A simple,rapid and sensitive liquid chromatography-mass spectrometry（LC-MS）method was developed for the determination of salidroside in rat plasma and study of its pharmacokinetics after oral administration of suspe...A simple,rapid and sensitive liquid chromatography-mass spectrometry（LC-MS）method was developed for the determination of salidroside in rat plasma and study of its pharmacokinetics after oral administration of suspension of Erzhi Wan and Fructus Ligustri lucidi into Wistar rats.Plasma sample of 200 μL was extracted with acetic ether-isopropanol（2∶1）and the extraction was performed on a Kromasil C18 column（150 mm×4.6 mm,5 μm）with the mobile phase of methanol-water（41∶59,v/v）within a run time of 6.0 min.The analyte was monitored with positive electrospray ionization（ESI）by selected ion monitoring（SIM）mode.The target ions were m/z 323.05 for salidroside and m/z 411.05 for internal standard（IS）geniposide.A good linear relationship was obtained over the range of 5.0-500.0 ng/mL and the lower limit of quantification was 5.0 ng/mL.The validated method was successfully applied to the pharmacokinetic study of salidroside in rat plasma after oral administration of suspension of Erzhi Wan and Fructus Ligustri lucidi.展开更多
OBJECTIVE Erzhi pills is a clas⁃sic prescription of Chinese medicine originated from Fu Shou Jing Fang in Ming dynasty,with the effects of nourishing kidney-Yin and hemosta⁃sis,black hair,strengthening muscles and bon...OBJECTIVE Erzhi pills is a clas⁃sic prescription of Chinese medicine originated from Fu Shou Jing Fang in Ming dynasty,with the effects of nourishing kidney-Yin and hemosta⁃sis,black hair,strengthening muscles and bones.As a classical prescription for nourishing kidney-Yin,Erzhi pills has been used to treat senile dementia in China for many years.Herein,our study aimed to investigate the protective effects of Erzhi pills in rat models of Alzheimer disease(AD)induced by ovariectomy as well as D-galactose and Aβ1-40 injection and to explore its potential mechanism.METHODS The model of AD rats was established by ovariectomy com⁃bined with D-galactose and Aβ1-40 injection.Ovariectomized rats were randomly divided into four groups:model group,estradiol valerate(0.80 mg·kg-1)group,Erzhi pills high(1.50 mg·kg-1)and low(0.75 mg·kg-1)doses group.In addition,rats of sham operation were selected as the sham operated group.Except for the sham oper⁃ated group,rats were injected intraperitoneally with D-galactose(100 mg·kg-1 per day,for 49 d)on the 8th day,then they were given intracerebro⁃ventricular injection of Aβ1-40(10μg per rat,1 g·L-1)on the 36th day,while the corresponding drugs were given by gastrointestinal administra⁃tion on the 22nd day.In our study,Morris water maze test was used to evaluate the learning and memory abilities,while ELISA kit was used to an⁃alyze serum estrogen level.The morphology of hippocampal neuron cells was observed by HE staining,and Nissl staining was utilized to ob⁃serve the Nissl body in cytoplasm.Then,the ex⁃pression of ERβpositive cells and hippocampal Aβ1-40 and p-Tau404 proteins was determined by immunohistochemistry.In order to further explore the molecular mechanism of Erzhi pills preven⁃tion and treatment of AD,proteomics was used to find potential targets and related pathways,Western blotting was used to verify the expres⁃sion of candidate differential protein.According to the results of proteomics in our experiment,Western blotting was used to detect the protein expression of PI3K,Akt,Bcl-2,Bcl-xl,Bad,14-3-3 and GSK3β.RESULTS The escape latency was significantly shortened,the number of crossing platform was increased,the neuron arrange⁃ment was more orderly and with less nuclear pycnosis in rats of Erzhi pills groups compared to the model group.In rats treated with Erzhi pills,the number of neurons,Nissl bodies,the estro⁃gen levels and ERβpositive cells were increased,while the number of Aβ1-40 and p-Tau404 positive cells was significantly decreased.Proteomics found that there were more than one hundred differentially expressed proteins of rats treated with Erzhi pills,which were involved in 48 signal⁃ing pathways.Among these proteins,five of them were involved in the PI3K/Akt signal path⁃way.As the down-stream protein of PI3K/Akt sig⁃naling pathway,the content of 14-3-3 protein was significantly increased.Western blotting analysis showed that the expression of p-GSK3β/GSK3βand Bad was decreased,while that of p-Akt/Akt,p-PI3K/PI3K,14-3-3,Bcl-xl and Bcl-2 was up-regulated in rats from the Erzhi pills groups compared with the model group.CON⁃CLUSION Erzhi pills can improve estrogen levels,alter proteomics expression of the hippocampus and activate PI3K/Akt pathway in AD rats,reduce Aβaggregation,inhibit the hyperphos⁃phorylation of Tau protein,maintain the morphol⁃ogy of hippocampal neurons and decrease the apoptosis of hippocampal neurons,thereby improving the learning and memory abilities of ovariectomized AD rats induced by D-galactose and Aβ1-40 injection.This study may provide an experimental basis for the clinical treatment of Erzhi pills.展开更多
