HPLC Fingerprint with Multi-components Analysis for Quality Consistency Evaluation of Traditional Chinese Medicine Si-Mo-Tang Oral Liquid Preparation

Si-Mo-Tang（SMT） oral liquid preparation, a traditional Chinese medicine, was prepared from four crude herbal drugs, Fructus Aurantii Submaturus, Radix Aucklandiae, Semen Arecae and Radix Linderae Aggregatae. A combinative method using HPLC fingerprint and quantitative analysis was developed and validated for quality consistency evaluation of SMT. Individual HPLC chromatograms were evaluated against the mean chromatogram generated via a similarity evaluation computer program. Data from chromatographic fingerprints were also processed with principal component analysis（PCA） and hierarchical cluster analysis（HCA）. Additionally, six components （naringin, isonaringin, hesperidin, neohesperidin, norisoboldine and potassium sorbate） in SMT were simultaneously determined to interpret the quality consistency. For fingerprint analysis, 20 peaks were selected as the characteristic peaks to evaluate the similarities of 26 SMT collected from different manufacturers. Among the 20 characteristic peaks, 10 peaks were assigned to be naringin, hesperidin, neohesperidin, isonaringin, neoeriocitrin, tangeretin, nobiletin, norisoboldine, 5-（ethoxymethyl）furan-2-carbaldehyde and potassium sorbate, respectively. The results of similarity analysis, PCA and HCA, indicate that the samples from different manufacturers were consistent with each other in composition. The results from the quantitative data show that the contents of six compounds were significantly different in SMT oral liquid preparations from different manufacturers. The combinative method of chromatographic fingerprint with quantitative analysis developed here offered an efficient way for the quality consistency evaluation of the traditional Chinese medicine SMT.

我国非国家组织药品集中采购模式比较

目的比较分析我国各省市的药品集中采购方案及相关政策,探讨各地非国家组织药品集中采购模式的特点。方法围绕采购内容、采购规则等比较分析各地的非国家组织药品集中采购模式的特点,以及采购内容、采购环境、采购规则之间的内在关系。结果我国目前的非国家组织药品集中采购模式可划分为药品集中采购组织(group purchasing organization,GPO)、非过评仿制药带量采购、专项药品带量采购、带量议价以及分类采购框架下的带量采购5种。我国非国家组织药品集中采购的特点是分品种、分批次,以政府主导为主,执行机构主要为医疗保障局。结论目前,各地的非国家组织药品集中采购仅覆盖了部分品种的药品,对非过评仿制药进行集中采购是未来的重要趋势,建立公平、科学的质量分组规则是非国家组织药品集中采购亟待解决的重要技术问题。

The production and practice of cold-rolled steel sheets for automobile

Shougang Group has carried out a strategic structure adjustment in order to realize the promise of Chinese people to the Olympic Games.Automotive sheets are chosen as a type of strategic product and an engine to upgrade enterprise management,technology and operation to reach the top international level during the transition from long products to steel sheets in Shougang Group.Since 2006,Shougang Group has made an elaborate preparation on steel sheet culture,production line construction,technology import,pilot plant and talent reserve.It lays the foundation for the development of automotive sheets.The developing history of cold rolled automotive sheets is reviewed and the research and development of cold rolled automotive sheets, tackling key problem of defect on surface and the latest progress of automotive sheets construction are described in this paper.The main contents were given as follows:①The products of automotive sheets realize zero breakthrough in Shougang Group.Monthly output was 300 ton in January,2009 and it increased to 48 000 ton in June,2010.The ratio of IF steel sheets increases to 70%from 40%.The proportion of outside panel in automotive sheets occupys more than 15%.②A high emulational pilot plant is used as a product developing platform to develop successfully automotive sheets with 1 000 MPa and below.It guarantees that the industrial development of DP and TRIP sheets gets success at a time.It covers continuous annealing sheets with tensile strength≤780 MPa and galvanizing sheets with tensile strength≤590 MPa.③Individual design is used to meet special requirement of customer.Shougang owns 23 inner brands of LCAK and IF steels.It insures that the grades of yield strength cover whole range from 120 to 270 MPa.It keeps the stabilization of steel performance by means of chemical composition control and high accuracy rolling technology.For example,the strength of soft steel fluctuates within±15 MPa.④The steel sheets with surface grade O5 are produced steadily by solving forming striation of IF steel,grain coarse on surface,edge curling skin and mountains - and - waters painting defects.⑤The safeguard mechanism on quality of products is improved steadily and the output of automotive sheets and outside panel increases greatly by building consistency quality management system、information - system and customer service system.

