Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines(Ⅰ): classification of processing routes / 中国中药杂志

Oral solid dosage(OSD) occupies a key position in the market of Chinese patent medicines and new traditional Chinese medicines. Processing route is the foundation for the research and development of traditional Chinese medicine OSDs. On the basis of prescriptions and preparation methods of 1 308 traditional Chinese medicine OSDs recorded in the Chinese Pharmacopoeia, we summarized the patterns of processing routes of both modern dosage forms(tablets, granules, and capsules) and traditional dosage forms(pills and powder) and constructed a manufacturing classification system(MCS) based on the processing routes. Based on the MCS, statistical analyses were conducted respectively on medicinal materials, pharmaceutical excipients, extraction solvents in the pretreatment process, crushed medicinal materials, methods of concentration and purification, and methods of drying and granulation, aiming to uncover the process features. The results showed that each dosage form can be prepared via different routes with different processing methods of decoction pieces and raw materials for dosage preparation. The raw materials for dosage form preparation of traditional Chinese medicine OSDs included total extract, semi-extract, and total crushed powder, which accounted for different proportions. The raw materials for traditional dosage forms are mainly decoction pieces powder. Semi-extracts are the main raw materials for tablets and capsules, which account for 64.8% and 56.3%, respectively. Total extracts are the main raw materials for granules, with a proportion of 77.8%. Compared with tablets and capsules, traditional Chinese medicine granules with dissolubility requirements had a larger proportion of water extraction process, a higher proportion of refining process(34.7%), and a lower proportion of crushed medicinal mate-rials in semi-extract granules. There are four ways to add volatile oil to the modern dosage forms of traditional Chinese medicine. In addition, some new technologies and processes have been used in concentration, filtration, and granulation processes of traditional Chinese medicine OSDs, and the application of pharmaceutical excipients is diversified. The results of this study are expected to provide reference for the processing route design and upgrading of OSDs for new traditional Chinese medicines.

Comparison of cataract surgery refractive outcomes in a tertiary hospital and an outreach cataract service centre

@#Objective: The aim of this study was to compare the postoperative refractive outcome after cataract surgery between a hospital-based and an outreach-based cataract service centre. Methods: This study was conducted at the Hospital Selayang (HS), Selangor, Malaysia, a tertiary referral centre and an outreach-based cataract service centre (Pusat Pembedahan Katarak MAIWP, PPKM). Data was sourced from the Cataract Surgery Registry (CSR) in the National Eye Database (NED). Results: A total of 2318 surgeries were analysed. PPKM achieved postoperative refraction outcome within ±1.0D in 94.3% of cases compared with 88.4% in Selayang Hospital. Mean absolute prediction error was also better in PPKM (0.39±0.27D vs. 0.33±0.24D, p<0.001). Multivariate analysis showed that the tertiary hospital, persons of Chinese ethnicity, history of uveitis, previous history of ocular surgery and intraoperative complications as significant independent predictive factors for poor refractive outcomes. Conclusion: The outreach-based cataract service centre, which incorporates streamlined process designs and workflows, achieved superior refractive outcomes within ±1 dioptre after cataract surgery compared to a tertiary hospital.

Comparison of Lactic Acid Production by L. casei in Batch, Fed-batch and Continuous Cultivation, Testing the use of Feather Hydrolysate as a Complex Nitrogen Source

Abstract A comprehensive comparison of the main fermentation parameters, productivity, yield and final L-lactic acid concentration, obtained through batch, fed-batch and continuous cultivations using Lactobacillus casei CCDM 198 and a model cultivation medium was carried out. Using this data, a pulse-feed fed-batch process was established for testing chicken feather hydrolysate as a replacement for all complex nitrogen sources (yeast and beef extracts and peptone) in the medium. As comparably high values of productivity (about 4.0 g/L/h) and yield (about 98 %) were reached under all cultivation conditions, the maximum final L-lactic acid concentration (116.5 g/L), as achieved through pulse-feed fed-batch fermentation, was chosen as the most important criterion for process selection. Fed-batch cultivation with chicken feather hydrolysate as both a complex nitrogen source and a neutralizing agent for maintaining constant culture pH yielded half the concentration of L-lactic acid compared to the model medium. We demonstrate here that chicken feather hydrolysate has potential for use in the production of L-lactic acid but its utilization requires further optimization

