Discussion on several statistical problems in establishing quality standards of standard decoctions / 中草药·英文版

Since 2016, a number of studies have been published on standard decoctions used in Chinese medicine. However, there is little research on statistical issues related to establishing the quality standards for standard decoctions. In view of the currently established quality standard methods for standard decoctions, an improvement scheme is proposed from a statistical perspective. This review explores the requirements for dry matter yield rate data and index component transfer data for the application of two methods specified in “Technical Requirements for Quality Control and Standard Establishment of Chinese Medicine Formula Granules,” which include the average value plus or minus three times the standard deviation (X-±3SD) or 70% to 130% of the average value (X-±30%X-). The square-root arcsine transformation method is used as an approach to solve the problem of unreasonable standard ranges of standard decoctions. This review also proposes the use of merged data to establish a standard. A method to judge whether multiple sets of standard decoction data can be merged is also provided. When multiple sets of data have a similar central tendency and a similar discrete tendency, they can be merged to establish a more reliable quality standard. Assuming that the dry matter yield rate and transfer rate conform to a binomial distribution, the number of batches of prepared slices that are needed to establish the standard decoction quality standard is estimated. It is recommended that no less than 30 batches of prepared slices should be used for the establishment of standard decoction quality standards.

Economic model for obtaining cyclodextrins from commercial cgtase

A repetitive batch process was employed followed by membrane ultrafiltration system to produce low-cost cyclodextrins (CDs) using commercial enzymes Toruzyme® cyclomaltodextrin glucanotransferase (CGTase) and its kinetic parameters were determined. The ultrafiltration system enabled the removalof inhibitory products from the reaction medium, allowing the enzyme to be recovered for reuse. A 10 kDa membrane was used to separate the different CDs produced by the CGTase. The substrates evaluated were maltodextrin, corn starch and cassava starch at 5, 10 and 15% (w/V), in the presence and absence of 10% (V/V) ethanol. After reaction for 132 h, 10% (w/V) cassava starch in the presence of ethanol provided the best results with 32.1 mg/mL of ß-CD. Maximum production occurred after 72 h of reaction, with a yield of 87.4% of ß-CD and an α-CD, ß-CD and γ-CD production ratio of 1:1:0.08 g, respectively. When eight repetitive batches of 72 h followed by ultrafiltration and crystallization of ß-CD were performed, 2.1 g of precipitate was obtained with a purity of 67.6% ß-CD. The supernatant from the crystallization process was lyophilized and resulted in 35.3% α-CD. The developed model can be used industrially for the production of low cost CDs from easily obtained raw material

Specific technique system management in rescue of batches of patients with severe blast injury / 医学研究生学报

Objective It is a tough job to rescue batches of patients with severe blast injury .The article aimed to construct specific technique system management in the rescue of batches of patients with severe blast injury and evaluate its effects . Methods Retrospective analysis was made on 9 patients with severe blast injury who hospitalized simultaneously .According to the difficulties in the nursing process of treating severe blast injury such as management of respiratory tract , continuous renal replacement therapy , vascular access, nutritional supply, skin nursing, etc, specific technique system management was constructed to evaluate technical support key points at different phases , including personalized nursing scheme with disease progression , professional nursing instruction on key points of different phases from specialists as well as corresponding nursing decision and professional caring . Results Specific technique system management was applied in these 9 patients with severe blast injury .Only 1 patients developed ventilator related pneumonia when receiving mechanical ventilation and no procedure related complications occurred in the aspects of blood purification , skin management , vascular access and nutrition support .6 patients discharged from hospital after recovery . Conclusion Specific techniques and systemic management in batch treatment of severe bast injury patients could help collaborative nursing , improve the management of specific management and prevent complication .

Application of whole-range fine management in infection prevention in batches of patients with extensive burns / 医学研究生学报

According to the infection characteristics of batches of patients with extensive burns in dust explosion, the article focused on the concept and mode of whole-range fine management.Based on the characteristics and rules of infection prevention in bat-ches of patients with extensive burns, the measurement and examination of infection management were refined, the infection monitoring indexes were designed scientifically, the infection prevention scheme and monitoring table were formulated.By early and whole-range intervention of infection prevention, quantitative evaluation, fine management and precise control at different times, all levels of infec-tion management teams could fully serve their purposes in order to realize effective infection prevention.

