Fujian Institute For Drug Control

Fuzhou, China

Fujian Institute For Drug Control

Fuzhou, China
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Cai T.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Zhang G.-L.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Li B.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Xiao H.,Anhui Institute for Food and Drug Control | And 76 more authors.
Chinese Pharmaceutical Journal | Year: 2010

OBJECTIVE: To screen the drug for injection with Pyrogen test in Ch. P(2000) Vol II, to evaluate the possibility for the replacement with bacterial endotoxin test; and to investigate the methodology of the bacterial endotoxin test for all kinds of injections required for Pyrogen test in Ch. P(2000) Vol II. METHODS: Interference tests were done on each sample of injections by using bacterial endotoxin gel-method. The samples were provided by the collaboration of Pharmacology Divisions of Institute for Drug Control in 28 provinces or cities. RESULTS: Determined the no interference concentration or the minimum no interference dilution of each drug and whether the drug is valid for bacterial endotoxin test. CONCLUSION: 84 drugs for injection are valid for bacterial endotoxin test, and 16 drugs for injection are not suitable for bacterial endotoxin test.


Chen X.-M.,Fujian Healthcare Hospital for Women and Children | Wu C.-M.,Fujian Institute for Drug Control | Xie M.,Fujian Institute for Drug Control
Chinese Pharmaceutical Journal | Year: 2010

OBJECTIVE: To establish a RP-HPLC method for the simultaneous determination of cumarin, cinnamyl alcohol, cinnamic acid and cinnamaldehyde in Cortex Cinnamomi. METHODS: The separation was performed on a Hypersil C18 column (4.6 mm x 250 mm, 5 μm) at 50°C. The mobile phase was acetonitrile- 0.1% phosphoric acid (28:72) at a flow rate of 1 mL·min-1. The detection wavelenge were set at 280 nm and 254 nm. RESULTS: All of 4 compounds were separated and good linearity was obtained in the rangeths 0.035 4-1.768 μg for cumarin (r = 1.000), 0.020 2-1. 008 μg for cinnamyl alcohol (r = 1.000), 0.026 4-1.318 μg for cinnamic acid of (r = 1.000), 0.113-5.637 μg for cinnamaldehyde (r = 1.000). The average recoveries were 101.4%, 103.7%, 100.2% and 97.4% with RSD 0.56%, 1.42%, 0.73%, and 1.16%, respectively. CONCLUSION: The method is simple, sensitive and accurate, and it can be used for quality eveluation of Cortex Cinnamomi.


Wu C.-M.,Fujian Institute for Drug Control | Jiang F.,Fujian Institute for Drug Control | Jin M.,Fujian Institute for Drug Control | Chen H.-B.,Fujian Institute for Drug Control
Chinese Pharmaceutical Journal | Year: 2012

OBJECTIVE: To identify the structure of illegal additive D- (-) -isoascorbic acid in vitamin C Yinqiao tablets and to screen for it in different samples. METHODS: The separation of D- (-) - isoascorbic acid in vitamin C Yinqiao tablets was performed on a CAPCELL PAK NH 2 column (4.6 mm × 250 mm, 5 μm) with mobile phase consisting acetonitrile -20 mmol · L -1 ammonium acetate (adjusted to pH 2.5 with formic acid) (60:40), the flow rate was 1.0 mL · min -1. D-(-)-isoascorbic acid was detected by diode array detector at 246 nm. Electrospray ionization (ESI) source in positive ion mode was applied for the identification with following parameters; nebulizer pressure of 220 kPa, drying gas temperature of 350°C, flow rate of 12 L · min -1, and capillary voltage of 3.5 kV. The additive D-(-)- isoascorbic acid in vitamin C Yinqiao tablets was separated and prepared by HPLC for further structure confirmation by 13C-NMR. RESULTS: The structure of the additive was elucidated by analyzing the fragment of [M + H] + of the additive and comparing with that the reference substance. The additive was further confirmed as D-(-)- isoascorbic acid by 13C-NMR. D-(-) - isoascorbic acid was detected in 64 of 366 batch samples. CONCLUSION: The LC-MS method is accurate and sensitive, which can be used for rapid screening and identification of the illegal additive D- (-) - isoascorbic acid in vitamin C Yinqiao tablets. Copyright 2012 by the Chinese Pharmaceutical Association.


