ABSTRACT
The chemical properties of characteristic components are significant to the manufacturing quality control of big brand traditional Chinese medicine. In this study, the Huangjing Zanyu Capsules were used as the research carrier to determine the content of five characteristic components including icraiin, emodin, schisandrin A, 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside, and osthole simultaneously by high-performance liquid chromatography(HPLC). The results showed that the chemical properties of five cha-racteristic components had a good linear relationship(r>0.999 9) within the quantitative range; the relative standard deviations(RSD) was 0.11%-2.0% and 0.25%-2.8% respectively for intra-day and inter-day precision; the RSD of repeatability was 1.8%-2.6%; the RSD of stability within 48 hours was 0.19%-2.8%, and the average recovery rate was 95.52%-100.1%, all meeting the requirements of pharmaceutical quantitative analysis. Additionally, the interval estimation method was used to directly reflect the distribution of samples with abnormal chemical properties of characteristic components, and the results showed ten samples were detected beyound the 95% control line of confidence level. Multivariate statistical process control(MSPC) method was used to monitor the abnormal samples of Huangjing Zanyu Capsules collectively, and the results showed that two samples were beyond the 95% control line of Hotelling's T~2 and three samples beyond the 95% control line of squared prediction error(SPE), indicating consistent quality control of Huangjing Zanyu Capsules. In conclusion, the proposed method is not only accurate and efficient but also a compensation for the traditional single-component quality control method, providing a scientific basis for the quality control in manufacturing process of Huangjing Zanyu Capsules. Furthermore, it could also serve as a reference method for the quality control in manufacturing big brand traditional Chinese medicine.
Subject(s)
Capsules , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality ControlABSTRACT
Translational medicine is a new concept presented in recent decades, the core of which is to build a bridge between basic medical research and clinical application. From the beginning of constitution of Chinese medicine, clinical application has been given priority. Therefore, the idea of translational medicine is fully demonstrated in the research into the three key scientific problems of "classification of constitution of Chinese medicine", "relationship between constitution and disease" and "adjustment of constitution". Under its guidance, not only was the systematic theory of constitution of Chinese medicine established, but also the Constitution of Chinese Medicine Scale and the Standards of Classification and determination of Constitution of Chinese Medicine were developed, which translates methods of classifying the nine constitutional types into guidance for prevention of disease, management of health and clinical application. The research findings of constitution of Chinese medicine have been applied in clinical practice and public health, establishing the diagnosis and treatment model of constitution-disease-syndrome differentiation. The nationwide application of constitution differentiation has shown good effect. In the future, constitution of Chinese medicine should strengthen the evidence-based research and multi-disciplinary cooperation, and establish a research team on comprehensive constitution of Chinese medicine and translational medicine, to translate the findings into clinical practice and public health more accurately and quickly.
Subject(s)
Humans , Biomedical Research , Medicine, Chinese Traditional , Syndrome , Translational Research, Biomedical , United States , United States Public Health ServiceABSTRACT
Constitution factor plays an important role in the occurrence, development, and transformation of diseases. The occurrence of allergic diseases is mainly caused by the disorganized physiological function and suitability regulation of patients, except for their exposure to outside allergens. Moreover, it represents susceptibility and hypersensitivity to allergens. The current study expresses the concept of allergic constitution from the perspective of Chinese medicine (CM) and presents the criterion of allergic constitution. In addition, the distribution of allergic constitution in population, its factors, and its relation to health-related quality of life (HRQOL) were investigated. The HRQOL scores of allergic constitution were found to be lower than those of the Pinghe constitution. After making a study on the gene expression profile of allergic constitution, the characteristics of up-regulated or down-regulated genes were found. Finally, CM drug was researched and developed to improve allergic constitution. Based on clinical trials and animal experiments, CM is found to have good regulatory effects on allergic constitution.