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1.
China Pharmacy ; (12): 210-213, 2024.
Article in Chinese | WPRIM | ID: wpr-1006180

ABSTRACT

OBJECTIVE To mine the adverse drug event (ADE) signals of selinexor, and to provide reference for its clinical safety medication. METHODS ADE data for selinexor reported from July 3rd, 2019 to March 31st, 2023 were collected from the FDA adverse event reporting system (FAERS). Data mining was performed by using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods, and categorization statistics were performed by using the system organ class (SOC) and preferred term (PT) from drug ADE terminology set in the MedDRA (version 26.0). RESULTS A total of 3 084 ADE reports were obtained for selinexor, with a total of 134 ADE-positive signals. Among the reported genders, there were 127 males and 124 females, with a predominant age of ≥65 years old (4.12%); the United States had the highest number of reports (96.53%), with consumers being the main reporters (77.27%); severe ADR was mainly characterized by hospitalization/prolonged hospitalization (26.26%), followed by death (17.15%). The top 3 ADE in the list of frequency were nausea (1 162 times), fatigue (790 times) and anorexia (610 times), all of which were mentioned in the selinexor’s instructions. The top 3 signals in the list of strength were device-associated bacteremia (ROR=115.07, PRR=114.94), blepharospasm dysfunction (ROR=106.70, PRR=106.54), and salmonella sepsis (ROR=99.90, PRR=99.81), all of which were not mentioned in the selinexor’s instructions. CONCLUSIONS In addition to the ADE of nausea mentioned in the instruction manual, attention should also paid to device-associated bacteremia, blepharospasm dysfunction, salmonella sepsis, and other ADE not mentioned in the instruction manual when using selinexor in clinical practice; weekly rechecking of the patient’s blood routine should be done to monitor the patient’s blood indexes, symptoms of infection, and so on, to ensure that the safety of 1661962346@qq.com drug use.

2.
Article in Chinese | WPRIM | ID: wpr-1039639

ABSTRACT

ObjectiveTo analyze and determine the differential components of freeze-dried and sun-dried Panacis Quinquefolii Radix(PQR), and to compare the differences in their pro-angiogenic activities. MethodFingerprints of freeze-dried and sun-dried PQR were established based on ultra performance liquid chromatography(UPLC), and chemometrics methods such as principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were combined to determine the differential saponin composition of the two decoction pieces, and six representative saponins were selected and their contents in freeze-dried and sun-dried PQR were determined by UPLC. Transgenic zebrafish line Tg(fli1a∶EGFP) embryos fertilized for 24 h were selected, and different doses of 70% methanol extracts of freeze-dried and sun-dried PQR(10, 30 mg·L-1) were used to intervene in normal zebrafish and in a zebrafish model of intersegmental vascular(ISV) injury induced by vascular endothelial growth factor(VEGF) receptor tyrosine kinase inhibitor Ⅱ(PTK787), then the development of subintestinal vein(SIV) and ISV of zebrafish was observed, SIV diameter, mean number of crossings and mean number of germinations were determined, and the ISV vascular index was calculated, in order to compare the pro-angiogenic activities of the two decoction pieces. ResultThe similarity of the fingerprints of freeze-dried and sun-dried PQR decoction pieces was>0.950, and 17 common peaks were identified, of which 6 common peaks were designated as peak 6(ginsenoside Rg1), peak 7(ginsenoside Re), peak 8(ginsenoside Rb1), peak 11(ginsenoside Rc), peak 13(ginsenoside Rb2), and peak 16(ginsenoside Rd), respectively. A total of 11 differential saponin components were screened by PCA and OPLS-DA, indicating that there were some differences in the contents of the components in the two decoction pieces. The results of determination showed that the contents of ginsenosides Rg1, Re, Rb1 and Rb2 in freeze-dried PQR were higher than those in sun-dried PQR, while the contents of ginsenosides Rc and Rd were lower than those in sun-dried PQR(P<0.05, P<0.01). In the study of the pro-angiogenic effect on normal zebrafish embryos, compared with the blank group, and the SIV vessel diameter, mean germination rate and mean crossover rate were significantly higher in the high-dose groups of freeze-dried and sun-dried PQR(P<0.01), and the vessel diameter, mean numbers of crossings and germinations in the freeze-dried PQR group were higher than those of the sun-dried PQR group(P<0.05). In the study of the pro-angiogenic effect on zebrafish embryos with ISV injury, the development of ISV in the model group was significantly inhibited when compared with the blank group, compared with the model group, different dose groups of freeze-dried and sun-dried PQR could promote the growth and sprouting of ISV, and the number of normal blood vessels in the freeze-dried PQR group was significantly higher than that in the sun-dried PQR group at the same dosage(P<0.05). ConclusionFreeze-drying can effectively avoid the loss and secondary transformation of ginsenosides in PQR, and its angiogenic activity is better than that of sun-dried PQR, which can provide a reference for the production and development of high-quality PQR decoction pieces.

