Data mining in traditional Chinese medicine product quality review / 中国中药杂志

The traditional Chinese medicine(TCM) enterprises have accumulated a large amount of product quality review(PQR) data. Mining these data can reveal the hidden knowledge in production and helps improve pharmaceutical manufacturing technology. However, there are few studies involving the mining of PQR data and thus enterprises lack the guidance to analyze the data. This study proposed a method to mine the PQR data, which consisted of 4 functional modules: data collection and preprocessing, risk classification of variables, risk evaluation by batches, and the regression analysis of quality. Further, we carried out a case study of the formulation process of a TCM product to illustrate the method. In the case study, the data of 398 batches of products during 2019-2021 were collected, which contained 65 process variables. The risks of variables were classified according to the process performance index. The risk of each batch was analyzed through short-term and long-term evaluation, and the critical variables with the strongest impact on the product quality were identified by partial least square regression. The results showed that 1 variable and 13 batches were of high risk, and the critical process variable was the quality of the intermediates. The proposed method enables enterprises to comprehensively mine the PQR data and helps to enhance the process understanding and improve the quality control.

Quality evaluation of inactivated poliomyelitis vaccine made from Sabin strains after optimization / 中国生物制品学杂志

@#Objective To evaluate the product quality of inactivated poliomyelitis vaccine made from Sabin strains(sIPV)after optimization of preparation formula.Methods The quality attributes of sIPV products after preparation optimization(no phenol red and no bacteriostatic agent)were evaluated,and the quality comparability with the listed sIPV products was analyzed;270 Wister rats of half male and half female were immunized with the finished products before and after preparation optimization simultaneously by intramuscular injection,measured for the level of neutralizing antibody in serum,evaluated for the immunogenicity,and analyzed for the compa-rability;The finished products with optimized preparation were placed at 37 ℃,room temperature(20～25 ℃)and 2～8 ℃ for accelerated and long-term stability tests separately,detected for the content of key indicator D antigen to evaluate the stability,and analyzed for the comparability with historical data of the listed products.Results After preparation formula optimization,the detection results of the sIPV vaccine for typeⅠ,Ⅱ,and Ⅲ D antigen content,protein content,pH value,Vero cell protein residue,bovine serum albumin residue,Vero cell DNA residue,and free formaldehyde content all conformed to the requirements of Chinese Pharmacopoeia Ⅲ (2020 edition)and the enterprise standard. Before and after the process optimization,the quality attributes,immunogenicity and accelerated and long-term stability trends were consi-stent.Conclusion The formulation of the optimized sIPV vaccine no longer contains phenol red and bacteriostatic agent ingredients,of which the safety has been improved;The quality attributes,immunogenicity,and stability of the product are highly similar to those before optimization;All indicators met the requirements during the validity period and the product has good stability.

Research on Current Situation of Quality Management of Artificial Intelligence Medical Device Enterprises / 中国医疗器械杂志

OBJECTIVE@#To understand the current situation of artificial intelligence production enterprise quality management system, so as to provide reference basis for the research and standardization of Artificial Intelligence Medical Device (AIMD) product quality management.@*METHODS@#Based on YY/T 0287-2017 Medical Device Quality Management System for Regulatory Requirements, Medical Equipment Production and the Quality Control Standard for Independent Software Appendix and Xavier GMLP report, the relevant factors were screened and the questionnaire was designed by combining expert consultation and literature review. Then, a total of 32 representative AIMD enterprises were invited to fill in the questionnaire. Descriptive statistical analysis was performed on the data results using Excel 2016.@*RESULTS@#Through in-depth analysis of the four themes in product planning and design, result output, product quality control and product change, it was found that it was necessary for enterprises participating in the survey to improve the quality management system of AIMD products to different degrees.@*CONCLUSIONS@#This study is the first time to systematically investigate the status quo of quality management of AIMD enterprises. The result will be useful for the establishment and continuous improvement of product quality management system. It will also provide a reference for the research of AIMD product quality management and the establishment of the standard.

