Quality control of traditional Chinese medicine (TCM) has become bottlenecks of TCM industry devel-opment and TCM international recognition. To solve the retational problems, we explored the establishment of new quality control method based on efficacy and safety. Firstly, material basis of TCM efficacy was investigated deeply and systematically. Then, quality control method based on efficacy was established by using active ingre-dients as markers. We also establish detection methods based on safety, such as pesticide residues, heavy metals and harmful elements , mycotoxins .

AIM:To establish a specific method for the identification of 26 chemical drugs added illegally into analgesic-antipyretic traditional Chinese medicines and health food. METHODS: The liquid chromatography-ion trap mass spectrometry method was used.Comparing with retention time and spectrums of references in library set up by ourselves,the target compounds in sample were screened and identified. RESULTS: Sixty samples were tested and Naproxen,Ibuprofen and Aspirin were detected out. CONCLUSION: The method is accurate,sensitive and easy to operate, which is first reported in China and so many compounds could be detected at the same time.

AIM:To assess the protective role of melatonin(MEL)in a rat model of oleic-induced acute lung injury.METHODS:Twenty-four rats were randomly allocated to three groups as follows:saline(NS)injection group,oleic acid(OA)injection group and MEL plus OA injection group,the lavage protein,lung wet-to-dry weight ratio,malondialdehyde(MDA)content,superoxide dismutase(SOD)activity and lung histopathology were examined.RESULTS:(1)Injection 0.15 mL/kg of OA led to a severe acute lung injury(ALI),characterized by significantly increasing in lavage protein,lung coefficient(P＜0.01),and by histopathological alterations which presented hemorrhage,edema.thickened alveolar septum and the existence of inflammatory cells in alveolar spaces;(2)Infusion of MEL(20 mg/kg,intraperitoneally for 60 min before the oleic acid)markedly alleviated above-mentioned symptom induced by OA,consistent with decrease of MDA level(P＜0.01) and the increase of SOD activty(P＜0.01).CONCLUSION:Pre-treatment with MEL can attenuate the OA -induced ALI in rats via cleaning and preventing the formation of free radicals and further lessening the increase of alveolocapillary membrane permeability,these data suggest that MEL may be effective in the prevention of ALI.

In order to reaction the quality present situation, problems on the current quality of animal sources of drugs are summed up by using test data analysis, literature search and marketing research. This paper can also help the improvement of the quality management, the revision of the relevant department policy system and the improvement of standards.
Animals ; China ; Medicine, Chinese Traditional ; standards ; Pharmaceutical Preparations ; analysis ; standards ; Quality Control

ObjectiveTo define the maximum tolerated dose (MTD) of weekly cisplatin in concurrent chemoradiotherapy for Chinese cervical carcinoma.MethodsCervical carcinoma of stage ⅠB2- ⅣA were eligible for the study.PhaseⅠstudy was dose-escalation trial with 15 patients.All patients received whole pelvic radiotherapy with three dimentional conformal radiotherapy technique. Concurrent cisplatin started from the dose of 20 mg/m2 to 25 mg/m2,30 mg/m2,35 mg/m2,40 mg/m2 for the weekly schedule ( ≥3 patients per dose group) and the doses were steadily escalated to 40 mg/.m2.If the dose was increased to 40 mg/m2 without dose-limiting toxicity ( DLT),40 mg/m2 would be the maximum tolerated dose (MTD).According to the MTD dose from Phase Ⅰ study,we conducted phase Ⅱ clinical trial with 36 patients.ResultsIn Phase Ⅰ study,cisplatin dose was escalated to 40 mg/m2 and DLT had not been reached.Thirty-six patients in Phase Ⅱ study included 9 inpatients and 27 outpatients.All 9 inpatients completed 6 cycles of chemotherapy. In 27 outpatients,18 patients (66％) completed 6 cycles of chemotherapy,19 patients (70％) completed 5 cycles and 25 patients (92％) completed 4 cycles of chemotherapy.All patients completed radiotherapy.Major adverse effects were grade 1 and 2 gastrointestinal toxicities and neutropenia.ConclusionsWeekly 40 mg/m2 cisplatin concurrent with radiotherapy is well tolerated when given to Chinese patients with cervical carcinoma. For outpatients with poor performance status,the cisplatin dose needs to be reduced.

Objective To summarize the experience of totally endoscopic thyroidectomy (TET) in treating differentiated thyroid carcinoma and to evaluate its feasibility, safety and the therapeutic result.Methods The clinical data of 25 cases of thyroid carcinoma treated with TET via the areola of breast or by axillary approach from November 2004 to July 2009 in our hospital were retrospectively analyzed.Result TET procedures were successfully performed in all 25 cases. Postoperative pathology confirmed that 23 cases were of papillary cancer and the other 2 were follicle cancer. Lobectomy and subtotal thyroidectomy were performed in 11and 14 cases respectively. In 7 cases additional lymph node dissection was performed.All the cases were followed-up, ranging from 5 to 58 months, with a median of 28 months. No recurrence was found during this period. There was no morbidity nor major complications and patients were all satisfied with the cosmetic effect. Conclusion Totally endoscopic thyroidectomy (TET) is curative, safe and cosmetic therapy for differentiated thyroid carcinoma.

