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

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.

Capsules ; Drug Compounding ; methods ; Drugs, Chinese Herbal ; chemistry ; Solubility

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

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

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 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

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

OBJECTIVETo prepare Qixian decoction pellets.

METHODThe formulation and technological factors influencing the preparation of Qixian decoction were investigated in tangential spray fluid bed choosing the yield of pellets, particle diameter distribution, repose angle, bulk density as inspecting indexes.

RESULTthe technological parameters for the preparation of blank pellets were as follows: the ratio of starch and dextrin was 2:1, the adhesive agent was 70% syrup, the rotating speed was 200 r x min(-1), the air blow flow was 15 x 20 L x min(-1), the rate of air flow was 15 L x min(-1), the spay air pressure was 0.15 MPa, and the rotating rate of spray solution pump was 20-50 r x min(-1); The optimized technological parameters for the preparation of Qixian decoction were as follows: the relative density of the extract was 1.12-1.15 g x min(-1), the diluent was MCC and its quantity was 8%, the rotating rate of spray solution pump was 10-12 mL x min(-1), the frequency of the rotor disc was 18-20 Hz, the atomizing pressure was 0.2 MPa, the frequency of the fan was 22 Hz, and the spheronisation and drying time was 30 mins.

CONCLUSIONthe appearance of the Qixian decoction pellets prepared in tangential spray fluid bed are smoothing and round, the yield of pellets are high, and pellets of the particle size between 500-700 microm is 90.6%.

Adhesives ; chemistry ; Drug Compounding ; instrumentation ; methods ; Drug Implants ; Drugs, Chinese Herbal ; chemistry ; Rotation ; Temperature ; Time Factors

Due to the limitation of science and technology in ancient times, traditional Chinese medicines (TCMs) could have prepared only in traditional dosage forms, such as pills, powders, ointments and pellets. Though studies on multi-component TCMs have become one of major development orientations of TCM, the druggability of their preparations has always been neglected. On the basis of two key difficulties--the integration of studies on multi-component TCMs and TCM theory as well as the evaluation on their druggability, the essay proposes methods and technologies that can be adopted in studies on multi-component TCM preparations, including the characteristic physicochemical property of multi-component TCMs and its correlation with forming process, the release-modified micro pill preparation technology based on prescription-symptom-dosage, and the evaluation technology on release of release-modified micro pill components based on mathematical set model.
Chemical Phenomena ; Drug Compounding ; Drug Dosage Calculations ; Medicine, Chinese Traditional ; methods ; Models, Theoretical