Classification optimization of traditional Chinese medicine materials based on additive physical properties of powder / 中国中药杂志

According to the method of predicting the physical properties of oily powder based on the additive physical properties of Chinese medicinal powder, Dioscoreae Rhizoma and calcined Ostreae Concha with high sieve rate and good fluidity were mixed and crushed with Persicae Semen, Platycladi Semen, Raphani Semen, Ziziphi Spinosae Semen, and other typical oily materials with high fatty oil content in proportion to obtain 23 mixed powders. Fifteen physical properties such as bulk density, water absorption, and maximum torque force were measured, and the physical properties of typical oily powders were predicted. When the mixing and grinding ratio was in the range of 5∶1-1∶1, the r value in the correlation equation between the weighted average score of the mixed powder and the powder proportion ranged from 0.801 to 0.986, and the linearity was good, indicating that the method of predicting the physical properties of oily powder based on the additive physical properties of traditional Chinese medicine(TCM)powder was feasible. The results of cluster analysis showed that the classification boundaries of the five kinds of TCM materials were clear, and the similarity of the physical fingerprints of powdery and oily materials decreased from 80.6% to 37.2%, which solved the problem of fuzzy classification boundaries of powdery and oily materials due to the lack of representativeness of oily material model drugs. The classification of TCM materials was optimized, laying a foundation for optimizing the prediction model of the prescription of personalized water-paste pills.

Research progress on therapeutic strategies for improving pulmonary vascular remodeling in pulmonary hypertension / 中国药理学通报

Pulmonary hypertension(PH)is a chronic,progressive,high-mortality disease characterized by a continuous increase in pulmonary vascular pressure. All types of PH have the same characteristics,i.e.,the excessive proliferation,anti-apoptosis and inflammation of pulmonary artery endothelial cells and smooth muscle cells,which leads to progressive thickening of pulmonary small vessels,resulting in pulmonary vascular remodeling and increased pulmonary vascular resistance,ultimately leading to right ventricular hypertrophy,heart failure,and death. The drugs used to treat PH mainly include L-type calcium channel blockers,phosphodiesterase 5 inhibitors,guanosine cyclase activators,endothelin receptor antagonists,and synthetic prostacyclin and its analogues. These drugs reduce pulmonary artery pressure by relaxing pulmonary blood vessels but do not cure the patient,and their prognosis remains poor. Therefore,the development of drugs that can effectively improve or even reverse pulmonary vascular remodeling is the key to treating PH. In recent years,studies on pulmonary vascular remodeling mainly included(1)the synthesis of new small-molecule compounds;(2)the transformation of mature drugs,such as the use of drug combinations and dosage form transformation,etc.;(3)the pharmacodynamic evaluation of traditional Chinese medicines and derived compounds based on the theory of "lung distension";(4)research into monomers of traditional Chinese medicine; and(5)research into new targets.

Establishment and analysis of microbial limit test methods for commonly used pediatric drugs / 上海预防医学

ObjectiveTo establish microbial limit test methods for 44 pediatric drugs. MethodsAccording to the general guidelines in Chinese Pharmacopoeia （2015 and 2020 edition， volume Ⅳ），a suitability test of the methods for 44 drugs was carried out by pour-plate method， neutralization method or dilution method. ResultsTotal aerobic microbial count： chemical oral liquid samples can be tested by 1∶10 plate method；traditional Chinese medicine need to be neutralized firstly. Then oral liquids could be tested by 1∶10 plate method and 1∶100 plate method was used for granules. Total count of molds and yeasts： all the samples can be tested by the 1∶10 plate method. The recoveries of five test strains were between 0.5 and 2.0. The specified microorganisms were all detected in the test group， while not found in the negative control group. ConclusionThe microbial limit test methods for the 44 pediatric drugs are established and the results are reliable and can be used in the quality control．

The research progress on the structure pharmaceutics and dosage form structures of traditional Chinese medicines / 药学学报

Traditional Chinese medicine (TCM) preparations have made tremendous progresses in modernization, whereas there exist relatively few researches pertaining to preparation structures. As demonstrated by the theory and practice of structure pharmaceutics, the structure properties of dosage forms have significant influences on the quality and efficacy of drugs, which might offer reference for the research and development of TCM dosage forms. With the application of synchrotron radiation X-ray micro-computed tomography (SR-μCT) and other novel technologies in recent years, researches in structure pharmaceutics have made huge advancement, which provide reference and methodology basis for the study of TCM preparations. The article generalized and summarized the recent progresses and methods in the structure researches of pharmaceutics and TCM preparations, and further explored the significance of the researches of structure of TCM preparations. It is expected to provide the basis for the dosage form design, production process improvement, and quality evaluation of TCM and promote the modernization of TCM preparations.