Biodegradable microparticulate drug delivery system of diltiazem HCl

The efficacy of a drug in a specific application requires the maintenance of appropriate drug blood level concentration during a prolonged period of time. Controlled release delivery is available for many routes of administration and offers many advantages (as microparticles and nanoparticles) over immediate release delivery. These advantages include reduced dosing frequency, better therapeutic control, fewer side effects, and, consequently, these dosage forms are well accepted by patients. Advances in polymer material science, particle engineering design, manufacture, and nanotechnology have led the way to the introduction of several marketed controlled release products and several more are in pre-clinical and clinical development. The objective of this work is to prepare and evaluate diltiazem HCl loaded albumin microparticles using a factorial design. Albumin (natural polymer) microparticles were prepared by emulsion heat-stabilization method. Selected formulations were characterized for their entrapment efficiency, particle size, surface morphology, and release behavior. Analysis of variance for entrapment efficiency indicates that entrapment efficiency is best fitted to a response surface linear model. Surface morphology was studied by scanning electron microscopy. Scanning electron microscopy of the microparticles revealed a spherical, nonporous and uniform appearance, with a smooth surface. The geometric mean diameter of the microparticles was found to be 2-9 µm, which more than 75% were below 3.5 µm and drug incorporation efficiency of 59.74 to 72.48% (w/w). In vitro release profile for formulations containing diltiazem HCl loaded BSA microparticles with heat stabilization technique shows slow controlled the release of the drug up to 24 hours. The release pattern was biphasic, characterized by an initial burst effect followed by a slow release. All selected microparticles exhibited a prolonged release for almost 24 hours. On comparing regression-coefficient (r²) values for Hixson Crowel, Higuchi and Peppas kinetic models, different batches of microparticles showed Fickian, non-Fickian, and diffusion kinetics. The release mechanism was regulated by D:P ratio. From the statistical analysis it was observed that as the drug:polymer (D:P) ratio increased, there was a significant increase in the encapsulation efficiency. Based on the particle size, entrapment efficiency and physical appearance, DTM-3 formulations were selected for in vivo release study and stability study. The in vivo result of drug loaded microparticles showed preferential drug targeting to liver followed by lungs, kidneys and spleen. Stability studies showed that maximum drug content and closest in vitro release to initial data were found in the formulation stored at 4 ºC. In present study, diltiazem HCl loaded BSA microparticles were prepared and targeted to various organs to satisfactory level and were found to be stable at 4 ºC.

