Analysis on Safety of Polysorbate 80 as a Solubilizing Excipient in Traditional Chinese Medicine Injections / 中国实验方剂学杂志

There are safety problems in traditional Chinese medicine(TCM) injections. Most of the adverse reactions of TCM injections are very similar to those of hypersensitivity reactions. The hypersensitivity reaction of macromolecular substances in TCM injections has also been confirmed by experiments. Polysorbate 80 (trade name of tween-80) is a solubilizing excipient commonly used in TCM injections. Polysorbate 80 contains macromolecular impurities and the material basic research is not clear enough, and its quality problems need to be solved urgently. Based on this, the authors concluded that the macromolecular impurities in polysorbate 80 were the important material basis for the safety of TCM injections contained polysorbate 80. In this paper, the research progress of application of polysorbate 80 as a solubilizing excipient in TCM injections was reviewed and analyzed, so as to provide ideas for improving the safety of TCM injections contained polysorbate 80 and to promote the healthy development of TCM injections.

Problems of Using Traditional Chinese Medicine Injections in Clinical Practice and the Suggestions about Making the Package Inserts / 世界科学技术-中医药现代化

In clinical practice, the application of Traditional Chinese Medicine injections (TCMIs) has several problems, for example, at some time, the components are complicated, the ingredients and pyrogen are uncontrollable, the usage, the dosage, and the drug interactions are unclear and the method of application is also ambiguous and non-standard. The factors have restricted the development of TCMIs. Based on the policies of the TCMI package inserts since 2006, this paper takes consideration of the problems and gives suggestions of making strict, normal and evidence-based TCMI package inserts.

Effects of Different Concentrations of 4 Traditional Chinese Medicine Injections on Insoluble Particles / 中国药师

Objective:To investigate the change of insoluble particles in 4 traditional Chinese medicine injections at different con-centrations in 0. 9% NaCl injection. Methods:Fufang Kushen injection, Shuxuetong injection, Lugua Duotai injection and Honghua Huangsesu injection were diluted by 0. 9% sodium chloride injection to obtain low concentration and high concentration solutions. The insoluble particles number of initial injections and dilutions at different time points(0,2,4,and 5 h) was detected according to the in-soluble particles test described in the fourth principle 0903 of China Pharmacopoeia (2015 edition). Results:The number of insoluble particles in 4 traditional Chinese medicine injections and 0. 9% sodium chloride injection met the requirements. The insoluble particles (≥25 μm) in 4 traditional Chinese medicine injections at different concentrations were few and almost stable with time, the insoluble particles(≥10 μm) showed an increasing trend in a concentration-dependent manner and varied with time. Conclusion:The insoluble particles(≥10 μm) in traditional Chinese medicine injections at high concentration are more than those at low concentration, which suggests that the concentration of traditional Chinese medicine injections should be restricted strictly according to the prescriptions and used up as soon as possible.

Utilization of traditional Chinese medicine injections for invigorating blood circulation and eliminating stasis with acute cerebral infarction in Ezhou Central Hospital from 2015 to 2016 / 药物评价研究

Objective To analyze the utilization of traditional Chinese medicine (TCM) injections for invigorating blood circulation and eliminating stasis in patients with acute cerebral infarction in Ezhou Central Hospital,and evaluate the rationality of drug use of this type of drugs.Methods Totally 480 patients with acute cerebral infarction from 2015 to 2016 were randomly stratified extraction,and evaluated by criteria according to drug information,drug utilization research and adverse drug reaction (ADR).Results A total of involving 12 kinds of TCM injections and 506 cases in 480.Drug utilization studies have shown that the top 3 drugs for aDDDs values respectively were Xuesaitong Injection,Shuxuetong Injection and Salvia Injection,and DUI values of all drugs were≤ 1.0.Evaluation of rational drug use showed irrational use of 81 cases and irrational rate of 16.0％.Mainly for a single dose or the type of solvent instructions for recommended of drug instructions,mixed other drug compatibility or same use of two kinds of TCM injection,irrational rate of Western medicine practitioners was significantly higher than Chinese medicine practitioners (P ＜ 0.01).ADR monitoring showed that ADR occurred in 11 cases,main clinical manifestations were skin and accessories damage.Conclusion The utilization of TCM injections for invigorating blood circulation and eliminating stas,is in patients with acute cerebral infarction in our hospital is basically rational yet it far from perfect.The clinical rational use of TCM injection needs to be further regulated.

