Effects of Compound α-Ketoacid Tablets on renal function, renal fibrosis indexes and oxidative stress in patients with diabetic nephropathy

Objective: To investigate the effects of Compound α-Ketoacid Tablets on renal function, renal fibrosis indexes and oxidative stress in patients with diabetic nephropathy. Methods: A total of 180 patients with diabetic nephropathy admitted to Nephrology Department of our hospital were randomly divided into control group and observation group, 90 cases in each group. The patients in the control group were given conventional treatment, such as antihypertensive drugs, diet and blood glucose control, and the patients in the observation group were given Compound α-Ketoacid Tablets on the basis of the control group. Renal function, renal fibrosis index and oxidative stress levels were compared between the two groups before and after treatment. Results: After treatment, the levels of serum ALB, BUN, Cr, Hcy, VEGF and MDA in two groups were significantly decreased than those before the treatment, and the levels of ALB, Hcy, VEGF and MDA in the observation group were significantly lower than those in the control group, the difference was statistically significant. After treatment, the levels of serum GFR, HGF, T-AOC and SOD in two groups were significantly increased than that before the treatment, and the levels of HGF, T-AOC and SOD in the serum of the observation group were significantly higher than that in the control group, the difference was significant. Conclusion:The Compound α-Ketoacid Tablets has good effect in the treatment of diabetic nephropathy. It can effectively improve the state of renal fibrosis and reduce the oxidative stress reaction of the patients, so as to achieve the protection of the kidney.

Compound Danshen tablets downregulate amyloid protein precursor mRNA expression in a transgenic cell model of Alzheimer's disease Effects and a comparison with donepezil

After gene mutation, the pcDNA3.1/APP595/596 plasmid was transfected into HEK293 cells to establish a cell model of Alzheimer＇s disease. The cell model was treated with donepezil or compound Danshen tablets after culture for 72 hours. Reverse transcription-PCR showed that the mRNA expression of amyloid protein precursor decreased in all groups following culture for 24 hours, and that there was no significant difference in the amount of decrease between donepezil and compound Danshen tablets. Our results suggest that compound Danshen tablets can reduce expression of the mRNA for amyloid protein precursor in a transgenic cell model of Alzheimer＇s disease, with similar effects to donepezil.

Compound Chaijin Jieyu Tablets ameliorating insomnia complicated with depression by improving synaptic plasticity via regulating orexin A,melatonin,and acetylcholine contents

Objective To investigate the efficacy and mechanism of action of Compound Chaijin Jieyu Tablets(复方柴金解郁片,CCJJYT)in rats with insomnia complicated with depression.Methods Seventy-two Sprague-Dawley rats were randomly assigned into eight groups:the control,chronic unpredictable mild stress(CUMS),sleep deprivation(SD),CUMS+SD,positive drug(venlafaxine hydrochloride+diazepam),CCJJYT high-dose(CCJJYT˗2×),medium-dose(CCJJYT˗1×),and low-dose(CCJJYT˗0.5×)groups,with nine rats in each group.Depression-like behavior was evaluated by body weight,food intake,and behavioral tests such as the sucrose preference test(SPT),open field test(OFT),forced swimming test(FST),and pentobarbital-induced sleep test(PST).Hematoxylin-eosin(HE)staining and Golgi-Cox staining were used to observe changes in pathological tissue and synaptic morphology,respectively.Enzyme-linked immunosorbent assay(ELISA)was used to detect the contents of orexin-A and acetylcholine.The expression levels of orexin receptor 1(OXR1),melatonin receptor 1(MT1A),melatonin receptor 2(MT1B),acetylcholinesterase(AChE),and choline acetyltransferase(ChAT)were detected by immunohistochemistry and Western blot.Results In the present study,rats in the model group showed significant behavioral changes as well as a reduction in hippocampal dendritic branch length and synaptic number,along with increasing the content of orexin A and acetylcholine(P<0.05),and altered expression levels of OX1R,MT1A,MT1B,ChAT,and AChE in the hippocampus and prefrontal cortex after modeling(P<0.05).CCJJYT can improve depressive insomnia behavior and synaptic plasticity of rats(P<0.05),which is similar to that of the positive drug group.It can also decrease the content of orexin A and acetylcholine,and reduce the expression levels of OXR1 and ChAT in hippocampus and prefrontal cortex(P<0.05),and increase the expression levels of MT1A,MT1B,and AChE proteins(P<0.05).Conclusion CCJJYT has good antidepressant and insomnia effects,probably through the regulation of orexin-A,melatonin,and acetylcholine content in hippocampus and prefrontal cortex of rats,improving synaptic plasticity and thus exerting antidepressant and insomnia effects.

