免费文献传递   相关文献

石茶感冒胶囊二种工艺样品的药效学对比研究



全 文 :*基金项目:省科研院所技术开发研究专项2003KFZX-28
 作者简介:赵春梅(1973~),女,云南昆明市人,医学硕士,工程师,从事药理、药代动力学研究。E-mail:zhaocm427@ya-
hoo.com.cn
石茶感冒胶囊二种工艺样品的药效学对比研究*
赵春梅,周铭涛,韦 迪,陈 娟,杨和金,崔 涛,苏 梅
(云南省药物研究所,云南 昆明 650111)
  摘 要:目的:观察与比较石茶感冒胶囊过柱和未过柱二
种工艺样品的镇痛、镇咳和免疫调节作用,为新药采用的提取
工艺的合理性提供药效学实验依据。方法:采用醋酸致小鼠
疼痛、浓氨水致小鼠咳嗽及2,4-二硝基氟苯致免疫功能低下
小鼠的迟发性超敏反应实验,对二种工艺样品进行同等生药
剂量的药效学对比研究。结果:在同等生药剂量下,二种样品
的药效作用以过柱样品作用较好,且用药量小于未过柱样品;
实验表明过柱样品具有明确的镇痛、镇咳及免疫调节作用。
结论:在保证药效作用的基础上,经过柱处理后的样品比未过
柱样品更具优势。研究结果为新药采用的提取工艺的合理性
提供了药效学实验依据。
关键词:石茶感冒胶囊;过柱;未过柱;镇痛;镇咳;免疫
调节
中图分类号:R286 文献标识码:A
文章编号:1007-2349(2012)09-0055-02
石茶感冒胶囊具有疏风散寒、益气解表的功效。用于接
触感冒群体,预防和治疗伤风感冒初起,症见恶寒发热,头痛
身痛,鼻塞流涕等症。本文综合评价石茶感冒胶囊二种工艺
样品(过柱样品、未过柱样品)对镇痛、镇咳及对免疫调节的影
响,为提取工艺的合理性提供药效学实验依据。
1 材料与方法
1.1 实验动物 SPF级ICR小鼠,雌雄兼用,体重18~22g;
SPF级SD大鼠,雄性,体重180~250g;合格证号:SCXK(滇)
20050008,由昆明医学院动物中心提供。
1.2  药 品 与 试 剂   石 茶 感 冒 胶 囊 未 过 柱 样 品,批 号
20080121;过柱样品,批号20080123,由云南省药物研究所
提供。
磷酸可待因购自国药集团工业股份有限公司、北京顺义
分公司;醋酸泼尼松片购自浙江仙琚制药股份有限公司;2,4
-二硝基氟苯(DNFB)购自中国医(集团)上海化学试剂公司;
苦甘冲剂购自青岛国风药业股份有限公司。
1.3 实验方法
1.3.1 对醋酸致小鼠疼痛的影响[1] 选用18~22gICR小
鼠108只,雌雄各半,按体重随机分为9组,每组雌雄各6只,
分组及给药情况见表1。除阿斯匹林组仅于实验当天灌胃给
药外,其余各组均预先每日灌胃给药1次,连续4d,各组灌胃
容积均为 20 mL/kg体重。末次给药后 30 min,每鼠按
0.1mL/10g体重的剂量腹腔注射0.6%冰醋酸,观察并记录
腹腔注射0.6%冰醋酸后15min内各鼠因疼痛引起的扭体
次数。
1.3.2 对浓氨水致小鼠咳嗽的影响[2] 选用18~22gICR
小鼠108只,雌雄各半,按性别和体重随机分为9组,每组雌
雄各6只,分组及给药情况见表2。除磷酸可待因组仅于实验
当天灌胃给药外,其余各组均预先每日灌胃给药1次,连续
4d,各组灌胃容积均为20mL/kg体重。末次灌胃后1h,将小
鼠逐一放入蒸发皿中,用500mL玻璃烧杯反扣于上,同时向
皿中迅速推入浓氨水0.08mL。以注入浓氨水至第一次张口
咳嗽的时间为动物的咳嗽潜伏期,观察并记录各鼠的咳嗽潜
伏期及120s内小鼠的咳嗽次数。
1.3.3 对2,4-二硝基氟苯诱导小鼠迟发性超敏反应的影
响[3] 选用18~22g小鼠108只,雌雄各半,按性别和体重随
机分为9组,每组雌雄各6只,分组及给药情况见表3。各组
动物每日按剂量灌胃给药1次,连续9d,阳性对照醋酸泼尼
松组和各给药组于给药第1、3、5、7、9d灌胃给予醋酸泼尼松
10mg/kg,各组灌胃容积均为20mL/kg体重。除空白对照组
外,其余各组动物于首次给药后1h于腹部皮肤均匀涂抹1%
DNFB混合液50uL/只致敏,并于第2、3天各加强1次。给
药第9d,以每耳10uL的容积于各鼠右耳两面均匀涂抹1%
DNFB混合液攻击,左耳涂等量丙酮:油混合液作为对照,激
发后16h脱颈椎处死动物,用直径6mm的打孔器将双耳同
部位等面积切下,取耳片称重,以左右两耳片重量之差即肿胀
度作为迟发性超敏反应值。
2 结果
2.1 对醋酸致小鼠疼痛的影响 石茶感冒胶囊未过柱样品
1.56g/kg剂量组、3.11g/kg剂量组、6.23g/kg剂量组能抑
制醋酸 所 致 小 鼠 的 扭 体 性 疼 痛,作 用 显 著 (P<0.01,
P<0.01,P<0.05),抑 制 率 分 别 为:54.17%、43.77%、
552012年第33卷第9期          云 南 中 医 中 药 杂 志
DOI:10.16254/j.cnki.53-1120/r.2012.09.039
37.73%;过柱样品0.30g/kg剂量组、1.20g/kg剂量组作用
显著(P<0.01,P<0.01),抑制率分别为:49.09%、45.10%。
未过柱样品镇痛作用与过柱样品相比较,无显著性差异。综
合评价对醋酸致小鼠的扭体性疼痛,未过柱样品镇痛作用与
过柱样品相当。结果见表1。
表1 二种工艺样品对醋酸致小鼠疼痛的影响
组 别
剂量
(/kg)
动物数
(只)
给药
途径
扭体次数
(-x ±s,次)
抑制率
(%)
空白对照 20mL  12 ig  68.92±25.13 ———
阿司匹林 0.20g  12 ig  9.33±15.36*** 86.46
苦甘颗粒 4.80g  12 ig  32.50±20.44** 52.84
1.56g  12 ig  31.58±20.41** 54.17
未过柱样品 3.11g  12 ig  38.75±16.76** 43.77
6.23g  12 ig  42.92±24.93* 37.73
0.30g  12 ig  35.08±15.11** 49.09
过柱样品 0.60g  12 ig  54.58±29.05  20.80
