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1.
Acta Pharmaceutica Sinica ; (12): 3216-3221, 2023.
Article in Chinese | WPRIM | ID: wpr-999098

ABSTRACT

Azithromycin dry suspension is one of the most commonly used drugs in pediatric clinic, but its taste masking has been difficult to achieve. 5 representative products of azithromycin dry suspension were chose to compare their tastes both using electronic tongue and human sensory evaluation methods, and there existed the differences of bitterness, later bitterness, graininess, and adhesion among these products. Raman micro-imaging was used to determine the difference in taste mainly due to different prescription ingredients and manufacturing techniques. Through mixing the dry suspensions with alkaline mixing solvent, the bad taste of each product was masked after evenly dispersing in the solvent, and their tastes were all close to the taste of the solvent. In the future, it is planned to investigate the stability and bioavailability of the solvent preparations, and then to give the medication suggestion of solvent preparation after ensuring their efficacy.

2.
Acta Pharmaceutica Sinica ; (12): 3210-3215, 2023.
Article in Chinese | WPRIM | ID: wpr-999097

ABSTRACT

Chloral hydrate is a commonly used central sedative drug before pediatric clinical examination, but its clinical safety and medication adherence are needed to focus on normally because of its poor stability and palatability. Under the premise of investigating the stability of different formulations, their palatability were also screened by using both human sensory and electronic tongue evaluation techniques. Human sensory evaluation has been conducted with the informed consent of all participants in accordance with the ethical requirements of the Good Clinical Practice for Drug Trials. The results showed that the addition of sorbitol and sucralose could effectively ensure the stability of the oral solution. Sorbitol is the main taste-masking component, and the ratio of 40% sorbitol and 0.5% sucralose can effectively mask the bitterness, astringency and spicy taste of 10% chloral hydrate oral solution. The results detected by human sensory and electronic tongue have good correlation and complementarity, and the combination of these two methods is more conducive to getting objective and reasonable conclusions.

3.
Acta Pharmaceutica Sinica ; (12): 3165-3172, 2023.
Article in Chinese | WPRIM | ID: wpr-999094

ABSTRACT

Electronic tongue is one kind of bionic detection technologies, which can objectively reflect the taste of drugs based on electrochemical principle. In this paper, the development histories of electronic tongue both of potential type and voltammetry type were introduced, including their detection principles and key innovation technologies. In order to comprehensively improve the understanding of electronic tongue, its technological progresses, such as the study of dedicated sensors or biosensors for specific tastes, and the development of miniaturized or hybrid devices, were also discussed in detail. And the challenges and countermeasures in the application of electronic tongue were analyzed to provide some suggestions for its further technology promotion.

4.
Acta Pharmaceutica Sinica ; (12): 3151-3159, 2023.
Article in Chinese | WPRIM | ID: wpr-999068

ABSTRACT

The taste of oral dosage forms has become a critical factor affecting the drug compliance and adherence to the treatment, and clinical application of the drug product may seriously restricted due to its bad taste. On the basis of the statement for the basic principle and specific performance of existing instruments, the application progress of electronic tongue on drug taste evaluation is addressed in detail. In view of its objective, fatigue-free, less harmful and accurate advantages, electronic tongue has been widely and meaningfully applied in the aspects of bitterness masking, and quality assessment and assurance of drug products. In addition, the reasons limiting the popularization of electronic tongue are mentioned in the paper, and some suggestions might be useful to enlarge the further application in the future.

5.
Asian Journal of Andrology ; (6): 5-12, 2023.
Article in English | WPRIM | ID: wpr-970984

ABSTRACT

Spermatogenesis is regulated by several Y chromosome-specific genes located in a specific region of the long arm of the Y chromosome, the azoospermia factor region (AZF). AZF microdeletions are the main structural chromosomal abnormalities that cause male infertility. Assisted reproductive technology (ART) has been used to overcome natural fertilization barriers, allowing infertile couples to have children. However, these techniques increase the risk of vertical transmission of genetic defects. Despite widespread awareness of AZF microdeletions, the occurrence of de novo deletions and overexpression, as well as the expansion of AZF microdeletion vertical transmission, remains unknown. This review summarizes the mechanism of AZF microdeletion and the function of the candidate genes in the AZF region and their corresponding clinical phenotypes. Moreover, vertical transmission cases of AZF microdeletions, the impact of vertical inheritance on male fertility, and the prospective direction of research in this field are also outlined.