Compound Chai Jin Jie Yu Tablets,Acts as An Antidepressant by Promoting Synaptic Function in the Hippocampal Neurons

Objective To investigate the effectiveness of compound Chai Jin Jie Yu Tablets(CJJYT)in ameliorating cognitive impairment associated with depression and its potential mechanism of action.Methods In vitro experiments,the hippocampus was isolated from the whole brain of the fetal rat and cultured into hippocampal neuron cells.50μM corticosterone(CORT)was added to each group 18 h before the experiment for modeling depression,with the exception of the control group.After modeling,the blank serum group was added with 10%blank serum,the CJJYT group and the venlafaxine group were added with the corresponding 10%drug-containing serum,and the control group and the model group were added with equal volumes of culture medium.The intracellular Ca^2+mean fluorescence intensity,miniature excitatory postsynaptic current(mEPSC)current amplitude,and frequency of different hippocampal neurons were evaluated as indicators of synaptic function in the hippocampal neurons.In addition,the expression of synaptic plasticity related proteins,synaptophysin-α(SYN-α),N-methyl-D-aspartate receptor 2A(NR2A),N-methyl-Daspartate receptor 2B(NR2B),post synaptic density 95 protein(PSD-95),calcium/calmodulin dependent protein kinaseⅡ(CaMKⅡ)and synaptic associated protein(SynGAP)were detected in the hippocampal neurons by immunofluorescence staining and high content analysis(HCA)system.Then,reverse transcription-polymerase chain reaction(RT-PCR)was used to detect the mRNA expression levels of SYN-α,NR2A,NR2B,PSD-95,CaMKⅡand SynGAP.For in vivo experiments,except for those in the blank control group,all rats were treated within a single cage for chronic unpredictable stress-induced depression modeling and subjected to corresponding drug interventions.Behavioral tests were used to detect depressive behavior and determine learning,memory and other cognitive abilities,whereas enzyme-linked immunosorbent assay(ELISA)was used to detect the CORT levels.Golgi-Cox staining was used to observe changes in the synaptic morphology of parahippocampal gyrus CA1 area(CA1)and dentategyrus(DG).Results In vitro,CJJYT treatment reduced the intracellular Ca^2+mean flurorescence intensity in the hippocampal neurons(P<0.05),causing a reduction in the frequency and current amplitude of mEPSC(P<0.05),and thus inhibited the excessive activation of post-synaptic receptors.CJJYT treatment reduced the protein and mRNA expression of SYN-α,NR2A,NR2B and PSD-95 in the hippocampal neurons(P<0.05),increased the mRNA and protein expression of CaMKⅡand SynGAP(P<0.05),and thereby improved the synaptic plasticity of the hippocampal neurons.In vivo,CJJYT intervention improved sucrose preference,voluntary activity,learning and memory ability of Morris water maze test,and suppressed appetite(P<0.05),and increased the despair feeling of forced swimming test(P<0.05).The CORT level was reduced(P<0.05),leading to the repair of synaptic damage in the hippocampal neurons.Conclusions CJJYT can improve the synaptic function of hippocampal neurons and has obvious protective effects on neurons.It can repair the structural damage in the hippocampal neurons,improving the cognitive ability of the depressed model rats.The mechanism of CJJYT improving cognition in depressed rats may be related to the transmission and function of SYN-α/NR and its downstream neurotransmitters.

Study on Determination of Tanshinones in Compound Danshen Tablets

[ Objective ] This study was conducted to improve quality standard of Compound Danshen tablets. [ Method] Tanshinones in Compound Danshen tab- lets were determined by HPLC method. [ Result] A good linear relationship was found in the range of 0.10 -0.50 μg, and the average recovery rate was 100.59% （RSD = 1.38% ）. [ Conclusion] The method is simple, rapid and reproducible, and could be used as a method for quality control of Compound Danshen Tablets.