Overview of Famous Classical Formulas and Discussion on Its Exploitation / 中国实验方剂学杂志

The famous classical formulas （FCF）， which occupy the most important position in the prescription theory， had been brought out following the progress of traditional Chinese medicine （TCM）. Its formation and exploitation， essentially the ingredient constitution and preparation technology， is an objective trend of TCM. The development of related product under the guidance of relevant national policies has its historical inevitability， as the development of formula granules in recent decades had laid a solid foundation for it. The key to exploit these FCF is to refine and standardize the clinical applications through the ages with the guidance of TCM theory， for the process design of massive industrial production. As a result of the analysis of its definition and connotation， it is clear that the core connotation of FCF is the medicinal substances with fixed formula compatibility and stable preparation process. Furthermore， the screening strategy， the exploitation value， and the applicability between ancient prescriptions and nowadays diseases， had also been discussed based on the current policy situation and research status.

Principles and methods for selecting membrane separation process of Chinese materia medica based on “green manufacturing” concept / 中草药

The Chinese materia medica pharmaceutical process route designed for green manufacturing, also known as “green design”, aims to minimize the resource consumption and environmental effect of the life cycle of products process, coordinate and optimize economic and environmental efficiency. With membrane technology at the core of the pharmaceutical separation process technology closely related to green manufacturing of drugs. The three major requirements and maturity of “environment, performance, and cost” and separation technology principle are the basic elements of the pharmaceutical separation process green design. The development and adoption of clean technology not only conforms to the “principle of precautionary superior to governance”, but also reduces the consumption of raw materials and energy, and at the same time improves the economic efficiency of the enterprises. It is the best way to protect the coordinated development of the ecological environment and economic construction. In this paper, taking the construction of “membrane and resin technology system integration” as an example, the specific implementation plan for the green design of Chinese materia medica pharmaceutical process is introduced, and the technical economical problems in the design of pharmaceutical separation process are analyzed and discussed.

Considerations of pharmaceutical research for new drugs of Chinese materia medica / 中草药

A series of policies to encourage innovative drug were issued and implemented in opinions of speeding up new drug review and approval by National Medical Products Administration, including application for drug clinical trials on 60 days of implied permission and the communication mechanism. In this article, we analyzed the adjustment of new drug review, and explained the necessity and difference in pharmaceutical research and development of Chinese materia medica (CMM), and illuminated the main problems and emphases in CMM pharmaceutical research in aspects of source of medicinal materials, production process, quality research and standards, expecting to provide reference for speeding up new drug review and benefit drug applicants.

Exploration of MBSE in process design of management business of medical college / 中国医学装备

Objective:To explore the application of model-based systems engineering (MBSE) in process design of management business of medical college and relevantly concrete practice.Methods:This research proposed a modeling method of MBSE to be used in Cameo Systems Modeler platform, and used systems modeling language (SysML) to complete the construction of simulating business environment of management business of medical college.And the business process of applying internet account was used as sample to construct activity graph of black box by adopting SysML.Through captured derivative demands to explore and construct activity graph of white box that based on SysML, and complete decoupling for the department of business process.At last, this research observed lane situation of user, and determined the relevant requirement and updated the design of business process.Results:The construction for top-level environment of business management in business process of medical college management has been completed.And a business process was chosen to implement optimization, and its results indicated the business that once need be completed in 3 times that included college, information center and finance office could be shortened to integrate directly entering information of new user, uploading identify card photography, completing check and opening account at backstage of information center and transferring account at backstage of finance office into completion at 1 time after the process was optimized.Conclusion:The modeling system of MBSE can meet the needs of sorting coupling business of medical college, and enhance design efficiency of system, and decrease iteration times of business process of users.