Objective:The aim of this study was to investigate the potential ability of medicated serum of Erzhi pills on growth,proliferation and inflammation of the human breast cancer cell line MCF-7 cells.Methods:3-month-old ...Objective:The aim of this study was to investigate the potential ability of medicated serum of Erzhi pills on growth,proliferation and inflammation of the human breast cancer cell line MCF-7 cells.Methods:3-month-old female Sprague–Dawley rats were used to prepared medicated serum,and randomly assigned into four groups:control group(distillated water),low doses(2.25g/kg/d),middle doses(4.5g/kg/d),high does(9.0g/kg/d).The growth curve was meas-ured by MTT method,the proliferation was examined by colony formation assay.Inflam-matory cytokines IL-1β,IL-18 and IL-6 was detected by Quantitative real time polymerase chain reaction(RT-qPCR).Western blot was used to examine the expression of NF-kB signal pathway.Results:The medicated serum of Erzhi pills could inhibit the growth and proliferation of breast cancer cell MCF-7,especially,in the group of middle doses and high does(P<0.05).The protein expression of IKKα,IκBαand p-NF-κB were significantly down regulated.As well as the mRNA expression levels of Inflammatory cytokine,such as IL-1β,IL-18 and IL-6,were decreased.Conclusion:Medicated serum of Erzhi pills played an anti-tumor role in breast cancer via inhibiting the growth and proliferation of MCF-7.Moreover,Erzhi pills could suppress in-flammatory responses from the NFκB signaling pathways,and reduced skeletal muscle pain caused by breast cancer endocrine therapy,and Erzhi pills may be a new target for the treatment of breast cancer.展开更多
OBJECTIVE: To study the effect of Erzhi Mingmu Decoction in the treatment of non-exudative age-related macular degeneration. METHODS: A total of 100 patients with non-exudative age-related macular degeneration admitte...OBJECTIVE: To study the effect of Erzhi Mingmu Decoction in the treatment of non-exudative age-related macular degeneration. METHODS: A total of 100 patients with non-exudative age-related macular degeneration admitted to our hospital from May 2017 to May 2018 were selected. They were randomly divided into the study group and the control group. The control group was treated with oral vitamin C and vitamin E while study group was treated with Erzhi Mingmu Decoction based on the same treatment of the control group. Both groups were continuously treated for 1 month, the visual improvement, fundus changes, and changes of serum VEGF and CRP levels were compared before and after treatment. RESULTS: The number of patients with visual improvement was higher in the study group than that in the control group(P < 0.05). The number of patients with fundus improvement in the study group was more than that of the control group(P < 0.05). Serum VEGF levels were decreased in the 2 groups after treatment, and they were decreased more in the study group than those in control group(all P < 0.05). Serum CRP levels were decreased in the 2 groups after treatment, and the serum CRP levels were decreased more in the study group than those in control group(all P < 0.05). CONCLUSION: The treatment of non-exudative age-related macular degeneration with Erzhimingmu Decoction can significantly improve the vision of patients, improve the condition of the fundus, and reduce the levels of serum VEGF and CRP, which is worthy of clinical promotion and application.展开更多
目的 观察白虎二至汤对热盛阴虚型糖尿病肾病(DKD)Ⅲ期患者的临床疗效。方法 将66例DKD患者随机分为对照组和治疗组,各33例。对照组采用缬沙坦胶囊治疗,治疗组在对照组治疗上加用白虎二至汤,观察2组患者空腹血糖(FBG)、餐后2 h血糖(2 h ...目的 观察白虎二至汤对热盛阴虚型糖尿病肾病(DKD)Ⅲ期患者的临床疗效。方法 将66例DKD患者随机分为对照组和治疗组,各33例。对照组采用缬沙坦胶囊治疗,治疗组在对照组治疗上加用白虎二至汤,观察2组患者空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)、尿蛋白/肌酐比(UACR)、尿素氮(BUN)、血肌酐(Scr)以及中医证候积分水平。结果 治疗组有效率显著优于对照组(P<0.05)。治疗后2组患者的2 h PG、HbA1c、UACR、BUN、Scr及中医证候积分水平均低于治疗前(P<0.05),且治疗组均低于对照组(P<0.05)。结论 白虎二至汤可显著改善早期糖尿病肾病患者的临床症状及中医证候,控制血糖水平,改善肾功能,延缓患者疾病进展,提高患者生活质量。展开更多
