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??OBJECTIVE To develop a supercritical fluid chromatography method for the separation of atorvastatin calcium and its enantiomer, meanwhile assaying the enantiomer. METHODS Atorvastatin calcium and its enantiomer were separated on a ACQUITY UPC² Trefoil CEL2 column(3.0 mm??150 mm, 2.5 ??m) maintained at 45 ?? with the mobile phase containing a mixture of CO₂ and methanol with 0.1% TFA(78??22, V/V) at 1.5 mL??min^-1, and the detection wavelength was set at 244 nm. The back pressure was set at 13.8 MPa. RESULTS The enantiomer and atorvastatin calcium were separated successfully in 5 min with a resolution factor of 4.1. Good linear relationship was established between the peak response and the concentration in the range of 2.5-50 ??g??mL^-1 for enantiomer(r²=0.999 9, n=6), the quantitative limit(S/N=10) was 2.5 ??g??mL^-1, and the detection limit(S/N=3) was 1.0 ??g??mL^-1. The spiked recovery of the enantiomer was 100.40%(n=9). CONCLUSION The proposed method shows high accuracy, repeatability and stability. It can be employed for the quality control and stability research of the enantiomer of atorvastatin calcium.     

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??OBJECTIVE To provide a reference for enhancing the level of research and development investment of the large-scale enterprises of pharmaceutical industry by identifying what kind of internal factors influence the the research and development investment and how they do with it. METHODS The thesis empirically analyzed the relationship between research and development personnel,firm sizes,profitability, research and development knowledge outputs and the research and development investment of pharmaceutical manufacturing ,based on 1995-2014 survey data of research and development conditions and economic conditions of large enterprises of pharmaceutical manufacturing and with the use of factor regression analysis method.RESULTS R& D personnel , firm size, profitability, research and development knowledge outputs are positively correlated with R& D expenditure of pharmaceutical manufacturing,but they have little effect on research and development intensity.CONCLUSION Increasing research and development personnel ,expanding firm sizes , enhancing profitability, and promoting research and development knowledge outputs can significantly improve the R & D investment of pharmaceutical manufacturing . Government and businesses can take the appropriate incentives for different aspects ,stimulating the investment in research and innovation.     

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??OBJECTIVE To establish an HPLC method for the simultaneous determination of butorphanol tartrate, dextroisomer and benzethonium chloride which works as the bacteriostatic agent in butorphanol tartrate injection on a cyclodextrin chiral column. METHODS The HPLC analysis was performed on an Astec Cyclobond ?? cyclodextrin chiral column (4.6 mm??250 mm,5 ??m), with mobile phase consisting of 0.05 mol??L^-1 ammonium acetate solution (pH was adjusted to 4.1 by acetic acid) and acetonitrile using gradient elution at a flow rate of 1.0 mL??min^-1. The detection wavelength was set at 280 nm. RESULTS The method showed good linearity for the three components to be measured. The linear ranges were 0.04-2.0 mg??mL^-1 for butorphanol tartrate (r=0.999 9), 0.01-2.0 mg??mL^-1 for dextroisomer (r=1.000 0), and 0.02-1.0 mg??mL^-1 for benzethonium chloride (r=0.999 9), respectively. The average recoveries were 100.2%, 100.7%, and 99.4%, respectively. CONCLUSION The method is simple, accurate and reproducible. It can be used for the quality control of butorphanol tartrate injection.     

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??OBJECTIVE To investigate the effects of anti CD3 monoclonal antibody (Ant-CD3 McAb) on immune function in cynomolgus monkeys, using the traditional immunotoxicity assessment methods and T cell dependent antibody response (TDAR) test, microarray, etc, and further explore the mechanism of Ant-CD3 McAb. METHODS Eighteen Cynomolgus monkeys were individually dosed with saline, 0.5 and 2.5 mg??kg^-1Ant-CD3 McAb for 7 d. The clinical observation, body weight, hematological test, antibody detection, TDAR test, lymphocyte subsets, bone marrow, histopathological examination and whole blood gene expression profile analysis were evaluated. RESULTS Ant-CD3 McAb significantly inhibited the immune response to keyhole limpet hemocyanin (KLH) in cynomolgus monkey, and caused the decrease of peripheral white blood cell counts and CD3⁺ cells, the decrease of lymphocytes in thymus cortex. Microarray test showed that the gene function of differently expressed genes mainly involved in cell proliferation, immune response, cytokine secretion, apoptosis etc. CONCLUSION Ant-CD3 McAb could induce obvious immunosuppression effects in cynomolgus monkeys. Detection of gene expression profile of whole peripheral blood is feasible in immunotoxicity evaluation. The apoptosis induction and proliferation inhibition of T lymphocytes might be the main cause of the decreased T lymphocytes. IL-8 might play an important role in the mechanism of Ant-CD3 McAb.     

