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??OBJECTIVE To establish the fingerprint of Aconitum Flarum Hand. Mazz Busch. METHODS UPLC analysis was performed on ACQUITY UPLC BEH C₁₈ column(2.1 mm??50 mm,1.7 ??m). Gradient elution was conducted. Mobile A was 0.2% formic acid and 0.005% TFA in water; mobile B was methanol; and mobile C was acetonitrile. The flow rate was 0.3 mL??min^-1. The detection was carried out at 275 nm. The column temperature was maitained at 35 ??. The injection volume was 1.0 ??L. RESULTS The UPLC fingerprint of Aconitum Flarum Hand. Mazz was established, and 14 common peaks were found including the peaks of two major constituents. The similarity factors ranged from 0.850 to 0.980. In addition, there was significant difference between wild and cultivated samples. CONCLUSION This UPLC method has satisfactory precision, stability, repeatability and specificity. It provides a scientific method for identifying wild and cultivated Aconitum Flarum Hand. Mazz using fingerprint.     

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??OBJECTIVE To establish the UPLC fingerprint of Gardeniae Fructus for providing reference for effective quality control. METHODS The samples were analyzed on a Waters ACQUITY UPLC BEH C₁₈ (2.1 mm??50 mm,1.7 ??m) column maintained at 30 ?? and eluted with methanol and water containing 0.02% phosphoric acid as mobile phases in a linear gradient mode.The flow rate was set at 0.4 mL??min^-1 and the injection volume was 0.2 ??L. The detection wavelengths were set at 238 nm (0-5.4 min) and 440 nm (5.4-10 min).RESULTS The fingerprints of 16 batches of samples were analyzed with similarity evaluation, principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA). The common mode of the fingerprint was established with 24 common peaks, and four of them were identified, which were genipin 1-gentiobioside (4), gardenoside (6), crocin ?? (15), and crocin ?? (17). The similarity degrees of the 16 batches of samples were between 0.986 0 and 0.995 0. The samples were divided into two groups, ZheJiang (S1-S6) and other areas (S7-S16), analyzed by principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA). Eleven significantly different components were found, including genipin1-gentiobioside, gardenoside, crocin ??, crocin ?? and some others. CONCLUSION The establishment of UPLC fingerprint of Gardeniae Fructus from different producing areas and the application of chemical pattern recognition can provide more comprehensive references for the quality control and evaluation of genuine Gardeniae Fructus from Zhejiang Province.     

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??OBJECTIVE To evaluate the bioequivalence of tested and reference torasemide tablets in healthy male volunteers. METHODS A single oral dose of the two formulations was given to 24 healthy male volunteers according to a randomized crossover design. Plasma drug concentrations were determined by HPLC-MS. RESULTS The pharmacokinetic parameters of torasemide of the two preparations were as follows: ??_max (1 408.29??337.27) and (1 487.86??360.24) ng??mL^-1, t_max (0.90??0.42) and (1.03??0.50) h, t_1/2(4.43??0.57) and (4.43??0.60) h, MRT (3.90??0.60) and (4.01??0.72) h, AUC_{0-24 h}(3 886.86??865.99) and (3 906.06??761.72) ng??h??mL^-1, AUC_0-?? (3 936.57??903.93) and (3 956.96??789.98) ng??h??mL^-1, respectively. The relative bioavailability of tested torasemide tablets were (99.8??11.7)% and (99.7??12.0)% when calculated by AUC_{0-24 h} and AUC_0-??, respectively. CONCLUSION The two formulations of torasemide are bioequivalent in healthy Chinese volunteers.     

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??OBJECTIVE To prepare smart & site-specific drug carrier for controlled release purpose and study the bio-compatibilities and release performance.METHODS By using high pressure thermo-heat method in autoclave, superparamagnetic core was obtained and further coated by SiO₂ and MCM-41, therefore the ??core-shell?? structure was formed. To make the carrier ??smart?? and thus responsive to stimuli which was light in this research, the tunnels of the molecular sieve were grafted with gating molecules, 4,5-diazafluoren-9-one (indicated in the paper as DAFO). For bio-compatibilities testing, MTT in-vitro experiment was conducted. Cytarabine was used as test drug to preliminarily evaluate the controlled release performance of the drug carrier in vitro.RESULTS The Fe₃O₄ nano-particles synthesized via high-pressure hydro-thermo procedure exhibited superparamagnetic with mean diameter of 280 nm. After SiO₂ & molecular sieve coating steps and ligand grafting steps, the particles grew to 540 nm. The sub-structure of the carrier was confirmed by scanning/transmission electron microscope(SEM & TEM) and nitrogen adsorption/desorption. Our ??smart?? carrier was able to be guided to the sites or organs with magnetic field and more importantly it was able to unload drug molecules under 510 nm light irritation that could flip the gating-molecule. Furthermore, the drug carrier illustrated bio-compatibility and showed obvious cytotoxicity.CONCLUSION The novel nanocomposites developed in this study can be used as targeted drug carrier.     

