OBJECTIVETo study the dissolution characteristics of seven active components of Xianlinggubao capsules in vitro, and compare the dissolution of Xianlinggubao capsules prepared by different processes.

METHODThe dissolution of Xianlinggubao capsules was determined by small cup method with the rotating speed of 100 r x min(-1) and phosphate buffer (pH 6.8) as dissolution medium. The different dissolution rates in vitro of seven kinds of active components (icariin, epimedin C, asperosaponin VI, psoralen, isopsoralen, salvianolic acid B and tanshinone IIA) of Xianlinggubao capsules were investigated. The contents of active components were determined by HPLC. The accumulative dissolution percentages were calculated, and the resemblance of release curves were compared by similarity factors (f2).

RESULTThe results of determination showed that the similarity factor values (f2) of the dissolution curves of seven active components after different preparation processes were all less than 50.

CONCLUSIONThere is significant difference in dissolution of active components between Xianlinggubao capsules of different preparation processes. The accumulative dissolution percentages of the active components in new Xianlinggubao capsules are higher than that of Xianlinggubao capsules.

Dryness is the inherent performance in traditional Chinese medicine. Dryness with a specific efficacy and side effect can be reduced suitably by processing and compatibility in the clinical application. Nowadays domestic scholars have developed research of dryness in traditional Chinese medicine. However, it remains problems such as evaluation index of dryness not clear. This paper takes medical literature mining technology to analyze the historical origin and features of dryness theory. Combing the modern literatures to explicate the dryness' research status and existing problems. Putting forward the traditional Chinese medicine and research should adopt multidisciplinary knowledge and study the system of comprehensive evaluation. Dryness is expected to further application in traditional Chinese medicine clinical research.
Data Mining ; Drug Compounding ; methods ; Humans ; Medicine, Chinese Traditional ; Research

Microcrystalline cellulose and chitosan were applied to prepare ginkgolides component solid dispersions micro pill drug release unit and study the dissolution of GKS. Microcrystalline cellulose, chitosan as composite carrier, solvent method was used to prepare ginkgolides component solid dispersions. Differential scanning calorimetry was used to Characterization of ginkgolides component solid dispersions. Ginkgolides component solid dispersions as principle agent were prepared for micro-pellet. Comparison of different types, different doses of the adhesive, drug-polymer interactions, and disintegrating agent for the preparation of ginkgolides components of micro-pellet drug release unit, the optimum preparation ginkgolides components of micro-pellet drug release unit was screened by orthogonal design experiment. Preparation of ginkgolides components solid dispersions with microcrystalline cellulose and chitosan at ratio 1: 3. Drug cumulative dissolution was more than 80% in 60 min. Solid dispersion-micro-pellet drug release unit can significantly improve the dissolution of ginkgolides components, it has practical application value.
Cellulose ; chemistry ; Chitosan ; chemistry ; Drug Compounding ; methods ; Ginkgolides ; chemistry

Extrusion-spheronisation method was used to prepare Rhus chinensis total phenolic acid pellets. The formula and preparation of R. chinensis total phenolic acid pellets were optimized. The formulas( drug loading capacity,diluent,wetting agent and anti-sticking agent) were determined by the single factor test with yield,appearance and performance as the indexes. The preparation was optimized by Box-Behnken design and response surface method,with the rate of extrusion,rate of spheronization and time of spheronization as the independent variables and the overall desirability value of yield,friability and roundness as the dependent variables. The optimal formula of pellets was as follows: drug loading capacity 28. 7%,MCC-lactose 9 ∶1,silicon dioxide as anti-sticking agent,and 60% ethanol as wetting agent. The optimal preparation was determined as follows: the rate of extrusion was 43 r·min-1,the rate of spheronization was 1 800 r·min-1,and the time of spheronization was 4 min. The absolute deviation between predicted value and estimated value under the conditions was less than 5. 0%,with a high degree of model fit. The preparation parameters obtained were accurate,reliable and reproducible. Under scanning electron microscopy( SEM),R. chinensis total phenolic acid pellets were uniform in diameter,round and smooth. The optimal formulation and process are stable and feasible for preparing R. chinensis total phenolic acid pellets.
Drug Compounding ; methods ; Hydroxybenzoates ; chemistry ; Particle Size ; Rhus ; chemistry ; Solubility

The fermentation processing of traditional Chinese medicines (TCMs), as an important processing method for TCM, originated from the ancient brewing technology. It has a long history in China. Fermented TCMs (FTCMs) are widely applied among folks for preventing and treating many diseases. There are many kinds of TCM processed by spontaneous fermentation, including Massa Medicata Fermentata, Rhizoma Pinelliae Fermentata, Red fermented rice, Semen Sojae Praepaaratum, Mass Galla chinesis et camelliae Fermentata and Pien Tze Huang. This essay summarizes historical origin, main varieties, the effect of microbial strains, current processing techniques and existing problems of FTCM, and look into the prospect of modern development of FTCMs.
China ; Drug Compounding ; methods ; trends ; Drug Industry ; methods ; trends ; Fermentation ; Industrial Microbiology ; methods ; trends ; Medicine, Chinese Traditional ; methods ; trends