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??Botanical Drug Development Guidance for Industry, replaced the Guidance for Industry on Botanical Drug Products issued in June 2004, was issued at December 2016. With the understanding and experience acquired in the reviews of NDAs and INDs for botanical drugs, specific recommendations have been modified and new sections have been added in this new edition. Compared new version with the old, ??loose requirement?? policy in early IND on consideration of prior human experience of botanical products was unchanged, but the requirements of quality and the rapeutic consistency on botanical raw material, drug substance and finished product in late-phase development and NDA submission for botanical drugs was very strict, especially, requirement to ensure that different marketing batches, with their variations, have the therapeutic effect consistent with those of the batches used in the phase 3 clinical studies. The new analytical methods, such as??totality of the evidence?? approach, biological assays, mass balance of all ingredients, multiple batch analyses and dose-response effect, were introduced to ensure the quality and therapeutic consistency. The manufacturing of botanical drug substance should be in compliance with both GACP and CGMPs may be warranted to cover the way in which the botanical raw material is grown, collected, processed and stored.     

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??Cerebral stroke is caused by the interrupt of blood supply either by the blockage or by the rupture of the brain blood vessels. After the activation of the ischemic cascades, a series of neurochemical reactions might occur which involves the excess release of the excitatory amino acids. The ionotropic glutamate receptor of N-methyl-D-aspartic acid subtype (NMDA receptor) has been proven to play dual roles in the ischemic insults. On one hand, NMDA receptor has been proven to initiate the ischemic impairment, leading to the neuronal death. On the other hand, NMDA receptor is involved in the endo-neurogenesis process after the ischemic onset. Herein, we summarized the recent studies about the structures and functions of NMDA receptor in ischemic stroke pathogenesis.     

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??OBJECTIVE To investigate the protection of lyophilized powder of catalpol and puerarin (C-P) on oxygen-glucose deprivation/reperfusion(OGD/R)-injured astrocytes and the possible mechanism in vitro.METHODS Primary astrocytes were isolated from the cerebral cortex of neonatal rats. The purity of astrocytes was identified by GFAP immunofluorescence. Astrocytes were divided into 6 groups:normal group, model group, excipients group, and three groups with gradient doses of C-P (12.25, 24.50, 49.00 ??g??mL^-1). After astrocytes suffered from OGD/R (OGD 6 h/R 12 h) with or without C-P, cell survival, LDH leakage, and apoptosis were analyzed by MTT, colorimetry, and TUNEL respectively. The apoptotic protein, caspase-3, was evaluated by Western blot. Meanwhile, oxidative indexes including SOD, GSH, ROS, MDA, and NO were detected by assay kits. In terms of inflammation, TNF-??, IL-1??, and PGE₂ in medium were evaluated via ELISA. iNOS, COX-2, NF-??B p65, p-NF-??B p65, I??B-??, and p-I??B-?? were examined by Western blot. RESULTS The purity of primary astrocytes was more than 97%. Compared with normal group, the cell survival rate of model group decreased significantly, while the LDH leakage rate and cell apoptosis rate markedly increased after OGD/R injury in model group. Meanwhile, SOD activity and GSH level in astrocytes markedly decreased. The level of MDA and ROS significantly increased. The content of NO, TNF-??, IL-1??, and PGE₂ released in medium also sharply increased. However, those changes of related biochemical indexes above could be reversed by different gradient doses of C-P. There was no significant difference between excipients group and model group. Further study found that C-P could inhibit the protein expression of caspase-3, iNOS, and COX-2, as well as the increase of phosphorylation level of NF-??B p65 and I??B-?? significantly. CONCLUSION C-P shows a protective effect on the OGD/R injured astrocytes in vitro, and its protection mechanism involves in anti-inflammation, antioxidant, inhibiting the cell apoptosis and activation of NF-??B signaling pathway.     