3.
Article in Chinese | WPRIM | ID: wpr-1013348

ABSTRACT

ObjectiveTo analyze the quantity-quality transfer of standard decoction of Ginseng Radix et Rhizoma(GRR) decoction pieces produced by fresh and traditional cutting, and to provide reference for quality control and application development of the decoction pieces produced by fresh cutting. MethodTen batches of representative GRR decoction pieces produced by fresh and traditional cutting and their standard decoctions were prepared by standard process, and high performance liquid chromatography(HPLC) fingerprint of the standard decoction was established and performed on an Agilent EC-C18 column(4.6 mm×150 mm, 2.7 μm) with acetonitrile(A)-0.1% phosphoric acid aqueous solution(B) as the mobile phase for gradient elution(0-23 min, 18%-21%A; 23-35 min, 21%-28%A; 35-80 min, 28%-32%A), and the detection wavelength was 203 nm. Then similarity evaluation, principal component analysis(PCA) and partial least squares-discriminant analysis(PLS-DA) of fingerprint of the standard decoction were performed to screen the differential components with variable importance in the projection(VIP) value>1. Quantitative analysis was carried out on the screened known differential components, and combined with the indicators of the dry extract rate and the transfer rate, to explore the differences in the quantity-quality transfer between the standard decoction of GRR decoction pieces produced by fresh and traditional cutting. ResultThe fingerprint similarity of the standard decoction of GRR decoction pieces produced by fresh and traditional cutting was more than 0.950, and 18 common peaks were identified, including 9 identified common peaks. The results of PCA and PLS-DA showed that there were some differences in the contents of index components between the two standard decoctions. The contents of ginsenoside Rg1, Re and Ro in GRR decoction pieces produced by fresh cutting were higher than those in traditional decoction pieces, while the contents of ginsenoside Rb1, Rc , Rb2 and Rd were lower than those in traditional decoction pieces. The contents of ginsenoside Rg1, Re, Rb1 and Ro in the standard decoction of GRR decoction pieces produced by fresh cutting were higher than those in the standard decoction of traditional decoction pieces, while the contents of ginsenoside Rc , Rb2 and Rd were comparable between the two standard decoctions. Compared with the standard decoction of the traditional decoction pieces, the average transfer rates of ginsenoside Rg1, Rb1, Rc, Rb2 and dry extract rate of the standard decoction of GRR decoction pieces produced by fresh cutting were significantly increased(P<0.05), and the average transfer rate of ginsenoside Re and Rd also increased, but the difference was not statistically significant. ConclusionThe dry extract rate, content and transfer rate of index components of standard decoction of GRR decoction pieces produced by fresh cutting are better than those of the standard decoction of traditional decoction pieces, which can provides data support for the subsequent clinical application of fresh cutting products.