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??OBJECTIVE To develop an easy to scale-up preparation process for exenatide-loaded long-acting microspheres, and develop a method that can be used to rapidly evaluate the in vitro release properties of the microspheres. METHODS The primary emulsion could be made by high shear emulsification process combined with high pressure homogenization method , then exenatide-loaded microspheres were prepared by a modified coacervation method. In the coacervation step, static mixer was used for mixing the primary emulsion and the coacervation reagent. RESULTS High pressure homogenization could reduce the size of the primary emulsion to about 200 nm. The encapsulation efficiency of microspheres was greater than 96.8%, and the amount of burst release in 1 h was less than 0.5%. When the scale of microspheres preparation was magnified by five times, the characteristics of the obtained microspheres was the same as the small scale batch. The in vitro release curves showed that the continued release time lasted for nearly 4 weeks after the 17 d lag phase. The drug release rate at 45 ??was as high as 2.5 times of that at 37 ??, with same release curves. CONCLUSION The established preparation process of exenatide-loaded long-acting microspheres, which uses static mixer for mixing the primary emulsion and coacervation reagent, is easy for scaling-up and industrialization. Accelerated test at 45 ?? can be used to rapidly evaluate the in vitro release profile of the microspheres.
     

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??OBJECTIVE To establish the quality evaluation method of the aerial roots of Ficus microcarpa L.f. based on their anti-inflammation activity. METHODS Twenty batches of samples from different producing areas were analyzed by HPLC on a Shimadzu Capcell Pak C₁₈ column(4.6 mm??250 mm,5 ??m)gradiently eluted with mobile phase of methanol and 0.1% formic acid aqueous at a flow rate of 1.0 mL??min^-1. The detection wavelength was set at 254 nm, and the column temperature was maintained at 35 ??. The chromatograms were analyzed by the software ??Similarity Evaluation System for Chromatographic Fingerprint of TCMs (Version 2012.1)?? and the common peaks were obtained. The anti-inflammatory effects of the aerial roots of Ficus microcarpa L.f. were assessed by murine model of xylene-induced ear edema. Spectrum-effect relationship was analyzed by bivariate correlation analysis using SPSS21.0. RESULTS Seventeen common peaks were identified in the HPLC fingerprints of 20 batches of aerial roots of Ficus microcarpa L.f. The anti-inflammatory effect of samples from Guangdong was better than those from Guangxi and Fujian (P<0.01). According to the result of spectrum-effect relationship analysis, six common peaks were closely related to the anti-inflammatory effects of the aerial roots of Ficus microcarpa L.f. (P<0.05). Cluster analysis was then carried out based on the six common peaks in order to divide the samples into different groups. CONCLUSION The quality evaluation method established in this research is successfully employed in the quality evaluation of the aerial root of Ficus microcarpa L.f..     

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??OBJECTIVE To evaluate the effects of hormone replacement therapy(HRT) on the quality of life in climacteric women.METHODS The 202 patients were collected and divided into three groups according to whether or not they were treated with HRT: group 1 (not HRT), group 2 (HRT for the first time), group 3 (HRT for more than one year). All patients received follow-up visiting once per three months for one year. They were evaluated by the professionals through Kupperman index(KI), menopause-specific quality of life questionnaire(MENQOL), self-rating anxiety scale(SAS), self-rating depression scale(SDS). All patients were guided to improve the way of life.RESULTS After a year, KI, MENQOL and SAS in the three groups were improved significantly (P=0.003, 0.007, 0.014). KI and MENQOL were improved earlier than SAS. SDS was improved but not significantly(P=0.109). KI, MENQOL, SAS and SDS of patients in group 1 were improved significantly, but improved more weakly than those in group 2 and group 3. There is negative correlation between HRT and the values of every scale, and there is positive correlation between culture degree and SAS, SDS score values. CONCLUSION HRT canim prove the quality of life in climacteric women. The improvement in physical symptoms is earlier than that in mental symptoms. Anxiety and depression are more likely to occur in menopausal patients with high degree of education. Traditional Chinese medicine, exercise therapy and physical rehabilitation can be used as an auxiliary treatment for patients who are unable or unwilling to accept the HRT.     