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??OBJECTIVE To establish a new determination method for free monosaccharides or disaccharides in glycopeptide drugs to eliminate their influence on polysaccharide content assay by colorimetric method adopted by the current national specifications. METHODS Solid phase extraction column was used for matrix elimination. A high performance anion exchange chromatograghy (HPAEC) in conjunction with pulsed amperometric detector (PAD) was performed on a CarboPac^?kPA20,using 200 mmol??L^-1 sodium hydroxide solution and 1 mol??L^-1 sodium acetate solution as mobile phase. RESULTS Twenty batches of raw materials and preparations of Bozhi glycopeptides, mannatide and polystictus glycopeptide were tested. Free monosaccharides of high content were detected in eight batches of samples, including glucose, sucrose, mannose, and fructose. CONCLUSION The HPAEC-PAD method is specific, sensitive, rapid and applicable widely, compared with other methods of saccharide detection, thus has good prospect of application and development. The assay methods in the current national specifications of glycopeptides drugs need to be improved.     

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??OBJECTIVE To investigate the pharmacokinetic interaction between ginsenosides and etoposide and provide useful information for clinical practice. METHODS Eighteen male Wistar rats were randomly divided into three groups: etoposide group(10 mgkg^-1),the high dose ginsenoside group(etoposide 10 mgkg^-1, ginsenoside 200 mgkg^-1), the low dose ginsenoside group(etoposide 10 mgkg^-1, ginsenoside 100 mgkg^-1). Plasma samples were collected at different times after the drug administration from the orbital veins of the rats. An HPLC method was developed to determine the concentration of etoposide in rat plasma,and the pharmacokinetic parameters were calculated using DAS3.2.7. RESULTS Compared with the etoposide group,AUC_0-t and MRT_0-t of the high dose ginsenoside group were increased by 46% and 24% respectively, and CL decreased by 19%, which was statistically significant difference. The AUC_0-t of the low dose ginsenoside group had a significant increased(21%) compared with the etoposide group, while other pharmacokinetic parameters had no significant differences. CONCLUSION Combination of ginsenosides and etoposide could significantly improve the plasma concentration and reduce excretion of etoposide.     

两个厂家的雷公藤多苷片对CIA模型大鼠干预作用比较

目的:观察并比较湖南千金协力(QJ)和浙江得恩德(DED)两个厂家的雷公藤多苷(TG)片口服后对Ⅱ型胶原诱导性关节炎(CIA)大鼠的药效及多脏器的干预作用。方法:72只SD大鼠随机分为正常组,模型组,千金协力TG片临床2倍,6倍等效剂量组(QJ-TG 0. 018,0. 054 g·kg~(-1)),得恩德TG片临床2倍,6倍等效剂量组(DED-TG 0. 018,0. 054 g·kg~(-1))。首次免疫后当天开始灌胃给药,每天1次。二次免疫后观察大鼠关节红肿和畸形症状,评价关节炎临床积分,分别在第21,42天取材,进行炎症关节组织病理学检查;血清酶学方法检测大鼠血清中碱性磷酸酶(ALP),丙氨酸氨基转移酶(ALT),天门冬氨酸氨基转移酶(AST),谷氨酰转移酶(GGT),总胆红素(TBIL),肌酐(CRE)和尿素(UREA)含量;评估大鼠附睾精子畸形率及睾丸与卵巢组织的损伤程度。结果:两个厂家TG片均能改善CIA模型大鼠炎症关节红、肿和畸形症状,降低临床积分,抑制关节滑膜炎症、血管翳、软骨侵蚀和骨破坏的病理改变。其中,QJ-TG 0. 018,0. 054 g·kg~(-1)组和DED-TG 0. 054 g·kg~(-1)组与模型组比较,有统计学差异(P 0. 05,P 0. 01),DED-TG 0. 018 g·kg~(-1)组与模型组比较未见明显变化;两个厂家相同剂量TG比较,DED-TG 0. 054 g·kg~(-1)组在第12和18 d比QJ-TG同剂量组对临床积分的抑制作用明显(P 0. 05)。除DED-TG 0. 054 g·kg~(-1)组能明显升高白细胞数和脾脏指数外,两个厂家TG片对CIA模型大鼠的体质量、其他脏器指数、消化系统、肝肾功能及肝肾病理均无明显影响,却能不同程度增加CIA雄性大鼠精子畸形率,对睾丸曲细精管造成显著损伤,其严重度随剂量和时间增加而增加,而同等剂量下DED-TG的雄性生殖毒性大于QJ-TG。DED-TG 0. 054 g·kg~(-1)组和QJ-TG 0. 054 g·kg~(-1)组除可见卵巢组织中血管分布减少,黄体体积缩小外,未见其他毒性作用。结论:两个厂家TG片2倍和6倍临床等效剂量口服均能延缓大鼠CIA的发病,降低关节炎临床积分,改善关节病理改变,并有一定程度的雄性生殖毒性。高剂量DED-TG比QJ-TG的毒-效作用更明显。     

