Abstract:
:In the present report, we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies, including the International Conference of Harmonization (ICH), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the China Food and Drug Administration (CFDA). Progresses with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Chinese Pharmacopoeia (ChP) to control impurities in antibiotics are also presented. Next, our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics, and the implementation of ICH, FDA and other technical guidelines for generic drugs impurity control in China. Existing problems are further reviewed, in order to improve the overall process for the control of antibiotic purity.
journal_name
Chin J Nat Medjournal_title
Chinese journal of natural medicinesauthors
Jiang Y,Xia JP,Yang JH,Zhang ZF,Hu CQ,Zhang ZRdoi
10.1016/S1875-5364(15)30044-3subject
Has Abstractpub_date
2015-07-01 00:00:00pages
498-506issue
7eissn
2095-6975issn
1875-5364pii
S1875-5364(15)30044-3journal_volume
13pub_type
杂志文章abstract::Cranberry extract (CBE) rich in polyphenols are potent to delay paralysis induced by alleviating β-amyloid (Aβ) toxicity in C. elegans model of Alzheimer's disease (AD). In order to better apply CBE as an anti-AD agent efficiently, we sought to deterrmine whether preventive or therapeutic effect contributes more promi...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(16)30039-5
更新日期:2016-06-01 00:00:00
abstract::The novel coronavirus pneumonia broke out in 2019 and spread rapidly. In 30 different countries, there are over seventy thousand patients have been diagnosed in total. Therefore, it is urgent to develop the effective program to prevent and treat for the novel coronavirus pneumonia. In view of Traditional Chinese Medic...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章,评审
doi:10.1016/S1875-5364(20)30022-4
更新日期:2020-03-01 00:00:00
abstract::A new γ-alkylated-γ-butyrolactone, named melongenolide A (1), along with nine known compounds were obtained from the roots of Solanum melongena, and their structures were identified as melongenolide A (1), (+)-syringaresinol (2), (+)-lyoniresinol (3), 5,5'-dimethoxy lariciresinol (4), (+)-(7R,8R)-4-hydroxy-3,3',5'-tri...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(15)30068-6
更新日期:2015-09-01 00:00:00
abstract::Hybanthus enneaspermus (L.) F. Muell belonging to the family Violaceae, popularly known as Ratanpurus (Hindi) is a herb or a shrub distributed in the tropical and subtropical regions of the world. In the Ayurvedic literature, the plant is reported to cure conditions of "Kapha" and "Pitta", urinary calculi, strangury, ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章,评审
doi:10.1016/S1875-5364(13)60017-5
更新日期:2013-05-01 00:00:00
abstract::Guanxinshutong capsule (GXSTC) is an effective and safe traditional Chinese medicine used in the treatment of cardiovascular diseases (CVDs) for many years. However, the targets of this herbal formula and the underlying molecular mechanisms of action involved in the treatment of CVDs are still unclear. In the present ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(18)30060-8
更新日期:2018-04-01 00:00:00
abstract:AIM:To study the chemical constituents of the fruits of Illicium henryi. METHOD:Chromatographic separations on silica gel, Sephadex LH-20 gel and MCI gel were used to isolate the compounds. The structures were elucidated based on extensive spectroscopic data analyses. RESULTS:Seven compounds were obtained and their s...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(14)60074-1
更新日期:2014-06-01 00:00:00
abstract::Taurochenodeoxycholic acid (TCDCA) is one of the main effective components of bile acid, playing critical roles in apoptosis and immune responses through the TGR5 receptor. In this study, we reveal the interaction between TCDCA and TGR5 receptor in TGR5-knockdown H1299 cells and the regulation of inflammation via the ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(20)60033-4
更新日期:2020-12-01 00:00:00
abstract:AIM:To study the chemical constituents of the aerial parts of Cirsium setosum (Willd.) MB.. METHODS:The chemical constituents were isolated and purified by various chromatographic techniques. Their structures were determined on the basis of physical properties and spectroscopic data. RESULTS:A new megastigmane glycos...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(13)60097-7
更新日期:2013-09-01 00:00:00