Perspectives on the integration of a supercritical fluid extraction plant to a sugarcane biorefinery: thermo-economical evaluation of CO2 recycle systems

Abstract In the present study, the software Aspen Plus® was used to analyse two different systems for CO2 recycle in a SFE process for extraction of more polar compounds using ethanol as co-solvent, the most common co-solvent used due to its environment-friendly nature. The extraction process of β-ecdysone from Brazilian ginseng roots was considered as example in the computational simulations. The first CO2 recycle system, named Recycle A, considered the compression of the CO2 separated in the second flash to the recycle pressure assumed at the first flash tank, its cooling to 25 °C and recirculation, while the second recycle system, named Recycle B, considered the cooling and pumping of the CO2 separated in the second flash, its heating to 25 °C and recirculation. The best techno-economic condition to operate the recycling step would be using Recycle A at 40 bar and 30 °C considering a stand-alone SFE process; and using Recycle B at 40 bar and 40 °C, considering this process in close proximity of a hypothetical sugarcane biorefinery. Therefore, these results suggest that the selection where would be located the SFE plant should be taken into account during the first steps of the process design.

Propuesta de proceso de planificación de sistemas de información para la industria biofarmacéutica cubana / Proposal of an information systems planning procedure for the Cuban biopharmaceutical industry

El objetivo del presente trabajo es realizar una propuesta parala planificación de sistemas de información de empresas de la industria biofarmacéutica cubana, mediante el diseño de proceso. Como métodos se emplearon casos de estudio, estándares de modelado de gestión de proceso y de diseño de proceso para facilitar la comprensión de los retos en la planificación objeto de estudio y fundamentar la solución propuesta y sus beneficios. Mediante el diseño de proceso realizado para la planificación de sistemas de información, se definen registros que han facilitado la diferenciación de sistemas de información de sistemas informáticos, la definición de indicadores más precisos y la realización de apreciaciones financieras para la planificación de proyectos de desarrollo de software acorde con las necesidades de la empresa. El proceso de planificación propuesto permite ajustar la evolución de los sistemas de información a las necesidades de la organización, en función del logro de sus objetivos estratégicos.

The paper proposes an information systems planning procedure based on process design for enterprises from the Cuban biopharmaceutical industry. Study cases and process management and design modeling standards were used to facilitate understanding of the challenges posed by the planning of the object of study and to substantiate the solution proposed and its advantages. Based on the process design developed for the planning of information systems, a definition is made of records facilitating differentiation between information systems and computer systems, as well as the description of more accurate indicators and the performance of financial assessments aimed at planning software development projects to meet the needs of the enterprise. The planning procedure proposed makes it possible to adjust the evolution of information systems to the needs of the organization, with a view to achieving its strategic goals.

Fulguración con láser de la recidiva de tumores vesicales superficiales bajo anestesia local: diseño de procesos / Laser fulguration of superficial bladder tumor recurrence under local anesthesia. design process

Introduction: The process design is one of the most interesting tools to ensure the quality of health care before the start of an activity. Although the gold standard treatment of superficial bladder tumors remains transurethral resection (TUR), the onset of laser energy source with better endourological systems allows us to adopt alternative therapies. The aim of this pilot study is to describe the design and protocol in 37 patients with a novel process consisting of outpatient treatment under local anesthesia of bladder tumors with holmium laser. Material and Methods: Pilot study includes 37 patients between January 2012 and December 2013, for the development of a process of holmium laser bladder fulguration without anesthetic infiltration in outpatient study. It analyzes and studies the procedure tolerance, development of immediate complications, visual analog scale (VAS) of pain, patient satisfaction, hospital stays avoided, problems during the application process and development. Results: The mean age of the patients was 69.2 +/- 10.3 years, 100 percent of patients prefer this procedure instead conventional transurethral resection and VAS rating presenting ≤ 3. There were no important complications. Only one patient was admitted at hospital due to hematuria resolved without surgical treatment. Conclusions: The development and implementation of fulguration of superficial papillary bladder tumors with holmium laser process is simple, well tolerated, ambulatory and without complications, with no need of hospital stay.

