In this paper, the process performance indexes (PPIs) P(p) and P(pk) were introduced and applied to evaluate the process capability and quality consistence of Chinese medicine products. The historical quality analysis data of Qingkailing injection were collected and taken as the research object. The confidence intervals of P(p) and P(pk) were estimated based on the Bootstrap sampling methods. Results showed that the value and width of the confidence interval P(p) of were smaller that of P(pk) suggesting that the P(pk) index was more sensitive than P(p) in process capability analysis. Within the production period concerned, the P(pk) values estimated from different quality indexes of Qingkailing injection, such as baicalin, cholic acid, geniposide and total nitrogen, were 1.122, 2.055, 1.564 and 0.891, respectively. It could be found that the cholic acid had the highest process capability, followed by the geniposide and baicalin. The total nitrogen had the lowest process capability, indicating that it is necessary to reinforce the quality management of total nitrogen related manufacturing processes. The case studies demonstrate the effectiveness and feasibility of PPIs, which are convenient to be used in production practice of Chinese medicine.
Chemistry, Pharmaceutical ; methods ; standards ; Drugs, Chinese Herbal ; chemistry ; standards ; Injections ; Quality Control

OBJECTIVEThis study aimed to observe the postoperative pain rate and degree of pain in preschool children with cleft lip and palate, and investigate the effect of nursing intervention on pain relief.

METHODSA total of 120 hospitalized cases of three- to seven-year-old preschool children with cleft lip and palate were selected from May to October 2011. The subjects were randomly divided into the control group and experimental groups 1, 2, and 3. The control group used conventional nursing methods, experimental group 1 used analgesic drug treatment, experimental group 2 used psychological nursing interventions, and experimental group 3 used both psychological nursing intervention and analgesic drug treatment. After 6, 12, 24, and 48 h, pain self-assessment, pain parent-assessment, and pain nurse-assessment were calculated for the four groups using the pain assessment forms, and their ratings were compared.

RESULTSThe postoperative pain rates of the four groups ranged from 50.0% to 73.3%. The difference among the four groups was statistically significant (P < 0.001). The differences among the control group and experimental groups 1 and 2 were not statistically significant (P = 0.871), whereas the differences among experimental group 3 and the other groups were statistically significant (P < 0.001).

CONCLUSIONPostoperative pain in preschool children with cleft lip and palate is common. Psychological nursing intervention with analgesic treatment is effective in relieving postoperative pain.

Child, Preschool ; Cleft Lip ; surgery ; Cleft Palate ; surgery ; Humans ; Pain, Postoperative

Objective To investigate the analgesic effect of salmon calcitonin(sCT)and its effect on expression of calcitonin receptor(CT-R)in periaqueductal gray(PAG). Methods Rat models of neuropathic pain were prepared by chronic constriction injury(CCI). Thermal withdrawal latency(TWL)and mechanical nociceptive threshold(MNT)were measured using hot plate test and yon Frey monofilaments test. The distribution of CT-R in PAG was detected by immunohistochemical method. CT-R protein was quantitatively determined by western blotting. Fourty male SD rats were randomized into 5 groups: normal group, sham-CCI group, CCI group, CCI plussubcutaneous sCT group, and CCI plus microinjection of sCT into PAG group. Results TWL, MNT, andexpression of CT-R in PAG showed no difference between normal group and sham-CCI group(P＞0. 05). TWL and MNT in CCI group were significantly lower than those in normal group(P＜0.05), and expression of CT-R in CCI group was significantly higher than that in normal group(P＜0.05). TWL, MNT and expression of CT-R in CCI rats increased significantly after sCT therapy(P＜0. 05), and the effect was more marked in PAG injection group than subcutaneous injection group(P＜0.05). Conclusions sCT raises the pain threshold and increase the expression of CT-R in PAG of CCI rats, while PAG injection showed more marked effect than subcutaneous injection.

Hepatitis, Alcoholic ; Humans

The design space of the high shear wet granulation process was established and validated within the framework of quality by design (QbD). The system of microcrystalline cellulose-de-ioned water was used in this study. The median granule size and bulk density of granules were identified as critical quality attributes. Plackeet-Burmann experimental design was used to screen these factors as follows: dry mixing time, the impeller and chopper speed of dry mixing, water amount, water addition time, wet massing time, the impeller and chopper speed of wet massing and drying time. And the optimization was implemented with the central composite experimental design based on screened critical process parameters. The design space of the high shear wet granulation process was established based on the quadratic polynomial regression model. Since the P-values of both models were less than 0.05 and values of lack of fit were more than 0.1, the relationship between critical quality attributes and critical process parameters could be well described by the two models. The reliability of design space, illustrated by overlay plot, was improved with the addition of 95% confidence interval. For those granules whose process parameters were in the design space, the granule size could be controlled within 250 to 355 μm, and the bulk density could be controlled within a range of 0.4 to 0.6 g x cm(-3). The robustness and flexibility of the high shear wet granulation process have been enhanced via the establishment of the design space based on the QbD concept.
Cellulose ; chemistry ; Reproducibility of Results ; Technology, Pharmaceutical ; methods ; Water

Ascites ; diagnosis ; etiology ; therapy ; Europe ; Humans ; Liver Cirrhosis ; complications ; diagnosis ; therapy ; Practice Guidelines as Topic