目的系统性评价二至天癸方改善高龄女性体外受精-胚胎移植(IVF-ET)结局的有效性和安全性,为高龄女性IVF-ET的临床用药提供循证医学依据。方法检索中国知网、万方、维普、PubMed、Web of Science、Cochrane Library数据库中有关二至天癸...目的系统性评价二至天癸方改善高龄女性体外受精-胚胎移植(IVF-ET)结局的有效性和安全性,为高龄女性IVF-ET的临床用药提供循证医学依据。方法检索中国知网、万方、维普、PubMed、Web of Science、Cochrane Library数据库中有关二至天癸方改善高龄女性IVF-ET结局的随机对照试验,检索时间为建库至2022年5月1日。采用RevMan 5.3软件对纳入文献研究进行Meta分析。结果最终纳入符合标准的文献共9篇,共677例患者。Meta分析结果显示,二至天癸方显著改善了行IVF-ET高龄女性的临床妊娠率、优质胚胎率、获卵数,且显著减少了促性腺激素(Gn)使用剂量(P<0.05)。试验组的2PN受精率虽优于对照组,但差异无统计学意义(P=0.06)。结论二至天癸方在改善高龄女性IVF-ET结局方面效果良好,是高龄女性IVF-ET临床用药中较有前景的中药方剂。展开更多
Objective： To investigate the effects of Erzhi Pill （二至丸,,EZP） on nerve cell apoptosis iinn senescence model rats.Methods： The rats model of senescence was established by peritoneal D-galactose injection combin...Objective： To investigate the effects of Erzhi Pill （二至丸,,EZP） on nerve cell apoptosis iinn senescence model rats.Methods： The rats model of senescence was established by peritoneal D-galactose injection combined with thymusectomy.Forty SD rats were randomized into four groups,the normal control group,the senescence model group,the EZP treated group,and the vitamins treated group,10 in each group.The rats were made into senescence model except those in the normal group.In the same time of D-galactose injection,the rats were treated respectively with distilled water,EZP 4.32 g/kg,and vitamins E and C 0.06 g/kg daily for 6 weeks via intragastric infusion.The index of main viscera （as brain,testis,etc.）,serum levels of superoxide dismutase （SOD） activity,and total anti-oxidation capacity （T-AOC） were measured after a 6-week treatment.Meanwhile,the cerebral cortex neuronal apoptosis proportion and mitochondrial membrane potential （MMP） were detected by flow cytometry.Results： Both EZP and vitamins E and C treatments showed effects on increasing testis index and serum level of T-AOC,reducing the percentage of neuronal apoptosis in the cerebral cortex,and elevating MMP in the aging rats model.Conclusions： EZP could inhibit the cerebral cortex neuron apoptosis and maintain the mitochondrial function in the senescent process of rats induced by peritoneal D-galactose injection combined with thymusectomy.It also shows antioxidation effect to some extents.展开更多
Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western ...Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western societies.To ensure the safety and quality of the herbal medicines that are a major part of the TCM tradition,they must be held to modern pharmaceutical standards.Erzhi pill(EZP)is a Chinese Pharmacopeia-listed herbal preparation that is used in the long-term clinical management of postmenopausal symptoms,osteoporosis and menstrual disorders.Until now,whether the drug release mechanism of EZP is in line with its intended TCM usage has not been studied.Methods:The release of specnuezhenide from three EZPs(self-made,Leiyunshang and Renhe)in simulated gastric fluid(SGF),acetate buffer(p H 4.5 buffer)and simulated intestinal fluid(SIF)was investigated in a dissolution test.The water uptake capacity and erosion extent of the three EZPs were investigated using swelling and erosion studies.The drug release mechanism was further assessed through statistical model fitting,using DDSolver software.Results:The release of specnuezhenide from all three EZPs in SGF was less than 50%within a 4 h period.However,over 70%of the specnuezhenide was released from each EZP in both p H 4.5 buffer and SIF in the same time.Analysis of the swelling and erosion behaviors and the drug release mechanism of the three EZPs confirmed that the release rate from EZP followed a sustained release profile,which was an interactive combination of swelling and erosion.Conclusion:This study showed that the release pattern from the pills was in line with the intended TCM use of EZP.TCM had not only theoretically considered sustained release from the pills,but also formulated them to achieve this release pattern.When establishing quality control standards for pills,the theoretical TCM usage and the actual release patterns need to be considered.展开更多
