Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

Objective:Based on the specific cleavage and non-specific "trans-cleavage" activities of the clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR-associated protein(CRISPR/Cas13), we established a visually amplification-free rapid detection technique of 2019-nCoV nucleic acid. This technique is easily processed with a low detection limit and good specificity.Methods:According to the 2019-nCoV gene sequence, specific CRISPR RNAs were screened and designed by bioinformatics analysis, and then synthesized as universal signal-strained RNA transcription targets in vitro to establish and optimize the reaction system. Moreover, the 2019-nCoV pseudoviral nucleic acid was used as a standard substance to evaluate the detection limit. A total of 65 positive samples were collected from various 2019-nCoV variants, while 48 negative samples included other clinically common respiratory pathogens, such as influenza A virus, influenza B virus, human parainfluenza virus, Klebsiella pneumonia, etc. All samples were tested by quantitative PCR (qPCR), digital PCR, and the method established in this study. The sensitivity and specificity of the newly established method were analyzed and evaluated. Results:With the newly established technique, the detection time for 2019-nCoV nucleic acid could be minimized to 6 minutes. In addition, the detection limit was 14 copies/μl when assisted by the displaying instrument, whereas it increased to 28 copies/μl with the naked eye. This technique had a sensitivity and specificity of 98.5% (66/67) and 100% (46/46) respectively, showing no statistically significant difference compared to the gold standard qPCR( P=1). Conclusions:This study has successfully established a CRISPR/Cas13a-based visually rapid detection technique for 2019-nCoV nucleic acid. This technique offers the advantages of a simple process, convenient operation, low environmental operating requirements, a detection limit close to qPCR, and a strong potential for on-site testing applications.

BACKGROUND:Efficacy of stem cel therapy is considerably influenced by oxidative stress. Sirtuin (SIRT) family of mammals is an important deacetylation and antioxidant enzyme that can regulate endogenous antioxidant activities in stem cel s and cel cycle related signaling pathways to reduce the damage and enhance the viability of stem cel s.
OBJECTIVE:To review the regulating function and mechanism of SIRT family.
METHODS:A computer-based search of Web of Science, PubMed and CNKI from 1990 to 2015 was performed for relevant articles about SIRT and stem cel oxidative stress, using the key words of“SIRT, stem cel , oxidative stress, molecular mechanisms”in English and Chinese, respectively. After eliminating literatures which have poor authority or have similar contents, 55 articles were involved.
RESULTS AND CONCLUSION:NAD+-dependent SIRT family is the key enzyme for deacetylation of histones and other proteins. It plays vital regulation roles in metabolism, genomic stability, DNA damage/repair, and chromatin remodeling/stress reaction. Progress in the SIRT-targeted stem cel research wil definitely provide more clues for clinical stem cel transplantation therapy.

Objective To investigate the clinical efficacy of trimetazidine combined with atorvastatin in the treatment of patients with coronary heart disease and its influence on serum lipid and hemorheology.Methods 140 cases with coronary heart disease were randomly divided into two groups.The control group was given trimetazidine on the basis of the conventional treatment,while the observation group was given atorvastatin on the basis of the control group.The clinical efficacy,changes of hemorheology and blood lipid were compared between the two groups.Results The effective rate of the observation group was 95.71％,which was significantly higher than 77.14％ of the control group (x2 =10.620,P ＜ 0.05).After treatment,TC,TG,LDL-C and HDL-C of the observation group were (2.54 ± 0.32) mmol/L,(1.41 ± 0.32) mmol/L,(1.53 ± 0.33) mmol/L and (0.73 ± 0.35) mmol/L,which were significantly lower than those of the control group (t =7.42,8.09,8.11,9.03,all P ＜ 0.05).After treatment,the nbh,nbl,np and HCT of the observation group were (5.11 ± 0.51) mPa/s,(8.03 ± 1.12) mPa/s,(1.02 ± 0.21) mPa/s and (40.34 ± 3.28) ％,which were significantly lower than those of the control group(t =8.33,9.14,8.08,9.44,all P ＜ 0.05).Conclusion Trimetazidine combined with atorvastatin in the treatment of coronary heart disease can significantly improve patients' lipid and hemorheology,and it can be promoted and applied in clinical practice.

Objectives To detect anti-basement membrane zone(BMZ)antibodies in systemic lupus ery-thematosus(SLE)patients and to explore its association with clinical manifestations.Methods Anti-BMZ anti-bodies were examined by indirect immunofluorescence in the sera of70patients with SLE.The correlation between anti-BMZ antibodies and clinical data of SLE was analyzed.Results Anti-BMZ antibodies could be found in the sera of about70%SLE patients,including IgG,IgM,IgA.They predominantly bound to the epidermis,but also bound to the dermis or both.The positive rate of anti-BMZ antibodies was significantly higher in patients with skin lesions than that of patients without skin lesions.There is no significant difference between the two groups in ac-tive and remission,kidney involvement,arthritis,alopecia,photoallergy,positive anti-dsDNA antibodies and the posi-tive rate of anti-BMZ antibodies.Conclusion Anti-BMZ antibodies presents in the sera of SLE patients with high positive rate.It is correlated with the development of skin lesions of SLE patients,but not with the activity of SLE,other clinical manifestations and anti-dsDNA antibodies.Anti-BMZ antibodies may be involved in the pathogenlic mechanism of the development of skin lesions in SLE patients.