It has been widely accepted in modern pharmaceutical industry that quality cannot be tested into products , instead quality should be built-in by design . However , the implementation of Quality by Design ( QbD ) in development , manufacture and supervision of traditional Chinese medicine ( TCM ) still remains to be a challenge . The program of safety re-evaluation of TCM injections provides an opportunity to practice QbD approach in TCM industry . This paper discussed some potential ways that improve the quality of TCM injec-tions base on QbD related tools , including identification of critical quality attributes , critical process parameters and critical material attributes, development of design space and control strategy.

BACKGROUND: Acupuncture in Chinese traditional medicine improves capacity of brain on resisting injury and accelerates injury repair in treatment of ischemic brain injury.OBJECTIVE: To observe the expressions of cerebral nerve growth factor (NGF) and choline acetyltransferase after simultaneous stimulation with electroacupuncture on Baihui (GV 20) and Dazhui (GV 14) so as to probe into the protection of electroacupuncture on hypoxia-ischemia brain injury.DESIGN: Randomized controlled experiment.SETTING: Department of Life Science in Zhengzhou Normal High Training School.MATERIALS: The experiment was performed in Human Anatomy Department of Basic Medical College of Zhengzhou University, in which, 50 cleangrade neonatal Wistar rats of 7 days old were employed and randomized into sham-operation group (10 rats), model control (20 rats) and electroacupuncture group (20 rats). Hypoxia cabin was self-made with constant pressure, 40 cm ×50 cm×60 cm in size, with two small holes of 2 cm ×2 cm for each to connect with the external. Soda lime was used to absorb moisture and CO2 in the cabin.The model was not prepared in sham-operation group. In model control and electroacupuncture group, hypoxia-ischemia model was set up. After modeling, the rats in two groups were recovered for 1 to 4 hours at room temperature; afterwards, hypoxia management was performed. The rats were placed in hypoxia cabin with constant pressure at constant temperature of 37 ℃, inputting O2 8 mL/L and mixed gas 920 mL/L, 1.5 L/minute; 2hours later, the rats were returned back to female rats for lactation continuously. In electroacupuncture group, on the 2nd day after modeling, a filiform needle of one cun was used to insert Baihui (GV 20) (midpoint of parietal bone) subcutaneously and Dazhui (GV 14) (between C7 and T1, on the midline of back). Electric stimulation was done simultaneously on two points with continuous wave, 16 Hz in frequency, 10V in intensity, retaining for 10 minutes, once per day, 10 days made 1 course, totally two courses at interval of 2 days. In model control, no any treatment was given group, 22 days after hypoxia and ischemia, the rats were anesthetized and sacrificed and brain tissue on the left side was collected to prepare paraffin slices. Immune positive cell was counted on slices of each group under optic microscope. For evaluation on the function of brain nerve cell, hippocampus was selected to count the positive cells of choline acetyltransferase. On each brain slice, 5 visual fields were randomized to calculate the average of positive cells. For evaluation on injury repair of nerve tissue, cortex and hippocampus were selected to count positive cells of cerebral NGF. The method was same as the above.MAIN OUTCOME MEASURES: Immune positive cell expressions of choline acetyltransferase and cerebral NGF in brain tissue after electric stimulation in neonatal rats.ferase in brain hippocampus: Compared with sham-operation group, that in model control was lower remarkably, but, there was no obvious change in electroacupuncture group [(24.46±8.24), (13.96±7.62), (25.54±5.05) pcs/visual field, P ＜ 0.05, P ＞ 0.05]; that in electroacupuncture group was of cerebral NGF in cerebral cortex and hippocampus: Compared with sham-operation group, that in both model control and electroacupuncture was increased remarkably [(14.14±6.11), (24.49±8.31), (31.35±9.92) pcs/visual field, P ＜ 0.05; (13.42±5.56), (21.93±5.12), (27.63±7.15) pcs/visual field, P ＜ 0.05], of which, that in electroacupuncture group was higher than model control (P ＜ 0.05).CONCLUSION: Electroacupuncture stimulates central cholinergic nerve system into positive active state in hypoxia-ischemia animals, increases cerebral nerve growth factor in quantity and enhances nerve repair of hypoxia-ischemia animals.

Objective To compare clinical effect and complications of micro-implant anchorage(MIA ) or self -driven titanium implant(SDIA) with headgear anchorage in treatment of maxillary dentoalveolar protrusion .Methods 50 patients with maxillary dentoalveolar protrusion were selected and divided into observation group and control group .Each group contained 25 patients .14 patients in observation group received MIA treatment while 11 patients received SDIA treatment .All patients in control group re-ceived headgear anchorage treatment .Comparison was made in respects of course of treatment ,clinical effect and complications .Re-sults The course of treatment in observation group was (19 .85 ± 2 .01) months while in control group was(23 .58 ± 1 .79) months . The treatment time in control group were longer than observation group (P < 0 .05) .U1-SN angle in observation group were de-creased(16 .8 ± 1 .9)° while the control group decreased(20 .2 ± 2 .1)° .In the vertical direction ,the observation group maxillary inci-sor and first molars were shorten (2 .0 ± 0 .8)mm and(1 .6 ± 1 .0)mm respectively ,while the control group were shorten (0 .7 ± 0 .5) mm and(0 .3 ± 0 .7)mm .In the sagittal direction ,the observation group maxillary first molars were moved (0 .6 ± 1 .1)mm while the control group were moved (1 .7 ± 0 .8)mm .The difference of U1-SN ,U1-X ,U6-Y ,U6-X between two group were statistically sig-nificant .The comparison of expulsion rate between MIA and SDIA had no statistical significance .But the rate inflammation symp-tom and hyperplasia of the gum in SDIA patients were higher than MIA patients .Conclusion MIA and SDIA had better ability in treatment of maxillary dentoalveolar protrusion in vertical direction than headgear and improve the curative effect of maxillary den -toalveolar protrusion and both of them had same fell off rate ,but SDIA had higher rate of inflammation .

