ABSTRACT
The quality control of traditional Chinese medicine (TCM) preparations is a key issue related to their curative effect, safety and stability. The application of modern analytical means and the development of new disciplines improve the quality control of TCM preparations to some extent. For a long time, however, the quality control level of TCM preparations remains low and the quality standards exist in name only unable to effectively control drug quality and ensure therapeutic effect and safety. The essay makes a systematic analysis on possible factors impacting TCM preparations and current situation of quality control and discusses possible approaches and new methods for improving quality control of TCM preparations, in order to give an impetus to the quality control standards and the mode evolvement of TCM preparations and ensure safety, efficiency and quality controllability of TCM preparations.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Methods , Quality ControlABSTRACT
The free membrane of Eudragit L100/S100 which is pH-sensitive, colon-specific was prepared by plane casting films. The film humidity, species and amount of plasticizers, the ratio of membrane material was investigated. The rate of membrane permeability and mechanical properties were used as indicators of orthogonal experiment, and its related properties were studied. The results show that the mechanical properties of the membrane and phragmoid capacity are the best when 30% TEC was used as plasticizer; the ratio of membrane material have little effect on the rate of membrane permeability and mechanical properties. By adjusting the species and amount of plasticizers, the ratio of Eudragit L100/S100, the free membrane which is colon-specific can be obtained.
ABSTRACT
The release kinetics research of sustained-release formulations of traditional Chinese medicines (TCM) is an inalienable part of the chain of TCM modernization, which plays an important role in the development of modern compound TCM preparation. However, the research method or pattern in line with the specific characteristics of TCM, i.e., multi-component and multi-target, is still lacking. On the basis of material rough set theory, this paper reviewed the advantages and disadvantages of the existing evaluation patterns and methods, a tentative idea about the "total amount" release characteristics evaluation on TCM compound sustained-release preparation has suggested so as to evaluate the release kinetics and to promote the development of evaluation methodology on TCM sustained-release preparations.
ABSTRACT
AIM: To establish the drug release method of Compound Salvia Multi-component released Doublelayer Tablet and investigate its in vitro drug release behavior and the influencing factors of the drug release rate.METHODS: The method of evaluating in vitro release rate of double-layer tablet was established with salvianolic acid B and gindenoside Rg_1 as index,The influencing factors of the release of rapid release layer and sustained release layer of double-layer tablet and their in vitro drug release behavior were studied.RESULTS: The rapid release layer showed the quick releasing effect; The drug release curve of sustained release layer accorded with Ritger-Peppas equation; artificial gastric juice had significant effect on the release curve of gindenoside Rg_1 which in double-layer tablets,but had no significant effect on the release curve of salvianolic acid B.CONCLUSION: The evaluation of in vitro release rate of Compound Salvia Multi-component released Double-layer Tablet shows good properties of fast and sustained release and clinic application is achieved.
ABSTRACT
<p><b>OBJECTIVE</b>To prepare Qixian decoction pellets.</p><p><b>METHOD</b>The 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.</p><p><b>RESULT</b>the 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.</p><p><b>CONCLUSION</b>the 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%.</p>
Subject(s)
Adhesives , Chemistry , Drug Compounding , Methods , Drug Implants , Drugs, Chinese Herbal , Chemistry , Rotation , Temperature , Time FactorsABSTRACT
<p><b>OBJECTIVE</b>To prepare enteric coated pellets containing panax notoginseng saponins.</p><p><b>METHOD</b>Panax notoginseng saponins loaded pellets were prepared by Extrusion-Spheronization method, and coated by Eudragit L30D-55 using Glatt fluid bed with the bottom spray process, central composite design was used to optimize the coating prescription.</p><p><b>RESULT</b>The drug release of enteric coated pellets of panax notoginseng saponins pellets would be lower than 5% in 2 h in simulated gastric fluid, but reach above 85% in 3 h in simulated human gastroenteric environment.</p><p><b>CONCLUSION</b>The enteric coated pellets of panax notoginseng saponins have good acid residence to avoid panax notoginseng saponins from degrading in gastric acid.</p>