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??OBJECTIVE To prepare montelukast sodium orally disintegrating tablets and investigate the bioequivalence in Beagle dogs.METHODS The orally disintegrating tablets were prepared by direct compression method,and the optimal formulation was screened by orthogonal test.HPLC-fluorescence method was developed for determination of montelukast sodium plasma concentration in Beagle dogs.RESULTS The optimized formulation(1 000 tablets) was montelukast sodium 10.4 g, microcrystalline cellulose 60 g, cross linked povidone 30 g, mannitol 15 g, magnesium stearate 2 g, aerosil 1 g, aspartame 1 g, flavor 0.6 g.CONCLUSION Montelukast sodium orally disintegrating tablets made of the optimized formulation could disintegrate rapidly. Relatively bioavailability of montelukast sodium orally disintegrating tablets is 90.7%.     

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??OBJECTIVE To establish the high-performance thin layer chromatographic(HPTLC)fingerprints of volatile oil and flavonoids in Alpinia katsumadai Hayata so as to provide scientific information for its quality control, and determine the fingerprints similarity of with its related species. METHODS The separation was performed on the pre-coated HPTLC GF₂₅₄ silica gel plates. The volatile oil was developed with solvent system of toluene-ethyl acetate(9??1). The relative humidity was 18%. The spots were visualized with 5% vanillin sulfuric acid solution. The flavonoides compounds were developed with solvent system of toluene-ethyl acetate-acetic acid (8??1.5??0.5). The spots were visualized with 5% aluminium chloride ethanol solution which needed to be observed at 365 nm. The common patterns of HPTLC fingerprints were obtained by CHROMAP 1.5 solution software, and authentication and quality assessment were performed by similarity and principle component analysis. RESULTS The common patterns of the volatile oil and flavonoids consisted of 10 characteristic peaks and 7 characteristic peaks, respectively. Eucalyptol and alpinetin were identified by chemical reference substances. CONCLUSION The qualities of Alpinia katsumadai Hayata collected from different areas are not distinctly different. Obvious difference exists in the chemical compositions of the volatile oil and flavonoids between Alpinia katsumadai Hayata and its counterfeit and other related species. This method is simple and rapid, which can serve as an effective identification and quality assessment method for Alpinia katsumadai Hayata.     

五味汤联合吉西他滨顺铂对非小细胞肺癌术后辅助化疗的影响

目的:探讨中药五味汤联合吉西他滨、顺铂在非小细胞肺癌术后辅助化疗的治疗效果。方法:将84例行手术治疗的非小细胞肺癌患者按照随机分组原则分成治疗组与对照组,每组42例,两组均采取吉西他滨、顺铂方案进行术后辅助化疗,28 d为1个周期,共4个周期,治疗组联合中药五味汤治疗,每日1剂,疗程4个月。化疗结束后观察两组患者近期疗效及药物毒性反应。结果:治疗组客观缓解率及中医证候总有效率均优于对照组(P<0.05),药物毒性反应明显低于对照组(P<0.05)。结论:中药五味汤联合吉西他滨、顺铂用于非小细胞肺癌术后辅助化疗,可显著增强化疗疗效,降低药物毒性反应。     

扶正消瘤汤辅助化疗对乳腺癌患者术后肿瘤标志物水平及免疫功能的影响

目的:探讨扶正消瘤汤辅助化疗对乳腺癌患者术后肿瘤标志物水平及免疫功能的影响。方法:选取乳腺癌患者74例,根据电脑产生的随机数字分为观察组和对照组,各37例,2组患者均给予常规化疗方案,观察组在此基础上增加扶正消瘤汤治疗。比较2组患者治疗后血清肿瘤标志物水平,治疗前后免疫功能及乳腺癌生命质量测评量表(FACT-B)评分。结果:治疗后观察组血清CEA、CA125、CA153、TSGF、VEGF-A、IGF-1及TK1水平均明显低于对照组(P0.05或P0.01);治疗后对照组CD3~+、CD4~+比例明显低于治疗前,观察组CD3~+、CD4~+比例及CD4~+/CD8~+均明显高于治疗前,CD8~+比例明显低于治疗前,差异有统计学意义(P0.05或P0.01),且2组间差异有统计学意义(P0.01),NK细胞比例治疗前后及2组间比较均无明显变化,差异无统计学意义(P0.05);治疗后观察组FACT-B评分明显升高,且明显高于对照组,差异有统计学意义(P0.01)。结论:乳腺癌患者化疗期间给予扶正消瘤汤可以明显提高机体免疫功能,降低血清肿瘤标志物水平,提高患者生命质量,一定程度上减少患者术后复发或转移。     