Semi-quantitative analysis on the content of berberine hydrochloride in compound berberine tablets with the fluorescence spectral imaging method

The content of berberine hydrochloride(BH)in compound berberine tablets(CBTs)is subject to strict requirements.Its content is usually measured based on chemical analysis.In this paper,the fluorescence spectral imaging method was used to study the relative content of BH from a physics perspective.By comparing the relative fluorescence intensity of self-made CBTs with di®erent mass percentages of BH,a linear positive relationship was observed between the BH content and the relative fluorescence intensity,and accordingly the quality of CBTs of different brands was evaluated.The results indicate that the fluorescence spectral imaging method can be a simple,fast and nondestructive semi-quantitative analysis method to determine the content of BH in CBTs,and this method has great potential in the quality control of CBTs.

Pseudo-hyperaldosteronism caused by compound glycyrrhizin tablets: a case report

Compound glycyrrhizin tablets(CGT)is a glycyrrhizin-containing preparation for the treatment of chronic hepatic diseases,it contained Glycyrrhizin,Monoammonium Glycyrrhizinate,Aminoacetic Acid and Methionine.CGT has been shown to have anti-inflammatory,anti-oxidative,and anti-viral effects.Although pseudo-hyperaldosteronism was reported as its important side effects,the frequency was unknown.A 59-year-old male patient with tuberculous pleurisy received CGT to prevent impairment in liver function which was caused by antituberculosis drugs.After more than one month,it appeared edema in the lower extremity,blood pressure increased,serum potassium lowed,serum sodium raised at the normal high limit.Finally,it was improved by suspending the CGT and diuretic treatment.

Effect of Compound Biejiaruangan Tablets combined with entecavir therapy on liver fibrosis process and immune response state in patients with chronic hepatitis b

Objective:To study the effect of Compound Biejiaruangan Tablets combined with entecavir therapy on liver fibrosis process and immune response state in patients with chronic hepatitis b.Methods: Patients with chronic viral hepatitis b who were treated in the Affiliated Hospital of Inner Mongolia Medical University between May 2015 and March 2017 were selected as the research subjects and divided into the combined group who accepted Compound Biejiaruangan Tablets combined with entecavir therapy and the control group who accepted entecavir monotherapy. The contents of collagen metabolism indexes and inflammatory response molecules in serum as well as the contents of immune cells in peripheral blood were determined before treatment and 24 weeks after treatment.Results: 24 weeks after treatment, PC-III, C-IV, MMP1, MMP2, TIMP1, IL-1β, IL-18, MIF, RANTES, MIP-1 and MIP-1β contents in serum as well as Th2, Treg and Th17 contents in peripheral blood of both groups of patients were significantly lower than those before treatment whereas Th1 contents in peripheral blood were significantly higher than those before treatment, and PC-III, C-IV, MMP1, MMP2, TIMP1, IL-1β, IL-18, MIF, RANTES, MIP-1 and MIP-1β contents in serum as well as Th2, Treg and Th17 contents in peripheral blood of combined group of patients were significantly lower than those of control group whereas Th1 content in peripheral blood was significantly higher than that of control group.Conclusion: Compound Biejiaruangan Tablets combined with entecavir therapy can delay the liver fibrosis process and improve the immune response state in patients with chronic hepatitis b.

Effects of tripterygium glycosides combined with compoundα-keto acid tablets on inflammatory response, oxidative stress and urinary TGF-β1, IV-C levels in patients with chronic renal failure