Utilization of traditional Chinese medicine injections for invigorating blood circulation and eliminating stasis with acute cerebral infarction in Ezhou Central Hospital from 2015 to 2016 / 药物评价研究

Objective To analyze the utilization of traditional Chinese medicine (TCM) injections for invigorating blood circulation and eliminating stasis in patients with acute cerebral infarction in Ezhou Central Hospital,and evaluate the rationality of drug use of this type of drugs.Methods Totally 480 patients with acute cerebral infarction from 2015 to 2016 were randomly stratified extraction,and evaluated by criteria according to drug information,drug utilization research and adverse drug reaction (ADR).Results A total of involving 12 kinds of TCM injections and 506 cases in 480.Drug utilization studies have shown that the top 3 drugs for aDDDs values respectively were Xuesaitong Injection,Shuxuetong Injection and Salvia Injection,and DUI values of all drugs were≤ 1.0.Evaluation of rational drug use showed irrational use of 81 cases and irrational rate of 16.0％.Mainly for a single dose or the type of solvent instructions for recommended of drug instructions,mixed other drug compatibility or same use of two kinds of TCM injection,irrational rate of Western medicine practitioners was significantly higher than Chinese medicine practitioners (P ＜ 0.01).ADR monitoring showed that ADR occurred in 11 cases,main clinical manifestations were skin and accessories damage.Conclusion The utilization of TCM injections for invigorating blood circulation and eliminating stas,is in patients with acute cerebral infarction in our hospital is basically rational yet it far from perfect.The clinical rational use of TCM injection needs to be further regulated.

Protocol of intensive hospital monitoring with long follow up and large sample: Diemailing Kudiezi injection as example / 中国中药杂志

This is a protocol of intensive hospital monitoring with long follow up and large sample of Diemailing Kudiezi injection, which aims to identify adverse drug reactions(ADRs) of Diemailing Kudiezi injection, including known incidence of adverse reactions, the incidence of new adverse reactions, the incidence of various ADR symptoms and the incidence of ADR among the sub populations; clarify the clinical features of ADRs of Diemailing Kudiezi injection; explore risk factors for ADRs; and analyze their usage in real world. After all, no existing experience about active surveillance on safety issues for postmarkeing traditional Chinese medicine injections could be used for us to learn. On the basis of references to related domestic policies and regulations as well as the design points for observational studies, we extensively solicited opinions from experts in the industry to develop this implementation protocol on monitoring research.

Analysis and exploration on adverse reactions of four kinds of andrographolide injections / 中国中药杂志

Concerned literature on four kinds of andrographolide injections in recent 15 years were searched in CNKI, Wanfang and VIP databases. The adverse drug reaction(ADR) cases of Chuanhuning, Yanhuning, Xiyanping and Lianbizhi injections were classified and analyzed statistically, including a total of 194 articles and 3 479 cases. The ADR clinical characteristics and occurrence regularity of these four andrographolide injections were analyzed and compared from the gender, age, primary disease, emergence time of ADR, clinical manifestation, allergy history, dosage, prognosis and combined medication of the patients. It is useful to provide valuable references for rational use of these andrographolide injections in clinical practice.

Effect of Traditional Chinese Medicine Injections on Allergic Reactions / 世界科学技术-中医药现代化

This study was aimed to investigate allergic reactions of traditional Chinese medicine (TCM) injections, and to determine contents of serum IgE in sensitized animals. The correlation between preceding contents in serum and allergic reactions may be found, in order to offer experimental evidences for advancing the accuracy of anticipa-tion by allergic reactions. Passive cutaneous anaphylaxis (PCA) tests and anaphylactoid reactions were used in a vari-ety of TCM injections. ELISA method was used to determine the content of total serum IgE in sensitized animals. The PCA results of SHL, QKL, YXC, XST, GGS and CHN were negative. The PCA result of CWJ was positive. There was no significant difference for total serum IgE level between the experimental group and the normal saline group in the group of SHL, QKL, YXC, XST, GGS, CHN and CWJ. All TCM injections caused anaphylactoid symp-toms in guinea pigs. It was concluded that all TCM injections can cause allergic reactions in guinea pig. And the al-lergic reactions of TCM injections were not correlated with serum total IgE.

