In this paper, angelica broken wall powder(ABWP) was taken as the research object, HPLC fingerprint combined with multi-component determination(ferulic acid, senkyunolide I, coniferyl ferulate, ligustilide and 3-butylidenephthalide), physical fingerprint(D_(90), particle size distribution range, particle size distribution width, bulk density, tap density, inter-particle porosity, Carr index, specific surface area, pore volume, angle of repose, Hausner ratio, loss on drying and hygroscopicity)were used to characterize the quality attribute of ABWP; similarity analysis, cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis were conducted to construct the quality evaluation method of holographic analysis based on traditional Chinese medicine QbD "4 H mode", in order to evaluate the quality of ABWP from different sources and find out differentiated indicators. The quality evaluation method could be used for scientific, comprehensive evaluation of the quality attribute of ABWP, and the quality consistency evaluation of cell-wall-broken powder of different sources or different processes.It provides new ideas for quality control and research of ultrafine granular powders of traditional Chinese medicine.
Angelica/chemistry* ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal/analysis* ; Medicine, Chinese Traditional ; Powders ; Quality Control

Based on the previous literatures, the overview on the history and recent advance of the quantitative analysis of multi-components by single-marker (QAMS) was summarized. The key questions of QAMS were also highlighted. It could be considered as a feasible method for the quality control of Traditional Chinese Medicines.
Chromatography ; Drugs, Chinese Herbal ; analysis ; Quality Control ; Research Design

Sankezhen (Berberidis Radix) is a traditional Chinese materia medica,cold in nature and bitter in taste,for treating syndromes of liver,stomach,and large intestinal meridians,in which berberine and berbamine are the major pharmacological components.Sankezhen has been readmitted in Chinese Pharmacopoeia 2010 following the 1977 version as the roots of Berberis spp.e.g.B.soulieana,B.wilsonae,B.poiretii,B.vernae,etc.Recent studies showed that Berberis spp.were potential phytomedicines with multiple spectrums therapeutic effects and various pharmaceutical parts.Here we reviewed Sankezhen in traditional use and phytochemistry,and its major active components berberine and berbamine with potential bioactivities recently discovered,such as antitumor,antidiabetic,antihyperlipidemic,anti-arrhythmic,and neuro-protective activities.It is necessary to mature the quality assessment of Sankezhen as a new admission of Chinese Pharmacopoeia 2010.Other parts of Berberis spp.should be investigated to better develop this herb in medicinal usage.

The application of the compound preparation of traditional Chinese medicine (TCM) and chemical drug in clinical has a long history. Drug regulatory requirements of the compound preparation of TCM and chemical drug in various periods were compared and analyzed, and the history and status of the way of scientific supervision of this preparation were summarized. This paper discussed the problems and deficiencies of the compound preparation of TCM and chemical drug, and put forward countermeasures and suggestions about to strengthen the scientific supervision of the compound preparation of TCM and chemical drug.
Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional ; standards ; Pharmaceutical Preparations ; standards

The prepared slices of Chinese crude drugs are growing important in recent years, and faced with new developments and opportunities. The author analyzed the importance of formulate national processing procedures of prepared slices of Chinese crude drugs combined actual work, proposed the overall objectives and tasks for the formulation, and emphasized to need to correctly deal with several important factors during the process of formulate "National processing procedures of prepared slices of Chinese crude drugs", unified the national standards of prepared slices, solved the real problems that the prepared slices of Chinese crude drugs industry faced.
Chemistry, Pharmaceutical ; methods ; standards ; China ; Drugs, Chinese Herbal ; chemistry ; Humans ; Medicine, Chinese Traditional ; methods ; standards

To improve the impurity control of extrinsic residues in Chinese crude drugs and ensure the quality of crude drugs, relative suggestions should be provided. The present situation of extrinsic residues control in crude drugs was reviewed, and relative problems existed were analyzed. To develop the impurity control of extrinsic residues in Chinese crude drugs, more effort focus on strengthening basic research, improving analytical methods and optimizing the pattern of administration should be made.
Drug Contamination ; prevention & control ; Drugs, Chinese Herbal ; analysis ; standards ; Medicine, Chinese Traditional ; standards ; Quality Control