Objective:To investigate the effects of tripterygium glycosides combined with compoundα-ketoacid tablets on inflammatory response, oxidative stress and urinary TGF-β1 and IV-C levels in patients with chronic renal failure.Methods: 102 patients with chronic renal failure admitted to Shuguang hospital from January 2017 to June 2018 were randomly divided into observation group (51 cases) and control group (51 cases). In the control group, the tripterygium glycosides tablets were orally administered, and the observation group was orally administered with tripterygium glycosides tablets and compoundα-keto acid tablets. The inflammatory response, oxidative stress index and urinary TGF-β1, IV-C levels were compared between the two groups.Results: There was no significant difference in CRP and TNF-α levels between the two groups before treatment (P>0.05). After treatment, the levels of CRP and TNF-α in the observation group were (9.32±1.10) mg/L and (3.14±0.36) ng/L, respectively, and the levels of CRP and TNF-α in the control group were (15.34±1.31) mg/ L, (5.01±0.53) ng / L. The CRP and TNF-α levels in the two groups were lower than those before treatment, and the CRP and TNF-α in the observation group were significantly lower than those in the control group (P<0.05). Before treatment, there was no significant difference in MDA, SOD and GSH-PX levels between the two groups (P>0.05). After treatment, the MDA level of the observation group was (3.01±0.32) μmol/L, and the MDA level of the control group was (5.17±0.61) μmol/L. The MDA of the two groups was lower than that before treatment, and the MDA of the observation group was significantly lower than that of the control group (P<0.05). After treatment, the levels of SOD and GSH-PX in the observation group were (101.45±13.16) U/L and (94.83±7.17) U/L, respectively. The levels of SOD and GSH-PX in the control group were (88.87±12.05) U/L, (87.38 ± 6.32) U/L. The SOD and GSH-PX of the two groups were higher than those before treatment, and the SOD and GSH-PX of the observation group were significantly higher than the control group (P<0.05). Before treatment, there was no significant difference in TGF-β1 and IV-C levels between the two groups (P>0.05). After treatment, the levels of TGF-β1 and IV-C in the observation group were (1.05±0.24) ng/L and (5.05±1.13) μg/L, respectively, and the levels of TGF-β1 and IV-C in the control group were (1.36±, respectively). 0.26) ng/L, (7.07±1.24) μg/L. The levels of TGF-β1 and IV-C in the two groups were lower than those before treatment, and the TGF-β1 and IV-C in the observation group were significantly lower than those in the control group (P<0.05).Conclusion: Tripterygium glycosides combined with compound -keto acid tablets can effectively reduce the inflammatory response, oxidative stress and renal interstitial fibrosis in patients with chronic renal failure.

Effect of compound α-ketoacid combined with routine nutritional intervention on inflammatory response and oxidative stress response in patients with maintenance hemodialysis

Objective: To study the effect of compound α-ketoacid combined with routine nutritional intervention on the inflammatory response and oxidative stress response in patients with maintenance hemodialysis. Methods: A total of 78 patients with uremia who received maintenance hemodialysis in Dangyang Changbanpo Hospital between February 2014 and November 2016 were collected and divided into control group and observation group according to the random number table method, 39 cases in each group. The control group received routine nutritional intervention, and the observation group underwent compound α-ketoacid combined with routine nutritional intervention. The serum levels of inflammatory factors and oxidative stress indicators in two groups of patients were detected before dialysis and 6 months after dialysis. Results: Before dialysis, differences in serum levels of inflammatory factors and oxidative stress indexes were not statistically significant between two groups of patients. After dialysis, serum CRP, IL-6, TNF-α, MDA and AOPP levels of both groups of patients were significantly higher than those before dialysis while SOD and GSHPx levels were significantly lower than those before dialysis and serum CRP, IL-6, TNF-α, MDA and AOPP levels of observation group after dialysis were significantly lower than those of control group while SOD and GSHPx levels were significantly higher than those of control group. Conclusions:Compound α-ketoacid combined with routine nutritional intervention can effectively reduce the systemic microinflammatory state and inhibit the oxidative stress response in patients with maintenance hemodialysis.

微生态制剂联合依达拉奉注射液对急性重症胰腺炎的疗效及肠道菌群、肠黏膜屏障功能改变

目的探讨复方嗜酸乳杆菌片联合依达拉奉对重症急性胰腺炎患者的临床效果。方法选取河南科技大学第一附属医院收治的172例重症急性胰腺炎患者,利用随机数字表法将其分为甲、乙、丙与丁4组,各43例。4组均接受常规综合治疗,乙组另接受依达拉奉治疗,丙组另接受复方嗜酸乳杆菌片治疗,丁组另接受复方嗜酸乳杆菌片联合依达拉奉治疗。对比治疗前后肠道菌群和肠黏膜屏障功能相关指标、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)及住院时间、并发症、病死率。结果4组双歧杆属、乳酸杆菌属相对丰度在治疗前、治疗7 d及14 d后均依次升高(P<0.05),丙组、丁组治疗7、14 d后均高于甲组、乙组(P<0.05),丁组治疗7、14 d后高于丙组(P<0.05);4组肠杆菌属、葡萄球菌属、肠球菌属相对丰度在治疗前、治疗7 d及14 d后均依次降低(P<0.05),丙组、丁组治疗7、14 d后均低于甲组、乙组(P<0.05),丁组治疗7、14 d后低于丙组(P<0.05);4组D-乳酸、内毒素、二胺氧化酶(DAO)水平在治疗前、治疗7 d及14 d后均依次降低(P<0.05),乙组、丙组、丁组治疗7、14 d后均低于甲组(P<0.05),乙组、丁组治疗7、14 d后均低于丙组(P<0.05),丁组治疗7、14 d后低于乙组(P<0.05);丁组住院时间短于甲组、乙组、丙组(P<0.05),丁组并发症发生率、病死率低于甲组(P<0.05);4组APACHEⅡ评分在治疗前、治疗7及14 d后均依次降低(P<0.05),乙组、丙组、丁组治疗7、14 d后均低于甲组(P<0.05),丁组治疗7、14 d后低于乙组、丙组(P<0.05)。结论在常规综合治疗的基础上接受复方嗜酸乳杆菌片能够调节重症急性胰腺炎患者机体肠道菌群,改善肠黏膜屏障功能,给予依达拉奉可改善肠黏膜屏障功能,二者均可减轻病情,且二者联合可增强对肠黏膜屏障功能的改善作用和对病情的控制作用,还可显著缩短住院时间,减少并发症,改善预后。