Introducción: El diseño de procesos es una de las herramientas de mayor interés para asegurar la calidad de la asistencia sanitaria antes del comienzo de una determinada actividad. Aunque el gold standard del tratamiento de los tumores vesicales superficiales sigue siendo la resección transuretral (RTU), la aparición de la fuente de energía láser con mejores medios endourológicos nos permite adoptar otras alternativas terapéuticas. El objetivo de este estudio piloto es describir el diseño y protocolo en 37 pacientes de un proceso novedoso consistente en el tratamiento en régimen ambulatorio y bajo anestesia local intravesical de los tumores de vejiga con láser de holmium. Material y Métodos: Estudio piloto que incluye 37 pacientes entre enero de 2012 y diciembre de 2013, para la elaboración de un proceso de fulguración vesical con láser de holmium sin infiltración anestésica en régimen ambulatorio. Se analiza y estudia tolerancia al procedimiento, desarrollo de complicaciones inmediatas, escala visual analógica (EVA) del dolor, satisfacción del paciente, estancias hospitalarias evitadas, problemas durante la aplicación del proceso y desarrollo del mismo. Resultados: La edad media de los pacientes fue 69,2 +/- 10,3 años, presentando puntuación EVA ≤ 3. No existieron complicaciones importantes. Hubo un ingreso por hematuria tardía que se resolvió de forma conservadora. Conclusiones: La elaboración y aplicación del proceso de fulguración de tumores vesicales papilares superficiales con láser holmium es una técnica sencilla, con buena tolerancia, ambulatoria y sin complicaciones de interés, con eliminación de estancias hospitalarias.

Overview of extracting technique of compound Chinese materia medica / 中草药

As the key operation step in the production of compound Chinese materia medica (CMM) or the natural products, extracting technique not only directly affects the quality of CMM preparations, medicinal resource utilization, and clinical efficacy, but also relates to the development of Chinese pharmaceutical industry. On the basis of consulting literatures, extracting techniques appearing in recent five years are particularly reviewed in the traditional extracting method, new extracting technique, evaluating indicator, and process variable optimization. Further research application and development prospects of these extracting techniques are also suggested.

Quality investigation of sanitary latrine construction in countryside households in schistosomiasis endemic areas of China / 中国血吸虫病防治杂志

Objective To assess the construction quality of sanitary latrines in schistosomiasis endemic areas of China. Methods Two counties per province were sampled randomly from total 7 provinces with schistosomiasis endemic including Hunan, Hu-bei, Jiangxi, Anhui, Jiangsu, Yunnan and Sichuan, then 2 villages with schistosomiasis endemic were selected from each target county as research sites, and 30 households per village were randomly selected as respondents. Results Among the sanitary latrines being constructed and on-going used in schistosomiasis endemic areas, 64.8% of them were built indoor or inside of yards, and 52.6% of the above household latrines were constructed keeping away from water sources beyond 10 meters. In addition, the latrines with curb height of feces outlet over 100 mm accounted for 75.0% , and 96.1% of the total sanitary latrines were equipped with urinals made of pottery, plastic and cement. There were 98.2% of the latrines with an area more than 1.2 m~2, and 95.8% with structure of the whole room. Among those sanitary latrines with three-case-cesspools, merely 23.1% reached or closed to the design and implementation requirements of Technical criterion of sanitary construction in schistosomiasis endemic areas (protocol) on the part of underground. Conclusions The sanitary latrine with three-case-cesspools and three-unit methane pool is the main type of the household latrine recommended in countryside in schistosomiasis endemic areas. The construction of sanitary latrines meet the requirements of relevant standards in general, however, the design and implementation of underground parts of the latrines with three-case-cesspools need to be improved.