Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.

Objective Taking the medicinal excipient pectin as an example,based on the ICH Q3C risk assessment and management concept,this paper explores the control standards for residual solvents in pectin in the variety text of the Chinese Pharmacopoeia.Methods Pectin products from different processes and manufacturers were analyzed,the types of solvent residues in pectin were identified,and the solvent residues of products from different manufacturers were analyzed by gas chromatography.Results According to the product process,there was a risk of residual methanol(class 2),ethanol and isopropanol(class 3)in pectin products.In 18 batches of samples,the residual amount of methanol was measured in the range of 0.05％-0.17％,the residual amount of ethanol was in the range of 0.01％-0.38％,isopropanol was not detected,and the total amount of residual solvents was in the range of 0.07％-0.55％.Conclusions It is suggested that the residual solvent inspection item may not be listed separately in the main text of the pectin standard of the Chinese Pharmacopoeia.It is recommended that the manufacturer is required to indicate the name and limit of residual solvents under the labeling item of the standard.

Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.

Objective To explore the application value of iterative model reconstruction(IMR)technique in low-dose lumbar CT scanning.Methods A total of 48 patients who underwent lumbar CT plain scan were selected and divided into regular-dose group(group A)and ultra-low dose group(group B).The group A underwent imaging with 120 kV tube voltage,automatic tube current modulation technology,and iDose 4 reconstruction.The group B was scanned with a tube voltage of 100 kV and a tube current of 80 mAs,and the images of B1 and B2 groups were reconstructed by iDose 4 and IMR,respectively.The standard deviation(SD)value(the SD value represents the noise of the measured tissue),signal-to-noise ratio(SNR),and contrast-to-noise ratio(CNR)of cancellous bone,intervertebral disc,dural sac,and psoas muscle were measured and calculated at the L3-L4 vertebral body level.Two diagnosticians rated the image quality.Sample t-test and ANOVA were used to compare the measurement results and subjective scores.Results The comparison of SD for intervertebral disc,dural sac,and psoas muscle showed group B2＜group A＜group B1,while the subjective score comparison indicated group A＞group B2＞group B1.The SNR for intervertebral disc and psoas muscle demonstrated group B2＞group A＞group B1.There was no significant difference in bone quality score between group A and group B1(P＞0.05),but there was a significantly different between the bone quality scores of group B2 and those obtained with iDose 4 reconstruction(group A and group B1)(P＜0.05).The effective dose(ED)of group B was reduced by approximately 70.28％compared with group A.Conclusion IMR can significantly reduce SD,improves SNR and CNR,resulting in high-quality images.Compared to iDose 4 technique,IMR has more advantages in soft tissue display,while iDose 4 technique is superior in observing fine bone structures.The combined application of iDose 4 and IMR technique ensures high-quality images for diagnosis,while significantly reducing the radiation dose to patients.

Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.

Objective Taking the medicinal excipient pectin as an example,based on the ICH Q3C risk assessment and management concept,this paper explores the control standards for residual solvents in pectin in the variety text of the Chinese Pharmacopoeia.Methods Pectin products from different processes and manufacturers were analyzed,the types of solvent residues in pectin were identified,and the solvent residues of products from different manufacturers were analyzed by gas chromatography.Results According to the product process,there was a risk of residual methanol(class 2),ethanol and isopropanol(class 3)in pectin products.In 18 batches of samples,the residual amount of methanol was measured in the range of 0.05％-0.17％,the residual amount of ethanol was in the range of 0.01％-0.38％,isopropanol was not detected,and the total amount of residual solvents was in the range of 0.07％-0.55％.Conclusions It is suggested that the residual solvent inspection item may not be listed separately in the main text of the pectin standard of the Chinese Pharmacopoeia.It is recommended that the manufacturer is required to indicate the name and limit of residual solvents under the labeling item of the standard.

Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.