文摘A simple,rapid and sensitive liquid chromatography-mass spectrometry（LC-MS）method was developed for the determination of salidroside in rat plasma and study of its pharmacokinetics after oral administration of suspension of Erzhi Wan and Fructus Ligustri lucidi into Wistar rats.Plasma sample of 200 μL was extracted with acetic ether-isopropanol（2∶1）and the extraction was performed on a Kromasil C18 column（150 mm×4.6 mm,5 μm）with the mobile phase of methanol-water（41∶59,v/v）within a run time of 6.0 min.The analyte was monitored with positive electrospray ionization（ESI）by selected ion monitoring（SIM）mode.The target ions were m/z 323.05 for salidroside and m/z 411.05 for internal standard（IS）geniposide.A good linear relationship was obtained over the range of 5.0-500.0 ng/mL and the lower limit of quantification was 5.0 ng/mL.The validated method was successfully applied to the pharmacokinetic study of salidroside in rat plasma after oral administration of suspension of Erzhi Wan and Fructus Ligustri lucidi.
文摘OBJECTIVE Erzhi pills is a clas⁃sic prescription of Chinese medicine originated from Fu Shou Jing Fang in Ming dynasty,with the effects of nourishing kidney-Yin and hemosta⁃sis,black hair,strengthening muscles and bones.As a classical prescription for nourishing kidney-Yin,Erzhi pills has been used to treat senile dementia in China for many years.Herein,our study aimed to investigate the protective effects of Erzhi pills in rat models of Alzheimer disease(AD)induced by ovariectomy as well as D-galactose and Aβ1-40 injection and to explore its potential mechanism.METHODS The model of AD rats was established by ovariectomy com⁃bined with D-galactose and Aβ1-40 injection.Ovariectomized rats were randomly divided into four groups:model group,estradiol valerate(0.80 mg·kg-1)group,Erzhi pills high(1.50 mg·kg-1)and low(0.75 mg·kg-1)doses group.In addition,rats of sham operation were selected as the sham operated group.Except for the sham oper⁃ated group,rats were injected intraperitoneally with D-galactose(100 mg·kg-1 per day,for 49 d)on the 8th day,then they were given intracerebro⁃ventricular injection of Aβ1-40(10μg per rat,1 g·L-1)on the 36th day,while the corresponding drugs were given by gastrointestinal administra⁃tion on the 22nd day.In our study,Morris water maze test was used to evaluate the learning and memory abilities,while ELISA kit was used to an⁃alyze serum estrogen level.The morphology of hippocampal neuron cells was observed by HE staining,and Nissl staining was utilized to ob⁃serve the Nissl body in cytoplasm.Then,the ex⁃pression of ERβpositive cells and hippocampal Aβ1-40 and p-Tau404 proteins was determined by immunohistochemistry.In order to further explore the molecular mechanism of Erzhi pills preven⁃tion and treatment of AD,proteomics was used to find potential targets and related pathways,Western blotting was used to verify the expres⁃sion of candidate differential protein.According to the results of proteomics in our experiment,Western blotting was used to detect the protein expression of PI3K,Akt,Bcl-2,Bcl-xl,Bad,14-3-3 and GSK3β.RESULTS The escape latency was significantly shortened,the number of crossing platform was increased,the neuron arrange⁃ment was more orderly and with less nuclear pycnosis in rats of Erzhi pills groups compared to the model group.In rats treated with Erzhi pills,the number of neurons,Nissl bodies,the estro⁃gen levels and ERβpositive cells were increased,while the number of Aβ1-40 and p-Tau404 positive cells was significantly decreased.Proteomics found that there were more than one hundred differentially expressed proteins of rats treated with Erzhi pills,which were involved in 48 signal⁃ing pathways.Among these proteins,five of them were involved in the PI3K/Akt signal path⁃way.As the down-stream protein of PI3K/Akt sig⁃naling pathway,the content of 14-3-3 protein was significantly increased.Western blotting analysis showed that the expression of p-GSK3β/GSK3βand Bad was decreased,while that of p-Akt/Akt,p-PI3K/PI3K,14-3-3,Bcl-xl and Bcl-2 was up-regulated in rats from the Erzhi pills groups compared with the model group.CON⁃CLUSION Erzhi pills can improve estrogen levels,alter proteomics expression of the hippocampus and activate PI3K/Akt pathway in AD rats,reduce Aβaggregation,inhibit the hyperphos⁃phorylation of Tau protein,maintain the morphol⁃ogy of hippocampal neurons and decrease the apoptosis of hippocampal neurons,thereby improving the learning and memory abilities of ovariectomized AD rats induced by D-galactose and Aβ1-40 injection.This study may provide an experimental basis for the clinical treatment of Erzhi pills.