Analysis of inorganic elements compositions of Naozhenning Granules by ICP-MS / 中草药

Objective: To analyze the inorganic elements composition of Naozhenning Granules (NG) by inductively coupled plasma spectrometer (ICP-MS), in order to evaluate the uniformity and safety of NG. Methods The sample of NG was prepared using the microwave digestion method, and the levels of 18 inorganic elements in 10 batches of NG were determined by ICP-MS. Then the results were analyzed by Heatmaps and Pearson Correlations. The uniformity of the products was evaluated by Inorganic elemental fingerprint, principal components analysis, and Cluster analysis. Results :The main inorganic elements in NG were K, Ca, P, Na, Mg, Fe, and there was positive correlations among the different elements. The contents of five heavy metal elements, including As, Hg, Cd, Pb, and Cu, were below the limit of Chinese Pharmacopoeia 2015. The inorganic elements reference fingerprint of NG was generated using the average and median methods. The results of fingerprint similarity, cluster analysis, and principal component analysis showed that the inorganic elements of NG showed good uniformity. The results of principal component analysis showed that K, Mg, Sr, Mn, P,and Pb may be the characteristic elements influencing the quality fluctuation of inorganic elements of NG. Conclusion: This study determined the inorganic element composition of NG, which laid a foundation for its uniformity and safety evaluation of NG.

Consumer Preferences, Carcass Characteristics and Sensory Evaluation of Meat of Four Guinea Fowl Genotypes in the Transitional Zone of Ashanti Region, Ghana

This study was conducted to investigate the effects of Guinea fowl genotype on consumer preferences, carcass characteristics and sensory attributes of meat in Ghana. The study was divided into 3 phases, where phase one consisted of sales of a total of 82 Guinea fowls made up of Pearl, Lavender, Black and White and the administration of questionnaires to consumers, retailers, producers and processors in one Municipal (Asante Mampong) and one district (Ejura/sekere dumase district) in Ashanti Region. The second phase involved the slaughter of 16 male Guinea fowls consisting of 4 each of the genotypes for carcass and biochemical analysis. The third phase entailed determination of sensory attributes of cooked meat samples from the four genotypes. Phase two and three were carried out at the Poultry Unit of the Department of Animal Science. Data were analyzed using Microsoft Excel 2007 for consumer preferences and Genstat Release 11.1 (Windows) for carcass and sensory analysis. The study revealed that Guinea fowl genotypes are preferred based on availability. The Pearl genotype was the most preferred. At 32 weeks of age, body weight was significantly (p˂0.05) higher in Lavender, White and Black genotypes. Breast weight was significantly (p˂0.05) highest in the White genotype. The Lavender recorded significantly (p˂0.05) higher drumstick weight. On the other hand, the Black had significantly (p˂0.05) higher thigh weight whiles Wing weight was significantly (p˂0.05) higher in Pearl, Lavender and Black genotypes. Empty gizzard weight was significantly (p˂0.05) highest in Pearl with the least in White. There were no differences in biochemical properties and sensory attributes of meat of genotypes except for raw meat samples where significant (p˂0.05) difference was observed between genotypes. This study concludes that, all the genotypes could be preferred by consumers if made available and that the Pearl could perform much better if improved upon. Breeders should therefore improve upon the Pearl and also concentrate on the production of the White, Lavender and Black Guinea fowls for commercial production. Sustainability of these genotypes will also be achieved to prevent extinction as these are not as common as the Pearl. Further research to elucidate comparable advantage of any one of the genotypes is suggested to give major attention to the specific one.

Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products

abstract The antiparkinson agent pramipexole dihydrochloride monohydrate was quantified in pharmaceutical products by high performance liquid chromatography (HPLC) and derivative spectrophotometry. The first method was based on HPLC using tamsulosin HCl as an internal standard. In this method, chromatographic separation was achieved using a LiChrospher 60 RP column at 25°C, with a flow rate of 1.0 mL/min at 263 nm. The eluent comprised 0.01 mol/L ammonium acetate (pH 4.4) and acetonitrile (35:65 by volume). The linearity range was found to be 10.0-30.0 µg/mL with a mean recovery of 100.5 ± 1.10. The limit of detection (8 ng/mL) and limit of quantification (50 ng/mL) were calculated. In the second method, the first derivative spectrophotometric technique for the determination of pramipexole dihydrochloride monohydrate was performed by measuring the amplitude at 249 and 280 nm. In the first derivative technique, the absorbance and concentration plot was rectilinear over the 5.0-35.0 µg/mL range with a lower detection limit of 1.5 ng/mL and quantification limit of 4.5 ng/mL. The typical excipients included in the pharmaceutical product do not interfere with the selectivity of either method. The developed methods were validated for robustness, selectivity, specificity, linearity, precision, and accuracy as per the ICH and FDA guidelines (ICH Q2B, 1996; FDA,2000). In conclusion, the developed methods were successful in determining the quantity of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products. The RSD values for the pharmaceutical product used in this study were found to be 0.97% for the HPLC method and 0.00% for the first derivative spectrophotometric method.

resumo O fármaco antiparkinsoniano, dicloridrato de pramipexol monoidratado, foi quantificado no produto farmacêutico por cromatografia líquida de alta eficiência (CLAE) e espectrofotometria derivada. No primeiro método baseado na CLAE, o cloridrato de tansulosina foi usado como padrão interno. Nesse método, a separação cromatográfica foi realizada usando uma coluna Lichrosper 60 RP a 25 °C e acetato de amônio 0,01 mol/L (pH:4.4): acetonitrila (35:65 em volume) como eluente com fluxo de 1,0 mL /min a 263 nm. A faixa de linearidade foi de 10.0-30.0 µg/mL com média da recuperação 100.5 ± 1.10. O limite de detecção (8 ng/mL) e o limite de quantificação (50 ng/mL) foram calculados. Por outro lado, a primeira técnica de espectrofotometria derivada para a determinação de dicloridrato de pramipexol monoidratado foi realizada através da medida da amplitude a 249 e 280 nm. Na técnia da primeira derivada, a absorvância e a plotagem da concentração foi retilínea na faixa de 5.0-35.0 µg/mL com limite inferior de detecção de 1.5 ng/mL e limite de quantificação de 4.5 ng/mL. Os excipientes típicos incluídos no produto farmacêutico não interferem com a seletividade dos métodos. Os métodos desenvolvidos foram validados quanto à robustez, seletividade, especificidade, linearidade, precisão e exatidão de acordo com as diretrizes do ICH e FDA (ICH Q2B,1996; FDA,2000). Concluindo, os métodos propostos foram aplicados com sucesso para a determinação quantitativa do agente antiparkinsoniano dicloridrato de pramipexol monoidrato em produtos farmacêuticos. Os valores de RSD para o produto farmacêutico utilizado neste estudo foi 0.97% para a CLAE e 0.00% para o método de espectrofotometria de primeira derivada.

Study of Importance of Empowered Delegation and Measures to Develop Empowered Delegation Skill Among Employees For Better Productiveness Of an Organization.

In modern business organizations the effective problem solving and taking corrective decision for organization by top level management and middle level management is being too complex and difficult. Delegation and empowerment are the two key aspect which can help the top and middle level management to face and perform in these situation effectively. The empowerment and delegation are the two side of a single coin which are deeply interconnected with each other and plays an important role in organizational business development process. Some measures are kept to develop empowered delegation skill in the employees, if they are not capable to take responsibility of organization effectively and making them productive for organization betterment. With the help of effective empowered delegation of work to subordinate, productivity of organization can be enhanced and product quality also improved which leads to achievement of organizational goals and objectives.

Animal welfare: concepts, study methods and indicators / Bienestar animal: conceptos, métodos de estudio e indicadores / Bem-estar animal: conceitos, métodos de estudos e indicadores

There is now increasing public concern about the welfare of animals in most countries of the world. Applied ethological studies of motivation, cognition and the complexity of social behaviour in animals has resulted in the rapid development of animal welfare science. A definition of animal welfare is: the state of the individual as regards its attempts to cope with its environment. Welfare concerns all of the mechanisms for coping: involving physiology, behaviour, feelings and pathological responses. Welfare is a wider term than health but health is an important part of welfare. In order to enforce laws and standards, animal welfare outcome indicators are useful. Many measures of welfare are now used and indicate how good or how poor the welfare is. The concept of animal welfare and the methods of assessment are now taught in hundreds of universities around the world. In recent years, animal welfare has become established as one of the criteria used to decide on whether a system is sustainable and whether product quality is good. Legislation on how animals should be kept is now referring to welfare outcome indicators and analysis of the scientific literature about animal welfare includes risk assessment and benefit assessment.

