicine. The purpose of the establishment of Chinese medicine fingerprint fully reflect the type and quantity of the chemical composition, and thus reflect the quality of TCM. Currently, the fingerprint has become one of the most effective way to Chinese medicine or natural medicine internationally recognized quality control. FDA, British Herbal Pharmacopeia, Indian Herbal Pharmacopeia, the German Institute of medicinal plants, medicinal plants in Canada Society, etc. are all accept fingerprints of quality control methods.This topic fingerprint of Salvia miltiorrhiza Bge produced by the Shandong region, the establishment of a standard fingerprint quality indicators and quality in accordance with the guidance of the actual medication.Herbs personally collected by the research group or to purchase are authentic Salvia, identificated by Shandong University, School of Pharmacy, Department of Pharmacognosy, Professor Chen Yonglin. The herbs in dried, crushed sieved for analysis.Salvia main ingredients are two categories:lipophilic components, water-soluble poly-phenolic acids. The two types of components for Salvia HPLC-UV determination of fingerprint, to inspect the precision, reproducibility, and solution stability, determined feasible, reproducible determination method.Determination of lipophilic components of the "Chinese Pharmacopoeia"2005. the fingerprints:Take the sample powder extracted with methanol, filtration system for the test solution, SHIMADZU VP-ODS (4.6mm idx250mm,5μm) column with water (A)-acetonitrile (B) as the mobile phase gradient elution; flow rate of1.0ml/min; injection volume:20μL; detection wavelength280nm; column temperature:30℃.Component and method for the determination of water soluble components of the "Chinese Pharmacopoeia"2005version of a collection contains fingerprints of:Take the sample powder with water, ultrasonic extraction, centrifugation and filtration system for the test solution, SHISEIDO, CAPCELL PAK C18-the MG Ⅱ (250mm×4.6mm5μm) column;0.1%phosphoric acid (A)-acetonitrile (B) as the mobile phase gradient elution; flow rate of1.0ml/min; injection volume:20μL; detection wavelength:254nm; column temperature:30℃.Results:The chromatographic fingerprint similarity evaluation system to the test data, the similarity calculation, obtained water-soluble ingredients, fat-soluble ingredients of a typical fingerprint, and this map as a standard SPSS statistical analysisstatistical software for data processingSignificance:We collected34samples of single herbs from different regions of Shandong, the content of fat-soluble and water-soluble components by different methods, respectively its determination with the fingerprints of the respective components of the standard fingerprintprovide a basis for quality control of Salvia miltiorrhiza Bge. |
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