1.20g  12 ig  37.83±20.89** 45.10
  与空白对照组相比:*P<0.05,**P<0.01,***P<0.001
2.2 对浓氨水致小鼠咳嗽的影响 石茶感冒胶囊过柱样品
的0.30g/kg剂量组、1.20g/kg剂量组能抑制小鼠的咳嗽次
数,作用显著(P<0.01,P<0.01),能明显减少小鼠的咳嗽次
数,抑咳率分别为57.16%、50.94%;未过柱样品仅有作用趋
势而无统计学差异(均为P>0.05);未过柱样品3.11g/kg剂
量组能抑制浓氨水致小鼠咳嗽的潜伏期(P<0.05),延长率为
62.79%。未过柱样品镇咳作用与过柱样品相比较,具有显著
性差异,过柱样品具有明显的镇咳作用(P<0.05)。综合评价
对浓氨水致小鼠咳嗽,过柱样品的镇咳作用强于未过柱样品。
结果见表2。
表2 二种工艺样品对浓氨水致咳嗽小鼠的影响
组别
剂量
(/kg)
动物数
(只)
给药
途径
咳嗽潜伏期
(-x ±s,s)
延长率
(%)
咳嗽次数
(-x ±s,次)
抑咳率
(%)
空白对照 20mL  11 ig  25.08±11.13 ——— 36.18±16.70 ———
磷酸可待因 60mg  12 ig  38.50±26.21 53.49 9.45±7.58** 73.87
苦甘颗粒 4.80g  10 ig  28.58±17.49 13.95 33.90±26.22  6.31
1.56g  12 ig  29.50±13.03 17.61 24.83±13.06  31.36
未过柱样品 3.11g  11 ig  40.83±20.29* 62.79 23.18±16.47  35.93
6.23g  12 Ig  26.17±11.71  4.32 35.17±23.19  2.80
0.30g  10 ig  30.33±13.12 20.93 15.50±13.52** 57.16
过柱样品 0.60g  12 ig  29.25±12.15 16.61 22.50±15.19  37.81
1.20g  12 ig  34.92±19.08 39.20 17.75±10.75**△50.94
  与 空 白 对 照 组 相 比:* P <0.05,** P <0.01,与 未 过 柱 样 品 组 相
比:△P<0.05
2.3 对2,4-二硝基氟苯诱导小鼠迟发性超敏反应的影响 
石茶感冒胶囊以未过柱样品6.23g/kg剂量组及过柱样品
0.30g/kg剂量组能增加由醋酸泼尼松致免疫功能低下小鼠
的迟发性超敏反应;作用显著(P<0.05,P<0.05),肿胀率分
别为183.84%、170.88%。未过柱样品免疫调节作用与过柱
样品相比较,具有显著性差异,过柱样品具有明显的免疫调节
作用(P<0.05)。综合评价对醋酸泼尼松致免疫功能低下小
鼠的迟发性超敏反应,过柱样品的作用略强于未过柱样品。
结果见表3。
表3 二种工艺样品对免疫功能低下模型小鼠迟发性超敏反应的影响
组 别
剂量
(/kg)
动物数
(只)
给药
途径
耳廓肿胀度
(-x ±s,mg)
肿胀率
(%)
空白对照 20mL  12 ig  1.67±1.20 —
醋酸泼尼松(模型) 0.20g  12 ig  0.73±0.68* —
苦甘颗粒+醋酸泼尼松 4.80g  12 ig  0.94±0.72  29.01
1.56g  12 ig  0.87±0.60  19.34
未过柱样品+醋酸泼尼松 3.11g  12 ig  1.18±0.83  61.22
6.23g  11 ig  2.08±1.81△ 183.84
0.30g  12 ig  1.98±1.70△▲170.88
过柱样品+醋酸泼尼松 0.60g  11 ig  1.21±0.89  65.31
1.20g  12 ig  1.30±0.72  77.47
  与空白对照组相比:*P<0.05,与模型组相比:△P<0.05,与未过柱
样品组相比:▲P<0.05
3 讨论
通过醋酸致小鼠疼痛、浓氨水致小鼠咳嗽及2,4-二硝基
氟苯致免疫功能低下小鼠的迟发性超敏反应实验,观察与比
较石茶感冒胶囊过柱 (批 号 20080123)和 未 过 柱 (批 号
20080121)二种工艺样品的药效作用,为新药采用提取工艺的
合理性提供药效学实验依据。结果表明:二种工艺样品均能
明显抑制醋酸所致小鼠的扭体性疼痛;减少浓氨水致小鼠咳
嗽的次数;对醋酸泼尼松致免疫功能低下小鼠的迟发性超敏
反应有明显增强作用。在同等生药剂量下,综合评价过柱样
品的药效强于未过柱样品;且在同等生药剂量下的用药量远
远小于未过柱样品,故可大大减少临床服用量。综上所述,在
保证药效作用的基础上,经过柱处理后的样品比未过柱样品
更具有优势。
参考文献:
[1]陈奇 .中药药理研究方法学[M].北京:人民卫生出版社,
1993:378.
[2]徐叔云 .药理实验方法学[M].北京:人民卫生出版社,1982:1166
~1168.
[3]徐 叔 云 .药 理 实 验 方 法 学 [M].北 京:人 民 卫 生 出 版 社,
1994:1226.
(收稿日期:2012-07-18)
65 云 南 中 医 中 药 杂 志          2012年第33卷第9期
Yunnan Journal of Traditional Chinese Medicine and Materia Medica
Vol.33.No.9 (General No.231) September,2012
Main Content
Clinical Study on the Lipid-reducing Effect of Jiaweishengjiang Powderon T2DM and Dyslipidemia Patients
   YANG Juan,LI Xue-mei………………………………………………………………………………………………………………………………
Clinical Observation on the Effect of Blood Stasis Removing Decoction Combined with Hyperbaric Oxygen on the Treatment