abstract:AIM:To improve the absorption and bioavailability of baicalin using a nanocrystal (or nanosuspension) drug delivery system. METHODS:A tandem, ultrasonic-homogenization-fluid bed drying technology was applied to prepare baicalin-nanocrystal dried powders, and the physicochemical properties of baicalin-nanocrystals were...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(14)60012-1
更新日期:2014-01-01 00:00:00
abstract::Saposhnikoviae divaricata (Turcz.) Schischk (SD) is a traditional Chinese herb commonly used to treat clinical conditions such as rheumatism and allergic rhinitis. This review article evaluates a collection of works on in vitro and biochemical studies of SD. The discourse on the diverse class of chromones and coumarin...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章,评审
doi:10.1016/S1875-5364(17)30042-0
更新日期:2017-04-01 00:00:00
abstract::A new ursane-type triterpenoid saponin, 2α,3α,24-trihydroxyurs-12,20(30)-dien-28-oic acid β-D-glucopyranosyl ester (1), together with six known triterpenoid saponins, was isolated and characterized from the aerial parts of Clematoclethra scandens subsp. actinidioides. ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(15)60008-5
更新日期:2015-01-01 00:00:00
abstract:AIM:To study the chemical constituents of the solid culture of the endophyte Phomopsis sp. IFB-E060 in Vatica mangachapoi. METHOD:Isolation and purification were performed through silica gel column chromatography, gel filtration over Sephadex LH-20, ODS column chromatography, and HPLC. Structures of the isolated compo...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(14)60080-7
更新日期:2014-07-01 00:00:00
abstract::The present study was designed to synthesize 2-Cyano-3, 12-dioxooleana-1, 9(11)-en-28-oate-13β, 28-olide (1), a lactone derivative of oleanolic acid (OA) and evaluate its anti-inflammatory activity. Compound 1 significantly diminished nitric oxide (NO) production and down-regulated the mRNA expression of iNOS, COX-2, ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(17)30055-9
更新日期:2017-05-01 00:00:00
abstract::Atractylenolide III (ATL-III), a sesquiterpene compound isolated from Rhizoma Atractylodis Macrocephalae, has revealed a number of pharmacological properties including anti-inflammatory, anti-cancer activity, and neuroprotective effect. This study aimed to evaluate the cytoprotective efficiency and potential mechanism...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(19)30030-5
更新日期:2019-04-01 00:00:00
abstract::The present study carried out a phytochemical investigation of the methanol extract of the branches and leaves of Clausena lansium and afforded nine carbazole alkaloids (compounds 1-9) including two new carbazole alkaloids, claulansiums A and B (compounds 1 and 2). The new compounds were elucidated on the basis of ext...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(18)30087-6
更新日期:2018-07-01 00:00:00
abstract::Two new steroidal saponins, named timosaponin P (1) and timosaponin Q (2), were isolated from the rhizome parts of Anemarrhena asphodeloides Bunge using various chromatographic methods. Their structures and absolute configurations were elucidated by a combination of spectroscopic and spectrometric data, including 1D, ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(17)30038-9
更新日期:2017-03-01 00:00:00
abstract::The present study was designed to investigate the effects of start codon of nosM on the biosynthesis of nosiheptide. Target genes were amplified by overlap PCR. After homologous recombination to construct engineered strains, nosiheptide production was analyzed by HPLC. Three mutants with different start codon of nosM ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(15)30089-3
更新日期:2015-11-01 00:00:00
abstract::Anti-influenza Chinese herbal medicines (anti-flu CHMs) have advantages in preventing and treating influenza virus infection. Despite various data on antiviral activities of some anti-flu CHMs have been reported, most of them could not be compared using the standard evaluation methods for antiviral activity. This situ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(16)30095-4
更新日期:2016-10-01 00:00:00
abstract::Ge Gen Decoction (GGD), a Traditional Chinese Medicine prescription, is mainly used to treat infectious respiratory diseases and can relieve the symptoms of influenza A virus (IAV) infection. However, the underlying mechanism of GGD against IAV infection remains unclear. In this study, we found that GGD had moderate a...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(19)30079-2
更新日期:2019-09-01 00:00:00