4.
Article in Chinese | WPRIM | ID: wpr-1013349

ABSTRACT

ObjectiveTo analyze the quantity-quality transfer of standard decoction of Ginseng Radix et Rhizoma(GRR) decoction pieces produced by fresh and traditional cutting, and to provide reference for quality control and application development of the decoction pieces produced by fresh cutting. MethodTen batches of representative GRR decoction pieces produced by fresh and traditional cutting and their standard decoctions were prepared by standard process, and high performance liquid chromatography(HPLC) fingerprint of the standard decoction was established and performed on an Agilent EC-C18 column(4.6 mm×150 mm, 2.7 μm) with acetonitrile(A)-0.1% phosphoric acid aqueous solution(B) as the mobile phase for gradient elution(0-23 min, 18%-21%A; 23-35 min, 21%-28%A; 35-80 min, 28%-32%A), and the detection wavelength was 203 nm. Then similarity evaluation, principal component analysis(PCA) and partial least squares-discriminant analysis(PLS-DA) of fingerprint of the standard decoction were performed to screen the differential components with variable importance in the projection(VIP) value>1. Quantitative analysis was carried out on the screened known differential components, and combined with the indicators of the dry extract rate and the transfer rate, to explore the differences in the quantity-quality transfer between the standard decoction of GRR decoction pieces produced by fresh and traditional cutting. ResultThe fingerprint similarity of the standard decoction of GRR decoction pieces produced by fresh and traditional cutting was more than 0.950, and 18 common peaks were identified, including 9 identified common peaks. The results of PCA and PLS-DA showed that there were some differences in the contents of index components between the two standard decoctions. The contents of ginsenoside Rg1, Re and Ro in GRR decoction pieces produced by fresh cutting were higher than those in traditional decoction pieces, while the contents of ginsenoside Rb1, Rc , Rb2 and Rd were lower than those in traditional decoction pieces. The contents of ginsenoside Rg1, Re, Rb1 and Ro in the standard decoction of GRR decoction pieces produced by fresh cutting were higher than those in the standard decoction of traditional decoction pieces, while the contents of ginsenoside Rc , Rb2 and Rd were comparable between the two standard decoctions. Compared with the standard decoction of the traditional decoction pieces, the average transfer rates of ginsenoside Rg1, Rb1, Rc, Rb2 and dry extract rate of the standard decoction of GRR decoction pieces produced by fresh cutting were significantly increased(P<0.05), and the average transfer rate of ginsenoside Re and Rd also increased, but the difference was not statistically significant. ConclusionThe dry extract rate, content and transfer rate of index components of standard decoction of GRR decoction pieces produced by fresh cutting are better than those of the standard decoction of traditional decoction pieces, which can provides data support for the subsequent clinical application of fresh cutting products.

5.
China Pharmacy ; (12): 904-910, 2021.
Article in Chinese | WPRIM | ID: wpr-876257

ABSTRACT

OBJECTIVE:To provide technical met hods for marketing authorization holder (MAH)to effectively use the data of adverse drug reaction (ADR),actively monitor and control the production quality risk ,and carry out drug production risk management. METHODS :Through establishing three-dimensional risk matrix and risk trend model ,the risk early warning system of MAH production line based on ADR report data is designed and developed ;the main functions of the system were applied and analyzed according to the actual ADR report data of a certain company. RESULTS :MAH production line risk warning system was established preliminarily. The main framework included data source and and processing module ,model construction module (three-dimensional matrix model included possibility index ,severity index and sensitivity index ,risk trend model was set according to the principle of product production batch number preparation ),and result output & analysis module. Five major functional modules included system configuratio ,production line signal detection ,visual statistical early warning ,ADR report management and standard data management. The application and analysis of ADR report data of a certain company showed that the system could realize detection and warning of the company ’s production line risk ,which intuitively reflected its high-risk production lines ,varieties and batch numbers. It was consistent wit h the actual safety sit uation of the company ’s varieties. CONCLUSIONS:The system can help MAH make use of ADR report data to actively monitor drug production quality risks in a timely manner ,investigate risk factors for high-risk production lines , high-risk varieties and high-risk batch numbers,and assist in decision-making on the direction of risk investigation.

6.
Article in Chinese | WPRIM | ID: wpr-811811

ABSTRACT

@#The purpose of this study was to evaluate the necrosis target and imaging potential of necrotic myocardium of 131I-emodin and 131I-emodic acid. The iodogen coating method was used to radioiodinate emodin and emodic acid with iodine-131. Mice model of muscular necrosis and rat model of myocardial infarction(MI)were established to evaluate the necrosis affinity and imaging potential of 131I-emodin and 131I-emodic acid. Mice were sacrificed at 2, 12 and 24 h after injection respectively. The radioactive uptake in major organs and necrotic muscle were calculated by a γ-counter. At 6 h after administration, SPECT/CT imaging of necrotic myocardium in rats, biodistribution detection, histopathological analysis were applied to evaluate their necrosis affinity and imaging potential. The results of biodistribution from mice demonstrated that 131I-emodin and 131I-emodic acid showed peculiar necrosis target and exhibited an obvious clearance of radioactivity from normal organs. On SPECT/CT images, relatively high uptake as a hot spot was shown in the heart of the model rat, while no obvious uptake was observed in the heart of the control rat. The radioactivity ratios of necrotic to normal myocardium of 131I-emodin and 131I-emodic acid amounted up to 9. 72 and 13. 14 by quantitative autoradiography analysis, respectively. These results suggested that 131I-emodin and 131I-emodic acid possess the necrosis target and imaging potential of necrotic myocardium.

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