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Objective To prepare optimization of notoginsenoside R1 chitosan nanoparticles,to provide a theoretical basis for clinical application of the drug.Methods Notoginsenoside R1 chitosan nanoparticles were prepared,HPLC method was used to detect the content of notoginsenoside R1 chitosan nanoparticles,preparation technology of nanoparticles were optimized by orthogonal experiment,and the optimized preparation technology of nanoparticles was verified.Results HPLC standard curve equation was A =911.49C -1803.4(r =0.999 9),linear range was from 25 to 900 g/mL.The intra day precision were 1.520%,0.884% and 0.969%(n =6),and the inter day precision were 1.591%,1.447% and 1.269%(n =6).The recovery rates of low,medium and high concentra-tions were (98.11 ±1.16)%,(101.27 ±0.59)% and (100.97 ±0.82)%.4 factors of orthogonal experiment:the concentration of chitosan,the mass ratio of drug and carrier,temperature and rotational speed,and 3 levels of each factor were selected.The average particle size,encapsulation efficiency and drug loading were selected as control indexes.The test results were determined by the method of comprehensive weighted scoring.The orthogonal design was designed according to L9(34)orthogonal design.The optimization process was 2% of chitosan concentration,20% of the weight ratio of drug and carrier,35 ℃ of temperature,600 r/min of rotational speed.According to the optimized process,the average particle size was (123.40 ±7.68)nm,the encapsulation efficiency was (58.41 ±1.59)%,and the drug loading amount was (10.46 ±0.53)%.Conclusion The optimized preparation process of notoginsenoside R1 chitosan nanoparticles is simple and easy to operate,the entrapment efficiency and drug loading amount were high. As a new dosage form,it has a good clinical application prospect.
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Objective To study the process of brain protein hydrolysate of inactivate and virus removal.Methods The Parvoviridae parvovirus genera of porcine parvovirus (PPV),vesicular stomatitis virus rhabdovirus genera of vesicular stomatitis virus (VSV) were chosen as a model virus,wherein PPV represents no envelope deoxyribonucleic acid(DNA) virus,VSV represents the envelope ribonucleic acid(RNA) virus.Simulation of the production process of virus inactivation steps 100 ℃ × 30 min,ultrafiltration as inactivation/removal condition.The virus respectively according to 1 ∶ 9 into the brain protein hydrolysate,high temperature and ultra filtration virus inactivation/removal.In pig kidney cells (PK-15) in PPV cell culture,Africa green monkey kidney cells(Vero cells) cultured VSV,determination of virus titer.Results PPV and VSV through the sterilization,virus median tissue culture infective dose(TCID50) were 6.15log/0.1mL(logs),5.37 log/0.1mL(logs) ;removal processaverage virus reduction coefficient were 6.15log/0.1mL(logs),5.37 log/0.1mL(logs).Conclusion The high temperature and ultra filtration produces brain protein hydrolysate solution process are effective virus inactivation/removal process.
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Objective To investigate the preparation process of cold -dampness medicine iron stick and the curative effect of cold -dampness medicine iron stick,thus to provide reference for the clinical treatment of cold -dampness lumbago.Methods Using science and technology of preparation and the thermal effect of cold -dampness medicine iron stick was observed.1 20 cases with cold -dampness lumbago of dampness type with low back pain, according to the order of treatment were divided into the observation group and control group.63 cases of the treatment group were given cold -dampness medicine iron stick affixed to the surface of the skin,57 cases of the control group were given kanlisha affixed to the surface of the skin.The treatment effect after one course of treatment was observed. Results Cold -dampness medicine iron stick heat effect index of heat time was 1 2min,to thermal time was 1 0.8h, the highest temperature was 56.5℃,thermal equilibrium curve was gentle and lasting.The efficacy of the two groups of drugs within the observation time effect was obvious.The total effective rate of the observation group was 90.5%(57 /63),which was higher than 75.4%(43 /57)of the control group,the difference was statistically significant (χ2 =4.87,P <0.05).During the treatment,local skin blisters,rash,itching and other low temperature burns and other allergic reaction were not found.Conclusion Cold -dampness medicine iron stick process is stable and controllable in quality and heat balance curve slow long -lasting,determine the efficacy,innovative therapies,it is easily accepted by patients and worthy to be popularized in clinical practice.
