Study On Quality Control Of The Crude Drug, Cell-broken Powder, Cell-broken Powder Granules Of Red Ginseng, Astragalus Membranaceus And Notoginseng

1 ObjectiveChinese medicinal cell-broken powder granule is a new product which has smaller granularity, and larger specific surface area than common powder of traditional Chinese medicine. It may effectively enhance drug bioavailability by improving in vivo release, absorption and metabolic rate. Quality control is an important part of drug, but the quality study of cell-broken powder has been reported rarely. The change of chemical constituents, formulation and clinical safety still have some problems for its quality. It is very necessary to carry out quality standard of cell-broken powder granule, especially the drug's stability.Astragalus membranaceus, Notoginseng, Red ginseng are famous and precious traditional Chinese medicine. This paper will estabilsh technical standards of quality control of Astragalus membranaceus, Notoginseng, Red ginseng cell-broken powder granules by studying on the raw material drug, intermediate products and products. Furthermore, the research will improve the quality of the cell-broken powder granule as a safe, effective, controllable and stable product.2 Methods2.1 Quality study of the crude drugs of Astragalus membranaceus, Notoginseng and Red ginsengThe qualities of crude drugs of Astragalus membranaceus, Notoginseng, Red ginseng will be evaluated by Chinese Pharmacopoeia 2010 and Principal Component Analysis.2.2 The establishment of determination methods for cell-broken powder of Notoginseng, Red ginseng HPLC was introduced to establish the determination methods by analyzing the major components in cell-broken powder of Notoginseng, Red ginseng. 2.3 The establishment of HPLC fingerprints of the three Chinese medicines'crude drug, cell-broken powder, cell-broken powder granulesHPLC fingerprint was used to analyze samples from crude drugs to products. The extraction methods and the chromatograms systemic methodology were optimized for the HPLC fingerprint establishment of the three Chinese medicines' crude drug, cell-broken powder, cell-broken powder granules. Furthermore, the similarity evaluation of chromatograms was processed by similarity evaluation system for chromatographic fingerprint of TCM.2.4 Stability study of different packaging of Astragalus membranaceus, Notoginseng, Red ginseng crude drug and cell-broken PowderThe quality stability of different packaging of Astragalus membranaceus, Notoginseng, Red ginseng's crude drug and cell-broken powder were evaluated at room temperature and accelerated conditions (40℃, relative humidity 75%) by the character, moisture, active ingredient contents and fingerprints in six months.3 Results3.1 Principal component analysis method was used to evaluate Notoginseng, Astragalus membranaceus and Red ginseng herbs'qualities. The content of ginseng saponins is the first key factor of Red ginseng. The content of astragaloside IV is the first key factor of Astragalus membranaceus. The content of ginseng saponins is the first key factor of Notoginseng.3.2 The content determination methods for cell-broken powder of Red ginseng and Notoginseng were establshed. Ginsenoside Rg1. ginsenoside Re, ginsenoside Rb1 were determined by HPLC for cell-broken powder of Red ginseng. Notoginsenoside R1. ginsenoside Rg1, ginsenoside Rb1 were inspected for cell-broken powder of Notoginseng.3.3 Fingerprints of the three Chinese medicines' crude drug, cell-broken powder, cell-broken powder granules were established. The fingerprint of Red ginseng has 11 common peaks. And 8 common peaks were selected for Astragalus membranaceus. The fingerprint of Notoginseng also has 8 common peaks.3.4 Stability study of different packaging of Astragalus membranaceus. Notoginseng, Red ginseng crude drug and cell-broken powder were showed that the qualities are stable in six months.4 Conclusion 4.1 Quality study of the crude drug of Astragalus membranaceus. Notoginseng, Red ginsengPrincipal Component Analysis for the comprehensive quality evaluation is effective and comprehensive. These methods are better than the single evaluation method for quality control. This research could be as a theoretical and practical reference for evaluation of the quality of Chinese medicine.4.2 Establishment of determination methods for cell-broken powder of Notoginseng, Red ginsengThe determination methods for cell-broken powder of Notoginseng and Red ginseng are simple, quick, and suitable for quality control.4.3 Establishment of the fingerprints of the three Chinese medicine's crude drug, cell-broken powder, cell-broken powder granulesThe HPLC fingerprints of the three Chinese medicines'crude drug, cell-broken powder, cell-broken powder granules are built up.The HPLC fingerprints can improve the quality control of modern medicine by similarity evaluation of their raw ingredients, intermediate products and products. 4.4 Stability study on different packaging of Astragalus membranaceus, Notoginseng, Red ginseng's crude drug and cell-broken PowderThe stability of different packaging of Astragalus membranaceus, Notoginseng, Red ginseng crude drug and cell-broken Powder are stable in 6 months.