| Objective: To research the preparation process and to estabilish quality control method of Antai Pill.To provide patients with stable quality preparations.To provide a reliable evidence for drugs selection and provide the foundation for further research on pharmacology based on meta-analysis,the pharmacodynamical study and pharmacological mechanism of Antai Pills was explored.Methods: 1.Meta-analysis of chinese and western medicine in the treatment of RSAComputer search for PubMed,Cochrane library,Embase,CNKI,Wanfang,VIP,China Biomedical Database(CBM)since the establishment of the library to the May 2017 Chinese and Western medicine combined treatment of recurrent spontaneous abortion RCT study,manual search Conference papers,new publications.Western medicine in the control group,the combination of Chinese and Western medicine in the experimental group for the treatment of patients with recurrent spontaneous abortion were included.The risk assessment of the included literature using the Cochrane Collaboration's offset risk assessment tool,and the statistical analysis of the included data by Rev-man 5.3.2.Study on preparation and quality control of Antai PillsAntai Pills were prepared according to the traditional Chinese medicine prescription of Tianjin Medical University General Hospital.It was determined that the ferulic acid in the angelica,the rehmannia in the rehmannia glutinosa and the hyperoside in the dodder were used as the indicators and were detected by HPLC according to the theory of Chinese medicine prescription analysis,combined with the literature and related contents of the Pharmacopoeia.The extraction method,mobile phase ratio and the detection wavelength were explored and the method was investigated.The content of the three batches of Antai Pill samples was determined.3.Clinical analysis of Antai Pills110 patients with recurrent abortion re-pregnancy in Tianjin Medical University General Hospital were included.The patients were randomly divided into two groups and 26 patients with incomplete case data were excluded.Antai pill was enrolled in 44 cases(experimental group),the Gushen Antai group 40 cases(positive control group).The patient's 7-12 weeks of B-ultrasound and 4-7 weeks serum HCG and P levels as indicators,and efficiency as the main outcome indicator,using Excel for data entry and cleaning and SPSS 22.0 for statistical analysis,comparing the efficacy and safety of Antai Pills and Gushen Antai Pills and conducting economic evaluation.4.Pharmacological experimental conditions of Antai PillsSFP-grade Wistar rats were used to construct a recurrent abortion model.The model drug selection,hormone determination time,positive drug administration mode,administration time and other conditions were explored to establish the model and determine experimental conditions by monitoring the body weight,drawing serum P curve and embryo morphology.Results: 1.Meta-analysis of chinese and western medicine in the treatment of RSAThrough literature screening,a total of 3298 patients with RSA were included in 43 literatures;the results of meta-analysis showed that there was a significant difference in the effective rate between the two groups(OR=3.57,95% CI(2.73,4.67),P=0.98,I2=0%).Subgroup analysis showed that the effective rate of each group was significantly different between the Bushen group,Bushen Jianpi group,Buqikang group and Bushen Huoxue group compared with using western medicine alone(OR=3.47,95%CI(2.60,4.63),P=0.97,I2=0%,).Combination of Chinese and Western medicine and western medicine alone,TCM syndrome efficacy in two groups(OR=4.54,95%CI(2.95,6.99),P=1.00,I2=0%)and symptom scores were significantly different(MD=-3.46,95%CI(-4.32,-2.60),P<0.0001,I2=71%).There was no significant difference between two groups in serum HCG levels at 8 weeks of pregnancy(SMD=-0.65),95% CI(-0.10,1.40),P<0.00001,I2=93%)and serum HCG levels at 10 weeks of pregnancy(SMD=0.10,95% CI(-0.78,0.98),P < 0.00001,I2= 93%).2.Study on preparation and quality control of Antai PillsAccording to the requirements of the preparation process of the honey pill,the pill was prepared by a pill machine,and each pill was weight 9g.The methodological investigation of the determination method showed that the separation of the three indicators was greater than 1.5,which met the detection requirements;ferulic acid and verbascoside had a good linear relationship in the concentration range of 0.4~5?g/ml.Hyperoside has a good linear relationship in the concentration range of 0.5~10?g/ml.Recovery rate of ferulic acid,verbascoside and hyperoside were 97.24%~101.20%,97.62%~102.91% and 97.17%~99.98%,the RSD value were less than 3%.Precision results showed that the RSD of ferulic acid,verbascoside and hyperoside peak area were less than 3%.Stability results showed that RSD values of peak area were less than 3% in 8h,the RSD of ferulic acid,verbascoside and hyperoside peak area were less than 3%.3.Clinical analysis of Antai PillsStatistical analysis showed that there was no significant difference in the efficacy and safety of Antai Pills and Gushen Antai Pills in patients with RSA recurrent pregnancy(P<0.05).Economic evaluation used the minimum cost analysis.On the basis of the average daily Chinese medicine costs of Gushen Antai Group and Antai Pill Group were 16.77 RMB and 9.27 RMB respectively,the total cost of traditional Chinese medicine was 821.57 RMB and 454.23 RMB respectively,so Antai Pill has higher economic cost performance than Gushen Antai Pills.4.Pharmacological experimental conditions of Antai PillsThrough the exploration of model drugs,P measurement time,positive drug administration mode and administration time,it was determined that mifepristone was used as a model drug;before pregnancy,the serum P was detected on 10 days after pregnancy(before mifepristone administration),the 11 th and 12 th day of pregnancy in the morning.The positive control drug progesterone were given on the 3rd day of pregnancy by intragastric administration.Conclusion: Antai Pills was researched in quality control methodology,meta-analysis,clinical efficacy and pharmacological experimental methods,and the conclusions were finally drawn.1.Established quality control method of Antai Pill,This method was with strong specificity,good linearity,high accuracy and good precision.The sample solution was stable within 8h.This method can meet the quality control requirements.The method was applied to the determination of three batches of Antai Pills,and the results showed that the quality of the preparation was stable.2.Compared with using western medicine alone,chinese medicine improves the endocrine environment of the patient through tonifying kidney,strengthening spleen,tonifying qi and promoting blood circulation.The combination of Chinese and western medicine can improve the curative effect of RSA,reduce the score of TCM syndrome,further reduce recurrence while improved Abortion rate.3.Compared with the positive control drug Gushen Antai pills,Antai Pill was effective and safe in the treatment of RSA patient re-pregnancy,and has a higher cost performance.4.Pharmacological researched the preliminary experimental conditions,established a stable modeling method and experimental conditions,which laid a foundation for later pharmacological experiments. |
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