[Technical system, strategy and development trend of excipient innovation research for pediatric preparations].

Under the background of the "14th Five-Year Plan" industry development, the pharmaceutical industry has ushered in a critical period of strategic transformation. Pharmaceutical excipients are a major categoryin drugs in addition tomedicinal substances, and the research and development of industrial technologies and innovative products play a decisive role in the development of high-quality drugs. The special drug for children is the focus ofthe pharmaceutical industry in the new era, and the application of standar-dized excipients is a key step indistinguishingbetween adult drugs and special drugs for children. In the context of the policy background in China, this paper reviewed the status quo of excipient industry, technical bottlenecks, application problems of pediatric excipients, and their development hotspots, interpreted the strategic layout of excipient innovation research and development suitable for pediatric preparations, and put forward prospects for their future development technicalroutes to lay a solid foundation for the industry transformation.

[Research on artificial substitutes of rare and endangered animal medicinal materials and industrialization].

Rare and endangered animal medicine, a kind of important Chinese medicine, plays an irreplaceable role in the prevention and treatment of serious acute and chronic diseases and major diseases. Due to resource limitation and depletion and the increasing demand, rare and endangered medicinal animal resources have been drastically reduced or even extinct, which threatens the inheritance of traditional Chinese medicine, the integrity of clinical medicine, and the development of the traditional Chinese medicine industry. For the protection and sustainable utilization of Chinese medicinal resources, artificial substitutes came into being. However, there is still a lack of systematic research on the pharmacological effects and clinical applications of artificial substitutes and whether they can completely replace the original medicinal materials in clinical practice. Therefore, this study focuses on the status quo of rare and endangered animal medicinal materials and their artificial substitutes that have been marketed. To be specific, the two were compared and whether the artificial substitutes can completely replace the original medicinal materials was analyzed. In addition, constructive suggestions on the industrialization of artificial substitutes were put forward, which was expected to promote the sustainable development of Chinese medicinal resources.

[History and application of foreign medicinal resources serving healthcare industry].

Foreign medicinal resources have always been an important part of Chinese medicine and have made great contributions to the development of the Chinese medical and health industry. Since the opening of the Silk Road in the Han Dynasty, foreign medicinal resources have been introduced for different purposes, some of which have become Chinese medicine in clinical practice and are still in use today.Today, foreign medicinal resources also serve the Big Health industry in China. They are introduced and applied to the fields in the Big Health industry, such as food, cosmetics, health products, decoction pieces, and daily chemical products. With the integration and development of the "Healthy China" initiative, more foreign resources will enter the Big Health industry. This paper retrospectedthe history of foreign medicinal resources serving the ancient medical and health industry, reviewedits current development under the Big Health industry, summarizedthe experience of foreign medicinal resources serving the ancient medical and health industry, as well as the development and problems of new foreign medicinal resources, and put forward some suggestions to provide ideas for the development and application of foreign medicinal resources under the Big Health industry.

[Establishment of industry promotion technology system in Chinese medicine secondary exploitation based on "component structure theory"].

The purpose of the secondary exploitation of Chinese medicine is to improve the quality of Chinese medicine products, enhance core competitiveness, for better use in clinical practice, and more effectively solve the patient suffering. Herbs, extraction, separation, refreshing, preparation and quality control are all involved in the industry promotion of Chinese medicine secondary exploitation of industrial production. The Chinese medicine quality improvement and industry promotion could be realized with the whole process of process optimization, quality control, overall processes improvement. Based on the "component structure theory", "multi-dimensional structure & process dynamic quality control system" and systematic and holistic character of Chinese medicine, impacts of whole process were discussed. Technology systems of Chinese medicine industry promotion was built to provide theoretical basis for improving the quality and efficacy of the secondary development of traditional Chinese medicine products.

[Assessment on analgesic and anti-inflammatory effects of Tongjingbao optimal formula and analysis on its active components].

OBJECTIVE: To assess the analgesic and anti-inflammatory effects of Tongjingbao optimal formula and analyze its active components. METHOD: Animals were divided into the model group, the Tongjingbao granule group and the Tongjingbao optimal formula group. The mice dysmenorrhea model was induced by oxytocin, and their content of blood calcium and MDA, NO, PGE2 in uterus were determined to assess the analgesic and anti-inflammatory effects of different components in Tongjingbao optimal formula and their impacts. RESULT: All components of Tongjingbao optimal formula could extend the dysmenorrhea incubation period of mice with dysmenorrhea, reduce their average writhing time, increase the writhing inhibition rate, lessen the content of blood calcium and MDA, PGE2 in uterus, and enhance the content of NO in uterus. CONCLUSION: All components of Tongjingbao optimal formula have the analgesic and anti-inflammatory effects, and different components show a synergistic effect in treating dysmenorrheal in many links.

Ultra-high-performance liquid chromatography-quadrupole/time of flight mass spectrometry based chemical profiling approach to rapidly reveal chemical transformation of sulfur-fumigated medicinal herbs, a case study on white ginseng.

Sulfur-fumigation may induce chemical transformation of medicinal herbs. Development of rapid method to reveal potential sulfur-fumigation induced chemical transformation of herbs is a very important issue for efficacy and safety of herb application. In present study, a new strategy was proposed to rapidly reveal chemical transformation of sulfur-fumigated herbs by ultra-high-performance liquid chromatography-quadrupole/time of flight mass spectrometry (UHPLC-QTOF-MS/MS) based chemical profiling approach. The non-fumigated herb was water-wetted and further treated with burning sulfur to get sulfur-fumigated herb. Then the chemical fingerprints of both non-fumigated and sulfur-fumigated samples were compared by UHPLC-QTOF-MS/MS analysis. The identities of all detected peaks, in particular those newly generated in sulfur-fumigated samples were confirmed by comparing the mass spectra and retention times of peaks with that of reference compounds, and/or tentatively assigned by matching empirical molecular formula with that of published compounds, and/or elucidating quasi-molecular ions and fragment ions referring to available literature information. The identification could be rationalized through deducing possible reactions involved in the generation of these newly detected compounds. The proposed strategy was extensively investigated in the case of white ginseng. Total 82 components were detected in non-fumigated and sulfur-fumigated white ginseng samples, among them 35 sulfur-containing compounds detected only in sulfur-fumigated white ginseng and its decoction were assigned to be sulfate or sulfite derivatives of original ginsenosides, and were deduced to be generated via reactions of esterification, addition, hydrolysis and dehydration during sulfur-fumigation and decocting of white ginseng. The established approach was applied to discriminate sulfur-fumigated white ginseng among commercial samples from America, Canada, and Hong Kong SAR, Macau SAR and Mainland of China, which indicated that the proposed approach is rapid and specific, and should also be useful for investigation of potential chemical transformation of other sulfur-fumigated medicinal herbs.