Objective: To establish a RP HPLC for determination of puerarin in Heat clearing Toxin resolving Decoction. Methods: A Hypersil C 18 column with acetonitrile 2% glacial acetic acid (8.5:91.5) as a mobile phase was used. The flow rate was 0.8ml?min 1 and the detective wavelength was 250nm. Results: The calibration curve was linear at a range of 0.424 4.240?g for the puerarin (r=0.9998). The average recovery was 101.3% and the relative standard deviation (RSD) was 1.4%. Conclusion: The methld is simple, accurate with a good reproducibility and can be used as a quantitative analysis method for this preparation.

Circulating DNA is defined as a kind of extracellular DNA that exists in plasma,cerebrospinal fluid and synovial fluid.The concentration of circulating DNA of cancer patients is significantly higher than that in healthy people.The genetic and epigenetic alterations of circulating cell-free nucleic acids are relevant to cancer development and progression,for example,gene mutation,DNA methylation and microsatellite instability and so on.The quantitative and qualitative detection of circulating DNA shows promising potential value in cancer screening,diagnosis,disease monitoring treatment and prognosis.

Objective: To establish a method for the determination of cinnamic acid in Lingguizhugan Decoction (Poria, Ramuls Cinnamomi, Rhizoma Atractylodis macrocephalae, Radix Glycrrhizae, etc.). Methods: Using RP HPLC with Hypersil C 18 column, methanol acetonitrile water acetic acid (10∶22∶70∶1.4,v/v) as mobile phase, detection wavelength at 254nm and p dimethylaminobenzaldehyde as the internal standard.Results: The mean recovery and RSD were 98.2% and 1.9% ( n =6), respectively, the linear range of cinnamic acid was 8.4～168?g?mL -1 ( r =0.9999). Conclusion: The method is simple, rapid, accurate and reproducible, and may be used for the determination of cinnamic acid in Lingguizhugan Decoction.

Objective: To study the compatibility and therapeutical basis of composite herbal medicines of Lingguishugan Decoction(LD)(Poria, Ramulus Cinnamomi, Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae.)Methods: Ethanol extract test solutions of the different combinations were prepared according to the orthogonal layout L 16 (4 5). Pharmacologic experiments, such as the time of survival of mice in shortage of oxygen in normal pressure, the antagonistic effect on arrhythmia induced by chloroform and the diuretic effect were carried out with LD. Variance analysis, canonical correlation and stepwise regression analysis were applied to interelationship between the amount of each drug and the pharmacologic data. Then, the fingerprints of the solutions were tested by HPLC method and 50 chromatographic peaks were obtained. Correlation and regression analysis was applied to interelationship between the area of each peaks and the pharmacologic data.Results: The results confirmed the poria and cinnamon twig are the basis, while ovate atractylodes and licorice are the adjuvans. 17 peaks, which were established as the therapeutical basis of the decoction, were selected from all compounds, and cinnamic acid of cinnamomum cassia, glycyrrhizin of Glycyrrhiza uralensis and dehydrotumulosic acid of Poria cocos were selected as the markers to evaluate the quality of the decoction.Conclusion: This study provided a significant try of studying the compatibility of composite herbal medicines.

Objective To observe the efficacy and safety of intravitreal injection of ranibizumab in the treatment of retinopathy of prematurity (ROP).Methods Data from 49 consecutive ROP patients (95 eyes) including type Ⅰ pre-threshold,threshold and aggressive posterior ROP who had received anti-VEGF treatment for the first time in our hospital from June 2014 to August 2015 were collected.60 eyes from the 95 eyes were confined as the zone Ⅰ disease group,while the remaining 35 eyes as zone Ⅱ disease group.The difference of birth weight,gestational age,corrected gestational age,treatment effects,recurrence and re-treatment time between two groups were compared.0.025 mL ranibizumab (10 mg · mL-1) was injected through 1.5 mm puncture after corneal limbus by using 30G 1 mL injection syringe.At the end of the injection,tobramycin and dexamethasone ophthalmic ointment eye bag was used.After the injection of 3 days,the portable slit lamp and tonometer were used to observe the intraocular pressure,intraocular hemorrhage and endophthalmitis.The indirect ophthalmoscope was used to observe the retinal vascular tortuosity and ridge regression of lesion expansion at 1 week after treatment.At the same time,the systemic adverse reactions related to treatment were observed.Results After receiving ranibizumab treatment for the first time,93 eyes (95.9％) exhibited ROP regression after single injection,including 58 eyes in zone Ⅰ disease group,35 eyes in zone Ⅱ disease group.There was no statistical difference between two groups (P ＞ 0.05).22 eyes required additional anti-VEGF injection or laser treatment for ROP recurrence,including 17 eyes in zone Ⅰ disease group,5 eyes in zone Ⅱ disease group.There was statistical difference between two groups (P ＜0.05).The time from recurrence to re-treatment was (6.50 ±2.54) weeks,which in zone Ⅰ disease group was (6.44 ± 2.74) weeks and in zone Ⅱ disease group was (6.67 ± 2.31)weeks,there was no statistical difference between two groups (P ＞ 0.05).No local or systemic adverse events associated with the treatment or drug was observed within the following period.Conclusion Intravitreal injection of ranibizumab is an effective and well tolerated method for zone Ⅰ and zone Ⅱ ROP,but the recurrence rate is high.There Is no local or systemic adverse events associated with the treatment or drug.

The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common re-quirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technolo-gies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.

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

Pharmaceutical excipients of animal origin, an important part in pharmaceutical excipients, are widely used in pharmaceutical preparations.However, compared with the pharmaceutical excipients of other origins, pharmaceutical excipients of animal origin have more special requirements in many aspects, such as raw materials, production, quality control, storage, supervision, etc.Chinese Pharmacopoeia 2020 first included the Guideline for Pharmaceutical Excipients of Animal Origin, which introduces the basic ideas and technical requirements for the life cycle quality control of pharmaceutical excipients of animal origin based on the risk management concept.This article illustrates the specificity of the pharmaceutical excipients of animal origin, and interprets the main contents of this guideline in conjunction with relevant domestic and foreign regulations and technical documents, thereby providing comprehensive reference for the implementation of the guideline.

The development of famous classical formula compound preparations has been a research hotspot in recent years， carrying great expectations from the government， academia and industry. During the process of its research and development， it reflects many problems related to traditional Chinese medicine （TCM） industry and deserves deep consideration by the academic community. Based on the current status of development of famous classical formulas， this paper summarizes the key problems and made an in-depth analysis. The results show that three key issues should be paid attention. The first is the weakness of basic research in TCM， which affect the healthy development of TCM. The second is the understanding of development of famous classical formula compound preparations is not in-depth， and the formulation of relevant policies needs to be more reasonable. Thirdly， the expectation for the development of famous classical formula compound preparations is too high， which affects the research and development process of the compound preparations. It is hoped that the TCM industry can take this opportunity to face the problems， propose solutions， and form new breakthroughs to promote the development and progress of TCM.