The National Medical Products Administration intends to simplify the registration and approval process of the classic Chinese herbal compound preparations that meet the requirements, but it is a prerequisite for obtaining preferential policies that the preparation method and the route of administration are consistent with the records of ancient medical books. As most of the famous classical formulas are recorded in the medical books of the Qing dynasty and before the Qing dynasty, during the use of medicinal materials in various dynasties, the processing of herbs, dose of medicinal herbs, and the method of decocting may have changed. If researchers simply adopt modern methods to study the formula, it is easy to deviate from policy requirements. The strengthening of preliminary data survey and definition of prescription component and the medication situation of the dynasties can provide strong theoretical support for the study of famous classical formulas. Based on this, the authors take Xiebaisan as an example, which being collected in the First Batch of Catalogue of Ancient Classical Formulas. By following the principles of ancient methods, the research and development ideas of the classic Chinese herbal compound preparations were expounded from the aspects of origin of medicinal materials, processing of medicinal materials, preparation of standard decoction and quality standard of Xiebaisan granules, so as to provide a referential method for the development and research of the famous classical formulas.

Objective: To study the concentration of salvianolic acid B (Sal B) in rat hippocampus after intranasal administration, and to inveategate the improvement on cognitive dysfunction of rats with cerebral ischemic treated by intranasal administration of Sal B and its mechnisms. Methods: HPLC method was employed to check the distribution of Sal B in hippocampus by intranasal administration. Sal B was intranasal administered after one week of cerebral ischemia. The effect of Sal B by intranasal administration on cognitive dysfuctiopn was checked using Morris water maze. The effect of Sal B by intranasal administration on the hippocampus morphological characteristics was studied using Cresyl violet (Nissl) staining. BrdU injection and immunohistochemical staining were used to test the effect of Sal B on the neurogensis in hippocampus of cerebral ischemic rats. Results: After intranasal administration of Sal B, the Cmax of Sal B was (2.47 ± 0.55) μg/g, and the AUC of Sal B was (336.4 ± 73.0) μg∙min/g. Morris water maze test results showed that Sal B by intranasal administration could reduce the average escape latency of cerebral ischemic rats, increase the time in the former platform quadrant and the time of rats across the platform. Compared with the Sham group, the hippocampal CA1 cell layers were reduced and the pyramidal cells showed an irregular arrangement in the model group. Compared with model group, hippocampal morphology was clear, nerve cells arranged in regular, and the number of neurons increased significantly in groups of Sal B by intranasal administration. Immunohistochemistry results showed that the groups of Sal B by intranasal administration could increase the BrdU-positive cell number in hippocampus. Conclusion: Intranasal administration of SalB can significantly improve the distribution in the hippocampus. Intranasal administration of Sal B could improve the cognitive dysfuction, and this effect maybe related to the directive effect of Sal B on promoting neurogenesis after cerebral ischemic.

Ultrafiltration is one of the most fascinating technologies, which makes it possible to improve the quality of traditional medicines for application in the pharmaceutical industry. However, researchers have paid little attention to the effect of ultrafiltration membrane on traditional medicines chemical constituents. In this work, Ophiopogon japonicus (L.f) Ker-Gawl. was used as an example to illuminate the influence of ultrafiltration with different material and molecular weight cut-off (MWCO) membrane on natural chemical constituents as measured by ultra-fast liquid chromatography coupled with ion trap time-of-flight mass spectrometry (UFLC-IT-TOF/MS). Our results indicated that ultrafiltration membrane significantly impacted homoisoflavonoids, especially homoisoflavonoids that were almost completely retained on the polyethersulfone (PES) membrane. We also found that the larger number of aglycone hydroxy and sugar moiety in steroid saponins, the higher the transmittance. Furthermore, the passage rate (%) of ophiogenin type saponins was higher than that of others. The possible adsorptive mechanisms were hydrogen bonding, hydrophobic interactions, and benzene ring interaction by π-π stacking. In conclusion, it is crucial to choose appropriate ultrafiltration membrane based on the characteristics of produce products for application of ultrafiltration technique.
Chromatography, High Pressure Liquid ; methods ; Chromatography, Liquid ; methods ; Drugs, Chinese Herbal ; Isoflavones ; analysis ; Molecular Structure ; Molecular Weight ; Ophiopogon ; chemistry ; Plant Extracts ; chemistry ; Polymers ; Saponins ; analysis ; Spectrometry, Mass, Electrospray Ionization ; methods ; Sulfones ; Ultrafiltration ; methods

Salvianolic acid is the water soluble extract of Salvia miltiorrhiza,and it can improve the blood circulation of the brain and improve the cognitive disorder of depression,anti-inflammation,anti-tumor and so on.At present,the research on its technology is relatively less.This particle will mainly review the research progress of analytical methods,extraction and purification technology of salvianolic acids.The main analysis methods used for salvianolic acids include UV spectrophotometry,near-infrared spectroscopy,quantitative analysis of multi-components by single marker (QAMS),colorimetry and so on.The extraction process is mainly heating reflux extraction and warm soaking method,percolation method,enzymatic extraction,etc.The purification process is macroporous resin purification,ZnCl2 precipitation method,ultrafiltration and so on.

Objective Determination of extractable components in medium/low borosilicate glass controlled injection bottles under 5 different extraction conditions,assess the risk of drug safety by the amount of migration.Methods Determination of 24 elements in extraction solution by ICP-MS.Result Establish the standard curves of 24 elements,and the detection limit and quantitative limit were determined.The determination of the elements in the 5 extraction solutions was completed and their safety was evaluated.Conclusion Medium/low borosilicate glass injection bottle for packing freeze-dried products of Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,the daily intake of Li、V、Cr、Fe、Co、Ni、Cu、Zn、As、Cd、Sb、Ba、Hg、Pb was lower than permitted daily exposure,the amount of migration does not pose a risk to drugs,therefore,the injection quality is not affected.

Currently, near infrared spectroscopy (NIRS) has been considered as an efficient tool for achieving process analytical technology(PAT) in the manufacture of traditional Chinese medicine (TCM) products. In this article, the NIRS based process analytical system for the production of salvianolic acid for injection was introduced. The design of the process analytical system was described in detail, including the selection of monitored processes and testing mode, and potential risks that should be avoided. Moreover, the development of relative technologies was also presented, which contained the establishment of the monitoring methods for the elution of polyamide resin and macroporous resin chromatography processes, as well as the rapid analysis method for finished products. Based on author's experience of research and work, several issues in the application of NIRS to the process monitoring and control in TCM production were then raised, and some potential solutions were also discussed. The issues include building the technical team for process analytical system, the design of the process analytical system in the manufacture of TCM products, standardization of the NIRS-based analytical methods, and improving the management of process analytical system. Finally, the prospect for the application of NIRS in the TCM industry was put forward.