of Traumatic Brain Injury Patients
   LIANG Shao-hua,HUANG Xin,ZHU Shou-hong………………………………………………………………………………………………
Study on the Inhibition of Panax Notoginseng Saponins on Cel HCCLM3of Liver Cancer Metastasis
   CHEN Peng,WANG Zhi-ping,LI Wen,et al.……………………………………………………………………………………………………
A Comparative Study on the Pharmacodynamic Effect of Two Process Samples of Stone Tea Colds Capsules
   ZHAO Chun-Mei,ZHOU Ming-tao,WEI Di,et al.………………………………………………………………………………………………
Clinical Study on the Lipid-reducing Effect of Jiaweishengjiang Powder on T2DM and Dyslipidemia Patients
YANG Juan,LI Xue-mei
(The Second Hospital Affiliated to Guiyang Medical Colege,Guiyang,Guizhou,550003)
Abstract:Objective:To observe the lipid-reducing effect of Jiaweishengjiang Powder on T2DM and dyslipidemia patients.Methods:90
TZDM and dyslipidemia patients were randomly divided into three groups,i.e.Jiaweishengjiang Powder group,lipids level control group and blank
control group,30patients per group.The patients of the 3groups were treated for 2months,and their clinical manifestations,blood lipids,free
fatty acids and insulin level were observed before and after the treatment.Results:(1)The lipid indicators of the treatment group showed a
significant difference(P<0.05)in its self-comparison in which the triglyceride of the patients showed more significant difference(P<0.01)
before and after the treatment.TCM syndrome improvement and the integrated efficacy of the treatment group were superior to that of the lipids
level control group.(2)The self-comparison of free fatty acid levels of the treatment group was significant difference(P<0.01)before and after
the treatment.(3)The self-comparison of the insulin levels of the treatment group was differences(P<0.05).The hyperinsulinemia of 7patients
improved after the treatment at varying degrees.(4)In the test procedure,2patients of the treatment group had mild diarrhea early in the
treatment,probably related to rhubarb.One patient was treated with reduced rhubarb dose and another kept the original treatment.Their diarrhea
symptoms disappeared.Conclusions:(1)TCM turbid-expeling,phlegm-reducing and activating boold circulation treatment has an extraordinary
effect on the treatment of T2DM and dyslipidemia patients.(2)The study discovers Jiaweishengjiang Powder has a certain regulatory effect on the
free fatty acids.(3)The study discovers Jiaweishengjiang Powder has a certain improvement for the insulin resistance and hyperinsulinemia of
T2DM patients.(4)The prescription is safe and effective for the lipid-lowering of T2DM patients.