Subject(s)
Humans , Male , Azoospermia/genetics , Sex Chromosome Aberrations , Prospective Studies , Chromosome Deletion , Chromosomes, Human, Y/genetics , Infertility, Male/genetics , Sertoli Cell-Only Syndrome/genetics , Oligospermia/genetics
6.
China Tropical Medicine ; (12): 811-2023.
Article in Chinese | WPRIM | ID: wpr-1005146

ABSTRACT

@#Abstract: Objective To investigate the clinical types of children's tinea capitis and the distribution of fungal pathogens in Wuhan from 2011 to 2020, and to provide scientific basis for the prevention, diagnosis and treatment of children's tinea capitis. Methods Laboratory data of children with tinea capitis in outpatient and inpatient department of dermatology in Wuhan No.1 Hospital from January 2011 to December 2020 were collected. A total of 542 cases of pediatric tinea capitis were included, with 239 male cases and 303 female cases. Microscopic examination of fungi and culture identification were performed on the affected skin lesions of the children. Chi-square test was used to analyze the differences in pathogen spectrum of children with different age groups and clinical type. Results Among the pediatric tinea capitis patients, the age group with the highest prevalence was preschool children(3 to <7 years old), accounting for 48.52%(263/542). The top three pathogenic fungi were Trichophytes violaceum(49.26%, 267/542), Microsporum canis(31.55%, 171/542) and Trichophyton mentagrophytes (9.96%, 54/542). Trichophyton violaceum was the main pathogen in all ages, followed by Microsporum canis. The infection rate of Microsporum canis in children over 7 years old was lower than that in children under 7 years old, and the infection rate of Trichophyton rubrum in infants was higher than that in other ages. The distribution of Trichophytes violaceum, Trichophyton mentagrophytes, Nannizzia gypseum and Microsporum ferrugineum was uniform in all age groups. Trichophytes violaceum and Trichophyton tousurans mainly caused black-dot ringworm, Microsporum canis mainly caused tinea alba, Trichophyton mentagrophytes,Nannizzia gypseum and Trichophytonrubrum mainly caused kerion. Except for Microsporum ferrugineum, the composition ratios of other fungi species showed statistically significant differences among different clinical types of tinea capitis(P<0.05). Conclusions Preschool children are the most commonly affected age group by pediatric tinea capitis, and black-dot ringworm caused by Trichophytes violaceum is the main clinical type. Analysis of the high-riskage group, pathogenic fungi and clinical types of tinea capitis in children can enhance the understanding of its epidemiological characteristics, which is helpful for early diagnosis and targeted standardized treatment of pediatric tinea capitis.

7.
China Journal of Chinese Materia Medica ; (24): 52-59, 2023.
Article in Chinese | WPRIM | ID: wpr-970501

ABSTRACT

This study investigated the choroplast genome sequence of wild Atractylodes lancea from Yuexi in Anhui province by high-throughput sequencing, followed by characterization of the genome structure, which laid a foundation for the species identification, analysis of genetic diversity, and resource conservation of A. lancea. To be specific, the total genomic DNA was extracted from the leaves of A. lancea with the improved CTAB method. The chloroplast genome of A. lancea was sequenced by the high-throughput sequencing technology, followed by assembling by metaSPAdes and annotation by CPGAVAS2. Bioiformatics methods were employed for the analysis of simple sequence repeats(SSRs), inverted repeat(IR) border, codon bias, and phylogeny. The results showed that the whole chloroplast genome of A. lancea was 153 178 bp, with an 84 226 bp large single copy(LSC) and a 18 658 bp small single copy(SSC) separated by a pair of IRs(25 147 bp). The genome had the GC content of 37.7% and 124 genes: 87 protein-coding genes, 8 rRNA genes, and 29 tRNA genes. It had 26 287 codons and encoded 20 amino acids. Phylogenetic analysis showed that Atractylodes species clustered into one clade and that A. lancea had close genetic relationship with A. koreana. This study established a method for sequencing the chloroplast genome of A. lancea and enriched the genetic resources of Compositae. The findings are expected to lay a foundation for species identification, analysis of genetic diversity, and resource conservation of A. lancea.