文摘Objective:The aim of this study was to investigate the potential ability of medicated serum of Erzhi pills on growth,proliferation and inflammation of the human breast cancer cell line MCF-7 cells.Methods:3-month-old female Sprague–Dawley rats were used to prepared medicated serum,and randomly assigned into four groups:control group(distillated water),low doses(2.25g/kg/d),middle doses(4.5g/kg/d),high does(9.0g/kg/d).The growth curve was meas-ured by MTT method,the proliferation was examined by colony formation assay.Inflam-matory cytokines IL-1β,IL-18 and IL-6 was detected by Quantitative real time polymerase chain reaction(RT-qPCR).Western blot was used to examine the expression of NF-kB signal pathway.Results:The medicated serum of Erzhi pills could inhibit the growth and proliferation of breast cancer cell MCF-7,especially,in the group of middle doses and high does(P<0.05).The protein expression of IKKα,IκBαand p-NF-κB were significantly down regulated.As well as the mRNA expression levels of Inflammatory cytokine,such as IL-1β,IL-18 and IL-6,were decreased.Conclusion:Medicated serum of Erzhi pills played an anti-tumor role in breast cancer via inhibiting the growth and proliferation of MCF-7.Moreover,Erzhi pills could suppress in-flammatory responses from the NFκB signaling pathways,and reduced skeletal muscle pain caused by breast cancer endocrine therapy,and Erzhi pills may be a new target for the treatment of breast cancer.
基金funded by the Natural Science Foundation of Liaoning Province (Project No.:20170520009)
文摘OBJECTIVE: To study the effect of Erzhi Mingmu Decoction in the treatment of non-exudative age-related macular degeneration. METHODS: A total of 100 patients with non-exudative age-related macular degeneration admitted to our hospital from May 2017 to May 2018 were selected. They were randomly divided into the study group and the control group. The control group was treated with oral vitamin C and vitamin E while study group was treated with Erzhi Mingmu Decoction based on the same treatment of the control group. Both groups were continuously treated for 1 month, the visual improvement, fundus changes, and changes of serum VEGF and CRP levels were compared before and after treatment. RESULTS: The number of patients with visual improvement was higher in the study group than that in the control group(P < 0.05). The number of patients with fundus improvement in the study group was more than that of the control group(P < 0.05). Serum VEGF levels were decreased in the 2 groups after treatment, and they were decreased more in the study group than those in control group(all P < 0.05). Serum CRP levels were decreased in the 2 groups after treatment, and the serum CRP levels were decreased more in the study group than those in control group(all P < 0.05). CONCLUSION: The treatment of non-exudative age-related macular degeneration with Erzhimingmu Decoction can significantly improve the vision of patients, improve the condition of the fundus, and reduce the levels of serum VEGF and CRP, which is worthy of clinical promotion and application.
