Continuous manufacturing, as an innovative pharmaceutical production model, offers advantages such as high production efficiency and ease of control compared to traditional batch production, aligning with the future trend of drug production moving toward greater efficiency and intelligence. However, the development of continuous manufacturing technology in wet granulation has been slow. On one hand, this is closely related to its high technical complexity, substantial equipment investment costs, and stringent process control requirements. On the other hand, the long-term use of the traditional batch production model has created strong path dependence, and the lack of mature standardized processes further increases the difficulty of technological transformation. To promote the deep integration of wet granulation technology with continuous manufacturing, this review systematically outlines the current application of wet granulation in continuous manufacturing. It focuses on the development of key technologies such as online detection, process modeling, and process scale-up, with the aim of providing a reference for process innovation and application in wet granulation.
Drug Compounding/instrumentation* ; Technology, Pharmaceutical/methods* ; Drugs, Chinese Herbal/chemistry* ; Models, Theoretical

In order to effectively remove the invalid impurities in Tongan injection, optimize the optimal parameters of the impurity removal technology of liquid mixing process, in this paper, taking Tongan injection as the research object, with the contents of celandine alkali, and sinomenine, solids reduction efficiency, and related substances inspection as the evaluation indexes, the removal of impurities and related substances by the combined process of refrigeration, coction and activated carbon adsorption were investigated, the feasibility of the impurity removal method was definited and the process parameters were optimized. The optimized process parameters were as follows: refrigerated for 36 h, boiled for 15 min, activated carbon dosage of 0.3%, temperature 100 degrees C, adsorption time 10 min. It can effectively remove the tannin, and other impurities, thus ensure the quality and safety of products.
Adsorption ; Charcoal ; chemistry ; Drug Compounding ; instrumentation ; methods ; Drug Contamination ; prevention & control ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Quality Control

Tetradrine-tashionone II(A)-PLGA composite microspheres were prepared by the SPG membrane emulsification method, and the characterization of tetradrine-tashionone II(A) -PLGA composite microspheres were studied in this experiment. The results of IR, DSC and XRD showed that teradrine and tashionone II(A) in composite microspheres were highly dispersed in the PLGA with amorphous form. The results of tetradrine-tashionone II(A) -PLGA composite microspheres in vitro release experiment showed that the cumulative release amounts of tetradrine and tashionone II(A) were 6.44% and 3.60% in 24 h, and the cumulative release amounts of tetradrine and tashionone II(A) were 89.02% and 21.24% in 17 d. The process of drug in vitro release accorded with the model of Riger-Peppas. Tetradrine-tashionone II(A) -PLGA composite microspheres had slow-release effect, and it could significantly reduce the burst release, prolong the therapeutic time, decrease the dosage of drugs and provide a new idea and method to prepare traditional Chinese medicine compound.
Benzofurans ; chemistry ; Benzylisoquinolines ; chemistry ; Drug Carriers ; chemistry ; Drug Compounding ; instrumentation ; methods ; Drugs, Chinese Herbal ; chemistry ; Kinetics ; Lactic Acid ; chemistry ; Microspheres ; Particle Size ; Polyglycolic Acid ; chemistry

The impact of key physical properties on granulated products by the high-speed mixing wet method was studied. Andrographis extracts were utilized as the model drug. Four processing methods were adopted to prepare mixed powder of microcrystalline cellulose (MCC) and starch with the mass ratio 1:0.5, 1:1 and 1:2 by the high-speed mixing wet method. The properties of the prepared granules were evaluated with such indexes as granule yield, the ratio of lumps and fine powder, granule-AOR and granule-HR. The impact of key physical properties on granulated products was analyzed through stepwise regression analysis. The results showed that angle of repose, moisture content, pore volume, density and contact angle with water were key physical properties of the powder. The key physical properties of Chinese medical extracts powder are the important factor impacting granulated products made by the high-speed mixing wet method. In this study, the impact of key physical properties on granulated products of Chinese medical extracts was analyzed from the physical angle.
Andrographis ; chemistry ; Drug Compounding ; instrumentation ; methods ; Drugs, Chinese Herbal ; chemistry ; Particle Size ; Powders ; chemistry

Traditional processes are mostly adopted in traditional Chinese medicine (TCM) preparation production and the quality of products is mostly controlled by terminal. Potential problems of the production in the process are unpredictable and is relied on experience in most cases. Therefore, it is hard to find the key points affecting the preparation process and quality control. A pattern of research and development of traditional Chinese medicine preparation process based on the idea of Quality by Design (QbD) was proposed after introducing the latest research achievement. Basic theories of micromeritics and rheology were used to characterize the physical property of TCM raw material. TCM preparation process was designed in a more scientific and rational way by studying the correlation among enhancing physical property of raw material, preparation process and product quality of preparation. So factors affecting the quality of TCM production would be found out and problems that might occur in the pilot process could be predicted. It would be a foundation for the R&D and production of TCM preparation as well as support for the "process control" of TCMIs gradually realized in the future.
Drug Compounding ; methods ; standards ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; standards ; Humans ; Medicine, Chinese Traditional ; standards ; trends ; Quality Control ; Research ; standards ; trends ; Research Design ; standards ; Technology, Pharmaceutical ; instrumentation ; methods ; standards

OBJECTIVETo study preliminarily on the relationship between properties of the mixture composed of Tongsaimai extract and different excipients and pellet molding.

METHODThe multivariate regression analysis was used to investigate the correlation of different mixture and pellet molding by measuring the cohesion, liquid-plastic limit of mixture, and the powder properties of pellets. The weighted coefficients of the powder properties were determined by analytic hierarchy process combined with criteria importance through intercriteria correlation.

RESULTThe results showed that liquid-plastic limit seemed to be a major factor, which had positive correlation with pellet molding, while cohesion had negative correlation with pellet molding in the measured range.

CONCLUSIONThe physical properties of the mixture has marked influence on pellet molding.

Dosage Forms ; Drug Compounding ; instrumentation ; methods ; Drugs, Chinese Herbal ; chemistry ; Excipients ; chemistry ; Particle Size ; Powders ; Surface Properties

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

OBJECTIVETo prepare traditional Chinese medicine formula Qiqi pellets by extrusion-spheronization and study the optimal formulation and process.

METHODQiqi pellets were prepared by a new style extrusion-spheronization equipment, the optimal formulation and process was obtained by the studies of influenitial factors and L9 (3(4)) orthogonal design, the micromeritic properties and product yield of pellets were determined.

RESULTThe formula Qiqi pellets prepared by extrusion-spheronization were all spheral with smooth surface; the product yield was high.

CONCLUSIONExtrusion-spheronization was suitable to produce Chinese Herbal Medicine pellets. The preparation process was simple and feasible; The quality of the prepared pellets was excellent. It was worth further study.

Astragalus membranaceus ; chemistry ; Cellulose ; chemistry ; Drug Combinations ; Drug Compounding ; instrumentation ; methods ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Ethanol ; chemistry ; Lycium ; chemistry ; Plants, Medicinal ; chemistry ; Technology, Pharmaceutical ; instrumentation ; methods ; Water ; chemistry