Dan-Ling G.,Fujian Institute for Drug Control | Shan L.,Fujian Institute for Drug Control | Ya-Li W.,Fujian Institute for Drug Control | Cheng-Xu L.,Fujian Institute for Drug Control | And 2 more authors.
Chinese Journal of Antibiotics | Year: 2013

Objective: To evaluate the quality status of domestic cefazolin sodium for injection and existing problems. Methods: According to the general requirements of national assessment programs in 2009 and 2011, use statutory testing methods and combine with the exploratory research to evaluate the quality of domestic cefazolin sodium for injection by statistical analysis of the results. Results: The qualified rate is not high enough in 2009, clarity of solution was the main cause of failure. The qualified rate is 97.8% in 2011, the cause of failure was also the clarity of solution. Conclusions: Through the evaluative testing, the quality status of domestic cefazolin sodium for injection has significantly improved. The results of the stability testing in samples show that the influence of medicines by some harmful substances in the rubber stopper is a lengthy process, using coated rubber stopper is able to prevent the substance that have an impact on the clarity of solution migration into the sample.


Wu C.M.,China Pharmaceutical University | Wu C.M.,Fujian Institute For Drug Control | Zhou L.M.,Fujian Institute For Drug Control | Chai Y.F.,China Pharmaceutical University | And 2 more authors.
Chinese Chemical Letters | Year: 2010

Three new sesquiterpene alkaloids, 1-desacetylwilforgine (1), 1-desacetylwilforine (2), and 9'-hydroxy-2-nicotinoylwilforine (3) were isolated from the roots of Tripterygium wilfordii Hook f., along with six known alkaloids. Their structures were established on the basis of spectral analysis. © 2010 Guo Rong Fan.


Zhou L.M.,Fujian Institute for Drug Control | Zhou L.M.,Kunming Biovalley Material Medical Research Institute | Du J.,Kunming Biovalley Material Medical Research Institute | Wu C.M.,Fujian Institute for Drug Control
Chinese Chemical Letters | Year: 2010

A new triterpenoid 3,4,6-trihydroxy-2-oxo-1(10), 3,5,7-tetraen-23, 24-nor-D: A-friedooleana-29-oic acid, as well as twelve known terpenes were isolated from the roots of Tripterygium wilfordii. Its structure was established on the basis of spectroscopic methods. © 2010 Jiang Du.


Wang Q.,Fujian Agriculture and forestry University | Huang Y.,Fujian Agriculture and forestry University | Wu B.,Fujian Agriculture and forestry University | Mei J.,Fujian Agriculture and forestry University | And 2 more authors.
Journal of Traditional Chinese Medicine | Year: 2014

OBJECTIVE: To investigate how the pretreatment of mice with Ganoderma spores affected the apoptosis of their splenic lymphocytes induced by dexamethasone after 19 days treatment. METHODS: Sixty Kunming mice were randomly divided into six groups: blank control groupdrenched with normal saline; a drug control group drenched with 150 mg/mL Ganoderma spores; a model group treated with saline; a low dose group with 50 mg/mL Ganoderma spores; a moderate dose group with 100 mg/mL Ganoderma spores; and a high dose group with 150 mg/mL Ganoderma spores. The effect of Ganoderma spores on apoptosis in spleen lymphocytes was analyzed. All groups were treated for 19 days. On day 20, the model group and the 3 treatment groups were intraperitoneally injected dexamethasone to induce apoptosis. Splenic index and apoptosis indes were employed to measure cell apoptosis. RESULTS: The results showed that Ganoderma spores reduced the splenic index to different degrees in each group and the best effect was seen in the high dose group (P<0.05). Terminal dexynucleotidyl transferase (TdT)-mediated 2'-Deoxyuridine 5'-Triphosphate nick end labeling staining revealed that the apoptotic index in all groups administered Ganoderma spores differed significantly from the model group, and a dose-response was observed. Flow cytometric analysis indicated that spleen lymphocyte apoptosis in the model group was extensive. Each dose of Ganoderma spores inhibited dexamethasone-induced apoptosis in spleen lymphocytes, and a dose-response was observed as well. The highest dose of Ganoderma spores decreased Malondialdehyde content in serum induced by dexamethasone (P<0.05). CONCLUSION: The findings imply that the pretreatment of the mice with Ganoderma spores could reduce the apoptosis rate induced by dexamethasone in their splenic lymphocytes. © 2014 JTCM. All rights reserved.

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