Establishment and application of quality evaluation method for Xiaochaihu Granules based on calibrator samples / 中国中药杂志

With reference to the production process documented in Chinese Pharmacopoeia, this paper prepared the calibrator samples of Xiaochaihu Granules from multiple batches and established a method for fingerprint analysis and content determination that could be used to evaluate Xiaochaihu Granules available in market. Multiple batches of Chinese herbal pieces contained in Xiaochaihu Granules were collected for preparing the calibrator samples according to the process in Chinese Pharmacopoeia. Following the establishment of fingerprints for calibrator samples by UHPLC, the method for determining the contents of saikosaponin B2, saikosaponin B1, baicalin, wogonoside, baicalein, liquiritin, glycyrrhizin G2 and glycyrrhizic acid in Xiaochaihu Granules was established. The experimental results showed that the fingerprints of calibrator samples had 26 common peaks, covering the chemical compounds of main herbs Bupleuri Radix, Scutellariae Radix, Changii Radix, Glycyrrhizae Radix et Rhizoma, and Rhizoma Zingiberis Recens. The similarity of fingerprints for 47 batches of Xiaochaihu Granules from 31 companies with the calibrator sample fingerprint ranged from 0.74 to 0.99, indicating good applicability of the established fingerprint. The contents of main components baicalin, saikosaponin B2, and glycyrrhizic acid in Xiaochaihu Granules were within the ranges of 22.917-49.108 mg per bag(RSD 19%), 0.28-2.19 mg per bag(RSD 62%), and 0.897-6.541 mg per bag(RSD 41%), respectively. The quality difference in saikosaponin B2, and glycyrrhizic acid among different manufacturers was significant. The fingerprint analysis and content determination method for calibrator samples of Xiaochaihu Granules prepared according to the production process in Chinese Pharmacopoeia has been proved suitable for evaluating the quality of Xiaochaihu Granules from different manufacturers. Saikosaponin B2, glycyrrhizic acid, and liquiritin should be added as content control indicators for Xiaochaihu Granules, aiming to further improve the product quality.

Formulation of technical guidelines in line with characteristics and principles of traditional Chinese medicine changes to improve quality of such preparations--interpretation of Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines / 中国中药杂志

In leading the high-quality development of Chinese medicine preparations, it is an important link to formulate the scientific, reasonable, and feasible guidelines for the change of Chinese medicines in accordance with the change characteristics and principles of the Chinese medicines is an important work to promote the Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines was formed by a broad consensus based on the characteristics and research results of the pharmaceutical changes in Traditional Chinese Medicines(TCM)with the principles of science and risk management. This guideline has clarified the basic principles and requirements for the evaluation of changes in TCM, specified the research and verification work of common change scenarios, defined the boundaries of changes in TCM, and proposed to encourage the use of new technologies, new methods, and new excipients that meet product characteristics. It will definitely promote the quality improvement and the secondary development of TCM. In this article, the revision background and main content of the guideline were introduced, and the main features of the Guideline were analyzed, in order to provide references for the industry.

Biomechanical Analysis of Orthopedic Screw Under Bone Remodeling / 中国医疗器械杂志

In order to evaluate the biomechanical stability of titanium alloy screw with different structural parameters under bone remodeling, some three-dimensional finite element models were established and the bone remodeling process after implanting the screw was simulated. Three-dimensional finite element models consist of bone and screw with different lengths and diameters. Bone remodeling process was simulated by user-defined subroutine. It is found that the stress on the bone is concentrated on the groove and root of the internal thread. The screw stress is mainly on the beginning of the thread, and the whole stress decreases along the long axis of the screw. The stress distribution trend of bone and screw did not change significantly during the bone remodeling. The maximum equivalent stress value was different, the maximum equivalent stress on the screw and cancellous bone increased while the maximum equivalent stress value on the cortical bone decreased.

Systematic research of secondary development of Shufeng Jiedu Capsule / 中草药

The study of secondary development of major Chinese materia medica varieties is the important content of Chinese materia medica (CMM) innovation research, and it is also the important approach of inheriting and developing traditional Chinese medine (TCM) theory and breaking the bottleneck restricting of the development of TCM theory and CMM industry. In this paper, the secondary development of Shufeng Jiedu Capsule (SJC) was systematically studied. The chemical components of SJC were elucidated by the identification and characterization of herbs, SJC and components ingested into the blood. The main effective components were further screened and cleared by integrating UPLC-Q/TOF-MS, NF-κB double luciferase reporter gene system, binding experiments of G protein coupled receptors, network pharmacology analysis, and spectrum-efficiency screening method. Based on the traditional efficacy, the mechanism of SJC was explained in terms of anti-inflammatory immunity, antipyretic effect, pharmacokinetics and tissue distribution of the main components based on the methods of animal model and genomics. The formula features, compatibility regularity were clarified and the action properties, comparative advantages and core clinical value were found and refined by the research of decomposed recipes and the comparison with the similar CMM recipes and chemical drugs. The quality control systems of SJC and related herbs were established by content determination of multi-target ingredients and multi-batch samples, and the establishment of the characteristic mode of HPLC fingerprint. The original quality standards were promoted comprehensively to ensure the uniformity, stability and controllability of product quality. This study not only provided important theoretical and experimental basis for clinical application and guidance of clinical practice, but also provided research ideas and modes for the secondary development of other major CMM varieties.

