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OBJECTIVE： To provide reference for pharmaceutical manufacturers improving the quality system of GMP and drug regulatory departments improving their supervision level. METHODS： Through analyzing and summarizing the problems existing in the 28 pharmaceutical enterprises which had been published on the website in the National Medical Products Administration from February 6th， 2018 to January 25th， 2019， the common problems were found and their causes were analyzed， then the regulatory countermeasures were put forward. RESULTS & CONCLUSIONS： Pharmaceutical enterprises have some problems of inadequate implementation of GMP， such as the inadequate performance of personnel in key positions and the unsatisfactory training effect of relevant personnel， the inconsistency between actual production technology and approved legal technology， the non-standard management of enterprise materials， the incomplete batch production records and the inability to effectively monitor the production cycle. However， there are also some problems in the supervision department， such as the large difference in the scale of inspectors’ on-site inspection， the need to strengthen the inspectors’ inspection ability and level， and the lack of innovation in the means of supervision. It is suggested that pharmaceutical manufacturers should improve the construction of GMP quality management system and strengthen the training of relevant personnel； the regulatory authorities should continue to promote the reform of “release， control and service”， strictly enforce the access conditions of inspectors， strengthen the training of inspectors and ideological construction of the inspector team，further strengthen the construction of supervision system and enhance the innovation of supervision means， so as to jointly maintain the safety， effectiveness and quality controllability of medicines.
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Objective:To develop a determination method for strychnine and brucine in Shiyifang vinum by LC-MS/MS. Meth-ods:The samples were separated on an Agilent Zorbax SB-C18column(2.1 mm×100 mm,3.5 μm). The mobile phase was metha-nol-10 mmol·L-1ammonium formate solution (adjusting pH to 3.0 with methane acid)(25: 75), and the flow rate was 0.2 ml· min-1. The eletrospray ionization( ESI) with positive source of the mass spectrometer and multiple reaction monitor( MRM) mode were used to detect strychnine(m/z 395.2→243.8;m/z 395.2→212.8)and brucine(m/z 335.2→183.9;m/z 335.2→155.9). Re-sults:The linear range of strychnine was 0.242-7.733 μg·ml-1,and that of brucine was 0.302-9.661 μg·ml-1. The average re-covery was 100.1% (RSD=0.8%,n=6) and 99.4% (RSD=1.4%,n=6),respectively. Conclusion:The method is simple and accurate,which can be used to determine the contents of strychnine and brucine in Shiyifang vinum.
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OBJECTIVE:To further enhance the implementation level of new Good Manufacturing Practices (GMP) in phar-maceutical enterprises. METHODS:Based on the new GMP criteria and Guidelines for Risk Assessment of Pharmaceutical Produc-tion Site Inspection,a tracking inspection was conducted for the 31 pharmaceutical enterprises in 11 prefecture-level cities of Guangxi area. Defects of implementing new GMP and their causes were analyzed,and the suggestions were put forward. RESULTS& CONCLUSIONS:In the 31 pharmaceutical enterprises,there were 30 enterprises(96.8%)passed the new GMP tracking inspec-tion. Totally 331 defect items were found,focusing on equipment(76 items,23.0%),factory and facilities(47 items,14.2%),quality control and quality assurance(43 items,13.0%). Causes for defects were mainly institutions and staff training,factory and facilities,equipments management,maintenance and periodic check were far from satisfactory;material and product did not speci-fy a validity period or a retest period;relevant confirmation was incomplete with verification;the quality control,assurance,man-agement,document and production management were not standard and completed;and self-test program was too simple,etc. It is suggested that drug regulatory authorities should establish and improve the legal system,explore new patterns of drug GMP track-ing inspection (such as sudden unannounced inspection,detailed inspection),strengthen inspector team training and unify inspec-tion scale. And the pharmaceutical enterprises should produce drugs in line with the requirements of new GMP,focus on the update of key knowledge,strengthen relevance of training to ensure the drugs quality effectively by multilateral force.
