Solvents ; chemistry ; Technology, Pharmaceutical ; methods

To ensure the stability of chemistry components and the convenience of operation, ultrasound method was chosen to study in this investigation. As the total common peaks area in chromatograms was set to be evaluation index, the influence on the technology caused by extraction time, ethanol concentration and liquid-to-solid ratio was studied by using single factor methodology, and the extraction technology of Paeoniae Radix Alba was optimized by using response surface methodology. The results showed that the extracting results were most affected by ethanol concentration; liquid-to-solid ratio came the second and extraction time thirdly. The optimum ultrasonic-assisted extraction conditions were as follow: the ultrasonic extraction time was 20.06 min, the ethanol concentration in solvent was 72.04%, and the liquid-to-solid ratio was 53.38 mL · g(-1), the predicted value of total common peaks area was 2.1608 x 10(8). Under the extraction conditions after optimization, the total common peaks area was 2.1422 x 10(8), and the relative deviation between the measured and predicted value was 0.86%, so the optimized extraction technology for Paeoniae Radix Alba is suitable and feasible. Besides, for the purpose of extracting more sufficiently and completely, the optimized extraction technology had more advantages than the extraction method recorded in the monogragh of Paeoniae Radix Alba in Chinese Pharmacopoeia, which will come true the assessment and utilization comprehensively.
Paeonia ; chemistry ; Technology, Pharmaceutical ; methods

OBJECTIVETo apply the membrane separation process in the concentration process of Chuanxiong Chatiao granules and to lay the foundation for its industrialized application.

METHODThe type of membrane, the optimal pressure, the optimal temperature and the optimal detergent were selected by the single factor method. A comparative study was conducted between qualities of extracts from Chuanxiong Chatiao granules by new and traditional processes.

RESULTThe type of membrane was determined to be SMN-130A2350054. The optimal pressure was 1.7 MPa. The optimal temperature was 36 degrees C and the optimal detergent was 1% sodium polyphosphate. The qualities of extracts from Chuanxiong Chatiao granules by new and traditional processes showed no difference.

CONCLUSIONThe selected membrane separation process can effectively achieve concentration and save energy. The extracts from Chuanxiong Chatiao granules by the new process show no difference with traditional processes. Therefore, it provides basis for the industrialized application of Chuanxiong Chatiao granules.

We surveyed the literatures domestic and abroad, and summarized the physical and chemical characterizations as well as preparation and applications of macroporous resin. The research of physical parameter and chemical parameter includes the measurement of the organic residue, the application research includes the separation and purification methods of the phytochemical ingredients. Macroporous resin show its advantages in the field of phytochemical studies, traditional Chinese medicine development and production, but there exist some disadvantages in its performance and application. It's necessary to establish the quality standard and the technical specifications to promote the standardization of the research and the application of the macroporous resin.
Resins, Synthetic ; chemistry ; standards ; Technology, Pharmaceutical ; methods

To determine the optimum process conditions for dry granulating technique of Qibai Pingfei granule, granule excipient type, rolling wheel speed and pressure and feeding speed were studied. Taking shaping rate at a time, moisture absorption and dissolubility as index, the type and amount of granule excipient were determined. In addition, taking shaping rate at a time as index, parameters of rolling wheel speed and pressure and feeding speed were researched through single factor test and response surface methodology. The optimum parameters were as follows: lactose as excipient, dry extract powder to excipient at 1:2, rolling wheel speed and pressure at 10.9 Hz and 6.4 MPa and feeding speed at 7.2 Hz. After validation of three batches pilot-scale production, the optimum processing parameters for dry granulating technique of Qibai Pingfei granule is reasonable and feasible, which can provide reliable basis for production.
Drugs, Chinese Herbal ; Powders ; Technology, Pharmaceutical ; methods

OBJECTIVEThe color difference meter and electronic nose fingerprint analyzer were introduced to discriminate processed betel nut's different huohou and quantize empirical index during the processing of Chinese medicine.

METHODBy collecting the color's and the smell's characteristic parameters of betel nut and its processed products to set up huohou's math discrimination modules and 90% reference value scale.

