格列吡嗪片在健康人体内的药物动力学及相对生物利用度

目的 :研究格列吡嗪片在健康人体的药物动力学及相对生物利用度。方法 :9名健康受试者单剂量随机交叉口服格列吡嗪片参比制剂和被试制剂 5mg ,采用HPLC法测定用药后不同时间的血药浓度。 结果 :2种制剂的体内过程均符合一房室开放模型 ,Tmax分别为 (3 .67± 0 .50 )h和 (3 .33± 0 .50 )h。Cmax分别为 (391± 37) μg·L- 1和 (40 0± 35) μg·L- 1 ,AUC分别为 (2 .46± 0 .39) μg·h·L- 1 和 (2 .2 3± 0 .88) μg·h·L- 1 ,被试制剂的相对生物利用度为 (1 0 2 .9± 1 5 .7) %。结论 :用NDST软件对两种制剂的AUC、Cmax、Tmax进行双单侧t检验 ,证明两种制剂具有生物等效性。     

尼莫地平在健康人体内的药动学和相对生物利用度

目的 :研究尼莫地平在健康人体内的药动学和相对生物利用度。方法 :8名健康受试者单剂量随机交叉口服尼莫地平标准参比制剂和待测制剂 1 2 0mg,采用HPLC法测定用药后不同时间的血药浓度。结果 :2种制剂的体内过程均符合一房室开放模型 ,AUC分别为 (1 4 3.1± 9.9) μg·h·L-1 和 (1 37.0± 7.3) μg·h·L-1 ,Cmax分别为 (83.1±7.4 ) μg·L-1 和 (80 .8± 4 .6 ) μg·L-1 ,Tmax分别为 (1 .0 0± 0 .0 0 )h和 (1 .0 6± 0 .1 7)h。待测制剂的相对生物利用度为 (96 .0± 5 .9) %。经双向单侧t检验证明 ,2种制剂的AUC、Cmax相比 ,差异均无统计学意义。结论 :2种制剂具有生物等效性。     

盐酸曲马多片剂人体相对生物利用度

目的:研究盐酸曲马多片剂在人体内的相对生物利用度。方法:采用HPLC法测定 18名男性健康受试者单剂量交叉口服 100mg2种盐酸曲马多片剂后不同时间血浆中的药物浓度。结果: 2制剂药 时曲线均符合一房室模型,Cmax分别为(410. 0±71. 1)μg·L-1和 (427. 0±57. 1)μg·L-1,Tmax分别为 (2. 20±0. 49)h和 (2. 20±0. 55)h;T1 /2ke分别为(7. 13±0. 83 )h和 ( 7. 08±0. 74 )h;AUCt0 分别为 ( 4 376±855 )μg·h·L-1和 ( 4 514±1 068)μg·h·L-1,AUC∞0 分别为(5 184±1 112)μg·h·L-1和(5 241±1 330)μg·h·L-1。与参比制剂相比,被试制剂的Ft0 为(98. 94±16. 04)%,F∞0 为(1 101. 90±21. 92)%。结论: 2种制剂具有生物等效性。     

格列齐特片健康人体药物动力学及相对生物利用度

目的　研究格列齐特片的健康人体药物动力学及相对生物利用度。方法　 8例健康受试者单剂量交叉口服格列齐特片标准参比制剂和被试制剂 80mg后 ,用高效液色谱法测定血浆中格列齐特片浓度。结果　两药体内过程均符合一房室开放模型 ,Tmax分别为 (5 5 0± 0 5 3)h和 (5 0 0± 0 5 3)h ,Cmax为 (2 95± 0 4 1)mg·L-1和 (3 0 2± 0 31)mg·L-1,AUC为 (45 79± 5 99)mg·h·L-1和 (42 99± 6 93)mg·h·L-1,被试制剂的相对生物利用度为 (10 2 9± 8 2 ) %。两种制剂的药动学参数无显著性差异。结论　两种制剂具有生物等效性。     

