Study on alternative method for vasopressin impurity test of oxytocin injection from biological extraction / 中国药理学通报

Aim To explore the alternative study on rat blood pressure method and HPLC method for vasopressin impurity test of oxytocin injection from biological extraction. Methods The HPLC method for the vasopressin impurity test in vitro was established and validated. The bio-extrac tion oxytocin injection samples and simulated samples were examined for vasopressin impurity by HPLC and rat blood pressure methods respectively. Results Vasopressin and adjacent impurity peaks were successfully separated by the established method. In the range of 210~13 330 IU•L -1the concentration of vasopressin had a good linear relationship with its peak area with r=0.999 9. The results of HPLC method were consistent with the biological examination method-rat blood pressure method in the current standard. Conclusions The method is proved to be specific, sensitive, and accurate, which can be used as a test method for vasopressin impurity to replace the rat blood pressure method in the current standard.

Proficiency testing for determination of photometric method of bacterial endotoxin / 中国药理学通报

Aim To design and implement the bacteri¬al endotoxin test proficiency testing plan to evaluate the laboratory's ability and level to determine bacterial en¬dotoxin. Methods According to the Chinese Pharma-copoeia (2015 edition, Vol IV) -1143 Bacterial Endo¬toxin Test-Photometric Method ( Method 2 ) , each la¬boratory used any of these methods to determine the endotoxin content of the sample to be tested. The stati- stical software JMP13 was used for statistical analysis of the feedback results of the participating laboratories. The consensus value of the participants, namely the ro¬bust average value of the effective test results of all the participating laboratories, was used as the assigned value X of the endotoxin content of the samples to be tested in the proficiency testing of the round. The re¬sults of participating laboratories were evaluated ac¬cording to the following criteria: (1) the laboratory test results were within 50% to 200% of the assigned value of the sample, which was evaluated satisfactory; ( 2 ) the laboratory test results were not within the 50 -200% range of the assigned value of the sample, which was evaluated dissatisfactory. Results A total of laboratories participated in this capacity verification plan, with 45 in the laboratory with satisfactory re¬sults, with a satisfaction of 91. 8% ; There were 4 la¬boratories that received "dissatisfaction" results, all of which were not within the range of 50% -200% of the assigned value of samples, and the dissatisfaction of 8. 2% . Conclusions Most of the participating labora¬tories can accurately detect the bacterial endotoxin con¬tent in the sample to be tested, indicating that the level of bacterial endotoxin detection in our country is gener¬ally good at present.

Study on bacterial endotoxin detection of egg yolk lecithin of Chinese Pharmacopoeia 2020 Edition / 中国药理学通报

Abstract; Aim To solve the problems in the appliea- tion of egg yolk leeithin endotoxin test method, and and to establish the baeterial endotoxin examination method for egg yolk lecithin (for injeetion). Methods The ethanol solution of Tween 80 ( the volume ratio of tween 80 to anhydrous ethanol was 2. 5 • 2. 7, mixed for 4 min) was used to prepare lecithin solution of egg yolk at 0. 1 kg • L 1 , and 10 test water was added to 1 mL lecithin solution of egg yolk (500 EU • mL 1 standard solution of endotoxin IOjxL was added for pos¬itive control). After diluted 20 times with endotoxin test water, the standard curve range was 10 ~0. 01 EU • mL 1 by kinetic-turbidimetrie assay. Methodology of endotoxin test was studied using limulus lysate from two manufacturers and eight hatches of samples. Results The recoveries of eight hatches of samples all met the requirement of interference test between 50% and 200% stipulated in the pharmacopoeia, which solved the problems of the current endotoxin test method in practical application. Conclusions The bacterial en¬dotoxin test method of egg yolk lecithin with good dura-bility is established to provide the basis for the revision of pharmacopoeia.

