Modernization of traditional Chinese medicines has been actively pursued over the past decades. Advanced biological, chemical, pharmacological and engineering research of traditional Chinese medicines has been pursued. Despite the advances, the lack of quality assurance of Chinese herbal medicinal (CHM) products with consistent quality remains a critical issue to be solved. Nowadays, a typical CHM product is manufactured by following a fixed recipe of extraction of a fixed herb formula. However, there is huge variation in the composition of herbs from different sources and inconsistent quality CHM products are common. The objective of this project is to develop a quality assurance (QA) methodology of CHM products, which provides a systematic and cost effective way of production...[ Read more ]

Modernization of traditional Chinese medicines has been actively pursued over the past decades. Advanced biological, chemical, pharmacological and engineering research of traditional Chinese medicines has been pursued. Despite the advances, the lack of quality assurance of Chinese herbal medicinal (CHM) products with consistent quality remains a critical issue to be solved. Nowadays, a typical CHM product is manufactured by following a fixed recipe of extraction of a fixed herb formula. However, there is huge variation in the composition of herbs from different sources and inconsistent quality CHM products are common. The objective of this project is to develop a quality assurance (QA) methodology of CHM products, which provides a systematic and cost effective way of production of consistent quality CHM products irrespective of herb sources.

To achieve this objective, a QA model was developed, which describes the physicochemical phenomena such as mass transfer and multiple-herb-extraction effect during herbal extraction. The solubility and the model parameters including partition coefficient, maximum available amount, mass transfer coefficient, etc. of chemical markers are determined using experimental methods developed as an integral part of the model. After specifying the product quality specifications in terms of proportions of chemical marker concentrations, the model along with the experimental data provides the extraction conditions, including the type of extraction solvent, volume, temperature and time, and the herb amount of each quality class needed to produce a CHM product that satisfies the product specifications.

This QA methodology was demonstrated with three single-herb CHM products (Danshen, Gegen and Ginkgo leaf extracts) and a multiple-herb CHM product (Danshen-Gegen extract). Experiments showed that the determined QA solutions for the four CHM products were able to produce products with proportions of chemical marker concentrations fall within 10% of the specified chemical marker compositions. An H9c2 cell assay was used to test the efficacy of three Danshen-Gegen extracts of the same quality but were prepared by different herb combinations. The results showed that the three Danshen-Gegen extracts provided consistent biological efficacy against menadione-induced toxicity in H9c2 cells.

In addition, the QA methodology is also capable of solving optimization problems, such as cost minimization and minimization of toxic chemical contents in a CHM product. Cost minimization of all the four examples was conducted and it was shown that the cost savings can be significant. The most expensive solution was 13 times the least expensive one in the case of Gegen extract. Another example was the production of Ginkgo leaf extract. A consistent quality extract with an acceptable amount of toxic alkylphenols was produced by the most cost effective option of production.