药食同源中药应用于结直肠癌患者化疗期间的作用

恶性肿瘤是当今社会的重大卫生健康问题,随着人们生活水平的提高及饮食结构的变化,我国消化道肿瘤的发展态势逐渐趋同发达国家。其中结直肠癌（CRC）在中国的发病率和死亡率居高不下,虽近年来靶向及免疫治疗大大改善了患者的预后,但临床中仍以化学治疗作为主要手段。然而化学治疗的不良反应常常严重影响患者的生活质量,甚至导致治疗中断,进而影响疗效。口服中药在CRC患者化疗期间中展现出增效减毒的独特优势,但其不良的用药体验不仅使患者难以坚持服用,还影响了中药在此阶段的普及性。药食同源中药（MEHs）是中药中的重要组成部分,其平和温润、香甜适口、简便惠民、营养丰富、安全性高等特点可能更适于CRC化疗期患者坚持治疗,但其药效常常为临床从业者所诟病,目前仅多用于食品和保健品行业,并未充分发挥其作为中药材的作用。该文通过文献统计的方法,总结了CRC化疗期中医临床常见证候和常用治法、整理了MEHs的性味归经和功效、梳理了MEHs现代药理学研究成果,发现MEHs的性味归经和功效与CRC化疗期中医临床常见证候和常用治法吻合度较高,且许多MEHs具有抑制CRC活性和抗CRC化疗不良反应的药理作用,进而从理论的层次证明M...     

鸦胆子油注射剂胃癌术后辅助化疗

目的:研究胃癌术后应用鸦胆子油注射剂辅助化疗的疗效。方法:选择在本院接受手术治疗的108名进展期胃癌患者作为研究对象,随机分为观察组和对照组,对照组给予XELOX辅助化疗(卡培他滨口服+奥沙利铂静脉滴注),观察组给予鸦胆子油注射剂辅助XELOX化疗(卡培他滨口服+奥沙利铂静脉滴注+鸦胆子油注射剂静脉滴注),观察远期预后情况、不良反应例数、总体生活质量以及免疫功能。结果:观察组完全缓解(CR)(8.62%)、有效率(58.62%)、获益率(79.31%)、卡氏行为状态(KPS)评分(84.37±8.21)分、生活质量核心量表(QLQ-C30)评分(81.84±8.34)分、T细胞亚群(CD3+,CD4+,CD8+,CD4+/CD8+)、自然杀伤(NK)细胞(9.31±1.34)%、肿瘤坏死因子α(TNF-α)含量(1.53±0.21)ng·L-1高于对照组,局部复发(10.34%)、远处转移(10.34%)、恶心呕吐(10.34%)、神经毒性(22.41%)、肝功能损害(10.34%)、肾功能损害(12.07%)低于对照组。结论:胃癌术后应用鸦胆子油注射剂辅助化疗能够改善远期预后、减少不良反应,具有积极的治疗价值。     

十全大补汤对结直肠癌术后化疗患者减毒增效及免疫功能的影响

目的:探讨十全大补汤对结直肠癌术后化疗患者减毒增效及免疫功能的影响。方法:选取2015年2月至2016年3月洛阳市第二中医院收治的结直肠癌患者98例,随机分为对照组(n=49)与观察组(n=49)。对照组患者采用FOLFOX4化疗方案进行化疗,观察组在对照组基础上应用十全大补汤治疗。比较2组治疗前后临床症状、外周血T淋巴细胞亚群(CD3~+、CD4~+、CD8~+)的变化及不良反应,并评价2组临床疗效。结果:观察组治疗有效率为81.63%(40/49),高于对照组61.22%(30/49),差异有统计学意义(P0.05);治疗后观察组CD3~+、CD4~+均上升,中医症候积分均下降,且观察组上述观察指标均优于对照组,差异有统计学意义(P0.05);观察组白细胞减少、胃肠道不适、脱发、恶心呕吐发生率均低于对照组,差异有统计学意义(P0.05)。结论:对结直肠癌术后化疗患者采用十全大补汤,可显著提高临床疗效,缓解临床症状,减少化疗所致的不良反应,增强患者免疫功能,促进身体恢复,具有临床推广意义。     

参苓白术散在结直肠癌术后化疗中的应用

目的观察研究参苓白术散在结直肠癌术后化疗中的应用。方法将60例结直肠癌手术后患者随机分为对照组和观察组两组,对照组30例患者在术后单纯采用化疗治疗,观察组30例患者在对照组化疗基础上,予参苓白术散结合中医辨证加减进行治疗,对比观察两种疗法的临床效果。结果对照组30例患者完全缓解9例,部分缓解11例,稳定7例,3例患者病情进展,总有效率为90%;观察组30例患者完全缓解20例,部分缓解5例,稳定4例,1例患者病情进展,总有效率为96.67%。结论参苓白术散联合化疗能明显缓解结直肠癌术后患者的病情,为中医药治疗本病提供了一个典范。     