Development of bacterial endotoxin standard for insoluble samples / 中国药理学通报

Aim To establish a batch of endotoxin standard for baeterial endotoxin detection of insoluble samples.Methods Candidate A and candidate B were prepared by freeze -drying bacterial endotoxin without excipient.The two batches of candidates were calibrated by three methods, including 13 laboratories for gel method, 9 laboratories for kinetic-turbidimetric assay and 5 laboratories for kinetic chromogenic assay.Results After statistical analysis, the geometric mean values of gel method, kinetic-turbidimetric assay and kinetic chromogenic assay calibration of candidate A were 680.1 EU, 827.0 EU and 800.8 EU, with RSD of 22.4%, 16.2% and 16.7%, respectively.The P value of variance analysis of calibration results of the three methods was 0.067, showing no significant difference.The weighted mean of potency was 774.0 EU (95% confidence interval 721.0 - 831.0, FL% 7.10).The geometric mean values of the calibration of candidate B by gel method, kinetic-turbidimetric assay and kinetic chromogenic assay method were 1 640.6 EU, 1 828.6 EU and 3 224.8 EU, with RSD of 33.9% , 47.0% and 54.4% , respectively.The P val¬ue of variance analysis of the calibration results of the three methods was 0.030, showing significant differ¬ence.Chi-square test was used to correct the weight of each method , and weighted average of the results of the three methods was used to obtain a corrected weighted average efficiency value of 1 822.7 EU (95% confi¬dence interval 1 548.7 -2 145.2, FL% 16.4).Can¬didate B was eliminated based on the results.Conclu¬sion Candidate A has become the first batch of na¬tional standard bacterial endotoxin (for insoluble sam¬ples only) approved by National Standard Substance Committee of China, and the potency is 700 EU.

Antioxidant activities of 10 active compounds from Clematis filamentosa Dunn. and their protective effects on H / 中国药理学通报

Aim To investigate the protective effects of the 10 compounds from Clematis filamentosa Dunn, on H

Meta-Analysis of the Efficacy and Safety of Imidafenacin for Overactive Bladder Induced by Benign Prostatic Hyperplasia in Men Receiving Alpha-Blocker Therapy / 대한배뇨장애요실금학회지

Purpose@#The aim of this meta-analysis was to evaluate the efficacy and safety of imidafenacin for overactive bladder (OAB) induced by benign prostatic hyperplasia (BPH) in men receiving alpha-blocker monotherapy. @*Methods@#We performed a systematic research of the PubMed, Embase, and Cochrane Library databases, and searched for studies about alpha-blocker with or without imidafenacin treatment for OAB in patients with BPH. We also investigated the original references of the included texts. @*Results@#Four randomized controlled trials including 779 participants with BPH (389 in the alpha-blocker+imidafenacin group and 390 in the alpha-blocker only group) were studied. The main efficacy endpoint was the Overactive Bladder Symptom Score, which showed a mean difference of -1.88 (95% confidence interval, -2.32 to -1.44; P<0.00001), suggesting that alpha-blocker and imidafenacin treatment was effective in treating men with OAB. As other primary efficacy end points, the International Prostate Symptom Score (IPSS) total score (P=0.47), the IPSS storage symptom score (P=0.07), the IPSS voiding symptom score (P=0.60), and the IPSS quality of life score (P=0.18) indicated that 2 methods had no significant differences in treating men with OAB. In terms of safety, which was assessed using postvoid residual volume (P=0.05) and maximum flow rate (P=0.53), the analysis suggested that combination treatment was very well tolerated. @*Conclusions@#This study suggested that imidafenacin plus alpha-blocker was an efficacious and safe treatment for OAB symptoms in BPH patients.

Meta-Analysis of the Efficacy and Safety of Imidafenacin for Overactive Bladder Induced by Benign Prostatic Hyperplasia in Men Receiving Alpha-Blocker Therapy / 대한배뇨장애요실금학회지

Purpose@#The aim of this meta-analysis was to evaluate the efficacy and safety of imidafenacin for overactive bladder (OAB) induced by benign prostatic hyperplasia (BPH) in men receiving alpha-blocker monotherapy. @*Methods@#We performed a systematic research of the PubMed, Embase, and Cochrane Library databases, and searched for studies about alpha-blocker with or without imidafenacin treatment for OAB in patients with BPH. We also investigated the original references of the included texts. @*Results@#Four randomized controlled trials including 779 participants with BPH (389 in the alpha-blocker+imidafenacin group and 390 in the alpha-blocker only group) were studied. The main efficacy endpoint was the Overactive Bladder Symptom Score, which showed a mean difference of -1.88 (95% confidence interval, -2.32 to -1.44; P<0.00001), suggesting that alpha-blocker and imidafenacin treatment was effective in treating men with OAB. As other primary efficacy end points, the International Prostate Symptom Score (IPSS) total score (P=0.47), the IPSS storage symptom score (P=0.07), the IPSS voiding symptom score (P=0.60), and the IPSS quality of life score (P=0.18) indicated that 2 methods had no significant differences in treating men with OAB. In terms of safety, which was assessed using postvoid residual volume (P=0.05) and maximum flow rate (P=0.53), the analysis suggested that combination treatment was very well tolerated. @*Conclusions@#This study suggested that imidafenacin plus alpha-blocker was an efficacious and safe treatment for OAB symptoms in BPH patients.

