The orphan drug management system can significantly improve the quality of care and that of life of patients suffering from rare diseases, and accelerate the progress of medicinal science. With experiences of practicing the orphan drug management system in developed countries and regions,including certification of orphan drugs, supports for developing orphan drugs, market protection and clinic application management. Based on such studies, the authors discussed the feasibility and methodology of establishing an orphan drug management system in China, along with the significance of such a system.

Objective To establish a method for content determination of hyodeoxycholic acid in Qingkailing Injection. Methods An UltimateXB-C18 column (5 ?m, 250 mm?4.6 mm) was used with a mobile phase of acetonitril-water-phosphoric acid (35∶65∶0.1). The flow rate was 1 mL/min. The temperature of the column was 40 ℃. The detection wavelength was 192 nm. Results There was a good linear relationship between the concentration of hyodeoxycholic acid and absorption area value in range of 0.201 35～1.006 75 mg/mL, r=0.999 6. The average recovery was 98.25% with RSD=1.26%. Conclusion This method was accurate, credible and repeatable which can be used to control the quality of Qingkailing Injection.

Matrix metalloproteinase-8 (MMP-8) is a collagen which belongs to matrix metalloproteinase.Its function is that degrades collagen and be involved in inflammation.In breast cancer,the level of expression of MMP-8 is related to the invasion and metastasis of breast cancer as well as the clinical and pathological stage of breast cancer,but it is unclear on the molecular mechanism of MMP-8 in the malignant tumor.The research of expression in breast cancer prognosis of breast cancer will provide a reliable assessment of molecular marker.

Objective To investigate the expression of matrix metalloproteinase-8 (MMP-8) in human breast cancers and its relationship with the clinicopathological parameters,evaluate the relevance of MMP-8 levels to metastases in breast cancer.Methods Human specimens were obtained from 50 patients with invasive ductal carcinomas,and 20 normal breast glands were enrolled.Intact clinical parameters were aviliable for all patients.The protein expression of MMP-8 was determined by immunohistocbemistry technology SP.Results The rate of MMP-8 positive breast cancer was significantly higher than that in normal breast glands [68 ％ (34/50) vs 15 ％ (3/20),P ＜ 0.05].The expression of MMP-8 showed a negative correlation with breast cancer staging.The expression of MMP-8 in stage Ⅰ was higher than that in stage Ⅱ and Ⅲ/Ⅳ[94 ％ (15/16),57 ％ (13/23),55 ％ (6/11),P ＜ 0.05].Lymph node negative patients had a higher MMP-8 expression than patients with lymph node metastases [84 ％ (21/25) vs 50 ％ (13/25),P ＜ 0.05].Conclusion MMP-8 expression is associated with human breast cancer metastases and might be involved in inhibiting metastases.

Nausea and vomiting are among the most common complications after surgery. Postoperative nausea and vomiting(PONV) may cause wound dehiscence, pulmonary aspiration, dehydration, and electrolyte disturbances. Despite the new classes of antiemetics and research published, PONV remains high incidence still. This article covers the different pharmacologic strategies taken introduced with multimodal approach by using antiemetic drugs for prevention and treatment of PONV.

Over the years,the sociological and medical researchers have worked together on smoking cessation intervention model and conducted extensive programs to improve the confidence of smokers,to overcome the withdrawal symptoms and other difficulties in quitting,and to improve the success rate of smoking cessation.This paper reviews the major intervention models of smoking cessation and their implementation in recent years,including psychological intervention,behavior intervention,drug intervention and combined intervention;and also some intervention methods including acupuncture therapy,nicotine vaccine and others.The systematic implementation of smoking cessation model facilitates the success of smoking cessation.

Objective]This article discussed Professor Xie Jianguo's survival with tumor experience on advanced lung cancer treatment in the last decade. [Methods]To observe Professor Xie Jianguo's survival with tumor experience of advanced lung cancer on the clinical treatment process, and organize related cases, which summarized the unique thoughts of treatment, commonly used empirical prescriptions and demonstrated with typical clinical cases. [Resluts] Professor Xie Jianguo's theoretical guidance on advanced lung cancer treatment, included tumor inhibition, anticancer effect, survival with tumor. Treatment methods, included recruitment of the vital qi, adjusting the internal environment, the phlegm, stasis toxin factors, with rigorous thinking, sophisticated medication. [Conclusion] Professor Xie Jianguo's survival with tumor experience on advanced lung cancer treatment has remarkable significance in guiding clinical treatment.

Objective To investigate the diagnostic and theraputic problems in patients with smooth muscle tumors of the duodenum.Method The clinical data from 7 cases smooth muscle tumors were analyzed retrospectively which were treated surgically and confirmed pathologically in our hospital from 1987 to 2001.Results Of all the cases,4 had a leiomyoma in the duodenum and 3 leiomysarcoma.This disease is lack of pathognomonic sign and difficult for early diagnosis.All the cases were treated surgically and got good results.Conclusions Upper gastrointestinal bleeding is common in patients with this disease.Upper gastrointestinal tract examination and gastrduodenoscopy and CT scan are the main methods for diagnosis.Operation is the best choice for treatment.

Some transport systems are foun d both in intestine and kidney with functional and morphological similarities, suc h as peptide transport system, organic anion transport system, organic cation tr ansport system, and P-glycoprotein-mediated transport system. All these transp ort systems participate in the transporting process of ?-lactam antibiotics in different extent. It suggests that inhibitors of renal transport may also affec t the drug absorption of the intestine.

OBJECTIVE:To establish a method for the determination of serum indapamide concentration.METHOD:10healthy male volunteers were assigned to receive7.5mg indapamide capsule on empty stomach with time-concentration de?termined by HPLC,and the pharmacokinetics parameters were accounted.RESULTS:C max was(0.212?0.167)mg/L,t max was(2.14?0.59)h,t 1/2 was(19.69?0.75)h,AUC 0～72 was(3.636?0.503)(mg?L)/h and AUC 0～∝ was(3.937?0.518)(mg?L)/h.CONCLUSION:The established method can be used for the clinical analysis on the use of indapamide and its pharmacokinetics study.