Management system and development strategy of quality Chinese medicine / 中国中药杂志

The development of quality Chinese medicine is an important way to improve the quality of Chinese medicine, and ensure the safety and effectiveness of Chinese medicine. This article systematically elaborates the definition, classification, standard and mana-gement certification strategy of quality Chinese medicine. We present the quality Chinese medicine which is higher quality than that of eligible Chinese medicine based on quality control standards. Quality Chinese medicine is strictly in accordance with management procedures, likely GAP and GMP et al, during the productive process, which quality indicators is higher than that of the current relevant national quality standards, such as Chinese Pharmacopoeia(ChP) et al; its limited indicators such as exogenous pollutants and endogenous toxic substances are lower than that of the current relevant national quality standards, likely ChP et al; meanwhile these Chinese herbal medicine, medicinal pieces, patent medicines, and health products and foods with Chinese medicine raw materials are been certificated by quality Chinese medicine. At the same time, this article systematically expounds the five major management systems of quality Chinese medicine, including technical training management for practitioners, productive process management, standard mana-gement, quality inspection and certification management, and product traceability management. And we put forward strategies to improve the supervision and management system, and promote the standardization and development of quality Chinese medicine by improving the technical management system of quality Chinese medicine, strengthening the quality management system and six sigma(6σ) management in the company. These strategies will provide a reliable basis and effective way to improve the quality of Chinese medicine.

Research on planting area and industrial development strategy of Tibetan medicine / 中国中药杂志

Appropriate producing areas can guarantee the quality of Tibetan medicine, but research on the suitable ecological factors and suitable producing areas of Tibetan medicinal plants is scarce. This paper used the Geographic Information System for Global Medicinal Plants(GMPGIS) to analyze the ecological suitability of Tibetan medicinal plants nationwide. For the first time, the range of ecological factors and main soil types of Tibetan medicinal plants were extracted, such as the average annual temperature-19.4-24.2 ℃, annual average precipitation 17-4 088 mm, annual average sunshine 124.2-171.6 W·m~(-2). The main soil types were black calcareous soil, thin layer soil, chestnut soil and so on. Based on 337 sampling points, the largest ecological similarity area of Tibetan medicine across the country was obtained through ecological similarity analysis. In addition to Tibet and Qinghai provinces and Tibetan Autonomous Prefectures in Sichuan, Gansu, and Yunnan provinces, Jiuquan city and Linxia county in Gansu province, Panzhihua and Ya'an in Sichuan province, and Xinjiang, Inner Mongolia, and Shanxi provinces also had larger suitable cultivation areas. In addition, by analyzing the current situation of Tibetan medicine industry, the research pointed out that there were some problems such as unreasonable development and utilization of resources, lack of standards and norms, weak basic research and imperfect industrial system, and made corresponding countermeasures for sustainable development of resources, formulation of standards and specifications, promotion of medicine through science and technology, expansion of domestic and foreign markets, etc. This study provided the basis for guiding the rational layout of production bases, introduction and breeding of plant Tibetan medicine nationwide, laying the foundation for the scientific and standardized production of high-quality Tibetan medicine, clarifying the development direction of Tibetan medicine industry, and providing ideas for the development strategy of Tibetan medicine and other national medicine industry.

Differences in anti-inflammatory effects between two specifications of Scutellariae Radix in LPS-induced macrophages in vitro / 中国天然药物

Scutellariae Radix (SR), the root of Scutellaria baicalensis Georgi, is used as an antipyretic drug and has been demonstrated to have anti-inflammatory activity. SR is divided into two specifications, "Ku Qin" (KQ) and "Zi Qin" (ZQ), for use against different symptoms (upper energizer heat or lower portion of the triple energizer), according to the theory of traditional Chinese medicine (TCM). However, differences in the efficacies of these two specifications have not been determined. In the present study, we aimed to characterize the differences in the anti-inflammatory activities between KQ and ZQ and to explore how their differences are manifested in lipopolysaccharide (LPS)-induced macrophages. Our results showed that, in RAW264.7 cells (a mouse macrophage cell line derived from ascites), KQ and ZQ displayed anti-inflammatory effects by inhibiting the release of nitric oxide (NO), inducible NOS (iNOS), and nuclear factor-κB (NF-κB) in a dose-dependent manner without distinction. In NR8383 cells (a rat alveolar macrophage cell line), KQ and ZQ displayed similar effects on NO, iNOS, and NF-κB as seen in RAW264.7 cells, but KQ showed a higher inhibition rate for NO and iNOS than that shown by ZQ at the same concentration. These results indicated that there were differences in efficacy between KQ and ZQ in treating lung inflammation. Our findings provided an experimental evidence supporting the different uses of KQ and ZQ in clinic, as noted in ancient herbal records.