Actualmente existe una creciente preocupación pública por el bienestar de los animales en la mayoría de los países del mundo. Los estudios etológicos aplicados de motivación, cognición y de complejidad del comportamiento social en los animales, han generado un veloz desarrollo de la ciencia del bienestar animal. Una definición de bienestar animal es: el estado del individuo respecto a sus intentos de enfrentar el ambiente en que se encuentra. El bienestar está relacionado con todos los mecanismos para enfrentarlo: involucrando la fisiología, el comportamiento, las sentimientos y las respuestas patológicas. Bienestar es un término más amplio que salud, pero la salud es una parte importante del bienestar. Con el objetivo de respetar las leyes y normas, el bienestar animal cuenta con algunos indicadores que son de gran utilidad. Gran cantidad de las mediciones del bienestar se utilizan para indicar que tan bueno o que tan pobre es el bienestar. El concepto de bienestar animal y sus métodos de evaluación se enseñan ahora en cientos de universidades de todo el mundo. En los últimos años, el bienestar animal se ha establecido como uno de los criterios utilizados para decidir si un sistema es sostenible y si la calidad del producto es buena. La legislación sobre cómo los animales deben mantenerse ahora se refiere a los indicadores de resultados de bienestar y al análisis de la literatura científica sobre el bienestar animal incluyendo la evaluación de beneficio-riesgo.

Atualmente há uma crescente preocupação pública sobre bem-estar animal na maioria dos países. Aplicados estudos etológicos de cognição, motivação e complexidade do comportamento social nos animais, levaram a um rápido desenvolvimento da ciência do bem-estar animal. A definição de bem-estar animal é o estado do indivíduo em suas tentativas de lidar com o ambiente em que ele está localizado. O bem-estar está relacionada com todos os mecanismos para lidar: envolver a fisiologia, comportamento, sentimentos e resposta patológica. Bem-estar é um termo mais amplo de saúde, mas a saúde é uma parte importante do ser. A fim de respeitar as leis e regulamentos, bem-estar animal tem alguns indicadores que são úteis. Um grande número de medidas a ser utilizado para indicar o quão bom ou quão pobre é o bem- estar. O conceito de bem-estar animal e os seus métodos de avaliação são agora ensinadas em centenas de universidades ao redor do mundo. Nos últimos anos, bem-estar animal foi estabelecida como um dos critérios utilizados para decidir se um sistema é sustentável e se a qualidade do produto é bom. A legislação sobre como os animais devem ser mantidos agora se refere a indicadores de resultados bem-estar e análise da literatura científica sobre bem-estar animal, incluindo a avaliação benefício-risco.

Gas-Liquid Chromamgraphic Analysis of Residual Ethylene Oxide and MMA Monomer in Various lntraocular Lenses

Recently, we performed an ezperi nlent to detect residual ethylene oxide(EO) gas and methylmethacrylate(MMA) monomer in the intraocular lenses from eleven different makers using gas-liquid chromatography. The residual EO gas over 25ppm was seen in 2 makers and also the MMA monomer over 2% was present in two makers. As a result, we recommend that the precise product quality-control of the IOLes is necessary especially for the lenses from foreign manufacturers.

Gas-Liquid Chromamgraphic Analysis of Residual Ethylene Oxide and MMA Monomer in Various lntraocular Lenses

Recently, we performed an ezperi nlent to detect residual ethylene oxide(EO) gas and methylmethacrylate(MMA) monomer in the intraocular lenses from eleven different makers using gas-liquid chromatography. The residual EO gas over 25ppm was seen in 2 makers and also the MMA monomer over 2% was present in two makers. As a result, we recommend that the precise product quality-control of the IOLes is necessary especially for the lenses from foreign manufacturers.