Chemistry, manufacturing, and controls regulatory considerations for human pluripotent stem cell-derived cellular products / 药学学报

In recent years, the number of clinical trials of stem cell products has increased, and the research and development technology and evaluation system have developed rapidly. Human pluripotent stem cell (hPSC)-derived cellular products are in the phase I/II stage of clinical trials. Related products include hPSC-derived neurons, retinal pigment epithelial cells, pancreatic beta cells, etc. They are generally used for the repair and replacement of functional cells related to degenerative diseases and genetic diseases via local transplantation. So far, no similar products have been officially approved on market. As hPSC possesses multi-directional differentiation potential and the ability to form teratoma in vivo, compared with other stem cell products, hPSC-derived cellular products have relatively higher risk of tumorigenicity, longer differentiation induction cycle, more complex production process, together with the rapidly updating quality characterization methods, which pose challenges to the scientific evaluation of their human applications. Based on the problems in the recent review and communication of clinical trial applications of stem cell products, and with reference to the relevant technical guidelines, this paper proposes the chemistry, manufacturing, and controls review considerations on the manufacturing process and quality study of hPSC-derived cellular products. We hope to improve the communications between developers and regulators.

Evaluation of cultivated and wild Herba Epimedii using UHPLC-PDA-Q-TOF/MSE / 药学学报

Qualitative and relatively quantitative methods were used to study the quality of cultivated Epimedium sagittatum (Sieb. et Zucc.) Maxim., Epimedium myrianthum Stearn, and Epimedium pubescens Maxim by ultra high-performance liquid chromatography coupled with photo-diode array and quadrupole time-of-flight mass spectrometry (UHPLC-PDA-Q-TOF/MSE). Thirty-two compounds in cultivated and wild samples of E. sagittatum, E. myrianthum and E. pubescens were identified using UHPLC-Q-TOF/MSE combined with the UNIFI data analysis platform. Principal component analysis (PCA) was used to compare the cultivated and wild samples of these three species. The results show that the chemical compositions of cultivated samples were consistent with the corresponding wild samples. UHPLC-PDA was used to determine the relative content of 12 flavonoids as well as total flavonoids in all samples. The results show that the relative chemical content of these flavonoids in cultivated and wild samples is similar and the quality of cultivated Epimedium is more stable. These qualitative and relatively quantitative methods using UHPLC-PDA-Q-TOF/MSE combined with the UNIFI data analysis platform and PCA can be used to study the quality of cultivated Herba Epimedii. This research provides a scientific basis for the cultivation and rational development and utilization of Epimedium medicinal materials.

Challenges of pharmaceutical evaluation of biosimilars / 中国药学杂志

OBJECTIVE: To propose some challenges of the pharmaceutical studies on biosimilars. METHODS: Some key points should be considered, including the investigation of original biologies, cell expression system and manufacture process, analytical methods and quality attributes, immunological properties, and formulation and primary packaging materials,when a biosimilar was developed. RESULTS AND CONCLUSION: Some suggestions we proposed on the pharmaceutical evaluation of biosimilars. Meanwhile, it is suggested that sponsors should be aware of the challenges and difficulties of developing biosimilars and develop biosimilars with equivalent quality to the original products, which not only meets the need of the public for the medicines, but also adapts to the international requirements.

Reflexões sobre o adoecer e mudanças dietéticas durante a assistência nutricional em pacientes com hepatite C / Reflections about getting sick and dietetic changes during nutritional assistance with hepatitis C patients

Trata-se de investigar os significados atribuídos por pacientes portadores do vírus da hepatite C sobre a doença e o tratamento dietético. Para tanto, adota-se a metodologia da pesquisa qualitativa em que o sujeito interage com sua narrativa sobre o objeto de estudo e os pesquisadores analisam cuidadosamente seus enunciados. As acepções sobre o adoecer e as mudanças dos hábitos alimentares e de vida dos pacientes foram analisadas por meio da obtenção de entrevistas em profundidade. Ao trazer os sentidos expressos sobre a doença, cria-se a possibilidade de compreensão dos aspectos culturais sobre a alimentação, a nutrição e a dietética; um desafio para os profissionais de saúde e nutrição, que precisam relatar a seus pacientes a necessidade de seguir hábitos alimentares mais saudáveis, implicando alterações nem sempre simples de serem realizadas. Consideram-se hábitos e representações do ato da alimentação, como parte da identidade cultural do sujeito. Justifica-se este estudo pela necessidade de situar maior interação entre profissionais, estudantes de saúde e pacientes de modo a ampliar a compreensão dos fenômenos que cercam a experiência da doença pelos pacientes. Conclui-se que os pacientes de hepatite C atendidos no ambulatório do Hospital Universitário da cidade de Salvador e o profissional podem atingir os objetivos de aconselhamentos nutricionais, se trilharem direções dialógicas. Com isso, observou-se a adesão à orientação dietética sem rupturas bruscas e sofrimentos dos pacientes.

This paper investigates the meanings attributed by patients to hepatitis C on disease and dietary treatment. To this end, we adopt the methodology of qualitative research in which the individual interacts with his narrative on the subject of study and the researchers carefully examine their statements. The meanings of the illness and changes in dietary habits and life of the patients were analyzed by obtaining in-depth interviews. By bringing the senses expressed about the disease, it creates the possibility of understanding cultural factors on diet, nutrition and dietetics - a challenge for health professionals and nutrition, which need to report their patients the need to follow dietary healthier, involving changes not always simple to perform. Habits and representations of the act of feeding are considered part of the cultural identity of the subject. This study is justified by the need to place greater interaction among professionals, students, patients and health so as to broaden the understanding of the phenomena that surround the experience of illness by patients. We conclude that outpatients with hepatitis C at the University Hospital in the city of Salvador and the professional can achieve the goals of nutritional advice, if they follow dialogic lines. Thus, there was compliance with dietary counseling without sudden breaks and suffering of patients.

Quality of Pinellia ternata grown in Funan / 中草药

Objective To study the quality of Pinellia ternata grown in Funan. Methods The contents of free and hydrolyzed amino acids and ephedrine in the samples from four habitats were determined. The components of methanol and acidic ethanol extracts of the four samples were compared by HPLC. The components of petroleum ether extracts of the four samples were compared by TLC. Results The content of amino acids and ephedrine and the kinds of amino acids of P. ternata grown in Funan were almost the same as those from the other three, the main components of methanol and petroleum ether extracts of P. ternata grown in Funan were the same as those from other three. Some components of acidic ethanol extracts of the four samples were different. Conclusion The quality of P. ternata grown in Funan is as good as that of the other three.

Quality Analysis of Different Specifications of Frutus Aurantii Immaturus / 中药新药与临床药理

Objective To study the quality standard of different specifications of Frutus Aurantii Immaturus. Methods The contents of synephrine, volatile oil, total ash, acid- insoluble ash and water in different specifications of Frutus Aurantii Immaturus were determined by HPLC or other methods according the china pharmacopoeia. Results The contents of volatile oil and synephrine in different specifications of Frutus Aurantii Immaturus were obviously different, and in accordance with empirically traditional classification. The contents of the total ash, acid- insoluble ash and water were similar in the different specifications and the total ash content was lower than 7 % which was in accordance with that recorded in China Pharmacopoeia.Conclusion Volatile oil, acid- insoluble ash, water and synephrine with a definite content limit can be chosen as the parameters for the research of quality standard of Frutus Aurantii Immaturus, which will supply evidence for the medicinal trade and research of Frutus Aurantii Immaturus.