地尔硫(艹卓)缓释片在健康人体的药物动力学

目的 :研究地尔硫 卓艹 缓释片在健康人体的药物动力学及相对生物利用度。方法 :以上海产地尔硫 卓艹 缓释片为参比制剂 ,焦作市第二制药厂产地尔硫卓艹 缓释片为受试制剂 ,分别进行单次和多次用药试验 ,12名受试者采用随机交叉口服单剂量 (12 0mg)和多剂量 (6 0mg ,3次 /d ,共用 5d)地尔硫卓艹 缓释片。高效液相色谱 (HPLC)法测定用药后不同时间血清中地尔硫 卓艹质量浓度 ,用 3P87软件处理药 时数据。结果 :单次用药后 ,2制剂的体内过程均符合一房室开放模型 ,血药浓度分别在用药后 (2 .0 0± 0 .5 2 )h和 (1.88± 0 .43)h达峰值 (131± 17) μg·L-1和 (12 2± 11)μg·L-1,药时曲线下面积 (AUC)分别为 (112 2± 2 5 6 ) μg·L-1和 (110 9± 2 32 ) μg·h·L-1,受试制剂的相对生物利用度为(10 0 .0± 11.9) % (84.4%～ 117.5 % ) ;多次用药血药浓度达稳态后 ,峰浓度 (Cmax)分别为 (111± 8) μg·L-1和 (10 9± 9)μg·L-1,谷浓度 (Cmin)分别为 (35± 9) μg·L-1和 (38± 10 ) μg·L-1。两者血药浓度波动系数 (FI)分别为 (1.2 3± 0 .2 9)和 (1.12± 0 .2 3)。结论 :受试制剂在健康人体具有明显的缓释特征 ,且和参比制剂具有生物等效性。     

克拉霉素分散片在健康人体内的相对生物利用度

目的：研究克拉霉素分散片在健康人体内的相对生物利用度，评价其生物等效性。方法：采用微生物法测定9名受试者单剂量交叉口服500mg克拉霉素分散片和片剂后不同时间血清中药物浓度，用3P87程序软件处理血药浓度-时间数据。结果：2制剂体内过程均符合一室模型，Cmax分别为(3．09±0．29)mg·L-1和(2．98±0．37)mg·L-1；Tmax分别为(1．37±0．35)h和(1．56±0．42)h；T1/2分别为(4．±0．92)h和(4．09±0．71)h；AUC为(22．6±3．6)mg·h·L-1和(23．00±3．90)mg·h·L-1，被试制剂的相对生物利用度为(98．7±10．9)％(82．5％～117．4％)。结论：2种制剂具有生物等效性。     

头孢克洛在健康人体的药代动力学和相对生物利用度

目的:研究头孢克洛在健康人体的药动学及相对生物利用度。方法:18名健康受试者随机交叉单剂量口服头孢克洛片标准参比制剂和被试制剂500mg,采用微生物法测定不同时间血清中药物浓度。结果:两制剂的体内过程均符合一房室开放模型,其主要药动学参数Cmax分别为(13.94±1.55)mg·L-1和(14.10±1.45)mg·L-1,Tmax为(0.72±0.15)h和(0.75±0.12)h,T1/2ke为(0.65±0.05)h和(0.69±0.06)h,AUCt0为(15.78±2.75)mg·h·L-1和(14.86±2.98)mg·h·L-1,AUC∞0为(15.96±2.74)mg·h·L-1和(15.10±3.04)mg·h·L-1。被试制剂的相对生物利用度为(107.99±17.82)%。结论:2种制剂具有生物等效性。     

吉非罗齐胶囊在健康人体内的相对生物利用度

目的 :研究吉非罗齐胶囊在健康人体内的相对生物利用度。方法 :采用高效液相色谱 (HPLC)法测定 18名男性健康受试者单剂量交叉口服 90 0mg 2种吉非罗齐胶囊后不同时间血浆中的药物浓度。结果 :二者药 时曲线均符合一房室模型 ,Cmax分别为 (45 .2 4± 10 .15 )mg·L-1和 (43.38± 9.84 )mg·L-1;Tmax分别为 (2 .4 7± 0 .93)h和 (2 .2 5±0 .75 )h ;T1/ 2 分别 (1.5 9± 0 .19)h和 (1.75± 0 .2 9)h ;AUC分别为 (16 5 .79± 37.79)mg·h·L-1和 (15 6 .39± 32 .2 8)mg·h·L-1。被试制剂的相对生物利用度为 (95 .5 5± 11.4 5 ) % (77.0 3%～ 119.4 5 % )。结论 :2种制剂具有生物等效性。     

