Analysis of innovative drug category 1.2 in traditional Chinese medicine and considerations on quality control of extracts / 中国中药杂志

In this article, the essence of innovative drug category 1.2 extracts and preparations in the new version of the New Drug Registration Category of traditional Chinese medicines(TCM) was analyzed by combing through the history of provisions on drug registration and comparing with other categories of drugs. After analyzing the characteristics of this type of preparations, the author concluded that the quality control objectives of category 1.2 extract should focus on ensuring the quality consistency of the active ingredients/components in batches, so as to guarantee the consistency of drug quality and efficacy. With reference to the relevant technical requirements for herbal medicinal products in European Medicines Agency(EMA) and botanicals in Food and Drug Administration(FDA),the key points in quality control of the extract should include the content and composition of the therapeutic constituents, the type and content of the concomitants, and the influence of exogenous contaminants on drug safety.

Consideration on critical quality attributes determination of Chinese materia medica preparations / 中草药

In this paper, through the analysis of the key issues in the confirmation of the critical quality attributes (CQAs) of traditional Chinese medicine preparations, it is proposed that the determination of the CQAs should fully consider factors such as the efficacy, safety, nature of the drug substance, requirements of formulation and overall requirements of drug quality control. Complete quality control items that can characterize the properties of drugs should be extracted to provide a basis for the establishment of process control and drug quality standards.

Comparison and review on specifications of fermented Cordyceps sinensis products / 中国中药杂志

There are five kinds of fermented Cordyceps crude drug and their preparations that have been approved as medicine on the market. Since the initial strains of the crude drug were all isolated from natural Cordyceps sinensis， they have similar names， chemical components and even clinical applications. However， because of the different strain species and fermentation processes， there was significant difference in quality. As a result， they should be clearly distinguished in clinical use. Most of the products were researched and developed during the 1980s and 1990s， so there was difference in quality standards for different products， and their quality control levels of some products were not perfect. At present， some of the products are approved as Chinese medicine， others are approved as chemical drugs， with a confusion in products name， management and clinical application. In this paper， the approval numbers， quality standards and clinical applications， and current problems of these products were summarized and compared; some suggestions were put forward， such as standardizing the product name， unifying the management of approval number category， and increasing the specific quality control attributes， in order to provide reference for standard implementation， quality control and drug regulation for fermented Cordyceps crude drugs and their preparations.

Correlation of TLR2 and TLR4 gene polymorphisms with the susceptibility and recurrence of condyloma acuminatum / 中华男科学杂志

<p><b>OBJECTIVE</b>To explore the correlation of the gene polymorphisms of Toll-like receptor 2 ( TLR2) and TLR4 with the susceptibility and recurrence of condyloma acuminatum (CA).</p><p><b>METHODS</b>Using Snapshot, we detected the gene polymorphisms of TLR2 597(T/C), 1350(T/C), 15607(A/G), and 2258(G/A) and TLR4 896(A/G) and 1196(C/T) in the peripheral blood of 140 CA patients and 105 HPV-negative controls. We made comparisons between the CA patients and controls as well as between the cases of recurrent CA and those of non-recurrence at 6 months after treatment.</p><p><b>RESULTS</b>There were 72, 48, and 20 cases of genotype TT, TC, and CC of TLR2 597 (T/C), respectively, in the CA patients, as compared with 71, 31, and 3 cases in the controls. The gene frequency of mutant C was 31. 43% in the patients, significantly higher than 17.62% in the controls (χ2 = 12.04, P < 0.01), and it was 38.68% in the recurrent cases, remarkably higher than 27.01% in the non-recurrent cases (χ2 = 4.16, P < 0.05). There were 74, 49, and 17 cases of genotype TT, TC, and CC of TLR2 1350( T/C), respectively, in the CA patients, as compared with 73, 29, and 3 cases in the controls. The gene frequency of mutant C was 29. 64% in the patients, significantly higher than 16. 67% in the controls (χ2 =11.05, P < 0.01), and it was 36.79% in the recurrent cases, markedly higher than 25. 29% in the non-recurrent cases (χ2 = 4.18, P < 0.05). There were 44, 66, and 30 cases of genotype AA, AG, and GG of TLR2 15607(A/G), respectively, in the CA patients, as compared with 26, 58, and 21 cases in the controls. There was no significant difference in the gene frequencies of mutant G between the two groups (χ2 = 0.33, P > 0.05). No mutant genes of TLR2 2508 (G/A) or TLR4 896(A/G) and 1196(C/ T) were detected in either the CA patients or the controls. Linkage disequilibrium analysis showed a tight linkage between TLR2 597 (T/C) and 1350(T/C) (D' = 1, r2 = 0.93).</p><p><b>CONCLUSION</b>TLR2 597(T/C) is tightly linked to 1350(T/C), which is correlated with both the susceptibility and the recurrence of condyloma acuminatum.</p>