进食对健康受试者口服盐酸艾咪朵尔片剂药动学的影响

 目的 比较研究在进食和空腹状态下中国健康受试者口服盐酸艾咪朵尔的药动学。方法 采用随机交叉给药方案,10名健康受试者进食或空腹单剂量口服400 mg盐酸艾咪朵尔,用高效液相色谱-串联质谱法测定血浆中艾咪朵尔的浓度,用DAS2.0 软件计算其主要药动学参数,t检验比较组间差异。结果 空腹和餐后单剂量给药的药时曲线均符合二室模型, 10 名健康受试者在进食和空腹状态下单次口服盐酸艾咪朵尔400 mg的主要药动学参数峰浓度ρ_max分别为(472.59±455.09)和(1 163.78±557.67) ng·mL-1,达峰时间tmax分别为 (1.3±1.1)和 (0.73±0.22) h,消除半衰期t1/2 分别为 (12.02±7.51)和 (7.44±3.39) h,药-时曲线下面积AUC_0-t 分别为 (945.5±711.44) 和 (1 636.93±706.34) ng·mL-1·h-1。进食状态下的ρ_max和AUC_0～t分别为空腹状态的40.61%和 57.75%,而t_max、t_1/2无显著性差异。结论 进食影响艾咪朵尔的吸收量,临床使用该药物时宜空腹服用。     

剂量对大黄在大鼠体内的药动学过程影响研究

目的:采用RP-HPLC法测定大鼠血浆中大黄各组分浓度,并考察剂量对大黄在大鼠体内药动学过程的影响。方法:血浆样品采用乙酸乙酯萃取后采用HPLC法测定。将大鼠分为高、中、低三个剂量组,口服给药后测定血药浓度,采用Winnonlin软件计算药动学参数。结果:大黄素甲醚未能检查得到。芦荟大黄素,大黄酸,大黄素,大黄酚3种剂量的消除半衰期无统计学差异。Cmax和AUC随着剂量的增加而增加。结论:芦荟大黄素,大黄酸,大黄素,大黄酚体内过程呈一级线性动力学过程。     

Effect of Wuzhi Tablet (Schisandra sphenanthera extract) on the Pharmacokinetics of Cyclosporin A in Rats

In our previous reports, Wuzhi tablet (an herbal preparation of ethanol extract of Wuweizi (Schisandra sphenanthera)) can significantly increase the blood concentration of tacrolimus and paclitaxel in rats by inhibiting the CYP3A‐mediated metabolism and the P‐gp‐mediated efflux. Cyclosporin A (CsA), a well‐known immunosuppressant agent, is also a substrate of CYP3A and P‐gp. Therefore, this study aimed to investigate whether and how WZ affects pharmacokinetics of CsA in rats. The AUC_0–48h and C_max of CsA were increased by 40.1% and 13.1%, respectively, with a single oral co‐administration of WZ and high dose of CsA (37.8 mg/kg). Interestingly, after a single oral co‐administration of WZ and low dose of CsA (1.89 mg/kg), the AUC_{0–36 h} and C_max of CsA were dramatically increased by 293.1% (from 1103.2 ± 293.0 to 4336.5 ± 1728.3 ng.h/mL; p < 0.05) and 84.1% (from 208.5 ± 67.9 to 383.1 ± 92.5 ng/mL; p < 0.05), respectively. The CL/F was decreased from 1.7 L/h/kg to 0.5 L/h/kg. Thus, the effect of WZ on high dose of CsA was not significant, but pharmacokinetic parameters of CsA at low dose were significantly influenced by co‐administration of WZ. The herb–drug interaction should be taken into consideration at this situation. Copyright © 2012 John Wiley & Sons, Ltd.     