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Objective To study the optimum condition of preparing ofloxaxcin gelatin microspheres. Methods Oflox?axcin gelatin microspheres were manufactured using the emulsion chemical-cross linking method and gelatin was employed as carrier, liquid paraffin as oil phase, Span80 as emulsifier, . The loading capability and entrapment efficiency of the ofloxax?cin gelatin microspheres were determined by UV Spectrophotometry. The effect of gelatin concentration, oil/water volume ra?tio, gelatin/ofloxaxcin mass ratio and volume fraction of span80 on drug loading capability and entrapment efficiency were in?vestigated. The optimum proportions of each component was obtained by L9 (34) orthogonal test, based on the above 4 factors, using sum of drug loading capability and entrapment efficiency as evaluation index. Results The optimum condition for manufacturing high quality ofloxaxcin gelatin microspheres used 20%of gelatin concentration,water/oil volume ratio at 3.5∶1, gelatin/ofloxaxcin mass ratio at 1∶1, the span 80 volume fraction of 2.5%. Conclusion Drug loading capability and entrap?ment efficiency of the ofloxaxcin gelatin microspheres reached 80%using this manufacture technology therefore the prepara?tion was stable and feasible.
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Objective To define the optimal process for spray drying of shengrnaisan prescription granule.Methods The optimal process for spray drying was investigate by single factor experiment.Results The optimal process for spray drying of shengmaisan prescription granule involved temperature of liquid feedstock of 30 ～ 40℃,relative density of extract of 1.10,the rate of liquid feedstock of 50 ～ 60 ml/min,inlet temperature of 175 ～ 180℃,and outlet temperature of 85 ～ 90℃.Conclusion The optimized process is rational and feasible.
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Objective:To investigate the preparation, optimization and in vitro properties of riboflavin sodium phosphate floating microspheres. Methods: The floating microspheres composed of riboflavin sodium phosphate and calcium alginate were prepared using ion gelatin-oven drying method. Results: The properties of the microspheres were investigated, including the buoyancy, release, appearance and entrapment efficiency. The formulation was optimized by response surface methodology (RSM). Conclusion: The optimized microspheres were round. The entrapment efficiency was 57.49%. All the microspheres could float on the artificial gastric juice over 8 hours. The release of the drug from the microspheres complied with Fick' s diffusion.
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[Objective] To optimize the conditions of the extracting process of Hujin Granules. [Methods] The orthogonal design was applied. With the total emodin and the total anthraquinone (TA) content as the parameters for the alcohol-extraction, the concentration of alcohol, the volume of solvent and the extracting time were used for optimization of alcohol-extraction. With the total polysaccharide (TP) as the parameters for water-extraction, the soaking time, the volume of water and the extracting time were used for optimization of water-extraction. [Results] The optimum conditions of alcohol-extraction were: extracting with 70% alcohol 245 mL for 2 hours and extracting twice. The optimum conditions of water-extraction were: extracting with 80 mL water (not for soaking) for 1.5 hours, extracting 3 times. [Conclusion] The results indicate that the extracting process is rational and feasible, and can provide evidence for the extracting process of Hujin Granules.
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Se estudia el escalado de los procesos de mezclado y secado según el flujo tecnológico instalado en un laboratorio de producción farmacéutica, haciendo uso del principio de semejanza (rigurosa para el mezclado y extrapolada para el secado), fundamento de la teoría de los modelos. A partir de las metodologías aplicadas, se obtienen ecuaciones de escala convenientemente validadas, que permiten predecir a partir del laboratorio el comportamiento de los procesos considerados.
The scale-up of the mixing and drying processes in studies according to the technological flow installed in a pharmaceutical production laboratory, making use of the resemblance principle (rigorous for mixing and extrapolated for drying), which is the basis of the theory of models. Conveniently validated scale ecuations are obtained from the applied methodologies, allowing to predict, starting from the laboratory, the behaviour of the processes under consideration.
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Se presenta un resumen de las consideraciones generales para la confección del protocolo de validación de métodos analíticos utilizados en la determinación cuantitativa de fármacos en forma de materia prima o en formulaciones y en estudios de estabilidad. Se describe detalladamente el proceso de validación que incluye los requisitos exigidos para la utilización de las materias primas, materiales de referencia, equipamiento, personal y determinación de los parámetros de linealidad, precisión, exactitud y selectividad (con el procesamiento estadístico de los resultados experimentales y criterios de aceptación), así como la presentación de los resultados en el informe final de la validación.
A summary of the general considerations fot the formulation of a validation protocol of the analytical methods used in drug quantitative determination in a raw material form, or in formulations and firmness studies. The validation process is fully described; it includes the necessary requirements for the usage of raw materials, reference materials, supplying, personnel, and determination of linearity, preciseness, exactness, and selectiveness (with the statistical processing of experimental results, and acceptance criteria), as well as the presentation of outcomes in the validation final report.
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Objective To select the optimal exacting process for Chuanping prescription (CP).Methods The anti- and the anti- asthma ticanti effects of extracts obtained by different extracting processes from CP were observed.Results The anti- asthmatic effect of extract obtained by ion exchange resin(IER) method was better than that by acid- liquid- extraction alcohol- precipitate method (ALEAP) (P