| ObjectiveChinese Herbal Medicine is one of the three pillars of Chinese medicine industry,It is an important material basis for direct prescriptions for the treatment of diseases,its quality directly affects clinical outcomes and people's health. But its current market situation is worrying, exploring whether there are differences between synonym homonym chinese herbal medical and new formulations(formula granules),including the active chemical components contents, based components content to regulate chinese herbal medicine level; determined varieties and sources of chinese herbal medical and new formulations, to ensure the stability of medicament quality imperative.To this end, the topic preferred ephedra and Tinglizi as representative herbals from cough and asthma drugs. While the two new forms- formula granules were selected in the study system as a positive control drug.The morphology, pharmaceutical ingredients, the main components contents,and other indicators were selected to multi-faceted analyse chinese herbal medicines; combining fingerprints and contents of indicators component to study the quality between different extraction process and different batches of the same granules, carding factors affecting the quality of chinese herbal medicine.Exploring differences between different varieties and different batches granules, and the factors of the quality stability.Sorting out the relevant factors of its quality; exploreing multi-sources ephedra and Tinglizi hebal medicine and formula granul quality equivalence;in order to formulate specification of quality control and treatment standards, provide an experimental basis on multi-sources ephedra and Tinglizi hebal medicine and formula granul quality equivalence assessment. Methods1. Adoption of microscopic technique for ephedrine and Tinglizi morphological identification.2. By Thin-layer chromatography and Infrared absorption Spectrometry, qualitative analysis of the sample composition.3. High Performance Liquid Chromatography and ultraviolet spectrophotometry component of the main content of the samples for quantitative data analysis. Results1. IR fingerprint similarity of ephedra and granules were more than 95%, indicating that the ingredients are basically the same, and the manufacturers in the industrial production of components retained relatively intact.2. The main ingredients in ephedra were statistically significant, not only in varieties but also in place of origin. Muzei Mahuang was the best, Cao Mahuang and Zhong Mahuang took the second places.3. Ephedra formulations main ingredients particles lower than in herbal, but there were significant differences among manufacturers and batches.4. Total cardiac glycoside content in South Tinglizi was higher than North Tinglizi, but quercetin-3-O-?-D- glucose-7-O-?-D- glucoside content of North Tinglizi was the best.5. The IR fingerprint between Tinglizi and formulations were differences, indicating some of the ingredients were altered or destroied in the extraction process.6. The components content of Tinglizi formulations from different manufacturers and batches were significant difference. Conclusions1. Establishment of Chinese herbal medicine morpholopy,fingerprint or characteristic spectrum and determination of main components of the combination quality control method.2. Species, origin etc. affect the quality of chinese herbal medicine.There were differences on different varieties in different type of components,even in similar components.Leading to drug efficacy attending the opposite,prompting that clinical application should be distinction, for different species of reasonable proportion with the standard medicine. Namely,the ratio of standardization is to ensure the consistency and stability of the medicine source quality.3. Among the factors,prtion and source of medicine were the most important.IR fingerprint combined with determination of main components is necessary to regulate, improve product quality, ensuring the quality of long-term stability.4. Taking formula granules as an example, provide experimental evidence for the control and stability of Chinese herbal medicines and new formulations,as raw materials for traditional chinese medicine and other new form medicine. |
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