RESULTWe set up a huohou's math discrimination module and 90% reference value range base on L a*b*, which discrimination coincidence was 100% and 90% reference value range respectively was Shengpin: L* (50.07-55.03), a* (4.136-6.906), b* (6.65-8.82); Chaopin: L* (43.874-47.998), a* (3.816-6.732), b* (3.786-6.558); Jiaopin: L* (38.744-40.616), a* (1.11-3.01), b* (-1.434-0.538). At the same time, we set up a huohou's math discrimination module base on smell's characteristic parameters too.

CONCLUSIONThe betel nut and its processed products' color and smell measurement based on the color difference meter and electronic nose fingerprint analyzer may be feasible, and provides a reference to better study on traditional Chinese medicine theory.

Microwaves can be directly transformed into heat inside materials because of their ability of penetrating into any substance. The degree that materials are heated depends on their dielectric properties. Materials with high dielectric loss are more easily to reach a resonant state by microwaves field, then microwaves can be absorbed efficiently. Microwave irradiation technique with the unique heating mechanisms could induce drug-polymer interaction and change the properties of dissolution. Many benefits such as improving product quality, increasing energy efficiency and reducing times can be obtained by microwaves. This paper summarized characteristics of the microwave irradiation technique, new preparation techniques and formulation process in pharmaceutical industry by microwave irradiation technology. The microwave technology provides a new clue for heating and drying in the field of pharmaceutics.
Chemistry, Pharmaceutical ; methods ; Drug Discovery ; instrumentation ; methods ; Microwaves ; Pharmaceutical Preparations ; administration & dosage ; chemistry ; Technology, Pharmaceutical ; methods

OBJECTIVETo study and establish the optimal technology for the preparation of evodiae juice.

METHODThe contents of evodiamine, rutaecarpine and evodin were simultaneously determined with HPLC, and each yield of the three compounds were chosen as the evaluating indicator. The orthogonal test coupled with the weighted coefficient method were adopted to acquire the optimal technology for the preparation of evodiae juice.

RESULTThe study showed that the optimal technology for the preparation of evodiae juice was as follows: decocted three times while the first time was with 12-fold of water socked 30 minutes and decocted 45 minutes, the second time was with 8-fold of water decocted 20 minutes and the third time was with 6-fold of water decocted 20 minutes.

CONCLUSIONThis method is simple and accurate. The optimal technology is suitable for industry manufacture of evodiae juice.

OBJECTIVETo improve the design of the technological process so as to solve the long existing quality problem in the process of producing pseudoephedrine hydrochloride.

METHODPseudoephedrine hydrochloride was developed on basis of developing pseudoephedrine. And its preparation condition was observed.

RESULTPseudoephedrine hydrochloride obtained in the improved process didn't show tendency to agglomerate, which solves the quality problem of the product and the rate of production was raised.

CONCLUSIONThe improved process of producing pseudoephedrine hydrochloride has great application value.

The design space of the high shear wet granulation process was established and validated within the framework of quality by design (QbD). The system of microcrystalline cellulose-de-ioned water was used in this study. The median granule size and bulk density of granules were identified as critical quality attributes. Plackeet-Burmann experimental design was used to screen these factors as follows: dry mixing time, the impeller and chopper speed of dry mixing, water amount, water addition time, wet massing time, the impeller and chopper speed of wet massing and drying time. And the optimization was implemented with the central composite experimental design based on screened critical process parameters. The design space of the high shear wet granulation process was established based on the quadratic polynomial regression model. Since the P-values of both models were less than 0.05 and values of lack of fit were more than 0.1, the relationship between critical quality attributes and critical process parameters could be well described by the two models. The reliability of design space, illustrated by overlay plot, was improved with the addition of 95% confidence interval. For those granules whose process parameters were in the design space, the granule size could be controlled within 250 to 355 μm, and the bulk density could be controlled within a range of 0.4 to 0.6 g x cm(-3). The robustness and flexibility of the high shear wet granulation process have been enhanced via the establishment of the design space based on the QbD concept.
Cellulose ; chemistry ; Reproducibility of Results ; Technology, Pharmaceutical ; methods ; Water