Analysis of 277 ADR Reported in Our Hospital / 中国药师

Objective:To survey the status quo of ADR occurred in our hospital. Methods:Totally 277 ADR reports were collect-ed and analyzed statistically in our hospital from January 2010 to June 2013. Results:Among the ADR cases,the ratio of male to fe-male was 1∶1. 565, and 59. 93% of ADR occurred in the people over 50 years old. Totally 240 ADR cases (86. 64%) were induced by intravenous administration and 32 ADR cases (11. 87%) were induced by oral administration. Totally 167 ADR cases were caused by antibiotics (60. 29%), among them, 54 cases wero by cephalosporins (32. 34%), 47 cases by quinolones (28. 14%) and 32 ca-ses by cephamycins (19. 16%). Totally 42 ADR cases were caused by traditional Chinese medicine injections (15. 16%), and 18 ca-ses were caused by cardiovascular system drugs (6. 5%). The main clinical manifestations were lesion of skin and its appendant organr and digestive system injury with 162 cases (58. 48%) and 62 cases (22. 38%), respectively. Conclusion: It is necessary to strengthen clinical ADR monitoring, rationally use antibiotics and emphasize the importance of safe medication of traditional Chinese medicine injections.

Medication Safety of Traditional Chinese Medicine Injections Viewed from Perspective of Package Inserts / 中国药房

OBJECTIVE:To discuss the safety of traditional Chinese Medicine injections from aspects of their package inserts. METHODS:The package inserts of traditional Chinese medicine injections collected from Ningxia Hui autonomous region people's hospital were analyzed statistically with regard to the percentages of those without such items as "adverse drug reactions" or "contraindications" etc. RESULTS & CONCLUSION:The contents in package inserts of Chinese traditional medicine injections are far from perfect and specific and they are not updated in time. The contents related to medication safety remain to be completed and standardized.

Necessity of Basic Principles for Clinical Use of Traditional Chinese Medicine Injections Viewed from Perspective of the Status Quo of Clinical Use of Traditional Chinese Medicine Injections / 中国药房

OBJECTIVE:To provide references for the understanding and implementation of the basic principles for clinical use of traditional Chinese medicine injections.METHODS:The main problems appeared in clinical use of traditional Chinese medicine injections and their effects on the medication safety of the injections were analyzed.RESULTS & CONCLUSION: Clinical rational use of traditional Chinese medicine injections is an important link in the process of ensuring the medication safety of the injections.The formulation of the basic principles of clinical use of traditional Chinese medicine injections is quite necessary aimed at the problems occurred in the clinical use of traditional Chinese medicine injections,and the principle serves as a guidance for rational use of traditional Chinese medicine injections.

Use of Traditional Chinese Medicine Injections in Our Hospital during 2003～2006 / 中国药房

OBJECTIVE:To evaluate the use of traditional Chinese medicine injections in our hospital for references of clinical rational administration.METHODS:The consumption sum,DDDs,daily drug costs(DDC) of traditional Chinese medicine injections in our hospital during 2003～2006 were analyzed statistically.RESULTS:Over the 4 years,the incremental rate of the consumption sum of traditional Chinese medicine injections in our hospital experienced a big change,with annual incremental rates of 187%,95%,and —0.4%,respectively.Dominating the first places over the 4 years in respect of DDDs has been the category for cardio-cerebral vessels.The antitumor traditional Chinese medicine injections took the lead in consumption sum and DDC.CONCLUSION:The consumption quantity of traditional Chinese medicine injections experienced a fast increase,suggesting its great market demand.But it has distinctive defects which limited its more broad use.

Detection of Insoluble Particles in 6 Traditional Chinese Medicine Injections / 中国药房

OBJECTIVE:To detect the insoluble particles in six kinds of traditional Chinese medicine injections. METHODS: The insoluble particles in six kinds of traditional Chinese medicine injections were detected by light blockage method specified in China Pharmacopeia (2005 edition). RESULTS: Insoluble particles of different size and number were noted in all the 6 kinds of traditional Chinese medicine injections. CONCLUSION:It is necessary to tighten control on the quality of traditional Chinese medicine injections and attach great importance to the monitoring of insoluble particles in drug use.

Analysis on Causes of ADR Associated with Traditional Chinese Medicine Injections / 中国药房

OBJECTIVE:To comprehend the causes for adverse drug reactions (ADR)associated with the traditional Chinese medicine injections in order to improve therapeutic safety.METHODS:Through tracking visits and retrospective study of patient cases,100 control cases and 93 ADR cases are analyzed in terms of medicine,patient,prescribing and nursing,both by single-factor and multi-factor approach.RESULTS:The main causes of ADR associated with traditional Chinese medicine injections are:overdosing,combined administration of drugs,longer-than-required time gap between dispensing and transfusion,failure to do pre-dosing liver or kidney function checkup,irrelevance of indication,lack of detailed instruction about way of administration and dosing,and lack of remarks on pharmacological action.CONCLUSION:It’s vitally important to improve prescribing and nursing behaviors for the sake of enhanced safety of clinical use of drugs.