Key words:T2DM diabetes,dyslipidemia,free fatty acids
Clinical Observation on the Effect of Blood Stasis Removing Decoction Combined with Hyperbaric Oxygen on the Treatment
of Traumatic Brain Injury Patients
LIANG Shao-hua,HUANG Xin,ZHU Shou-hong
(Ruikang Hospital Affiliated to Guangxi Medical University,Nanning,Guangxi,530011)
Abstract:Objective:To observe the clinical efect of blood stasis removing decoction combined with hyperbaric oxygen on the treatment of traumatic brain
injury patients.Methods:84patients were randomly divided into two groups.The observation group was treated with the therapy of the blood stasis removing
decoction combined with hyperbaric oxygen while the control group were treated with conventional hyperbaric oxygen therapy.Results:The GCS score of the
observation group improved significantly,compared with that of the control group in the first 10days and 20days.The eficacy evaluation of the observation group
was significantly higher than that of the control group in the three months after the injury.Conclusion:The therapy of blood stasis removing decoction
combined with hyperbaric oxygen has a good effect on the treatment of traumatic brain injury patients.
Key words:blood stasis removing decoction,traumatic brain injury,hyperbaric oxygen
Study on the Inhibition of Panax Notoginseng Saponins on Cel HCCLM3of Liver Cancer Metastasis
CHEN Peng,WANG Zhi-ping,LI Wen,et al.
(Hepatobiliary Surgery Department,The Second Affiliated Hospital of Kunming Medical University,Kunming,Yunnan,650101)
Abstract:Objective:To study the effect of panax notoginseng saponins(PNS)on the HCCLM3proliferation of liver cancer metastatic cels.
Methods:HCCLM3of high metastatic hepatocelular carcinoma cel lines were used as the study object to detect the impact of different
concentrations of PNS on the growth of the liver cancer cels by MTT and a phase-contrast microscope was used to observe the impact of PNS on
hepatoma cel morphology.Results:The cel survival rate of PNS treatment group reduced compared with that of the control group.This effect
becomes more obvious with the increasing time and concentration of the drug.The cel density reduced after the treatment of PNS through the
observation under the phase-contrast microscope.Conclusion:PNS has an inhabitation effect on the growth of HCCLM3cels.
Key words:PNS,liver tumors,proliferation
A Comparative Study on the Pharmacodynamic Effect of Two Process Samples of Stone Tea Colds Capsules
ZHAO Chun-Mei,ZHOU Ming-tao,WEI Di,et al.
(Yunnan Institute of Materia Medica,Kunming,Yunnan,650111)
Abstract:Objective:To observe and compare the analgesic,antitussive and immunomodulatory efect of stone tea colds capsules of two process samples to
provide pharmacodynamic experimental basis for a new drug extraction process.Methods:The painful mice induced by acetic acid and mouse cough induced by
concentrated ammonia and delayed hypersensitive mice by 4-dinitrofluorobenzene were used to compare the pharmacodynamic efect of two process samples with
equal crude drug dose.Results:In the same crude drug dose of the two samples,the column chromatographic separation drug had a better pharmacodynamic efect
and the dosage was less than the non-column chromatographical separation sample.The experiments showed the column chromatographic separation sample had
clear analgesic,antitussive and immunomodulatory efects.Conclusion:Based on the assurance of pharmacodynamic efect,the column chromatographic separation
sample has a better efect than that of non-column chromatographical separation sample.
Key words:tea stone colds capsule,column chromatographic separation,non-column chromatographic separation,analgesia,antitussive,
immunomodulatory