中药质量标准与中药的科学发展

TheQuality Standards and Scientific Development of TCM

中药的价值是治疗疾病,用于衡量中药价值的标准称之为质量标准,评价中药质量的经典方法是使用中药的标准物质标化。中药一直缺少标准和标准物质,导致在实际工作难以控制中药的质量。所以说,影响中药发展的核心问题是中药质量标准及其标准物质。中药的标准物质是其药效组分,它可以准确地标化出中药质量的特征,具体的表达方式是用药效组分的标示量或分解为有效性﹑安全性和稳定性的指标。在过去中药科学发展目标中,对中药的定位上出现了偏差,致使中药质量标准出现了明显的不科学内容,直接阻滞了中药的发展。中药的标准物质是中药本身而非某种或某些化学成分,要用临床中药学的观点去研究和认识中药。指导中药发展的新理论是"中药药效组分理论"。传承的中药必定是在中药药效组分理论指导下产生的"组分中药",组分中药也是传统中药的标准物质。

Objective： The value of Chinese medicine is curing diseases.The standard for weighing the value of commercial Chinese medicine is quality standard.The classical method for controlling quality standard effectively is using standard materials to evaluate it. Chinese medicine has been being the state of lacking standards and standard materials.So it is difficult to control the quality of Chinese medicine in the practical work.Quality standard and standard materials are the key issues which affect the development of Chinese medicine. Chinese medicine＂ standard materials are active components alignments ,which can standardize the quality characteristics of Chinese medicine accu- rately. The specific expression is using the labelled amount of active components alignments or resolving indexes of effectiveness,security and stability. In the past,the errors appeared in the research locations, which have led to obvious unscientific contents in the current quality standard, and which directly block the development of Chinese medicine.The standard materials of Chinese medicine are themselves rather than certain or some kind of chemical compositions. Researching and knowing Chinese medicine should use the viewpoints of clinical Chinese drug science. The new epoch-making theory that can guide the development of Chinese medicine is the active components alignment. Inherited Chinese medicine must be components alignment which generated under the guidance of the components alignment theory of Chinese medicine. The components align- ment of Chinese medicine are also standard materials of Chinese medicine.