贞芪扶正片辅助治疗食管癌术后化疗的疗效观察

目的探讨贞芪扶正片辅助治疗食管癌术后化疗的临床效果。方法 132例食管癌分成研究组76例和对照组56例,研究组采用贞芪扶正片辅助术后化疗,对照组仅给予常规护理,评价临床疗效及不良反应发生率。结果研究组患者卡氏评分提高率和稳定率之和为73.7%,对照组患者为55.4%(P0.05);研究组患者外周血免疫球蛋白G(Ig G)、免疫球蛋白A(Ig A)和免疫球蛋白M(Ig M)等均明显优于对照组(P0.05)。结论贞芪扶正片辅助化疗有助于提高其免疫功能、改善其生活质量以及减少不良反应发生。     

中医药治疗大肠癌及其术后患者的临床研究进展

大肠癌是常见的恶性肿瘤之一,其发病率逐年上升,目前西医治疗以手术、放化疗为主。但由于手术后复发与转移的发生率相当高,导致病人生存期不高;且放化疗等所产生的不良反应,严重时致使患者不能耐受。故在大肠癌术后各阶段配合以中医中药治疗,对缓解化疗不良反应、增强化疗疗效、术后调整机体功能、降低复发率与转移率、延长病人生存期、提高生活质量等方面都具有明显优势。通过对近年来相关专著、期刊报道等文献资料的查阅,从学术经验及临床研究两方面对大肠癌及其术后患者的中医药治疗进展加以归纳综述。     

培元抗癌汤治疗大肠癌术后化疗临床研究

目的:观察培元抗癌汤治疗大肠癌术后化疗患者的临床疗效及对血管内皮生长因子(VEGF)、免疫功能的影响。方法:选取80例行大肠癌根治术后接受化疗的患者,以简单随机化法分为对照组与治疗组各40例。对照组采取奥沙利铂⁺亚叶酸钙⁺5-氟尿嘧啶(FOLFOX4)化疗,治疗组在对照组基础上给予培元抗癌汤治疗。比较2组临床疗效、不良反应及治疗前后血清肿瘤因子水平、免疫功能。结果:治疗组治疗总有效率85.00%,高于对照组65.00%(P<0.05)。与同组治疗前比较,治疗后2组VEGF、血清癌胚抗原(CEA)、糖类抗原199 (CA199)水平均降低(P<0.05);与对照组治疗后比较,治疗组治疗后VEGF、CEA、CA199水平均较低(P<0.05)。与同组治疗前比较,治疗组治疗后CD3⁺、CD4⁺、CD4⁺/CD8⁺水平升高(P<0.05),CD8⁺水平降低(P<0.05);对照组治疗后CD3⁺     

益气化痰散结方联合XELOX化疗方案治疗晚期复发性结肠癌的临床研究

目的 :探讨益气化痰散结方联合XELOX化疗方案治疗晚期复发性结肠癌的临床疗效。方法:将60例晚期复发性结肠癌患者随机分成对照组和治疗组各30例,对照组予XELOX方案化疗:奥沙利铂130 mg/m2,静滴,第1 d;希罗达1000 mg/m2,口服,每日2次,第1¹4 d;治疗组在化疗的同时内服益气化痰散结方,均21 d为1个周期。3周期后对临床近期疗效、疾病无进展生存期(PFS)、不良反应及生活质量进行评估。结果:两组治疗后,治疗组和对照组的有效率分别为56.7%,50.0%,两组比较差异无统计学意义(P>0.05);治疗组的中位PFS为(254.00±6.25)d,对照组的中位PFS为(217.00±7.38)d,治疗组优于对照组(P<0.05);治疗组与对照组血液学毒性主要表现为白细胞减少,发生率分别为53.3%和70.0%;恶心呕吐的发生率分别为40.0%,56.7%,治疗组明显低于对照组,两组比较有显著差异(P<0.05)。两组患者在治疗后生活质量评分均有明显升高,与治疗前比较差异有统计学意义(P<0.05),两组治疗后比较差异亦有统计学意义(P<0.05)。结论:与单纯化疗相比较,益气化痰散结方与化疗联合能进一步延长晚期结肠癌患者疾病无进展生存期,改善生活质量,并降低化疗毒副反应。