Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang ...Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang Qi,黄芪),Paeoniae Radix Alba(Bai Shao,白芍)and Moutan Cortex(Mu Dan Pi,牡丹皮),which have well-established histories of use for treatment of rheumatic and arthritic diseases.We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis(RA).Methods The combinative approaches of chemical assessment,toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT.Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents,potent anti-inflammatory and antinociceptive activities,and favorable safety profile.Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography(HPLC)demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent.General toxicological studies showed a favorable safety profile of QFJBT.The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose.In the chronic oral toxicity study,the results of laboratory investigation showed that QFJBT at doses of 3.89,6.80 and 9.72 g/kg body weight(equivalent to 40,70 and 100-fold clinical doses,respectively)caused no changes in all hematological parameters and blood biochemical parameters of rats.No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT.Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.展开更多
Objective To observe the analgesia effectiveness and safety of electroacupuncture at Neimadian （内麻点 Extra） after abdominal surgery. Methods One hundred and twenty patients with routine abdominal surgery were rand...Objective To observe the analgesia effectiveness and safety of electroacupuncture at Neimadian （内麻点 Extra） after abdominal surgery. Methods One hundred and twenty patients with routine abdominal surgery were randomly divided into an acupuncture group and a medication group, 60 cases in each group. The acupuncture group was treated with electroacupuncture at Neimadian （内麻点 Extra）, which was located on the medial side of lower leg, 7 cun above the medial malleolus and about 0.5 cun from post edge of tibia. The medication group was treated with patient-controlled intravenous analgesia （PCIA） with Sufentanil. After the treatment, the Visual Analogue Scale （VAS）, the security, the analgesic effect and plasma β-endorphin content in the two groups were compared.Results The postoperative VAS scores at 2, 4, 8, 16, 24 and 48 h in the acupuncture group were lower than those in the medication group （all P〈0.05）. The analgesic effects at 2, 4, 16 and 24 h after surgery in the acupuncture group were superior to those in the medication group （P〈0.05, P〈0.01）. The plasma β-endorphin contents at 0, 8, 16 and 48 h after surgery in both groups were increased, and the acupuncture group was superior to the medication group （all P〈0.05）. The security class after surgery in the acupuncture group was higher than that in the medication group （P〈0.05）. Two cases in acupuncture group stopped treatment due to overstress and fear of needling, 24 cases in medication group presented adverse reactions, among them, 3 cases stopped the treatment due to nausea, vomiting. Conclusion The analgesic effect and safety of electroacupuncture at Neimadian （内麻点 Extra） after abdominal surgery are superior to those of the PCIA with Sufentanil.展开更多
基金support from the National Natural Science Foundation of China(No.81704065)China Postdoctoral Science Foundation(No.2016M600632 and No.2017T100604)+3 种基金Hunan Provincial Natural Science Foundation(No.2017JJ3239 and No.2018JJ2293)Hunan Education Department’s Science&Research Project(No.17K069)Hunan Provincial Science&Research Project of Chinese Medicine(No.201790)National First-class Disciple Construction Project of Chinese Medicine of Hunan University of Chinese Medicine
文摘Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang Qi,黄芪),Paeoniae Radix Alba(Bai Shao,白芍)and Moutan Cortex(Mu Dan Pi,牡丹皮),which have well-established histories of use for treatment of rheumatic and arthritic diseases.We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis(RA).Methods The combinative approaches of chemical assessment,toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT.Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents,potent anti-inflammatory and antinociceptive activities,and favorable safety profile.Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography(HPLC)demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent.General toxicological studies showed a favorable safety profile of QFJBT.The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose.In the chronic oral toxicity study,the results of laboratory investigation showed that QFJBT at doses of 3.89,6.80 and 9.72 g/kg body weight(equivalent to 40,70 and 100-fold clinical doses,respectively)caused no changes in all hematological parameters and blood biochemical parameters of rats.No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT.Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.
文摘Objective To observe the analgesia effectiveness and safety of electroacupuncture at Neimadian （内麻点 Extra） after abdominal surgery. Methods One hundred and twenty patients with routine abdominal surgery were randomly divided into an acupuncture group and a medication group, 60 cases in each group. The acupuncture group was treated with electroacupuncture at Neimadian （内麻点 Extra）, which was located on the medial side of lower leg, 7 cun above the medial malleolus and about 0.5 cun from post edge of tibia. The medication group was treated with patient-controlled intravenous analgesia （PCIA） with Sufentanil. After the treatment, the Visual Analogue Scale （VAS）, the security, the analgesic effect and plasma β-endorphin content in the two groups were compared.Results The postoperative VAS scores at 2, 4, 8, 16, 24 and 48 h in the acupuncture group were lower than those in the medication group （all P〈0.05）. The analgesic effects at 2, 4, 16 and 24 h after surgery in the acupuncture group were superior to those in the medication group （P〈0.05, P〈0.01）. The plasma β-endorphin contents at 0, 8, 16 and 48 h after surgery in both groups were increased, and the acupuncture group was superior to the medication group （all P〈0.05）. The security class after surgery in the acupuncture group was higher than that in the medication group （P〈0.05）. Two cases in acupuncture group stopped treatment due to overstress and fear of needling, 24 cases in medication group presented adverse reactions, among them, 3 cases stopped the treatment due to nausea, vomiting. Conclusion The analgesic effect and safety of electroacupuncture at Neimadian （内麻点 Extra） after abdominal surgery are superior to those of the PCIA with Sufentanil.