Subject(s)
Phylogeny , Atractylodes/genetics , Genome, Chloroplast , Whole Genome Sequencing , Microsatellite Repeats , Lamiales
8.
Indian J Pediatr ; 2022 Aug; 89(8): 785–792
Article | IMSEAR | ID: sea-223728

ABSTRACT

Objectives To explore the associations between higher antibiotic use rates (AURs) and adverse outcomes in very-low-birthweight (VLBW) infants without culture-proven sepsis or necrotizing enterocolitis (NEC) in a multicenter of China. Methods A prospective cohort study was performed on VLBW infants admitted to 24 neonatal intensive care units from January 1, 2018, to December 31, 2018. AUR was calculated as calendar days of antibiotic therapy divided by total hospital days. The composite primary outcome was defned as mortality or severe morbidity, including any of the following: severe neurologic injury, bronchopulmonary dysplasia (BPD), and stage 3 or higher retinopathy of prematurity. Results A total of 1,034 VLBW infants who received antibiotics without culture-proven sepsis or NEC were included in this study. The overall AUR of eligible VLBW infants was 55%, and the AUR of each eligible VLBW infant ranged from 3 to 100%, with a median of 56% (IQR 33%, 86%). After generalized propensity score and logistic regression analysis of 4 groups of VLBW infants with diferent AUR range, infants in the higher quartile AUR, (Q3, 0.57~0.86) and (Q4, 0.87~1.00), had higher odds of composite primary outcome (adjusted OR: 1.81; 95% CI: 1.23–2.67; adjusted OR 2.37; 95% CI: 1.59–3.54, respectively) and BPD (adjusted OR: 3.09; 95% CI: 1.52–6.57; adjusted OR 3.17; 95% CI: 1.56–6.57, respectively) than those in the lowest AUR (Q1). Conclusions Antibiotic overexposure in VLBW infants without culture-proven sepsis or NEC was associated with increased risk of composite primary outcome and BPD. Rational empirical antibiotic use in VLBW infants is urgently needed in China.

9.
Journal of Pharmaceutical Practice ; (6): 374-378, 2022.
Article in Chinese | WPRIM | ID: wpr-935041

ABSTRACT

Objective To explore the effect and significance of electronic account books on the management of anesthesia and psychotropic drugs. Methods The data of electronic account books from January 2020 to June 2020 in the inpatient pharmacy of the hospital (observation group), and manual account books from July 2019 to December 2019 (control group) were collected respectively. The data of daily accounting time, monthly settlement accounting time and accounting accuracy between the two groups were compared and analyzed. Results The daily average time for pharmacists to manually accounting was (162.8±22.5) min, and the daily average time for pharmacists to make accounts electronically was (33.2±7.0) min. It took (245.5±7.2) min for manual accounting of monthly settlement and (46.8±2.5) min for electronic accounting of monthly settlement. The accuracy rate of daily counting records, special account books, special register and empty ampoule waste paste recovery records included in electronic accounting is up to 100%. Conclusion The implementation of electronic account books not only significantly improved the work efficiency of pharmacists, but also strengthened drug supervision, formed a comprehensive traceability system, which could ensure the safety of clinical medication, and make the management of narcotic psychotropic drugs more efficient and standardized.

10.
Chinese Journal of Digestive Endoscopy ; (12): 301-306, 2022.
Article in Chinese | WPRIM | ID: wpr-934108

ABSTRACT

Objective:To evaluate the effects of single spay of L-menthol (NPO-11) on suppressing gastric peristalsis during upper gastrointestinal endoscopy and the influencing factor.Methods:This study was a multicenter, randomized, double-blind, placebo-parallel controlled study. The eligible patients were randomly divided into two groups by randomized blocks. Patients received local spray of either NPO-11 (160 mg L-menthol) or placebo 20 mL during upper gastrointestinal endoscopy. The gastric peristalsis was recorded and evaluated before, 2 minutes after and at the end of endoscopy. The complexity of the procedure was evaluated by the researchers. The influencing factors for antiperistaltic effect of NPO-11 were analyzed.Results:A total of 220 patients were enrolled from five research centers. There were 109 cases in the NPO-11 group and 111 cases in the placebo group. The baseline data of the two groups were similar and comparable. The proportion of patients with grade 1 peristalsis at 2 minutes after the treatment and at the end of endoscopy was significantly higher in the NPO-11 group than that in the placebo group [40.37% (44/109) VS 16.22% (18/111), χ2=15.93, P<0.001]. Compared with the placebo group, the proportions of weak peristalsis (grade 1 and 2) were higher in the NPO-11 group at 2 minutes after the treatment [67.89% (74/109) VS 46.85% (52/111)] and at the end of endoscopy [79.82% (87/109) VS 48.65% (54/111)]. Subgroup analysis showed that the inhibitory effect of NPO-11 on gastric peristalsis was more significant in Helicobacter pylori antibody positive group. Conclusion:Local spray of NPO-11 can effectively inhibit gastric peristalsis during upper gastrointestinal endoscopy, and its effect is more significant in Helicobacter pylori antibody positive group. It could be recommended for no obvious adverse reactions , its safety, and the convenient procedure.

