探析《神农本草经》常用上品药脏腑用药法则之别

《神农本草经》(以下简称《本经》)是我国现存最原始的一部中药学专著。全书载药365种,按药物功效的不同分上、中、下三品,上品120种“主养命以应天”,功以滋补强壮、延年益寿,颇具研究价值。后人根据《黄帝内经》(以下简称《内经》)对脏腑生理特性的描述,总结出“五脏以守为补,六腑以通为补”的观点,并应用于临床治病用药上,具备很强的科学性。现根据该论点试探析《本经》常用上品药用药法则之别。

《神农本草经》三品分类浅析——胡随瑜教授《神农本草经》讲记(一)

胡随瑜,中南大学湘雅医院中西医结合研究所教授、一级主任医师、博士研究生导师、湖南省名中医,兼任国务院学位办第五届终审委员（中西医结合学科组）,国家药品食品监督管理局审评专家。主要从事中医肝脏象传统理论的现代研究;抑郁症中医证治规律研究;中药新药药效学、毒理学研究。

Analysis on Epidemiology Causality Relationship Theory under Food and Drug Safety Context

Violation of food and drug safety and other hazard crimes have the features of long latency and multiple factors. Traditional criminal law causality theory is no controversy to determine causality of criminal responsibility, thus it is necessary to introduce the epidemiology causality theory-it is a kind of causality theory based on epidemic diseases, and it is the high degree of probability in the determination of causality in criminal laws so as to solve the traditional attribution problem, but the theory also exists applicable restriction conditions in judicial practice.

Postmarketing safety evaluation: depside salt injection made from Danshen(Radix Salviae Miltiorrhizae)

OBJECTIVE: To systematically examine the postmarketing safety of depside salt injection made from Danshen(Radix Salviae Miltiorrhizae),identifythe potential risk factors, and ensure its clinical safety.METHODS: We examined a comprehensive series of studies on the production process, quality standards, pharmacology, population pharmacokinetics, and safety evaluation of depside salt injection made from Danshen(Radix Salviae Miltiorrhizae). Data from Ⅰ-Ⅳ clinical drug trials, hospital information systems(HIS), and spontaneous reporting systems(SRS) were also analyzed.RESULTS: The effective components of salvianolic acid salt content reached almost 100%, and the magnesium lithospermate B content reached morethan 80%. The median lethal dose(LD50) calculated by the Bliss method was 1.49 g/kg, with 95%confidence intervals of 1.29-1.72 g/kg. Long-term tests on Beagle dogs indicated that doses of less than 80 mg/kg were safe and doses of 320 mg/kg were toxic. Adverse drug reactions(ADRs) included digestive disorders; drug-induced erythrocyte deformation in lung, liver, spleen, kidney, bone marrow, intestinal mucosa, lymph nodes, and other tissues; megakaryocytes in lung, liver, and spleen resulting from mild hemolysis; and mild hyperplasia in bone marrow hematopoietic tissue. Other studies indicated no irritative effect of the injection on local tissues and blood vessels, and no allergic reactions, erythrocyte coagulation, or hemolysis. SRS data showed that the most common ADRs were headache, head distention, dizziness, facial flushing, skin itching, thrombocytopenia, and the reversibility of elevated Aspartate transaminase. HIS data indicated no damage to renal function from using depside salt injection made from Danshen(Radix Salviae Miltiorrhizae) at a dosage higher than the recommended dose.CONCLUSION: This study analyzes the clinical characteristics of ADRs from depside salt injection made from Danshen(Radix Salviae Miltiorrhizae),and discusses the factors influencing such reactions. It provides scientific reference and recommendations for clinically safe medication of the Danshen injection.

Regulation of online pharmacies in China:the current situation and suggested improvements

Through literature research, expert investigation, and stakeholder interviews, this article summarizes related regulation policies and industry developments of China＇s online pharmacies. Based on the main problems, suggestions to improve the regulatory policies of online pharmacies in China were put forward regarding prescriptions, pharmaceutical services, medical insurance, and drug delivery.

Postmarketing studies on safety of Dengfeng~ shenmai injection

OBJECTIVE: To systematically research the postmarketing safety of Dengfeng shenmai injection, identify potential risk factors, and ensure its clinical safety. METHODS: We investigated a comprehensive series of studies on the production process, quality standards, pharmacology, postmarketing clinical studies, and safety evaluation of Shenmai injection, including literature analysis of adverse drug reaction(ADR) case analysis and systematic review. Data from the hospital information system(HIS) and spontaneous reporting system(SRS) were also analyzed. RESULTS: The approximate dosage leading to death in dogs is 45.0-67.5 g raw drug/kg and the toxic reactions are restlessness, skin irritation, salivation, and vomiting. The results of chronic toxicity tests in mice and dogs, and the other tests such as 6-month toxicity, drug safety, genetic toxicity, and reproductive toxicity of rats and dogs, were positive or qualified. Patient ADR history and ADR family history were closely associated with itching based on the data analysis from SRS. There was no damage to renal function from Shenmai injection use at a dosage and a treatment course outside the recommended dosage and treatment course as specified based on data analysis from HIS. The most common ADR from Shenmai injection are difficulty breathing, facial flushing, nausea, vomiting, chest tightness, skin itching, rash, and back pain. CONCLUSION: This study includes complete information on Shenmai injection ADR incidence rate. We found that Shenmai injection is safe and this study can provide clinical, research, and production institutions with an objective, reliable, and scientific basis for use of Shenmai injection.