Judgment on decocting endpoint of decoction in "Treatise on Febrile Diseases" and "Treatise on Differentiation and Treatment of Epidemic Febrile Disease" / 中草药

The time of decocting plays an important role in ensuring the clinical efficacy of Chinese medicine decoction and the quality of traditional Chinese medicine, but from ancient times to the present, the judgment of the endpoint of Chinese medicine decoction has always been a technical problem. In this paper, the decocting time and the judgment methods in the Chinese medicine classics "Treatise on Febrile Diseases" and "Treatise on Differentiation and Treatment of Epidemic Febrile Disease" were analyzed. Certain laws of decocting time were found. It was demonstrated that the main factors affecting the decocting time were the disease, the efficacy of the prescriptions, the drug properties, and the characteristics of the medicine, etc. Combined with modern research results, the judgment method of the endpoint of traditional Chinese medicine decoction was expounded, hoping to seek a reasonable scientific basis for the boiling time of Chinese medicine decoction and the extraction process of modern Chinese medicine preparation, and provide a theoretical basis for ensuring the clinical efficacy of Chinese medicine decoction and the quality of Chinese medicine preparations.

Study on pigmentation in the livers and kidneys of rats caused by a compound Chinese medicine preparationXIA / 预防医学

Objective@#To explore the cause and type of pigmentation in the livers and kidneys of rats caused by a compound Chinese medicine preparation. @*Methods@#The experiment consist of low, medium, and high dose groups and a control group, the Sprague-Dawley rats in these groups were orally given 1.0, 2.0 and 4.0 g/kgbw of a compound Chinese medicine preparation of gardenia and distilled water for 30 days, respectively. The body weight, diet, hematology and histopathology of the rats in each group were observed for changes in pigment metabolism. @*Results@#In the first and second weeks of the experiment, the rats in the low, medium, high dose groups and the control group showed no abnormal symptoms or signs. From the third weekend, the urine of the rats in the high dose group turned thick yellow and green, and the stool color became light. During the experiment, no rats died. There were statistically significant differences in body weights and weight gains among these groups ( P<0.05 ) . There were statistically significant differences in total food utilization, direct bilirubin, r-glutamyl transferase, alkaline phosphatase, and liver/body ratios among these groups ( P<0.05 ). Gross examination revealed that the livers and kidneys of rats in the high dose group were dull and green. Microscopic examination revealed changes in dark pigment particles in the livers and kidneys of rats in the high dose group. Histochemical staining confirmed that pigments in the livers and kidneys were bile pigments. @*Conclusions@#At a dosage of 4.0 g/kgbw, a compound Chinese medicine preparation of gardenia can lead to bile pigment deposition in the livers and kidneys of rats due to cholestasis.

Quantification of hepatotoxic pyrrolizidine alkaloid adonifoline in traditional Chinese medicine preparations containing Senecionis Scandentis Herba / 中国中药杂志

Pyrrolizidine alkaloids(PAs) are a kind of natural toxins, which can cause severe hepatotoxicity, pulmonary toxicity, genotoxicity, neurotoxicity, embryotoxicity and even death. Therefore, international organizations and countries such as World Health Organization have paid great attention to herbal medicines and preparations containing PAs. PAs are widely distributed in Chinese herb medicines and contained in hundreds of traditional Chinese medicine preparations. The content of adonifoline, the main PAs in Senecionis Scandentis Herba, shall be less than 0.004% in herbal medicines as described in Chinese pharmacopeia. However, there is no guidance in preparations which contain Senecionis Scandentis Herba. In this study, 14 preparations were analyzed by an UPLC-MS method. Among them, 8 preparations were found to contain adonifoline much higher than the content limits of such countries as Germany, Netherlands and New Zealand. And the highest contents of adonifoline were found in Qianbai Biyan Tablets and Qianbai Biyan Capsules, which are officially recorded in Chinese Pharmacopeia. The contents of adonifoline varied in different batches of the same preparations. The highest content was 156.10 μg·g~(-1) Qianbai Biyan Tablets, whose daily intake of adonifoline was up to 1 030.26 μg according to the recommended dosage of the preparation. Our results showed the potential risk of these preparations, and the content limit of adonifoline shall be inspected Chinese medicine preparations containing Senecionis Scandentis Herba.

