North China Pharmaceutical Corporation

Shijiazhuang, China

North China Pharmaceutical Corporation

Shijiazhuang, China
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Patent
North China Pharmaceutical Company. | Date: 2015-05-18

Provided is a compound of formula (I) or a pharmaceutically acceptable salt thereof, wherein X is selected from a 3-9 membered carbon ring or a ring which is formed by 3-9 membered carbocyclic ring fused with benzo ring, and a 4-10 membered heterocyclic ring or a ring which is formed by 4-10 membered heterocyclic ring fused with benzo ring; Y and Z are independently selected from 4-9 membered saturated heterocyclic rings respectively; R_(1-3 )are independently selected from H, F, Cl, Br, I, CN, OH, SH, NH_(2), CHO, COOH respectively, or selected from the group, optionally substituted by R_(01), consisting of C_(1-10 )alkyl, C_(1-10 )heteroalkyl, C_(3-10 )cyclohydrocarbyl, C_(3-10 )heterocyclohydrocarbyl, C_(1-10 )alkyl substituted by C_(3-10 )cyclohydrocarbyl or C_(3-10 )heterocyclohydrocarbyl, and C_(1-10 )heteroalkyl substituted by C_(3-10 )cyclohydrocarbyl or C_(3-10 )heterocyclohydrocarbyl. The compound can be used as an anticoagulant for treating and preventing thrombotic disorders, and can meet the real needs of selectivity and a potent inhibitor for coagulation Xa.


Patent
North China Pharmaceutical Company. | Date: 2017-03-29

Provided is a compound of formula (I) or a pharmaceutically acceptable salt thereof, wherein X is selected from a 3-9 membered carbon ring or its phenyl ring, and a 4-10 membered heterocyclic ring or its benzo ring; Y and Z are independently selected from 4-9 membered saturated heterocyclic rings respectively; R_(I-3) are independently selected from H, F, Cl, Br, I, CN, OH, SH,NH_(2), CHO, COOH respectively, or selected from C_(1-10) alkyls or heteroalkyls optionally substituted by R_(01), C_(3-10) alkyls ring hydrocarbon groups or heterocyclic hydrocarbon groups, C_(1-10) alkyls or heteroalkyls substituted by C_(3-10) ring hydrocarbon groups or heterocyclic hydrocarbon group. The compound can be used as an anticoagulant for treating and preventing thrombotic disorders, and can meet the real needs of selectivity and a potent inhibitor for coagulation Xa.


Zhang T.-J.,Shenyang Pharmaceutical University | Zhang T.-J.,North China Pharmaceutical Co. | Han W.-T.,North China Pharmaceutical Huasheng Co. | Han J.,Shenyang Pharmaceutical University
Chinese Journal of New Drugs | Year: 2017

Data integrity deficiencies found during the GMP inspection process by EDQM, WHO, FDA and CFDA for the pharmaceutical manufacturers attracted great attention. Data integrity is a basic requirement of quality system and GMP. Chinese pharmaceutical manufacturers have to strengthen the quality awareness, promote the quality management level, and improve the quality management system to dissolve the data integrity deficiencies fundamentally and finally pass the GMP inspection. In this article, the authors analyzed the impact of data integrity on GMP inspection of Chinese pharmaceutical manufacturers from the above-mentioned aspects. © 2017, Chinese Journal of New Drugs Co. Ltd. All right reserved.


Chen S.-H.,North China Pharmaceutical Corporation | Ren F.-Z.,North China Pharmaceutical Corporation | Li L.-H.,North China Pharmaceutical Corporation | Gao Y.-Q.,North China Pharmaceutical Corporation | Wang N.,North China Pharmaceutical Corporation
Chinese Pharmaceutical Journal | Year: 2010

OBJECTIVE: To study the chemical constituents of Croton crassifolius Geisel. METHODS: The compounds were isolated by chromatography on silica gel and HPLC. Their structures were identified by their physical, chemical and spectral analysis. A high through-put screening method was used to explore the HLE inhibitor. RESULTS: Seven compounds were isolated and identified as cyperenoic acid(1), mallotucin B(2), chettaphanin II (3), chettaphanin I (4), teucvidin(5), 6-[2-(furan-3-yl)-2-oxoethyl]-1,5,6-trimethyl-10-oxatricyclo[7. 2. 1.0 2,7]dodec-2(7)-en-11-one(6) and penduliflaworosin(7). Among them, there are two compounds showed strong inhibitor activity against human leukocyte elastase. CONCLUSION: Compound 3, 5, 6 and 7 were isolated from this plant for the first time. And compound 3 and 7 had significant anti-inflammation activity.