Effect of matrine on Fas, VEGF, and activities of telomerase of MCF-7 cells / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study the effect of matrine on Fas, VEGF, and activities of telomerase of MCF-7 cells.</p><p><b>METHODS</b>In vitro cultured human breast cancer MCF-7 cells were randomly divided into the experimental group and the control group. The matrine solution was added in cells of the experimental group. Equal volume of culture medium was added in cells of the control group or the negative control group. Zedoary Turmeric Oil, the telomerase inhibitor was added in cells of the positive control group. Morphological changes were observed under an inverted microscope. The telomerase activity was detected by TRAP-ELISA. Expressions of Fas and VEGF protein were detected by immunocytochemical assay.</p><p><b>RESULTS</b>Matrine obviously inhibited the growth and induced apoptosis of breast cancer cells. MCF-7 cells were treated by matrine of different concentrations at 24, 48, and 72 h, the telomerase activity gradually decreased along with increased matrine concentration and prolonged action time, showing dose-effect and time-effect positive relations. Matrine could up-regulate Fas protein expression and downregulate VEGF protein expression of MCF-7 cells.</p><p><b>CONCLUSION</b>Matrine showed obvious effect in inhibiting the growth of MCF-7 cells and promoting the apoptosis, which might be achieved by up-regulating the expression of Fas protein, inhibiting telomerase activity induced apoptosis of breast cancer cells, down-regulating the expression of VEGF protein, and inhibiting the tumor vascular formation.</p>

Evaluation of neuro-intensive care unit performance in China: predicting outcomes of Simplified Acute Physiology Score II or Glasgow Coma Scale / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Severity scoring systems are useful tools for measuring the severity of the disease and its outcome. This pilot study was to verify and compare the prognostic performance of the Simplified Acute Physiology Score II (SAPS II) and Glasgow Coma Scale (GCS) in neuro-intensive care unit (N-ICU) patients.</p><p><b>METHODS</b>A total of 1684 patients consecutively admitted to the N-ICU at Xuanwu Hospital between January 1, 2005 and December 31, 2011 were enrolled in this study. The data-base included admission data, at 24-, 48-, and 72-hour SAPS II and GCS. Repeated measure data analysis of variance, Logistic regression analysis, the Hosmer-Lemeshow goodness-of-fit statistic, and the area under the receiver operating characteristic were used to evaluate the performance.</p><p><b>RESULTS</b>There was a significant difference between the SAPS II or GCS score at four time points (F = 16.110, P = 0.000 or F = 8.108, P = 0.000). The SAPS II scores or GCS score at four time points interacted with the outcomes with significant difference (F = 116.771, P = 0.000 or F = 65.316, P = 0.000). Calibration of the SAPS II or GCS score at each time point on all patients was good. The percentage of a risk estimate prediction corresponding to observed mortality was also good. The 72-hour score have the greatest consistency. Discriminations of the SAPS II or GCS score at each time were all satisfactory. The 72-hour score had the greatest discriminative power. The cut-off value was 33 (sensitivity of 85.2% and specificity of 74.3%) and 6 (sensitivity of 70.6% and specificity of 65.0%). The SAPS II at each time point on all patients showed better calibration, consistency and discrimination than GCS. The binary Logistic regression analysis identified physiological variables, GCS, age, and disease category as significant independent risk factors of death. After the two variables including underlying disease and type of admission were excluded, we built the simplified SAPS II model. A correlation was suggested between the simplified SAPS II score at each time point and outcome, regardless of the diagnosis.</p><p><b>CONCLUSIONS</b>The GCS scoring system tends to be a little weaker in the predictive power than the SAPS II scoring system in this Chinese cohort of N-ICU patients. The advantage of SAPS II scoring system still exists that it dose not need to take into account the diagnosis or diseases categories, even in the special N-ICU. The simplified SAPS II scoring system is considered a new idea for the estimation of effectiveness.</p>

Experimental studies on the preparation techniques of Tongjingshu babu sticking plaster / 中国中药杂志

<p><b>OBJECTIVE</b>to establish the optimum preparation procedure for Tongjingshu babu sticking plaster.</p><p><b>METHOD</b>Orthogonal design was used to observe the adhesion power, cohesion by the multi-electronic experimental equipment.</p><p><b>RESULT</b>The best formulation is composed of ointment, polypropylene acid, glycerin, bond and its proportion is 0.2:4:8:1.2, the final plaster contains 35% water with idea stability to the skin.</p><p><b>CONCLUSION</b>The formulation of Tongjing-shu babu sticking plaster is resonable and its preparation is simple and rapid.</p>