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Objective:To discuss the effects of panax notoginseng saponins (PNS) enteric-coated pellets on hemorrheology in rabbits.Methods:The rabbits were divided into the normal control group,the model control group,Xueshuangtong injection (lyophilization) group(15 mg·kg-1·d-1 ,im),PNS enteric-coated pellets groups respectively at high(45 mg·kg-1·d-1,ig),medium(30 mg·kg-1·d-1,ig) and low (15 mg·kg-1·d-1,ig) dose.The model was established by intragastric administration of high-fat diet.The whole-blood viscosity,plasma viscosity,erythrocyte aggregational index,crythrocyte index of rigidity and erythrocyte electro-phoresis rate in the groups were detected using hemorheological methods.Results:The above indices of hemorheology in the model control group were all significantly higher than those in the normal control group (P0.05).Compared with Xueshuangtong injection (lyophilization) group,PNS enteric-coated pellets group at medium dose could significantly reduce the whole blood middle shear viscosity(P<0.05).Conclusion:PNS enteric-coated pellets can reduce the whole-blood viscosity,plasma viscosity,erythrocyte aggregational index,crythrocyte index of rigidity and erythrocyte electro-phoresis rate,and effectively promote blood circulation and remove stasis,inhibit thrombosis formation and increase blood supply for heart and cerebral vessels.
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Objective: To compare the post-infectious irritable bowel syndrome [PI-IBS] and none post-infectious irritable bowel syndrome [NPI-IBS] clinically and experimentally
Methods: From May 2013 to January 2015, eighty-nine patients with irritable bowel syndrome [IBS]were recruited in the internal department of the affiliated hospital of Shandong University of Traditional Chinese Medicine. The clinical data were collected for all the patients, and a blood sample was collected to detect the level of C-reactive protein [CRP] and intestinal fatty acid binding protein [IFABP], an investigation questionnaire of gastrointestinal symptom rating scale [GSRS] and self-rating anxiety scale [SAS] were carried out to evaluate the gastrointestinal function and anxiety status
Results: In the study, forty-eight patients were included in PI-IBS group and 41 in Non-PI-IBS group. There was no significant difference in age, gender and GSRS between the two groups [p>0.05]. In PI-IBS group 70.8% patients presented with the primary symptom of diarrhea and 60.4% presented with a SAS scores over 50, but in Non-PI-IBS group, the values were only 19% [p<0.05] and 34.1% [p<0.05]. The level of IFABP and CRP were significantly higher in PI-IBS group than those in Non-PI-IBS group [p<0.05]
Conclusion: The PI-IBS may be different from Non-PI-IBS in mechanism and should be treated using different strategies
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OBJECTIVE:To optimize preparation formulation of Tetrandrine solid dispersion tablets. METHODS:Tetrandrine solid dispersion tablets were prepared by direct compression method. Excipients were screened with single factor test. Taking disinte-gration time as index,the formulation of Tetrandrine solid dispersion tablets was optimized by orthogonal design using the amount of PVPP,lactose-microcrystalline cellulose proportion and the amount of gum acacia as factors. The optimized formulation was vali-dated. Prepared tablets were compared with Tetrandrine common tablet in dissolution rate,and the contents of the tablets prepared by optimized formulation were also determined. RESULTS:Optimal formulation was as follows as 9.5% PVPP as disintegrating agent,lactose-microcrystalline cellulose(1∶2)as filler,mixing,1% aerosil as lubricant,direct compression. For 3 batches of tab-lets,disintegration time were 79,81 and 78 s;contents were 98.66%,99.24%,99.85%;RSDs were 0.72%,1.16%,1.33%,re-spectively. Combined with Tetrandrine common tablets,the dissolution rate of prepared tablets had been improved significantly. CONCLUSIONS:Tetrandrine solid dispersion tablets are prepared successfully with rational reproducible formulation.
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Objective:To establish an HPLC method for the determination of two components in compound artemisinin analgin tab-lets. Methods:A Waters Symmetry C18 column (250 mm × 4. 6 mm,5 μm) was used with methanol-0. 02 mol·L-1 KH2 PO4 solution (25 ∶75, adjusting pH to 3. 5 with phosphoric acid ) as the mobile phase. The flow rate was 1. 0 ml·min-1 and the detection wave-length was 250 nm. The column temperature was 30℃ and the injection volume was 20 μl. Results:There was a good linear relation-ship when the content of analgin and puerarin was within the range of 50.11-601.36 μg·ml-1(r=0.999 9) and 2.64-31.74 μg· ml-1(r=0. 999 8), respectively. The average recovery was 99. 1%(RSD=0. 7%,n=9)and 99. 9%(RSD=0. 6%,n=9),respec-tively. Conclusion:The method is simple and accurate with good reproducibility,which can be used to control the quality of the prepa-ration.