复方甘草酸苷片与火把花根片治疗掌跖脓疱病疗效比较

目的对比复方甘草酸苷片和火把花根片治疗掌跖脓疱病的临床效果。方法纳入我院在2022年1月—2023年2月收治的35例掌跖脓疱病患者,随机分为甘草组(18例)和火把花组(17例)。甘草组选择采用复方甘草酸苷片治疗,火把花组选择火把花根片治疗,每组均治疗2~3个疗程,分析两组患者的临床治疗效果。结果①甘草组与火把花组临床总有效率未显示出统计学差异(P>0.05)。②两组的银屑病皮损面积和严重程度指数(PASI)评分均较治疗前明显改善(均P<0.05),但改善程度在两组间无统计学差异(均P>0.05)。③两组的IL-17A、IL-22和INF-γ水平均较治疗前明显下降(均P<0.05),但下降程度在两组间无统计学差异(均P>0.05)。④在不良反应发生率方面,甘草组与火把花组之间未显示出统计学差异(P>0.05)。结论在复方甘草酸苷片和火把花根片治疗掌跖脓疱病具有较一致的临床疗效,且两种药物具有较高的安全性。

复方高滋斑片联合右佐匹克隆片治疗老年精神疾病伴睡眠障碍的疗效分析

目的探讨复方高滋斑片联合右佐匹克隆片治疗老年精神疾病伴睡眠障碍的疗效。方法将我科收治的72例老年患者,随机分为对照组和观察组,各36例。两组均服用右佐匹克隆片,观察组加用复方高滋斑片,疗程均为4周。治疗前、治疗4周后评定匹兹堡睡眠质量指数(PSOI)、失眠严重程度指数(ISI)、疲劳严重程度指数(FSS)。结果与治疗前比较,治疗4周后观察组和对照组PSQI、ISI以及FSS总分均下降,差异有统计学意义(P<0.01);治疗4周后,与对照组比较,观察组PSQI总分、ISI总分及FSS总分下降,差异有统计学意义(P<0.05)。结论在右佐匹克隆片治疗的基础上加用复方高滋斑片干预精神疾病伴睡眠障碍老年患者,可改善患者的睡眠质量。

复方甘草酸苷结合硫酸羟氯喹片治疗玫瑰痤疮的临床效果分析

目的观察复方甘草酸苷结合硫酸羟氯喹片治疗玫瑰痤疮的临床效果。方法选取本院皮肤科收治的98例玫瑰痤疮患者(2022年1月~2024年1月)作为研究对象。患者均采用复方甘草酸苷结合硫酸羟氯喹片治疗,统计治疗前、治疗后总积分,评估临床疗效,并观察患者是否出现胃肠功能紊乱、皮疹等不良反应。结果98例患者治疗后主要症状(2.60±1.09分)、次要症状评分(1.91±1.21分)和总积分(4.51±1.68分)均显著低于治疗前(8.01±1.17分、5.37±1.14分)(P<0.05)。98例患者治疗后总有效率为94.90%(93/98)。患者不良反应发生率为7.14%(7/98)。结论两者联合治疗效果可靠,可有效改善患者潮红、红斑、毛细血管扩张等症状,总有效率较为理想,且不良反应风险较低,该用药方案安全可靠。