Research progress and secondary development ideas of Astragali Radix polysaccharides for injection / 中国中药杂志

Astragali Radix( AR) polysaccharide for injection( Guoyao Zhunzi Z20040086) is a traditional Chinese medicine for intravenous powder injection developed by Shanxi Academy of Traditional Chinese Medicine in early 1990 s by taking advantage of AR resources in Shanxi province. The effective parts of AR polysaccharides were obtained by advanced technology. The hemogram of patients with radiotherapy and chemotherapy showed alleviations in clinic. However,due to the technical bottleneck in separation of the complex polysaccharides mixture and the difficulties in accurate measurement of the polysaccharide structures,the pharmacodynamic mechanism of the drug remained unclear,and the side effect was hard to control. In recent years,the theoretical studies for polysaccharide receptors have indicated that when polysaccharides bound to protein receptors,only the oligosaccharide fragments of the polysaccharide molecule bound to the receptors,and one or more active sites of oligosaccharide fragments may existed in the polysaccharide molecule.Therefore,the active center of polysaccharides can be studied based on the level of oligosaccharides through degradation of the polysaccharides,which provided a new strategy for breaking through the bottleneck in polysaccharide structure determination. Therefore,this paper reviews the current status of studies for AR polysaccharides for injection,the polysaccharide receptors theory and successful cases,in order to propose the secondary development ideas of AR polysaccharides for injection. The study results will lay a material foundation for the development of new drugs of polysaccharides from traditional Chinese medicine,and provide a basis for the resolution of international difficulties in quality control of polysaccharide drugs and molecular models,so as to further study of glycobiology,and enrich the polysaccharide receptors theory.

Druggability and preparation modification of Chinese materia medica based on supramolecular “imprinted template” / 中草药

Chinese materia medica (CMM) is a multi-component system. In addition to the study on single-component druggability, the focus should be also on how to integrate the rules of single-component druggability to construct a research system of suitable multi-component druggability of CMM. According to the basic theory of CMM guidance, the druggability of CMM has been accumulated by long-term clinical practice experience, and the curative effect is affirmed. The most critical issue is how to determine the attribution and intermolecular interaction of the well-defined CMM component group and develop a component CMM. However, how to integrate the physicochemical and biological apparent properties of the multi-component based on the apparent physical and chemical properties of the single-component is the key to the study on druggability and preparation modification of CMM. Therefore, the druggability study of the single-component medicine and the study of the change rules of multi-component CMM druggability by using compatibility principle of CMM and modern supramolecular chemistry theory are needed to performed to study on the druggability of CMM. The combination of CMM druggability, preparations and chemical modifications can maximize the success rate of the development of new CMMs. The characteristic of the autonomous “Qi-xi” for CMM “imprinting template” of supramolecules has an important guiding role in druggability research of CMM both in theory and practice.

Study of secondary development of Liujing Toutong Tablets / 中草药

To study the secondary development of major Chinese materia medica (CMM) varieties is the important content of CMM innovation research, and it is also the important approach of inheriting and developing traditional Chinese medicine (TCM) theory and breaking the bottleneck restricting the development of TCM theory and CMM industry development. In this paper, the secondary development of Liujing Toutong Tablets (LTT) was systematically studied. The chemical components of LTT were elucidated by identification and characterization of herbs, LTT and components ingested into the blood. The main effective components were further screened and cleared by binding experiments of G protein coupled receptors and network pharmacology analysis. The mechanism of LTT was explained by the studies of animal models, isolated organs, cells, functional receptors, and network pharmacology related with headache. The formula features, compatibility regularity were clarified and the action properties, comparative advantages and core clinical value were found and refined by the research of decomposed recipes and the comparison with the similar CMM recipes and chemical drugs. The quality control systems of LTT and related herbs were established by systematic research of identification and characterization of chemical components, the LTT chemical information herbal source, content determination of multi-target ingredients, establishment of the characteristic mode of HPLC fingerprint, sample determination of multiple batches. The original quality standards were promoted comprehensively ensuring the uniformity, stability and controllability of product quality. This study not only provided important theoretical and experimental basis for clinical application and guiding clinical practice, but also provided research ideas and modes for the secondary development of other major CMM.

Secondary development strategy of Chinese materia medica enterprises in China / 中草药

Developing along with the chemicals to tend gradually hard and adopting the natural medicine to rise,the international pharmacy field interesting in Chinese materia medica(CMM) increases gradually.The exterior competition of the CMM enterprises is becoming drastic and the secondary deve-(lopment) of CMM for the medicine enterprises in our country should be a better choose to face the international medicine market competition.The internal and external process about the secondary development of CMM should be taken into account and the strategy that should be adopted in the secondary development put forward.Such as: secendary development of new medicine of the CMM compound recipe;turning deeply to the CMM foundation research;the importance of developing the safe and valid CMM whose qua-(lity) is stabile and controlled;the importance of rising the processing level of the product,etc.It emphasized the importance in appling modern science and technology in the text.