青霉素V钾颗粒剂在健康人体中的药动学及相对生物利用度

目的 :研究青霉素V钾颗粒剂在健康人体中的相对生物利用度 ,评价其生物等效性。方法 :以美国进口的青霉素V钾片为标准参比制剂 ,研究洛阳春都制药公司研制的青霉素V钾颗粒剂相对生物利用度。 10名健康受试者随机交叉口服青霉素V钾被试及参比制剂各 15 0 0mg后 ,采用微生物法测定不同时间血清中药物浓度 ,用3P87软件经微机处理药 时数据。结果 :2种制剂的体内过程均符合二房室开放模型。Cmax分别为 (12 92± 2 2 1)mg·L- 1 和 (12 91± 2 0 4)mg·L- 1 ,Tmax均为 (0 70± 0 11)h ,曲线下面积 (AUC)分别为 (2 0 30± 2 90 )mg·h·L- 1 和 (19 39±2 35 )mg·h·L- 1 。与参比制剂相比 ,被试制剂的相对生物利用度为 (96 0 0± 5 5 6 ) % (86 14%～ 10 5 35 % )。结论 :对2种制剂的AUC、Cmax等进行方差分析、双单侧t检验证明 ,2种制剂具有生物等效性。     

国产与进口降糖药瑞格列奈片的生物等效性研究

目的 :评价国产与进口降糖药瑞格列奈片的生物等效性。 方法 :2 2名男性健康志愿者双周期随机交叉单剂量口服国产与进口瑞格列奈片 4m g,服药间隔为 1周 ,高效液相色谱法测定血浆中瑞格列奈浓度。 结果 :国产与进口片 t1 / 2 分别为(0 .86± 0 .2 4)和 (0 .83± 0 .31) h;tmax分别为 (0 .79± 0 .37)和 (0 .75± 0 .41) h;cmax分别为 (5 2 .43± 2 0 .92 )和 (5 3.32±2 4.94) μg/ L;AU C0 - t分别为 (79.87± 36 .48)和 (74.95± 30 .5 7) μg· h· L- 1。单剂量口服国产瑞格列奈片的相对生物利用度为 (10 6 .5 5± 16 .15 ) %。 结论 :方差分析和双向单侧 t检验结果表明两种制剂具有生物等效性。     

Acupuncture Treatment of Vomiting

CASE HISTORY A female patient, 46 years old, head of the foreign affairs department of a certain university in Beijing, paid her first visit on October 9, 2006, with the chief complaint of vomiting for one month. She got vomiting after meals in early September. Before that, she had discomfortable sensation in the stomach due to angry with others, but she didn't pay much attention. Later, it developed into vomiting after eating. After the vomiting, the discomfort would be relieved, but with slight hypodynamia. She was once diagnosed as having 'neurogenic vomiting'. Having taken some western and Chinese drugs, the above symptoms were a little bit improved, but she would have nausea upon eating and with regurgitation. Because of the fear for vomiting, she did not dare to have food intake, with body weight reduction of 6 kilos in one month.     

Qiu Baoguo''''s Experience in Treating Consumptive Syndromes after Radio-Chemotherapies

Radiotherapy and chemotherapy are the important modern medical therapies for malignant tumors,yet they can also bring about serious local and systemic toxic side reactions so to decrease the patient;'s life quality,manifested by a series of consumptive symptoms.Having engaged in the combined work of Chinese and western medicine for nearly 50 years,the research fellow Qiu Baoguo in Henan Provincial Academy of TCM has developed his unique views on the TCM study of consumptive syndromes.The author of this essay had once the fortune tO follow Dr.Qiu in clinic,and specially would like to introduce in the following Dr.Qiu's experience in treating consumptive syndromes after radio-chemotherapies for patients with malignant tumor.     