复方青黛胶囊联合左西替利嗪治疗玫瑰糠疹的临床疗效及对Th17/Treg细胞平衡的影响

目的探讨复方青黛胶囊联合左西替利嗪治疗玫瑰糠疹的临床疗效及安全性。方法选择2022年1—12月于本院就诊的96例玫瑰糠疹患者作为研究对象,随机分为对照组和治疗组两组,每组各48例。对照组给予盐酸左西替利嗪片口服,1次/d,1片/次;治疗组在对照组的基础上口服复方青黛胶囊,3次/d,4粒/次。两组均治疗3周。比较两组临床疗效、PRSS评分、体征和症状至少缓解50%所需时间、血清IL-17、IL-22和IL-10的表达水平及不良反应发生率的差异。结果治疗后,与对照组相比,治疗组总有效率明显升高,差异具有统计学意义(P=0.037)。治疗后与对照组相比,治疗组PRSS评分[(2.37±0.28)vs.(3.22±0.85),P<0.05]明显降低。与对照组相比,治疗组皮疹数目[(8.56±2.01)vs.(10.25±2.91),P<0.05]、红斑[(7.42±1.28)vs.(9.63±1.55),P<0.05]、厚度[(6.22±1.17)vs.(7.40±1.35),P<0.05]、鳞屑[(4.55±1.04)vs.(6.26±1.33),P<0.05]和瘙痒感[(5.22±1.67)vs.(7.68±2.39),P<0.05]至少减轻50%所需时间均有所降低。治疗后与对照组相比,治疗组IL-17[(24.01±4.34)vs.(54.33±8.75),P<0.05]及IL-22[(69.76±12.23)vs.(95.45±14.32),P<0.05]表达水平明显降低,而IL-10[(132.12±22.23)vs.(92.12±19.45),P<0.05]表达水平明显升高。对照组和治疗组治疗期间不良反应发生率分别为16.67%和14.58%,不良反应发生率相比较无显著差异(P=0.779)。结论复方青黛胶囊联合盐酸左西替利嗪片治疗玫瑰糠疹的临床疗效明显,能快速且有效改善患者的皮损和瘙痒感,可能机制与改善Th17/Treg细胞平衡有关。

药食同源复合泡腾片研究进展

泡腾片作为一种新型片剂,具有方便携带、崩解迅速、生物利用度高等特点。药食同源复合泡腾片结合了原料的食用和药用价值,兼具补充营养素和保健的功能。综述国内外药食同源复合泡腾片的功效作用及成分的优化配比,总结复合泡腾片的常用辅料、制备方法及质量评价指标,并展望药食同源复合泡腾片的发展前景。

大柴胡汤加减联合复方嗜酸乳杆菌片治疗功能性便秘患者临床疗效观察

目的探讨大柴胡汤加减联合复方嗜酸乳杆菌片治疗功能性便秘(FC)患者的临床疗效。方法根据随机数字表法将河南中医药大学第三附属医院2020年5月—2022年4月门诊治疗的70例FC患者随机分为两组,对照组(35例)服用复方嗜酸乳杆菌片治疗,治疗组联合大柴胡汤加减治疗。对比两组临床疗效、临床症状和便秘评分、胃肠道生活质量指数(GIQLI)、胃肠激素[P物质(SP)、胃动素(MTL)、胃泌素(GAS)]水平及不良反应。结果治疗组临床有效率(97.14%)高于对照组(80.00%)(P<0.05)。与治疗前相比,治疗后两组临床症状评分和便秘评分降低,胃肠激素水平和生活质量评分升高(P<0.05);与对照组相比,治疗组上述指标均优于对照组(P<0.05)。对照组与治疗组不良反应发生率(8.57%vs 5.71%)无统计学差异(P>0.05)。结论大柴胡汤加减联合复方嗜酸乳杆菌片治疗FC安全有效,且可减轻患者便秘症状,调节胃肠激素水平,提高生活质量。