Hao R.-X.,North China Pharmaceutical Co. | Zhu F.-C.,Chinese Pharmaceutical Association | Liu Y.,National Institutes for Food and Drug Control
Chinese Pharmaceutical Journal | Year: 2017

OBJECTIVE: To study and analyze FDA issued guidance on Bioequivalence Recommendations for Specific Products related with long Half-life drugs. METHODS: Bioequivalence Recommendations for Specific Products related with long Half-life drugs was analyzed from multiple aspects, including bioequivalence study designs, selection of bioequivalence subjects, dosage, selection of reference products, analytes to measure, bioequivalence waiver on multiple-strength products and implementation of the Biopharmaceutics Classification System. RESULTS: Bioequivalence Recommendations for Specific Products issued by FDA are to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLSUTION: Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since there is not corresponding bioequivalence guidance on specific long Half-life drugs released by CFDA yet. Copyright 2017 by the Chinese Pharmaceutical Association.


Li Z.,Hebei University of Science and Technology | Li Z.,Tsinghua University | Zuo J.,Tsinghua University | Tian B.,Hebei University of Science and Technology | And 4 more authors.
Biotechnology and Biotechnological Equipment | Year: 2012

There is still insufficient practical experience in the removing and degrading of streptomycin bacterial residues. The effect of thermal-alkaline pre-treatment on the decomposition of a streptomycin bacterial residue was investigated. Without NaOH pretreatment, the effect of thermal pre-treatment was not obvious. Soluble chemical oxygen demand and volatile suspended solids were 66.39% and 55.0% at 0.10 NaOH/TS ratio (g/g) and 368.15 K, respectively. The methane yield was 380 mL CH4/gVSadded at 303.15 K and no added NaOH and increased to 434 mL CH4/gVSadded at 0.10 NaOH/TS ratio (g/g) and 368.15 K. Thermalalkaline pretreatment could significantly enhance not only the SCOD and VSS solubilization, but also the biodegradability. Methane production was enhanced, probably as a result of the breakdown of cell walls and membranes of microorganisms by thermal-alkaline pretreatment, which may facilitate the contact between organic molecules and anaerobic microorganisms. © 2012 American Scientific Publishers.


Gao J.,Hebei Medical University | Zhu S.-Q.,North China Pharmaceutical Corporation | Niu C.-Q.,North China Pharmaceutical Corporation
Chinese Journal of New Drugs | Year: 2012

Objective: To establish a capillary electrophoresis method for chiral separation of ondansetron hydrochloride. Methods: The kinds and concentration of cyclodextrin, the pH value and concentration of buffer, the voltage and temperature were selected to optimize the conditions of chiral separation. Results: The optimal separation conditions were a 33 mmol · L-1 Tris buffer containing carboxymethyl-β-cyclodextrin (30 mg · mL-1), detection at 214 nm, voltage at 30 kV and separation temperature at 25°C. The separation of ondansetron hydrochloride enantiomers was achieved in the optimal conditions. Conclusion: The newly established method can be used in quality control of products in new drug development process.


Zhang S.-X.,North China Pharmaceutical Corporation | Cheng L.-J.,North China Pharmaceutical Corporation
Chinese Journal of Biologicals | Year: 2012

Objective: To develop a more sensitive and effective method for differentiation of glycoprotein by staining. Methods: An improved gel staining method was developed based on periodic acid-Schiff method by optimizing the formula of fixing, reduction and oxidation solutions as well as time for staining, and compared with periodic acid-Schiff method. Results: Samples of recombinant monoclonal antibody were stained by the improved method, and the result showed that only the heavy chain was stained, while the light chain was unstained. However, after counter-stain with Coomassie brilliant blue, both heavy and light chains were stained. The sensitivity of the improved method for determination of sugar content was 0.15 μg, while that of traditional periodic acid-Schiff method was 3 μg. Conclusion: A novel method for differentiation of glycoprotein by staining was successfully developed, which was highly specific, sensitive and time-saving.


Wang H.,North China Pharmaceutical Corporation | Wei J.-S.,North China Pharmaceutical Corporation
Chinese Journal of Biologicals | Year: 2015

An IgG molecule is composed of two heavy and two light chains covalently linked by interchain disulfide bonds. Each domain of the heavy or light chain contains one additional disulfide bond. However, there is unpaired non-canonical cysteine in a handful of natural immunoglobulin and recombinant antibody molecules. This paper reviews the unpaired non-canonical cysteine in IgG and its influence on cell expression and molecular stability, characterization of its cysteinylation and the means of de-cysteinylation.


Cheng L.-J.,North China Pharmaceutical Corporation
Chinese Journal of Biologicals | Year: 2011

Objective: To verify the process for virus removal from recombinant monoclonal antibody product by affinity chromatography. Methods: The efficacies of virus removal from recombinant monoclonal antibody against rabies virus by novel and traditional rProtein A Sepharose Fast Flow (rProtein A SFF) chromatography were evaluated using influenza virus subtype H1N1, herpes simplex virus type 1 and adenovirus type 5 as model viruses. Results: All the titers of three kinds of model viruses decreased by more than 4. 0 log 10 after purification by novel and traditional rProtein A SFF chromatography. Conclusion: The rProtein A SFF affinity chromatography is effective in removal of potential virus contamination from recombinant monoclonal antibody products.

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