Insomnia Due to Deficiency of Both the Heart and Spleen Treated by Acupuncture-Moxibustion and Chinese Tuina

OBJECTIVE: To observe therapeutic effects of the comprehensive therapy of acupuncture-moxibustion and Chinese Tuina for treatment of insomnia due to deficiency of both the heart and spleen. METHODS: 92 cases were divided randomly into the treatment group (treated by acupuncture-moxibustion and Chinese Tuina) and the control group (treated by acupuncture-moxibustion). RESULTS: The therapeutic effect of the treatment group was obviously superior to that of the control group (the CHI2 test showed P < 0.01). CONCLUSIONS: The comprehensive therapy of acupuncture-moxibustion and Chinese Tuina can give marked therapeutic effects for treatment of insomnia due to deficiency of both the heart and spleen.     

Analysis of CK-19,PDX-1,Nestin,Ngn3 in different donor islet purity in rats

Objective: To investigate if there are the CK-19, PDX-1, Nestin, Ngn3 positive cells in the donor islets of different purity in rats. Methods: Thirty male adult SD rats were randomly divided into 3 groups. Islets were isolated using digestion by ductal injection of collagenase. Group Ⅰ (n=10): Separating cell preparations were not purified, Group Ⅱ(n=10): Islet sediment was purified with 25% Ficoll400 ,Group Ⅲ (n=10): Islet sediment was purified with 25% and 11% Ficoll-400. The levels of protein of CK-19, PDX-1, Nestin and Ngn3 were detected by immunohistochemistry and the mRNA of CK-19, PDX-1, Nestin, Ngn3 was amplified by RT-PCR. Results: After two different purification methods applied, three islet preparations of different purities were obtained. The difference of islet purity was significant among various groups (P＜0.05). Compared with group Ⅱ and group Ⅲ,the protein and mRNA of CK-19, PDX-1, Nestin,Ngn3 were both higher in group Ⅰ; group Ⅲ was poorly expressed. Conclusions: The three different islet purity donor islet have different CK-19, PDX-1, Nestin, Ngn3 positive cells within them, indicating that there are some islet stem cells in the purified donor islet.     

A preliminary screening study on the associated proteins in human psoriasis vulgaris by serum proteomics technologies

Objective：To investigate the optimum screening conditions of associated proteins in human psoriasis vulgaris by serum proteomics technique, and to screen the different expression proteins related with psoriasis vulgaris. Methods：Serum samples of peripheral blood were collected from newly diagnosed psoriasis vulgaris patients in the clinic, and 20 matched healthy persons. Serum albumin IgG was removed by filtering with ProteoExtract Albumin/IgG. After comparative proteomics analysis the different protein spots were identified using 2-DE and MS. Results ：Electrophoresis figures with high resolution and reproducibility were obtained. Three different expression proteins were found only in the serum from psoriasis vulgaris patients, while nine other different proteins expressing from healthy volunteers. Conclusion：The protein expression was different in the serum between the psoriasis vulgaris patients and healthy volunteers. It was hoped that we could find the biomarkers related to psoriasis vulgaris by using proteomics.     

A CASE OF HUGE GASTRIC DISOPYROBEZOAR

PYTOBEZOARS are common bezoars in gastrontestinal tract, commonly seen in stomach and mall intestine,1but huge disopyrobezoars are     

Acupuncture Treatment of Chest Bi Syndrome

CASE HISTORY A male,a retired officer of 61 years old,paid his first visit on May 12,2006.The patient stated that 2 weeks before he suddenly got paroxysmal precordial choking pain,with irregular attacks.Each attack would last several seconds to several minutes.The attack was accompanied with heavy oppressed sensation in the precordial region,palpitation,lassitude,and in severe cases,sweating,which was once diagnosed by a hospital as'coronary heart disease'.Recalling the case history,the patient said that several days before he got angry with others because of some affairs in work,and he was not so used to the life pattern since he had just retired from his busy working post.At usual times,he was quick tempered and peevish.In recent days,he had poor appetite,and loose stool.     

Instructions to Contributors

The English edition of Chinese Journal of Integrative Medicine is edited and published by the Chinese Journal of Integrated Traditional and Western Medicine Press.Original scientific papers of advanced clinical and experimental medicine in the field of complementary/alternative medicine or integrative medicine are expected.     

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