11.
Korean Circulation Journal ; : 401-413, 2022.
Article in English | WPRIM | ID: wpr-926517

ABSTRACT

Pragmatic clinical studies, an emerging clinical research discipline, include a wide range of studies that are largely embedded with routine clinical practice and aim to evaluate the comparative effectiveness and safety of different clinical intervention strategies. Increased availability and quality of electronic medical/health records drives the development of pragmatic clinical studies. In this review, we describe evolution of the conceptual framework of pragmatic clinical studies and share perspectives on the importance of pragmatic clinical studies in evidence-based practice for cardiovascular diseases, as a complement to conventional randomized controlled trials. We also highlight specific needs of pragmatic clinical studies in improving evidence-based practice for cardiovascular disease in Asian countries. The main challenges of pragmatic clinical studies are discussed briefly in this review.

12.
Biomolecules & Therapeutics ; : 246-256, 2022.
Article in English | WPRIM | ID: wpr-925614

ABSTRACT

The present study focused on the potential mechanism of betulin (BT), a pentacyclic triterpenoid isolated from the bark of white birch (Betula pubescens), against chronic alcohol-induced lipid accumulation and metaflammation. AML-12 and RAW 264.7 cells were administered ethanol (EtOH), lipopolysaccharide (LPS) or BT. Male C57BL/6 mice were fed Lieber-DeCarli liquid diets containing 5% EtOH for 4 weeks, followed by single EtOH gavage on the last day and simultaneous treatment with BT (20 or 50 mg/ kg) by oral gavage once per day. In vitro, MTT showed that 0-25 mM EtOH and 0-25 μM BT had no toxic effect on AML-12 cells. BT could regulate sterolregulatory-element-binding protein 1 (SREBP1), lipin1/2, P2X7 receptor (P2X7r) and NOD-like receptor family, pyrin domains-containing protein 3 (NLRP3) expressions again EtOH-stimulation. Oil Red O staining also indicated that BT significantly reduced lipid accumulation in EtOH-stimulated AML-12 cells. Lipin1/2 deficiency indicated that BT might mediate lipin1/2 to regulate SREBP1 and P2X7r expression and further alleviate lipid accumulation and inflammation. In vivo, BT significantly alleviated histopathological changes, reduced serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and triglyceride (TG) levels, and regulated lipin1/2, SREBP1, peroxisome proliferator activated receptor α/γ (PPARα/γ) and PGC-1α expression compared with the EtOH group. BT reduced the secretion of inflammatory factors and blocked the P2X7rNLRP3 signaling pathway. Collectively, BT attenuated lipid accumulation and metaflammation by regulating the lipin1/2-mediated P2X7r signaling pathway.