复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎肝硬化代偿期临床研究

目的:观察复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎肝硬化代偿期的疗效,分析该治法对患者肝功能、纤维化指标的影响。方法:选择70例慢性乙型肝炎肝硬化患者为研究对象,按照自愿原则分为恩替卡韦组和鳖甲软肝组各35例。恩替卡韦组予以恩替卡韦片治疗,鳖甲软肝组在恩替卡韦组的基础上予以复方鳖甲软肝片治疗。比较2组临床疗效、不良反应,比较2组治疗前后肝功能、肝纤维化指标。结果:2组治疗总有效率、不良反应总发生率比较,差异均无统计学意义(P>0.05)。治疗后,2组总胆红素(TBil)、丙氨酸转移酶(ALT)及天门冬氨酸转移酶(AST)水平均下降(P<0.05),且鳖甲软肝组低于恩替卡韦组(P<0.05)。治疗后,2组透明质酸(HA)、层粘蛋白(LN)以及Ⅲ型前胶原(PcⅢ)水平均下降(P<0.05),且鳖甲软肝组低于恩替卡韦组(P<0.05),2组Ⅳ型胶原(Ⅳ-C)水平均升高(P<0.05),且鳖甲软肝组高于恩替卡韦组(P<0.05)。治疗后,2组肝脏弹性硬度明显下降(P<0.05),且鳖甲软肝组低于恩替卡韦组(P<0.05)。结论:复方鳖甲软肝片联合恩替卡韦能够明显改善慢性乙型肝炎肝硬化患者的肝功能,并抑制和逆转肝纤维化进程,且不增加不良反应。

对国家药品监督管理局公布的复方丹参片质量抽检不合格问题的分析和建议

目的:提取和整理国家药品监督管理局(NMPA)2016-2022年发布的复方丹参片抽检数据,梳理其质量不合格问题特点和趋势,为促进中成药提升质量提供参考。方法:在NMPA官网数据查询系统“全国药品抽检”界面,以“复方丹参片”作为关键词检索并提取抽检不合格相关信息。通过归类分析,统计复方丹参片质量不合格数据,并对涉事药品生产企业产品的不合格批次等进行分析。结果:共检索到54条本品不合格记录,涉及24家生产企业的46批产品,含量测定与重量差异未达标的批次占比分别为63.0%和34.8%。在含量测定未达标的29批产品中,主要不合格项目依次为三七含量(34.5%)、丹参酮IIA含量(20.7%)与丹酚酸B含量(20.7%)。药品不合格现象集中于某些生产企业,在涉及到的24家企业中,有6家(25.0%)出现3批或以上不合格产品,涉及不合格产品24批,占总不合格批次的52.17%。结论:自2017年至2022年,复方丹参片质量抽检不合格的批次与项目呈下降趋势,表明本品质量整体向好,但质量风险仍然存在,提示生产企业应持续加强内部质量控制,经销商应完善药品运输和储存过程管理,避免湿度等环境因素引起的质量变化。建议药品监督管理部门继续加强本品抽检与探索性研究,进一步提升复方丹参片的质量标准,保障公众用药质量。

肉苁蓉复方咀嚼片制备工艺及质量控制的研究

目的研究肉苁蓉复方咀嚼片的制备工艺及质量控制方法。方法基于中医理论对肉苁蓉、黄精和党参进行配伍,将其药材提取物与若干辅料等量递加混合,再加入硬脂酸镁,混合后过80目筛3次,每次混合时间超过5 min,压片制成肉苁蓉复方咀嚼片;以外观、硬度和口感等为指标进行工艺初步筛选,用正交实验法优选最佳处方;对用最佳处方制得的咀嚼片进行质量评价,用HPLC法测定有效成分的含量;通过研究肉苁蓉复方咀嚼片低、中、高剂量对小鼠体质量、力竭游泳时间及疲劳代谢产物等的影响来验证该咀嚼片在缓解体力疲劳方面的功效。结果3批工艺验证结果显示,用最佳处方制得的咀嚼片口感细腻、酸甜适宜,片质量为0.5 g·片^(−1),硬度>8 kg·mm^(−2)、脆碎度<1%;每片含松果菊苷>0.025 g,松果菊苷>0.003 g。0.25、0.50、1.50 g·kg^(−1)·d^(−1)剂量的肉苁蓉复方咀嚼片均能显著延长小鼠力竭游泳时间,降低尿素氮和乳酸的含量,增加肝糖原、肌糖原的含量,差异有统计学意义(P<0.01)。结论优选了肉苁蓉复方咀嚼片的处方工艺。用最优处方制备的肉苁蓉复方咀嚼片的外观性状、口感、硬度及脆碎度等均达到预期要求。肉苁蓉复方咀嚼片对体力疲劳有缓解作用。