Objective To explore the application value of iterative model reconstruction(IMR)technique in low-dose lumbar CT scanning.Methods A total of 48 patients who underwent lumbar CT plain scan were selected and divided into regular-dose group(group A)and ultra-low dose group(group B).The group A underwent imaging with 120 kV tube voltage,automatic tube current modulation technology,and iDose 4 reconstruction.The group B was scanned with a tube voltage of 100 kV and a tube current of 80 mAs,and the images of B1 and B2 groups were reconstructed by iDose 4 and IMR,respectively.The standard deviation(SD)value(the SD value represents the noise of the measured tissue),signal-to-noise ratio(SNR),and contrast-to-noise ratio(CNR)of cancellous bone,intervertebral disc,dural sac,and psoas muscle were measured and calculated at the L3-L4 vertebral body level.Two diagnosticians rated the image quality.Sample t-test and ANOVA were used to compare the measurement results and subjective scores.Results The comparison of SD for intervertebral disc,dural sac,and psoas muscle showed group B2＜group A＜group B1,while the subjective score comparison indicated group A＞group B2＞group B1.The SNR for intervertebral disc and psoas muscle demonstrated group B2＞group A＞group B1.There was no significant difference in bone quality score between group A and group B1(P＞0.05),but there was a significantly different between the bone quality scores of group B2 and those obtained with iDose 4 reconstruction(group A and group B1)(P＜0.05).The effective dose(ED)of group B was reduced by approximately 70.28％compared with group A.Conclusion IMR can significantly reduce SD,improves SNR and CNR,resulting in high-quality images.Compared to iDose 4 technique,IMR has more advantages in soft tissue display,while iDose 4 technique is superior in observing fine bone structures.The combined application of iDose 4 and IMR technique ensures high-quality images for diagnosis,while significantly reducing the radiation dose to patients.

Objective To investigate the effects of different ratios of ω-3 polyunsaturated fatty acids(ω-3 PUFA)on depression and cognitive impairment in patients with major depression.Methods A randomized,double-blinded controlled trial was used to randomly assign patients with depression to a cognitive improvement group,a depression improvement group,and a placebo group.The cognitive improvement group took 1388 mg of docosahexaenoic acid(DHA)and 692 mg of eicosapentaenoic acid(EPA)every day and the depression improvement group took 1248 mg of EPA and 832 mg of DHA every day.The placebo group took the same dose of soybean oil for 12 weeks,during which psychiatric medication was maintained.The 24-item Hamilton depression scale(HAMD-24)was used to evaluate depressive symptoms,and the standardized MATRICS consensus cognitive battery(MCCB)was used to evaluate cognitive function after 6 weeks and 12 weeks,respectively.Results The study recruited a total of 46 patients with depression including 22 in the cognitive improvement group,12 in the depression improvement group,and 12 in the placebo group.After 6 weeks of treatment,the HAMD-24 scores were significantly lower in the depression improvement group(19.00±10.70)and cognitive improvement group(16.58±9.39)than in the placebo group(31.10±10.03)(P<0.01).After 12 weeks of treatment,HAMD-24 scores were significantly lower in the depression improvement group(13.58±8.43)than in the placebo group(28.10±15.04)(P=0.02).No significant interaction effect was found on the cognitive assessment scores in any dimension after 6 weeks and 12 weeks of treatment(P>0.05).The incidence rate of adverse events in the depression improvement group was 16.7%(2/12),and no adverse events were reported in the other two groups.There was no significant difference in the incidence of adverse events among the three groups(P=0.13).Conclusion Treatment with ω-3PUFA for 6 weeks can improve the depressive symptoms of patients with depression.The formula with a higher ratio of EPA exhibits higher effectiveness while the two groups of ω-3PUFA formulas with different ratios do not improve cognitive function.

Alkaline phosphatase(ALP)is widely expressed in human tissues.ALP plays an important role in the dephosphorylation of proteins and nucleic acids.Therefore,quantitative analysis of ALP plays a vital role in disease diagnosis and the development of biological detection methods.Terminal deoxynucleotidyl transferase(TdT)catalyzes continuous polymerization of deoxynucleotide triphosphates at the 3'-OH end of single-stranded DNA in the absence of a template.In this study,we developed a highly sensitive and selective method based on TdT and endonuclease Ⅳ(Endo Ⅳ)to quantify ALP activity.After ALP hydrolyzes the 3'-PO4 end of the substrate and generates 3'-OH,TdT can effectively elongate the 3'-OH end with deoxynucleotide adenine triphosphate(dATP)and produce a poly A tail,which can be detected by the poly T probes.Endo Ⅳ digests the AP site in poly T probes to generate a fluorescent signal and a new 3'-OH end,leading to the generation of exponential fluorescence signal amplification.The substrate for TdT elongation was optimized,and a limit of detection of 4.3×10-3 U/L was achieved for ALP by the optimized substrate structure.This method can also detect ALP in the cell lysate of a single cell.This work has potential applications in disease diagnosis and biomedical detection.