文摘目的 观察白虎二至汤对热盛阴虚型糖尿病肾病(DKD)Ⅲ期患者的临床疗效。方法 将66例DKD患者随机分为对照组和治疗组,各33例。对照组采用缬沙坦胶囊治疗,治疗组在对照组治疗上加用白虎二至汤,观察2组患者空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)、尿蛋白/肌酐比(UACR)、尿素氮(BUN)、血肌酐(Scr)以及中医证候积分水平。结果 治疗组有效率显著优于对照组(P<0.05)。治疗后2组患者的2 h PG、HbA1c、UACR、BUN、Scr及中医证候积分水平均低于治疗前(P<0.05),且治疗组均低于对照组(P<0.05)。结论 白虎二至汤可显著改善早期糖尿病肾病患者的临床症状及中医证候,控制血糖水平,改善肾功能,延缓患者疾病进展,提高患者生活质量。
文摘目的系统性评价二至天癸方改善高龄女性体外受精-胚胎移植(IVF-ET)结局的有效性和安全性,为高龄女性IVF-ET的临床用药提供循证医学依据。方法检索中国知网、万方、维普、PubMed、Web of Science、Cochrane Library数据库中有关二至天癸方改善高龄女性IVF-ET结局的随机对照试验,检索时间为建库至2022年5月1日。采用RevMan 5.3软件对纳入文献研究进行Meta分析。结果最终纳入符合标准的文献共9篇,共677例患者。Meta分析结果显示,二至天癸方显著改善了行IVF-ET高龄女性的临床妊娠率、优质胚胎率、获卵数,且显著减少了促性腺激素(Gn)使用剂量(P<0.05)。试验组的2PN受精率虽优于对照组,但差异无统计学意义(P=0.06)。结论二至天癸方在改善高龄女性IVF-ET结局方面效果良好,是高龄女性IVF-ET临床用药中较有前景的中药方剂。
基金Supported by the National Natural Science Foundation of China(No.30901991)the Business Fees of China Academy of Chinese Medical Sciences for Independent Topics of Basic Researches (No.ZZ2006037)
文摘Objective： To investigate the effects of Erzhi Pill （二至丸,,EZP） on nerve cell apoptosis iinn senescence model rats.Methods： The rats model of senescence was established by peritoneal D-galactose injection combined with thymusectomy.Forty SD rats were randomized into four groups,the normal control group,the senescence model group,the EZP treated group,and the vitamins treated group,10 in each group.The rats were made into senescence model except those in the normal group.In the same time of D-galactose injection,the rats were treated respectively with distilled water,EZP 4.32 g/kg,and vitamins E and C 0.06 g/kg daily for 6 weeks via intragastric infusion.The index of main viscera （as brain,testis,etc.）,serum levels of superoxide dismutase （SOD） activity,and total anti-oxidation capacity （T-AOC） were measured after a 6-week treatment.Meanwhile,the cerebral cortex neuronal apoptosis proportion and mitochondrial membrane potential （MMP） were detected by flow cytometry.Results： Both EZP and vitamins E and C treatments showed effects on increasing testis index and serum level of T-AOC,reducing the percentage of neuronal apoptosis in the cerebral cortex,and elevating MMP in the aging rats model.Conclusions： EZP could inhibit the cerebral cortex neuron apoptosis and maintain the mitochondrial function in the senescent process of rats induced by peritoneal D-galactose injection combined with thymusectomy.It also shows antioxidation effect to some extents.
基金supported by Mitacs,Canada(Mitacs Accelerate:IT13686)and JRC Pharmaceuticals Inc,Canada。
文摘Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western societies.To ensure the safety and quality of the herbal medicines that are a major part of the TCM tradition,they must be held to modern pharmaceutical standards.Erzhi pill(EZP)is a Chinese Pharmacopeia-listed herbal preparation that is used in the long-term clinical management of postmenopausal symptoms,osteoporosis and menstrual disorders.Until now,whether the drug release mechanism of EZP is in line with its intended TCM usage has not been studied.Methods:The release of specnuezhenide from three EZPs(self-made,Leiyunshang and Renhe)in simulated gastric fluid(SGF),acetate buffer(p H 4.5 buffer)and simulated intestinal fluid(SIF)was investigated in a dissolution test.The water uptake capacity and erosion extent of the three EZPs were investigated using swelling and erosion studies.The drug release mechanism was further assessed through statistical model fitting,using DDSolver software.Results:The release of specnuezhenide from all three EZPs in SGF was less than 50%within a 4 h period.However,over 70%of the specnuezhenide was released from each EZP in both p H 4.5 buffer and SIF in the same time.Analysis of the swelling and erosion behaviors and the drug release mechanism of the three EZPs confirmed that the release rate from EZP followed a sustained release profile,which was an interactive combination of swelling and erosion.Conclusion:This study showed that the release pattern from the pills was in line with the intended TCM use of EZP.TCM had not only theoretically considered sustained release from the pills,but also formulated them to achieve this release pattern.When establishing quality control standards for pills,the theoretical TCM usage and the actual release patterns need to be considered.