13.
Chinese Journal of Obstetrics and Gynecology ; (12): 317-327, 2021.
Article in Chinese | WPRIM | ID: wpr-884358

ABSTRACT

Objective:To evaluate the clinical efficacy and safety of oral mifepristone (10 mg/day) versus placebo in the preoperative treatment of uterine fibroids.Methods:This study was a multi-center, randomized, double-blind, placebo, parallel controlled trial. A total of 132 patients with uterine fibroids were randomly divided into study group and control group, with 66 cases in each group. The patients in the study group orally took 1 tablet/day of mifepristone (dose of 10 mg/tablet), the patients in the control group orally took 1 tablet/day of placebo, and both groups were treated for 3 months. The primary efficacy evaluation indicators were the change rate of maximum fibroid volume; the secondary efficacy evaluation indicators included amenorrhea rate, improvement of subjective symptoms and anemia; the safety evaluation indicators included the analysis of adverse events and changes in laboratory biochemical indicators.Results:At the end of treatment, the maximum leiomyoma volume was reduced by 25.97% (95% CI: -34.79%--15.95%) in the study group and reduced by 1.51% (95% CI: -13.03%-11.54%) in the control group. The change rate of the maximum leiomyoma volume before and after treatment in the study group was significantly greater than that in the control group, and the difference in the change rate of the maximum leiomyoma volume between the two groups was -24.84% (95% CI: -36.56%--10.94%), which was much higher than the 10% superiority threshold goal set by this study within the 95% CI interval. At the end of treatment, the complete amenorrhea rate [84% (52/62)], dysmenorrhea elimination rate [98% (61/62)], and menstrual blood loss disappearance rate [87% (54/62)] in the study group were significantly higher than those in the control group (all P<0.05). At the end of treatment, the mean hemoglobin [(131±13) g/L], red blood cell count [(4.5±0.4)×10 12/L] and hematocrit (0.39±0.03) in the study group were significantly increased compared with the baseline, and the differences had statistical significance (all P<0.05); after treatment, the differences in the above three indicators between the two groups had statistical significance (all P<0.01). The serum estradiol level in the study group was significantly lower than that in the control group at the end of treatment, and the difference was statistically significant ( P<0.01). There were no significant differences in follicle-stimulating hormone and cortisol levels before and after treatment between the two groups ( P>0.05). The overall incidences of any adverse event were not significantly different between the two groups (all P>0.05). Abdominal pain was the most common adverse event in the study group [9% (6/65)], but the incidence was not significantly increased compared with the control group [3% (2/64); P>0.05]. Conclusion:Compared with placebo, oral mifepristone 10 mg/day is significantly superior to placebo in reducing the size of uterine fibroids and improving anemia, without significant adverse reactions, and could be used as a drug treatment for patients with of uterine fibroids before surgery.

14.
Chinese Medical Journal ; (24): 1720-1725, 2021.
Article in English | WPRIM | ID: wpr-887614

ABSTRACT

BACKGROUND@#Geriatric hip fracture patients receiving clopidogrel are a surgical challenge. In China, most of these patients undergo delayed surgical treatment after clopidogrel withdrawal for at least 5 to 7 days. However, delayed surgery is associated with increased complications and mortality in the older adults. This retrospective paralleled comparison study investigated the safety of early surgery for geriatric hip fracture patients within 5 days of clopidogrel withdrawal.@*METHODS@#Acute hip fracture patients (≥65 years) who were hospitalized in the orthogeriatric co-management ward of Beijing Jishuitan Hospital between November 2016 and April 2018 were retrospectively reviewed. Sixty patients taking clopidogrel before injury and discontinued  0.050). The percentages of patients with coronary heart disease (61.7% vs. 18.3%; P  0.050). There was no significant difference in perioperative complications, and 30-day and 1-year mortality rates between the groups.@*CONCLUSIONS@#Early hip fracture surgery is safe for elderly patients within 5 days of clopidogrel withdrawal, without increased perioperative blood loss, transfusion requirement, complications, and mortality compared with patients not taking antiplatelet drugs.


Subject(s)
Aged , Humans , Case-Control Studies , Clopidogrel/therapeutic use , Hip Fractures/surgery , Platelet Aggregation Inhibitors/adverse effects , Retrospective Studies , Ticlopidine/adverse effects
15.
Acta Pharmaceutica Sinica ; (12): 1677-1682, 2021.
Article in Chinese | WPRIM | ID: wpr-881543

ABSTRACT

Research on polymer impurities has always been important in the quality control of cephalosporins. Research on polymers in cephalosporins that lack active amino groups on the C-7 side chain has not been reported. Therefore, our study used cefazolin sodium, which is widely used in the clinic, as an example. The polymer in cefazolin sodium and its product "cefazolin sodium pentahydrate for injection" was analyzed by column switching liquid chromatography-high resolution mass spectrometry. Two polymer impurity peaks were detected and the possible structures of these polymers were suggested. Through two-dimensional liquid chromatography, the chromatographic peaks following Sephadex gel chromatography and high-performance gel chromatography were compared to those obtained by reverse high-performance liquid chromatography (HPLC) for cefazolin sodium as reported in the Chinese Pharmacopoeia. The HPLC method proves more suitable for polymer detection than Sephadex gel chromatography and high-performance gel chromatography. The method of polymer detection for cefazolin sodium was established using the method of related substances HPLC as described in the Chinese Pharmacopoeia.