OBJECTIVETo observe effects of Ligustrazine on serum S100p protein and neuron-specific enolase (NSE) in elderly patients undergoing orthopedics operations.

METHODSTotally 60 patients undergoing selective total hip replacement, 65-80 years old, who were in line with American Society of Anesthesiologists (ASA) grade I or II, were randomly assigned to the Ligustrazine group (Group L) and the normal saline control group (Group S). The right internal jugular vein catheters were placedcephalad and ensured theirs tips in jugular venous bulbs after anesthesia induction and tracheal intubation. Patients in Group L received 2 mg/kg Ligustrazine Injection (40 drops within one minute) and those inGroup S received equal volume of normal saline via central veins before operations. Other medicines were the same for all patients during and after operation. Five millimeter blood sample was collected frominternal jugular venous bulbs before operation (T0), 24 h (T1), 72 h (T2), 168 h (7th day, T3) after operation. Serum was collected after centrifuge. S100β protein and NSE concentration were analyzed usingELISA. Mini-mental state examinations (MMSE) were scored by the same doctor at T0, T1, T2, and T3,respectively.

RESULTSThere was no statistical difference in MMSE scores, serum S1000 protein, or NSE at TO (P > 0.05). Compared with TO, S100 P protein and NSE concentration increased and MMSE scores decreased at T1, T2, and T3 in the two groups. All indices except S100P protein and NSE at T3 were statistically different between Group L and Group S (P < 0.05).

CONCLUSIONSerum S100P protein and NSE could be changed by pre-operation injecting Ligustrazine at certain dose in elderly patients undergoing orthopedics operations.

Aged ; Aged, 80 and over ; Arthroplasty, Replacement, Hip ; Humans ; Phosphopyruvate Hydratase ; blood ; Pyrazines ; therapeutic use ; S100 Calcium Binding Protein beta Subunit ; blood

The characteristics of On-line Near Infrared Spectroscopy Technology are introduced and its applications in various industries, such as petro-chemical, pharmaceutical, agriculture and food are reviewed. Considering the features in TCM manufacturing, the application potentials of On-line Near Infrared Spectroscopy Technology in Manufacturing TCM are forecasted and the key problems to be solved are discussed.
Drugs, Chinese Herbal ; analysis ; Plants, Medicinal ; chemistry ; Quality Control ; Spectroscopy, Near-Infrared ; methods ; Technology, Pharmaceutical ; methods

Objective To investigate the effect of human testing of Fundamentals of Nursing in cultivating nurses students' Humanistic Concern ability.Methods 200 nurse students attended the college at 2008 were selected,they learned the courses of nursing foundation which penetrated by Humanistic Concern and integrated with the human testing.The teaching effect was surveyed by questionnaire before and after the human testing.Results Cognition level of nurse students about Humanistic Concern was obviously improved,the correct cognition rate about using humanistic nursing research to improve the doctor-patient relationship and improving nursing quality elevated from 92.5％ to 97.5％,there was statistically significant difference( x2 =3.09,P ＜0.05 ).Conclusions The connotation of humanistic concern can be understood by nurse students through applying the courses of nursing foundation which penetrated by Humanistic Concern and integrated with the human testing.It is good for cultivating nurse students' humanistic concern consciousness and ability.

OBJECTIVETo evaluate the therapeutic effect of Compound Xuanju Capsule on type III prostatitis.

METHODSA total of 242 patients with type III prostatitis diagnosed by the NIH criteria were randomly divided into an experimental and a control group of equal number, the former treated with Compound Xuanju Capsule + Tamsulosin Hydrochloride, and the latter with Quinolinone antibiotics + Tamsulosin and Hydrochloride, both for 6 months. After treatment, we assessed the therapeutic effects based on the NIH-CPSI scores and the improvement of relevant complications.

RESULTSAll the 242 patients completed the treatment. The total effectiveness rate was 77.69% (94/121) in the experimental group, 71.56% (78/109) in those with complications. In comparison, it was only 47.10% (57/121) in the control group, 31.78% (34/107) in those with complications. Both the NIH-CPSI scores and the improvement of complications were significantly higher in the experimental than in the control group (P < 0.05).

CONCLUSIONCompound Xuanju Capsule has a good therapeutic effect on type III prostatitis.

Adolescent ; Adult ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Male ; Middle Aged ; Phytotherapy ; Prostatitis ; drug therapy ; Treatment Outcome ; Young Adult