Establishment of one-step approach to detoxification of hypertoxic aconite based on the evaluation of alkaloids contents and quality

Aconite is a valuable drug and also a toxic material, which can be used only after detoxification processing. Although traditional processing methods can achieve detoxification effect as desired, there are some obvious drawbacks, including a significant loss of alkaloids and poor quality consistency. It is thus necessary to develop a new detoxification approach. In the present study, we designed a novel one-step detoxification approach by quickly drying fresh-cut aconite particles. In order to evaluate the technical advantages, the contents of mesaconitine, aconitine, hypaconitine, benzoylmesaconine, benzoylaconine, benzoylhypaconine, neoline, fuziline, songorine, and talatisamine were determined using HPLC and UHPLC/Q-TOF-MS. Multivariate analysis methods, such as Clustering analysis and Principle component analysis, were applied to determine the quality differences between samples. Our results showed that traditional processes could reduce toxicity as desired, but also led to more than 85.2% alkaloids loss. However, our novel one-step method was capable of achieving virtually the same detoxification effect, with only an approximately 30% alkaloids loss. Cluster analysis and Principal component analysis analyses suggested that Shengfupian and the novel products were significantly different from various traditional products. Acute toxicity testing showed that the novel products achieved a good detoxification effect, with its maximum tolerated dose being equivalent to 20 times of adult dosage. And cardiac effect testing also showed that the activity of the novel products was stronger than that of traditional products. Moreover, particles specification greatly improved the quality consistency of the novel products, which was immensely superior to the traditional products. These results would help guide the rational optimization of aconite processing technologies, providing better drugs for clinical treatment.

An approach to optimize the batch mixing process for improving the quality consistency of the products made from traditional Chinese medicines

The efficacy of traditional Chinese medicine(TCM)is based on the combined effects of its constituents.Variation in chemical composition between batches of TCM has always been the deterring factor in achieving consistency in efficacy.The batch mixing process can significantly reduce the batch-to-batch quality variation in TCM extracts by mixing them in a well-designed proportion.However,reducing the quality variation without sacrificing too much of the production efficiency is one of the challenges.Accordingly,an innovative and practical batch mixing method aimed at providing acceptable efficiency for industrial production of TCM products is proposed in this work,which uses a minimum number of batches of extracts to meet the content limits.The important factors affecting the utilization ratio of the extracts(URE)were studied by simulations.The results have shown that URE was affected by the correlation between the contents of constituents,and URE decreased with the increase in the number of targets and the relative standard deviations of the contents.URE could be increased by increasing the number of storage tanks.The results have provided a reference for designing the batch mixing process.The proposed method has possible application value in reducing the quality variation in TCM and providing acceptable production efficiency simultaneously.

GOP-Level Bit Allocation Using Reverse Dynamic Programming

An efficient adaptive group of pictures （GOP）-Ievel bit allocation algorithm was developed based on reverse dynamic programming （RDP）. The algorithm gives the initial delay and sequence distortion curve with just one iteration of the algorithm. A simple GOP-level rate and distortion model was then developed for two-level constant quality rate control. The initial delay values and the corresponding optimal GOP-level bit allocation scheme can be obtained for video streaming along with the proper initial delay for various distortion tolerance levels. Simulations show that the algorithm provides an efficient solution for delay and buffer constrained GOP-level rate control for video streaming.