Ethylene vinyl alchohol copolymer can be developed into new kinds of liquid embolization material possessing a great number of advantages in comparison with the current embolization substarces. The authors reviewed the advancement of ethylene vinyl alchohol copolymer in the treatment of cerebral arteriovenous malformation in recent years.

OBJECTIVE:To study the preparation and the quality control of the compound lomefloxacin nose-drops MET_HODS:The first order derivative spectrophotometry was used to determine the content of lomefloxacin with no need of isolation The detecting wavelengths were 293nm and 315nm RESULTS:The correlation coefficient was 0 9 999 The average recovery was 100 77%,with RSD of 0 82% CONCLUSION:The preparation process of compound lomefloxacin nose-drops was simple,the first order derivative spectrophotometry for the determination was rapid,simple and accurate

0.05). Conclusion The LDH method applied in the in vitro inhibition assay for P. falciparum seems simple, reliable and has generated a satisfactory result.

Objective To explore the value of transesophageal atrial pacing (TEAP) in assessing the mechanism of paroxysmal supraventricular tachycardia (PSVT) in children. Methods The electrophysiological data of 50 children with PSVT who had undergone TEAP and, at a later stage, radio-frequency catheter ablation (RFCA) examination were retrospectively analyzed from January 2008 to December 2013. Results When using the intracardiac electrophysiological study (IEPS) as the diagnostic gold standard, the sensitivity of TEAP for atrioventricular nodal reentrant tachycardia (AVNRT), left accessory pathway (LAP) and right accessory pathway (RAP) was 92.9%, 83.1%and 90%respectively;the speciifcity was 86.4%, 100%and 95%respectively;the accuracy was 90%, 96%, and 94%respectively. The diagnostic accuracy of TEAP for AVNRT was 92.9%(26/28), the diagnosis accuracy for slow-fast AVNRT was 100%, but 2 cases of fast-slow AVNRT were both misdiagnosed as AVRT. The diagnostic accuracy of TEAP for AVRT was 86.4%(19/22) and 3 cases were misdiagnosed as slow-fast AVNRT. Conclusions TEAP has good clinical value in ifnding the mechanism of PSVT and its preliminarily location in children, but it has some limitations for some types of PSVT.

Objective To analyze the differences of positive detection rate and copy number of human papillomavirus (HPV) DNA and E6/E7 mRNA between different grades of cervical lesions, and evaluate their clinical values in early screen?ing of cervical cancer. Methods The cervical exfoliated cell samples from 154 women undergoing biopsy examination and 32 objects undergoing hysterectomy (control group) were collected in Tianjin Central Hospital of Gynecology Obstetrics in 2014. According to the pathological results of cervical biopsy, 154 samples were divided into low-grade squamous intraepi?thelial lesion group (LSIL, n=51), high-grade squamous intraepithelial lesion group (HSIL, n=71), and squamous cell carci?noma group (SCC, n=32). HPV DNA was tested with hybrid capture technology, and E6/E7 mRNA was detected with fluores?cence quantitative hybridization. Immunohistochemistry was performed by detecting E6/E7 protein in all patients after sur?gery or cervical biopsy. Results Combined results of HPV DNA and E6/E7 mRNA demonstrated that the positive detection rate was significantly lower in control group than that of all levels of lesion groups (P<0.05). The copy number of high risk HPV E6/E7 mRNA was significantly increased with the aggravation of lesions (P<0.05), whereas no difference was found in that of HPV DNA. Compared with the normal control and low-grade squamous intraepithelial lesion group, cervical cancer patients with mRNA copies > 10 000 E6/E7 were significantly increased in high-grade squamous intraepithelial lesion group. Immunohistochemical results showed that the positive detection rate of E6/E7 was significantly lower in control group than that of all levels of lesion groups (P<0.05). The positive rate of E6/E7 was significantly higher in the high-grade squa?mous intraepithelial lesion group than that of low-grade group (P<0.05). Conclusion HPV infection is closely related to cervical abnormalities, which is one of effective measures for early screening of cervical cancer. The negative result of HPV DNA is very helpful to exclude the cervical abnormality, whereas the positive detection of mRNA has great value in predict?ing the disease. Combined results of positive detection and copy number make a comprehensive evaluation for the risk of cer?vical lesions.

OBJECTIVE:To investigate the drug-induced renal injury of inpatients in our hospital and provide information for rational use of drugs.METHODS:A retrospective analysis was performed in 102 cases whose blood Cr level was abnormal in June,August,and October in 2007.RESULTS:Of the 102 cases,20 patients(19.6%)suffered from drug-induced renal injury induced by 22 suspected drugs including dehydrants,antibiotics and ACEI et al.CONCLUSION:To avoid drug-induced renal function injury,medication should be carried out by strictly following indications and the dosage and administration stated in the drug package insert.

Objective To discuss the rule of distribution of TCM syndromes of Psoriasis (Ps).Methods The 205 Ps vulgaris outpatients were investigated and the case research forms were filled in.Based on the diagnosis standard of TCM syndromes,the patients were differentiated into different syndromes.The correlation between the syndromes and clinical materials were discussed.Results The main TCM syndromes of Ps were blood heat,blood stasis,blood dryness,blood heat-stasis,blood heat-dryness and blood stasis-dryness.The distribution of these six main syndromes in different ages,disease stages,and recurrent time in different groups was significantly different (P