Analysis of the factors of how to build the bacterial endotoxin test laboratory with GPCL quality management concepts / 中国药学杂志

OBJECTIVE: To summarize and analyze the factors of building the bacterial endotoxin test laboratory. These factors should meet the GPCL quality management concepts. METHODS: Give Some specific methods and experience in five aspects were given, which combine the GPCL quality management concepts with the characteristics of bacterial endotoxin test. RESULTS AND CONCLUSION: Summarizes The applications of GPCL concept for bacterial endotoxin test laboratory is summarized.

Comparison of result judgment algorithm of test for interfering factors in the bacterial endotoxins test among Chinese, Japanese, European, American, and Indian pharmacopeias / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The bacterial endotoxins test (BET) is a method used to detect or quantify endotoxins (lipo-polysaccharide, LPS) and is widely used in the quality control of parenteral medicines/vaccines and clinical dialysis fluid. It is also used in the diagnosis of endotoxemia and in detection of environment air quality control. Although BET has been adopted by most pharmacopoeias, result judgment algorithms (RJAs) of the test for interfering factors in the BET still differ between certain pharmacopoeias. We have evaluated RJAs of the test for interfering factors for the revision of BET described in the Chinese Pharmacopoeia 2010 (CHP2010).</p><p><b>METHODS</b>Original data from 1 748 samples were judged by RJAs of the Chinese Pharmacopoeia 2010, the Japanese Pharmacopoeia 2011 (JP2011), the European Pharmacopoeia 7.0 (EP7.0), the United States Pharmacopoeia 36 (USP36), and the Indian Pharmacopoeia 2010 (IP2010), respectively. A SAS software package was used in the statistical analysis.</p><p><b>RESULTS</b>The results using CHP2010 and USP36, JP2011, EP7.0, and IP2010 had no significant difference (P = 0.7740). The results using CHP2010 of 1 748 samples showed that 132 samples (7.6%) required an additional step; nevertheless there was no such requirement when using the other pharmacopeias. The kappa value of two RJAs (CHP2010 and EP7.0) was 0.6900 (0.6297-0.7504) indicating that the CHP2010 and other pharmacopoeias have good consistency.</p><p><b>CONCLUSIONS</b>The results using CHP2010 and USP36, JP2011, EP7.0, and IP2010 have different characteristics. CHP2010 method shows a good performance in Specificity, mistake diagnostic rate, agreement rate, predictive value for suspicious rate, and predictive value for passed rate. The CHP2010 method only had disadvantages in sensitivity compared with other pharmacopeias. We suggest that the Chinese pharmacopoeia interference test be revised in accordance with the USP36, JP2011, EP7.0, and IP2010 judgment model.</p>

Effect of Electroacupuncture on the Synaptic Number Density and Surface Density in the Cerebral Ischemic Areas of Rats with Focal Cerebral Ischemia at Different Time / 广州中医药大学学报

Objective To investigate the effect of electroacupuncture(EA)in improving the reconstruction of synapse after cerebral ischemia.Methods Forty-five Wistar rats were divided into 3 groups:sham-operated group,ischemia group and EA group.The number density(Nv)of synapses and the surface density(Sv)of synaptic joint band were observed 1 hour,1 day,3 days,1 week and 3 weeks after ischemia and EA, respectively.Heat-coagulation-induced occlusion of the middle cerebral artery was performed to establish the model of focal cerebral ischemia.EA group received EA on the acupoints of Baihui and Dazhui.The changes of synaptie structure,Nv and Sv as well as the influence of EA on the above indexes were observed in different time.Results There existed significant decrease of Nv and Sv 1 hour,1 day and 3 days after establishment of models in the isehemia group(P0.05).Conclusion EA can reduce the cerebral ischemic injury by increasing the synaptic amount and area in the cortex of rat model of cerebral isehemia at early stage,promoting the cerebral recovery after ischemia,which will provide substantial morphological basis for the improvement of synaptic reconstruction and recovery from cerebral isehemia by EA at different time after ischemic cerebral injury.