雷公藤流浸膏片治疗红斑狼疮的疗效观察

用雷公藤流浸膏片治疗23例红斑狼疮患者,并与同期仅用强的松治疗的19例系统性红斑狼疮(SLE)患者作对照。结果15例 SLE 患者症状得到控制,雷公藤组9/15例,对照组6/19例(P>0.10);消除关节痛,雷公藤组7/10例,对照组7/15例;消除盘状红斑,雷公藤组6/8例,对照组5/12例。8例盘状红斑狼疮(DLE)患者仅用雷公藤治疗,4例病情控制好转。雷公藤的副作用有外周血白细胞数下降,个别病例出现蛋白尿,表明雷公藤毒性作用与治疗有效量很接近,应用时应慎重,尤其对有肾脏损害的患者应注意。目前用雷公藤的适应症以 DLE 及无肾脏损害的 SLE 为宜。     

布渣叶总黄酮固体分散体片的大鼠体内生物利用度研究

目的:建立了一种同时测定大鼠血浆中牡荆苷、异牡荆苷、水仙苷的HPLC/MS方法,并分析了布渣叶总黄酮提取物(BZY)和布渣叶总黄酮固体分散体片(SDT)的大鼠体内药代动力学特征,评价SDT体内生物利用度。方法:SD大鼠随机分为两组,分别灌胃给予BZY和SDT,分别于不同时间点取血,采用HPLC/MS测定牡荆苷、异牡荆苷、水仙苷的血药浓度,绘制药时曲线,运用kinetica4.4软件计算药动学参数。结果:比较口服布渣叶总黄酮提取物和布渣叶总黄酮固体分散体片的药动学参数,牡荆苷AUC_(0→12)分别为(3.425±0.135)和(5.257±0.257)mg·L~(-1)·h,MRT_(0→t)分别为(4.317±0.129)和(4.467±0.104)h,t_(1/2)分别为(9.128±2.556)和(11.335±4.102)h,tmax分别为(0.500±0.000)和(1.0±0.000)h,Cmax分别为(0.7±0.049)和(1.295±0.042)mg·L~(-1),异牡荆苷AUC_(0→12)分别为(3.547±0.056)和(6.057±0.242)mg·L~(-1)·h,MRT0→t分别为(4.417±0.109)和(4.235±0.147)h,t_(1/2)分别为(6.382±1.429)和(7.411±3.566)h,tmax分别为(0.692±0.047)和(0.583±0.204)h,Cmax分别为(0.692±0.047)和(1.455±0.024)mg·L~(-1),水仙苷AUC_(0→12)分别为(11.962±0.584)和(20.400±0.444)mg·L~(-1)·h,MRT0→t分别为(4.270±0.088)和(4.310±0.056)h,t1/2分别为(2.879±0.840)和(3.054±0.588)h,tmax分别为(1.500±0.000)和(1.500±0.000)h,Cmax分别为(2.542±0.134)和(4.665±0.060)mg·L~(-1)。以BZY为对照,SDT中牡荆苷、异牡荆苷、水仙苷的相对生物利用度分别为178.9%、187.5%、166.2%,且各指标的药动学参数AUC0→t、AUC0→∞、Cmax均显著性升高(P0.01)。结论:提示制剂技术能提高布渣叶总黄酮中牡荆苷、异牡荆苷、水仙苷的生物利用度,达到了实验预期要求。     