A semimicroquality evaluation method on Panax notoginseng and its application in analysis of continuous cropping obstacles research samples / 中国中药杂志

Panax notoginseng is a commonly used traditional Chinese medicine with blood activating effect while has continuous cropping obstacle problem in planting process. In present study, a semimicroextraction method with water-saturated n-butanol on 0.1 g notoginseng sample was established with good repeatability (RSD<2.5%) and 9.6%-20.6% higher extraction efficiency of seven saponins than the conventional method. A total of 16 characteristic peaks were identified by LC-MS-IT-TOF, including eight 20(S)-protopanaxatriol (PPT) type saponins and eight 20(S)-protopanaxadiol (PPD) type saponins. The established method was utilized to evaluate the quality of notoginseng samples cultivated by manual intervened methods to overcome continuous cropping obstacles.As a result, HPLC fingerprint similarity, content of Fa and ratio of notoginsenoside K and notoginsenoside Fa (N-K/Fa) were found out to be as valuatable markers of the quality of samples in continuous cropping obstacle research, of which N-K/Fa could also be applied to the analysis of notoginseng samples with different growth years.Notoginseng samples with continuous cropping obstacle had HPLC fingerprint similarity lower than 0.87, in consistent with normal sample, and had significant lower content of notoginsenoside Fa and significant higher N-K/Fa (2.35-4.74) than normal group (0.45-1.33). All samples in the first group with manual intervention showed high similarity with normal group (>0.87), similar content of common peaks and N-K/Fa (0.42-2.06). The content of notoginsenoside K in the second group with manual intervention was higher than normal group. All samples except two displayed similarity higher than 0.87 and possessed content of 16 saponins close to normal group. The result showed that notoginseng samples with continuous cropping obstacle had lower quality than normal sample. And manual intervened methods could improve their quality in different levels.The method established in this study was simple, fast and accurate, and the markers may provide new guides for quality control in continuous cropping obstacle research of notoginseng.

Systematic study on QAMS method for quality control of Panax notoginseng / 中国中药杂志

<p><b>OBJECTIVE</b>To establish a quantitative method of multi-components by single marker (QAMS) for determining ginsenoside Rg1, Rb1, Rd, Re and notoginsenoside R1 for the purpose of the quality control of Panax notoginseng.</p><p><b>METHOD</b>The relative correction factors (RCFs) between the five active saponins were determined by HPLC-DAD. With any of the five consituents as reference, a QAMS method was established for detect the quantitation of the other four consituents. The durability of the method was evaluated with five different HPLC instruments, five different Cis18 chromatographic columns and four detective wavelengths. Subsequently, the new QAMS method was used to determine the contents of five saponins contained in 43 batches of notoginseng samples, and compare with external standard methods, in order to evaluate the accuracy of the QAMS method.</p><p><b>RESULT</b>When the five saponins were taken for reference, there was no significant difference between the contents of Rg1, Rb1, Rd, Re and R1 contained in the 43 batches of medicines calculated by the QAMS method (Wf) and the content determination result of the external standard method (Ws). The ratio of their results was (Ws/Wr) (94.02 +/- 2.11)%-(99.75 +/- 0.79)%, suggesting that the method was highly accurate. Their relative correction factors showed good durability, ranging between 0.42%-3.7%, 0.52%-3.5% and 0.79%-4.9%, respectively, with different chromatographic columns, different instruments and different detective wavelengths. The relative retention value method could be adopted for accurately position the chromatographic peak of the five consituents, with their values ranging between 0.18%-13%.</p><p><b>CONCLUSION</b>An accurate, rapid and highly durable QAMS method is established for simultaneous determination and location of five saponins, so as to provide reliable basis for the application of the QAMS method in quality control of traditional Chinese medicines.</p>