16.
Journal of Preventive Medicine ; (12): 649-655, 2021.
Article in Chinese | WPRIM | ID: wpr-881446

ABSTRACT

Objective@#To analyze the influencing factors for the 20-69-year-old residents in Anhui Province with substandard physiques, so as to provide a basis for improving the physiques of population. @*Methods @#The 2014 physical fitness survey data of residents aged 20-69 years in Anhui Province were collected, including demographic information, physical exercise status and physical indicators ( height, weight, vital capacity, blood pressure and so on ). The physiques of residents was rated according to the "National Fitness Standards" ( 2003 edition ) . The multivariate logistic regression model was used to analyze the influencing factors for substandard physiques in different age groups. @*Results@#Among 39 803 residents recruited, 5 081 were rated as substandard physiques and the rate was 12.77%. The rates of substandard physiques in the residents aged 20-<40, 40-<60 and 60-69 years were 11.08%, 13.11% and 16.74%, respectively. The results of multivariate logistic regression analysis showed that age, gender, household registration, education level, occupation and time spent each exercise were the influencing factors for substandard physiques among the residents aged 20-<40 years ( P<0.05 ); age, household registration, education level, occupation and physical exercise were the influencing factors for substandard physiques among the residents aged 40-<60 years ( P<0.05 ); age, gender, education level, occupation, physical exercise and time spent each exercise were the influencing factors for substandard physiques among the residents aged 60-69 years ( P<0.05 ).@*Conclusions@#The residents aged 20-69 years in Anhui Province have higher rate of substandard physiques in the 2014 survey. Age, education level, occupation and physical exercise may affect physical fitness and vary in different age groups, thus interventions should be carried out according to age.

17.
Acta Pharmaceutica Sinica ; (12): 1889-1896, 2020.
Article in Chinese | WPRIM | ID: wpr-825166

ABSTRACT

To establish a method for the determination of polymer impurities in ceftazidime raw materials and preparations, a ceftazidime degradation solution containing polymer impurities was prepared by forced polymerization. Polymer impurities in the degradation solution were separated and identified by high performance gel chromatography and the column switching-LC-MSn method. A new RP-HPLC method for ceftazidime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.02 mol·L-1 phosphate buffer, methanol and acetonitrile. The results showed that when using this high performance gel chromatography method some small molecular weight impurities were co-eluted with the polymers, resulting in a poor specificity and poor quantitative accuracy. But when using the RP-HPLC method, four polymer impurities were detected in the 25-45 min time range with good specificity, sensitivity and robustness, including two ceftazidime dimers, trimers, and derivatives. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in ceftazidime, and ceftazidime degradation solution can be used as suitable solution for analysis of ceftazidime polymers.

18.
International Journal of Surgery ; (12): 145-149, 2020.
Article in Chinese | WPRIM | ID: wpr-863298

ABSTRACT

Endovascular aortic aneurysm repair has become the preferred treatment for most patients with infrarenal abdominal aortic aneurysm. However, for juxtarenal abdominal aortic aneurysm with a short-neck, visceral branch reconstruction is required, and the conventional endovascular aortic aneurysm repair effect is not satisfactory. In recent years, the application of innovative techniques such as chimney technique, fenestration technique, branch technique and octopus technique have provided a variety of solutions for the endovascular treatment of patients with juxtarenal abdominal aortic aneurysms. This article reviews and summarizes the current progress of endovascular treatment in order to analyze and reflect on the application difficulties of various techniques.

19.
Acta Pharmaceutica Sinica ; (12): 2854-2861, 2020.
Article in Chinese | WPRIM | ID: wpr-862284

ABSTRACT

With the in-depth study of related substances and the development of consistency evaluation of generic drugs, relative correction factors are gaining increasing attention. By analyzing the domestic and foreign literature on correction factors in recent years, this paper describes the correction factor component, the current measurement method and its application. The rules and key points of use of an impurity correction factor and its determination and application are described, and some problems in its determination and application are discussed, providing a reference and basis for the standardization of research on impurity correction factors in the future.

20.
Acta Pharmaceutica Sinica ; (12): 2442-2448, 2020.
Article in Chinese | WPRIM | ID: wpr-829382

ABSTRACT

To establish a method for the determination of polymer impurities in cefixime raw materials and preparations, a cefixime degradation solution containing polymer impurities was prepared by forced polymerization. Polymer impurities in the degradation solution were separated and identified by high performance gel chromatography and the column switching-LC-MSn method. A new RP-HPLC method for cefixime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.5% formic acid-water solution and 0.5% formic acid-acetonitrile solution. The results showed that when using this high performance gel chromatography method some small molecular weight impurities were co-eluted with the polymers, resulting in a poor specificity and poor quantitative accuracy. But when using the RP-HPLC method, three polymer impurities were detected with good specificity, sensitivity and robustness, including two cefixime dimers, and dehydrate dimer. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in cefixime, and cefixime degradation solution can be used as suitable solution for analysis of cefixime polymers.

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