abstract::Atherosclerosis (AS) is a chronic inflammatory disease, the main causes of which include abnormal lipid metabolism, endothelial injury, physical and chemical injury, hemodynamic injury, genetic factors and so on. These causes can lead to inflammatory injury of blood vessels and local dysfunction. Bunao-Fuyuan decoctio...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(21)60004-3
更新日期:2021-01-01 00:00:00
abstract:AIM:JS-38 (mitothiolore), a synthetic version of a metabolite isolated from Xenorhabdus sp., was evaluated for its anti-tumor and white blood cell (WBC) elevating activities. METHOD:These anti-proliferative activities were assessed in vitro using a panel of ten cell lines. The anti-tumor activities were tested in vivo...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(14)60117-5
更新日期:2014-10-01 00:00:00
abstract:AIM:The compound B19 (C21H22O5) is a newly synthesized, mono-carbonyl analog of curcumin that has exhibited potential antitumor effects. This present study was performed to identify the anti-angiogenic activity of this compound. METHODS AND RESULTS:B19 inhibited migration and tube formation of human umbilical vein end...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(14)60002-9
更新日期:2014-01-01 00:00:00
abstract:AIM:To study the chemical constituents from the seeds of Griffonia simplicifolia Baill. METHODS:The chemical constituents were isolated and purified by a combination of chromatographic materials including silica gel, Sephadex LH-20, and preparative TLC. Their structures were elucidated on the basis of MS and NMR data ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(13)60059-X
更新日期:2013-07-01 00:00:00
abstract::Tripolinolate A (TLA) is recently identified as a new compound from a halophyte plant Tripolium vulgare and has been shown to have significant in vitro activity against the proliferation of colorectal cancer and glioma cells. This study was designed to further investigate the effects of TLA on the proliferation of hum...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(17)30085-7
更新日期:2017-08-01 00:00:00
abstract:AIM:To investigate the radioprotective effect of adenine on irradiated lymphocytes and discover the possible mechanisms of protection. METHODS:Lymphocytes were pretreated for 12 h with adenine (0.001-0.1 μmol·L(-1)) and then exposed to 4 Gy radiation. Cell viability was observed by the MTS assay, apoptosis was detecte...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(13)60040-0
更新日期:2013-03-01 00:00:00
abstract::To investigate the non-alkaloidal chemical constituents of the stems and leaves of Melodinus suaveolens and their antibacterial activities. Compounds were isolated and purified by repeated silica gel, Sephadex LH-20, RP18, and preparative HPLC. Their structures were elucidated by comparison with published spectroscopi...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(15)30020-0
更新日期:2015-04-01 00:00:00
abstract::Ginsenoside Rh2 (Rh2) is one of the major bioactive ginsenosides in Panax ginseng. However, the oral bioavailability of Rh2 is low, with P-glycoprotein (P-gp) and CYP3A4 being reported to be the main factors. The purpose of the present study was to determine the enhancing effect of piperine on the oral bioavailability...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(18)30041-4
更新日期:2018-02-01 00:00:00
abstract::Considering that high levels of nitric oxide (NO) exert anti-cancer effect and the derivatives of oleanolic acid (OA) have shown potent anti-cancer activity, new O2-vinyl diazeniumdiolate-based NO releasing derivatives (5a-l, 11a-l) of OA were designed, synthesized, and biologically evaluated in the present study. The...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(18)30009-8
更新日期:2017-12-01 00:00:00
abstract::Penicildiones A-D (1-4), four new steroids derivatives together with three known compounds including 16α-methylpregna-17α,19-dihydroxy-(9,11)-epoxy-4-ene-3,18-dione-20-acetoxy (5), stachybotrylactone B (6) and stachybotrin (7) were isolated from the soft coral-derived fungus Penicillium sp. SCSIO41201, cultured in the...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(20)30030-3
更新日期:2020-04-01 00:00:00
abstract::In the present study, two new compounds from Ipomoea cairica were identified and demonstrated to have α-glucosidase inhibitory activity. They were isolated by column chromatography on silica gel and sephadex LH-20 and finally purified by prep-HPLC, with their structures being elucidated by spectroscopic methods, such ...
journal_title:Chinese journal of natural medicines
pub_type: 杂志文章
doi:10.1016/S1875-5364(16)30020-6
更新日期:2016-03-01 00:00:00