Discussion of the Supervision Mode for the Quality of Traditional Chinese Medicine and Traditional Chinese Medicine Pieces in Traditional Chinese Medicine Preparations / 中国药学杂志

OBJECTIVE: To discuss the supervision mode of traditional Chinese herbal medicines and traditional Chinese medicine pieces in the production of traditional Chinese medicine preparations, and provide advice for the scientific and effective supervision of traditional Chinese medicine preparations with Chinese herbal medicines and Chinese medicine pieces. METHODS: Through the study of relationship between the quality, processing, preservation of medicinal herbs and the quality of preparations, the relationship between the implementation of Good Manufacture Practice (GMP) of traditional Chinese medicine preparations, and the relationship between imperfect quality standards and the quality of traditional Chinese medicine preparations, we put forward measures to solve the problems. RESULTS AND CONCLUSION: In the supervision of Chinese herbal medicines and traditional Chinese medicine pieces during the production of traditional Chinese medicine preparations, we should be closely around the core to ensure the quality of traditional Chinese medicine preparations, and should take different supervision modes of herbs and pieces according to different types and characteristics of traditional Chinese medicine preparations. At the same time, we should ensure the stability of the sources and origins of Chinese herbal medicines and ensure that manufacturing comply with GMP. We should standardize the preparation process of Chinese herbal medicine pieces by the traditional Chinese medicine preparation enterprises and implementation of traditional Chinese medicine pieces production filing system. And the quality standard of Chinese medicinal herbs and Chinese prepared herbs should be improved, with the objective to ensure the safety and effectiveness of traditional Chinese medicine preparations.

Influence factors of hepatotoxicity of traditional Chinese medicine preparation products based on multidimensional structure dynamic process / 中国中药杂志

Traditional Chinese medicine (TCM) products are the finished products by adopting certain preparation processes according to the profile of the herbs, with Chinese herbs or decoction pieces as the raw materials.Among their adverse reactions to the organs, hepatotoxicity can not be ignored. As a new stage of quality control in TCM, dynamic quality control system of the multidemensional structure process emphasized on the research of the effectiveness and safety, focused on the pretreatment, preparation process,dosage forms and drug delivery methods to control the quality of TCM preparation products and reduce the generation of hepatotoxicity.In this paper, we will start from these factors to discuss the causes of hepatotoxicity underlying drug products and hope to provide the reference for developing low toxicity and high quality modern Chinese medicine products.

Status, problems and warranty strategy of quality uniformity for traditional Chinese medicine preparations / 中国中药杂志

The quality uniformity of traditional Chinese medicine (TCM) preparation is the base for guaranteeing the safety and effectiveness of clinical medication. At present, the quality of TCM preparation is uneven. At present, the same TCM preparation in different manufacturers, TCM preparations in the same manufacturer, and even different batches of a same TCM preparation in the same manufacturer have great differences in quality, which can not reach stability and uniformity. This paper would discuss the possible factors that influence the uniformity of quality in the whole process of pharmacy by means of consulting relevant literature on quality control of Chinese herbal preparations and analyzing the present situation and problems of the quality of TCM preparation. In addition, some strategies such as standardization of cultivation of TCM, processing standardization, standardization of pharmaceutical equipment, mixed batch feeding, and Quality by Design would be also put forward to provide references for the quality uniformity of TCM preparation.

Application of HPLC Fingerprint in Quality of Traditional Chinese Medicine Preparations / 世界科学技术-中医药现代化

High performance liquid chromatography (HPLC) fingerprint technology is an important means of quality control of traditional Chinese medicine (TCM) preparations,which can reflect the whole process of raw materials as well as the whole process and quality of finished products.It has become the primary quality control method of modern TCM preparations.In this paper,recent advances in HPLC fingerprints and their combination techniques in the quality control of TCM preparations were reviewed,which provided the basis for quality control of TCM preparations.