The philosophy of quality by design (QbD) is now leading the changes in the drug manufacturing mode from the conventional test-based approach to the science and risk based approach focusing on the detailed research and understanding of the production process. Along with the constant deepening of the understanding of the manufacturing process, the design space will be determined, and the emphasis of quality control will be shifted from the quality standards to the design space. Therefore, the establishment of the design space is core step in the implementation of QbD, and it is of great importance to study the methods for building the design space. This essay proposes the concept of design space for the production process of traditional Chinese medicine (TCM) preparations, gives a systematic introduction of the concept of the design space, analyzes the feasibility and significance to build the design space in the production process of traditional Chinese medicine preparations, and proposes study approaches on the basis of examples that comply with the characteristics of traditional Chinese medicine preparations, as well as future study orientations.
Desiccation ; Drug Compounding ; methods ; Feasibility Studies ; Medicine, Chinese Traditional ; methods ; Risk ; Temperature ; Time Factors

In this paper, microcrystalline cellulose WJ101 was used as a model material to investigate the effect of various process parameters on granule yield and friability after dry granulation with a single factor and the effect of comprehensive inspection process parameters on the effect of granule yield and friability, then the correlation between process parameters and granule quality was established. The regress equation was established between process parameters and granule yield and friability by multiple regression analysis, the affecting the order of the size of the order of the process parameters on granule yield and friability was: rollers speed > rollers pressure > speed of horizontal feed. Granule yield was positively correlated with pressure and speed of horizontal feed and negatively correlated rollers speed, while friability was on the contrary. By comparison, fitted value and real value, fitted and real value are basically the same of no significant differences (P > 0.05) and with high precision and reliability.
Cellulose ; chemistry ; Drug Compounding ; methods ; Hardness ; Models, Chemical ; Particle Size ; Regression Analysis ; Technology, Pharmaceutical ; methods

The pellet-preparating theories and processes of two kinds of methods of extrusion-spheronization and fluid-bed coating method were compared. The micromeritic properties, yield and in vitro dissolution of Danggui Buxue pellets prepared by the two methods were determined. Results showed that the Danggui Buxue pellets prepared by extrusion-spheronization were all spheral with smooth surface, the yield of those pellets was higher and in vitro dissolution of those pellets was more satisfactory. So the two kinds of methods were all suitable to prepare Dang-gui-bu-xue pellets, but Extrusion-spheronization was superior to fluid-bed coating method.
Chemistry, Pharmaceutical ; methods ; Dosage Forms ; Drug Compounding ; methods ; Drugs, Chinese Herbal ; chemistry

Thermogravimetry (TG), TG-MS, Fourier transform infrared spectroscopy (FTIR), scanning electron microscope (SEM)-energy dispersive spectrometer(EDS) were adopted to investigate the pyrolysis characteristics of calamina. According to the findings of the qualitative and quantitative studies on the changes in the content of relevant elements, the whole shape, the functional groups, and the volatile components of calamina before and after being pyrolyzed, the 200-360, 580-750 degrees C were two sensitive temperature ranges related to the changes in effective component during calamina processing. Thermal weight loss was observed for ZnCO3, Zn(OH)2 and ZnCO3-2Zn(OH)2-H2O under 200-360 degrees C and for CaCO3 under 580-750 degrees C. The results of studies on chemical reaction kinetics showed good linear relations. This experiment integrated relevant methods and theories of physical chemistry and science of traditional Chinese medicine processing, and interpretes calamina processing techniques and mechanism, in order to provide a good example for modem studies on other traditional Chinese medicine processing.
Drug Combinations ; Drug Compounding ; methods ; Ferric Compounds ; chemistry ; Kinetics ; Temperature ; Zinc Oxide ; chemistry

The total effect of Chinese medicine pair (CMP) was not the simply addition of two single herbs, but the interaction of their different components. Therefore, the research on the bio-active components of CMP is the basis of CMP compatibility study, and has important significance for revealing the compatibility effect and action mechanism, and creating traditional Chinese medicine (TCM) new drugs. This paper summed up the latest research progress of CMP on the basis of the bio-active components variation regularity of CMP from chemical solutions and content changes in vitro and the actions of CMP on bodies in vivo, in order to further drive the modern basic and applied research of CMP, and to reveal the scientific essence of CMP compatibility.
Animals ; Drug Compounding ; Drug Interactions ; Humans ; Medicine, Chinese Traditional ; methods ; Pharmacokinetics