ObjectiveTo evaluate the potential value of acoustic radiation force impulse (ARFI)elastography in the characterization of solid liver tumors.MethodsForty-three patients with 56 liver tumors were evaluated with ARFI,which included 21 patients with hepatocellular carcinoma (HCC),8 patients with metastase,5 patients with cholangiocarcinoma(CCC),and 9 patients with hemangioma.The shear wave velocity of the tumor and background liver parenchyma were calculated,and results were compared with 30 healthy subjects.Statistical analysis was performed on the shear wave velocity for differentiation of normal liver,background liver parenchyma,and tumors.ResultsHCC and CCC had greater stiffness than metastase (P ＜0.05),there were no statistical differences between HCC and CCC (P = 0.179).Malignant liver tumors had significantly greater stiffness than hemangioma and normal liver (P = 0.000).34.5% (9/26) HCC and 33.3% (4/12) hemangioma appeared softer than the background liver.With a cut-off value of 1.5 m/s for the shear wave velocity,the sensitivity,specificity,positive predictive value and negative predictive value for malignancies were 79.5%,83.3%,94.5% and 52.6%,respectively.ConclusionsARFI elastography quantification is a promising noninvasive technique for assessing solid liver tumors.Use of ARFI elastography quantification may lead to new quantitative tissue characterization parameters for differentiating hemangioma and malignant liver tumors.

Alisma orientalis is a traditional herb medicine commonly used in clinical. With the increasing report of its toxicity in clinical, the renal toxicity of Alisma orientalis has got gradually attention. This paper systematically reviews the research on the chemical material basis of Alisma orientalis including its chemical composition and toxicity of ingredients; and also declares its toxic ingredients and targets according to Network toxicology. Based on the controversy on renal toxicity of Alisma orientalis, we analyzed the possible reasons that may be associated with renal toxicity. It might be associated with the differences of the material basis composition and regulatory toxicology network, differences in employed processing technology, the metabolic function leading to accumulation of compounds, dosage and duration of the experiment and compatibility. The review provides possible reference and ideas for the quality control and rational use of Alisma orientalis.
Alisma ; chemistry ; toxicity ; Animals ; Drugs, Chinese Herbal ; chemistry ; toxicity ; Humans ; Molecular Structure

Development of the disease is the result of several factors involved in biological network changes. The nature of drug intervention is to regulate these pathological changes to the normal range. Advantages of traditional Chinese medicine (TCM) are to integrally and systematically regulate this biological networks and systematic pathology through multi-targets, multi-levels, multi-channels. Structural components TCM provides the controlled and precise basis "substance" for this regulation and also to clarify the "truth" of the nature of the regulation by the network pharmacology. Network pharmacology provides new strategy for the research on mechanism of structural components TCM. This study not only reflects the overall characteristics of the development of the disease, but also fully embodies the essence of TCM for preventing and treating diseases through changing traditional model on "one drug, one gene, one disease". This paper explores systematically the integration essence, features and research strategies of structural components TCM and the network pharmacology, understand the interaction of structural components TCM and body from the perspective of the overall concept of improving or restoring the balance of.biological networks. It is effective measure to reveal the structure of a multi-component for regulating biological networks mechanisms, and also provide new ideas and methods for further scientific research and innovation of structural component TCM.
Drug Interactions ; Drug Therapy ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; Gene Regulatory Networks ; drug effects ; Humans ; Medicine, Chinese Traditional

OBJECTIVETo evaluate the effects of Bevacizumab on the tumor growth, proliferation and apoptosis of gastric cancer xenograft, and the impacts on the VEGF and Sp1 expression.

METHODSGastric cancer xenografts in nude mice were established using SGC-7901 gastric cancer cell line. The nude mice were randomly divided into two groups, Bevacizumab treatment group and PBS group. The tumor sizes were measured for tumor growth curve. The proliferation and angiogenesis were evaluated by immunohistochemistry (IHC) staining of Ki67 and CD34. TUNEL assay was used for apoptosis evaluation. The expression of VEGF and Sp1 in tumor cells were detected by IHC and Western blot.

RESULTSCompared to the PBS group, the tumor growth decreased significantly (P<0.05), the proliferation of tumor cells and angiogenesis decreased, and apoptosis index increased significantly [(5.3 ± 1.8)% vs. (16.7 ± 6.7)%, P<0.01] in Bevacizumab group. The results of IHC and Western blot demonstrated that the expression of VEGF and the microvessel density (MVD) was decreased (4.0 ± 1.0 vs. 16.3 ± 1.5, P<0.001) in Bevacizumab treatment group. No obvious changes of Sp1 expression were observed in Bevacizumab treatment group.

CONCLUSIONSBevacizumab can inhibit the growth of gastric cancer xenografts in nude mice, decrease the VEGF expression and MVD. However, the compensatory up-regulation of transcription factor Sp1 is not affected by Bevacizumab.

Animals ; Antibodies, Monoclonal, Humanized ; pharmacology ; Apoptosis ; Bevacizumab ; Gene Expression Regulation, Neoplastic ; drug effects ; Humans ; Mice ; Mice, Nude ; Sp1 Transcription Factor ; metabolism ; Stomach Neoplasms ; metabolism ; pathology ; Vascular Endothelial Growth Factor A ; metabolism ; Xenograft Model Antitumor Assays