A eficácia terapêutica de um fármaco depende da manutenção de seu nível plasmático adequado em determinado intervalo de tempo. Nesse sentido, a liberação modificada de fármacos está disponível em muitas vias de administração e oferece muitas vantagens (como micropartículas e nanopartículas) quando comparada às formulações de liberação imediata. Essas vantagens incluem reduzida frequência da dosagem, melhor controle terapêutico e menos efeitos colaterais. Assim sendo, esses produtos apresentam maior aceitação pelos pacientes. Os avanços na ciência dos materiais, na engenharia das partículas, em manufatura e em nanotecnologia permitiram a introdução no mercado de vários produtos de liberação modificada e vários outros se encontram em desenvolvimento pré-clínico e clínico. O objetivo do presente trabalho foi preparar e avaliar o fármaco cloridrato de diltiazem associado a micropartículas de albumina utilizando planejamento fatorial. As micropartículas de albumina, um polímero natural, foram preparadas por método de emulsão empregando estabilização por calor. As formulações selecionadas foram caracterizadas no que se refere à sua eficiência de encapsulamento, tamanho médio de partículas, morfologia de superfície e perfil de liberação do fármaco. A análise de variância relativa à eficiência de encapsulamento indicou superfície de resposta linear. Com referência à morfologia superficial, essa foi avaliada empregando microscopia eletrônica de varredura. Essa análise revelou micropartículas esféricas, não porosas e de aparência uniforme, com superfície lisa. O diâmetro médio das micropartículas foi entre 2 e 9 µm, sendo que mais de 75% das micropartículas se apresentaram abaixo de 3,5 µm. Além disso, a eficiência de encapsulamento foi entre 59,74 e 72,48%. Quanto ao ensaio para avaliação do perfil de liberação in vitro do fármaco associado às micropartículas, as formulações apresentaram liberação lenta até 24 horas. O comportamento foi caracterizado por liberação inicial (efeito burst) seguida por liberação lenta. Todas as fórmulas selecionadas apresentaram liberação prolongada por aproximadamente 24 horas. Na comparação entre os valores de coeficientes de regressão (R²), os modelos propostos por Hixson Crowel, Higuchi e Peppas, para diferentes formulações de micropartículas, demonstraram cinética de liberação de acordo com modelo Fickiano e não-Fickiano. O mecanismo de liberação do fármaco foi regulado pela razão entre o fármaco e o polímero. A análise estatística revelou significativo aumento da eficiência de encapsulamento quando essa razão aumentou. As avaliações relativas à análise dimensional das micropartículas, à eficiência de encapsulamento do fármaco e à morfologia permitiram a seleção da formulação DTM-3 para os ensaios de liberação in vivo e para o estudo da estabilidade. O ensaio de liberação in vivo do fármaco associado às micropartículas demonstrou sítio-alvo preferencial no fígado, seguido pelos pulmões rins e baço. No presente estudo, as micropartículas de albumina contendo cloridrato de diltiazem foram adequadamente preparadas e orientadas satisfatoriamente para vários órgãos. Além disso, a formulação selecionada apresentou estabilidade físico-química a 4 ºC.

Evaluation of the botanical origin of commercial dry bee pollen load batches using pollen analysis: a proposal for technical standardization

High quality of bee pollen for commercial purpose is required. In order to attend the consumer with the best identification of the botanical and floral origin of the product, 25 bee pollen batches were investigated using two techniques of pollen grain preparation. The first started to identify pollen loads of different colors in two grams of each well mixed batch, and the second to identify pollen grains in a pool made of all the pollen loads comprised in two grams. The best result was obtained by this last technique, when a pollen grain suspension was dropped on a microscope slide and circa 500 pollen grains were counted per sample. This analysis resulted in the recognition of monofloral and bifloral pollen batches, while the use of the first technique resulted in all samples receiving a heterofloral diagnosis.

É exigida alta qualidade para a comercialização de pólen apícola. A fim de atender o consumidor com a melhor identificação da origem botânica e floral do produto, 25 partidas de pólen apícola feram investigadas usande duas diferentes técnicas na preparação dos grãos de pólen. A primeira partiu da identificação das cargas polínicas contidas em dois gramas de cada partida bem misturada segundo suas cores. A segunda visava identificar os grãos de pólen de um agrupamento ("pool") de todas as cargas polínicas contidas em dois gramas de cada amostra. O melhor resultado foi obtido pela última técnica, quando uma suspensão de grãos de pólen era gotejada sobre uma lâmina de microscopia e cerca de 500 grãos de pólen eram centades por amostra. Esta análise resultou no reconhecimento de partidas monoflorais e biflorais de pólen apícola, enquanto que usando a primeira técnica, todas as amostras receberam a diagnose heterefloral.

Information Management System for Rescuing Batches of the Sick and Wounded / 医疗卫生装备

Objective To investigate the information management method for improving the efficiency of rescuing batches of the sick and wounded.Methods A portable palm computer were used to collect the information of the sick and wounded and the collected data were transmitted in real time to the server of the higher rescuing institution in the hospital via wired and wireless networks after being counted up,analyzed and summarized.Results The higher rescuing institution took the real-time information as the decision-making base at any time to give orders and provide assistance that fed back to the rescuing site at any moment.Conclusions The system combines medical rescuing with modern computerized information system,realizing the informatization,digitalization and automation of direction and management models in rescuing batches of the sick and wounded and greatly improving the efficiency for rescuing the sick and wounded.