大黄苷及大黄苷元对大鼠脑缺血损伤保护作用的研究

目的探讨大黄苷及大黄苷元保护脑缺血损伤的作用机制.方法将大鼠随机分为模型组、假手术组、尼莫地平组、大黄苷粉组、大黄苷及大黄苷元高、中、低剂量组,观察局灶性脑缺血模型 (MCAO)大鼠的神经症状及脑组织病理学改变,检测血清和脑组织 TNF-α、 IL- 1β变化.结果模型组大鼠神经症状评分增高,病理损伤明显,正常神经元细胞数目减少,血清和脑组织 TNF-α、 IL- 1β水平均较假手术组增高;大黄苷和大黄苷元可明显改善神经症状、减轻脑组织病理损伤,使正常神经元细胞数目增多;大黄苷和大黄苷元组脑组织 TNF-α、 IL- 1β水平均较模型组显著降低;大黄苷中剂量组、大黄苷元高剂量组脑组织 TNF-α水平较尼莫地平组和大黄粉组降低显著;大黄苷元组血清、脑组织 IL- 1β水平较模型组显著降低,其高剂量组脑组织 IL- 1β较尼莫地平组降低显著.结论大黄苷和大黄苷元对大鼠脑缺血损伤具有显著保护作用,其作用机制可能与其降低脑缺血大鼠的 TNF-α、 IL- 1β水平有关.     

雷公藤对下丘脑—垂体—肾上腺轴的影响

目的:探讨了雷公藤(TW)对下丘脑—垂体—肾上腺轴(HPA 轴)的作用以及有关雷公藤的耐受性问题。方法:实验大鼠随机分为4组,分别为正常组、TW Ⅰ组、TWⅡ组、TWⅢ组。正常组不作任何处理,余下3组给予 TW 灌胃,剂量为每次20mg/kg,每天2次。给药时间分别为1个月、2个月、3个月。检测血浆促肾上腺皮质激素(ACTH)、皮质酮水平、肾上腺重量以及肾上腺病理学改变。结果:TW Ⅰ、TWⅡ组血浆 ACTH、皮质酮水平以及肾上腺重量均显著高于正常(P<0.01,P<0.05);TW Ⅲ组血浆 ACTH、皮质酮水平以及肾上腺重量与正常组比较无显著性差异(P>0.05)。结论:实验结果表明 TW 对 HPA 轴有促进作用;大鼠能对此作用产生耐受性。     

匹卡米隆片在健康人体的药动学研究

 目的 探讨匹卡米隆片在健康人体的药动学。 方法 采用液 - 质联用法测定 12 名健康志愿者口服匹卡米隆片后的血药浓度 , 计算药动学参数。 结果 受试者单次口服匹卡米隆片 50 , 100 和 200 mg 后的实测平均达峰时间 <> t _max 分别为 (0.73 ± 0.41) , (0.67 ± 0.33) 和 (0.67 ± 0.31)h ; <> t _1/2 分别为 (0.68 ± 0.22) , (0.89 ± 0.41) 和 (0.91 ± 0.21)h ;平均 <> ρ _max 分别为 (1 328.75 ± 552.33) , (2 460.83 ± 571.19) 和 (4 415.00 ± 1 077.45)μg·L^{- 1} ; AUC _{0 -t<>n} 平均值分别为 (1 617.37 ± 575.48) , (3 117.08 ± 620.93) 和 (5 987.01 ± 1 365.57)μg·h·L^{- 1} ; AUC _{0 - ￥} 平均值分别为 (1 697.45 ± 584.78) , (3 227.39 ± 641.54) 和 (6 192.36 ± 1 388.59)μg·h·L^{- 1} 。 结论 血浆药物的 <> ρ _max 和 AUC 随剂量的增大而增加,匹卡米隆的体内药代过程无性别差异。     

雷络酯片治疗类风湿性关节炎的临床研究

目的：观察雷公藤叶制剂－－雷络酯片治疗类风湿性关节炎的毒副作用。方法：采用前瞻性、多中心、随机双盲对照的方法，共观察类风温性关节炎２７７例，治疗组１４０例，口服雷络酯片，每次２片。，每天３次；对照组１３７例，口服雷公藤根制剂－－雷公藤多甙片，每次２片，每天３次。均６周为１个疗程。结果：治疗组愈显率２５．７１％， 有效率为８６．４３％；对照组愈显率２６．２８％，总有效率为８３．９４％，两组比较无显著