Design and characterization of clindamycin-loaded nanofiber patches composed of polyvinyl alcohol and tamarind seed gum and fabricated by electrohydrodynamic atomization

In this study, we developed a polymeric nanofiber patch(PNP) for topical disease treatment using electrohydrodynamic atomization(EHDA). The nanofibers were prepared using various concentrations of polyvinyl alcohol(PVA) and tamarind seed gum and loaded with clindamycin HCl as a model drug. The precursor polymer solutions were sprayed using the EHDA technique; the EHDA processing parameters were optimized to obtain blank and drug-loaded PNPs. The skin adherence, translucence, and ventilation properties of the prepared PNPs indicated that they are appropriate for topical application. The conductivity of the polymer solution increased with increasing PVA and clindamycin concentrations, and increasing the PVA concentration enhanced the solution viscosity. Based on scanning electron microscopy analysis, the PVA concentration had a pronounced effect on the morphology of the sprayed product. Nanofibers were fabricated successfully when the solution PVA concentration was 10%, 13%, or 15%(w/v). The applied voltage significantly affected the diameters of the prepared nanofibers, and the minimum nanofiber diameter was 163.86 nm. Differential scanning calorimetry and X-ray diffraction analyses indicated that the modeldrug was dispersed in PVA in an amorphous form. The PNP prepared with a PVA:gum ratio of 9:1 absorbed water better than the PVA-only PNP and the PNP with a PVA:gum ratio of 9.5:0.5. Moreover, the PNPs loaded with clindamycin at concentrations of 1%–3% prohibited the growth of Staphylococcus aureus more effectively than clindamycin gel, a commercially available product.

Effects of Clindamycin on Sperm Function in Mice

[ Objective] To study the effects of clindamycin on germ cells of male mice. [Method] A total of 48 healthy adult male mice were randomly divided into group A, group B, group C and control group, 12 mice in each group. The mice in the group A, group B and group C were respectively administrated with clindamycin at doses of 15, 30 and 60 mg/kg.d via intraperitoneai injection, and those in the control group were trea- ted with normal saline. On Day 29 after administration, the mice were killed by dislocation, and the sperm motility rate, sperm deformity rate and the percentage of sperm having swollen tail membrane were determined, respectively. [ Result] The sperm motility rate and the percentage of sperm having swollen tail membrane of the group B and group C were lower than those of the control group; and the sperm deformity rate of the group B and group C was higher than that of the control group. The sperm motility rate, sperm deformity rate and percentage of sperm having swollen tail membrane had no significant difference between the group A and control group. [ Conclusion] The clindamycin at a dose equal to or more than that used for severe infection affects the normal function of sperm in mice.

A report on infection dynamics of inducible clindamycin resistance of Staphylococcus aureus isolated from a teaching hospital in India

Objective:To investigate the infection of hospital-and community-acquired"erythromycininduced clindamycin resistant"strains or D-test positives of clinical isolates of Staphylococcus aureus(S.aureus)(with and without methicillin resistance)in a hospital.Methods:Strains of S.aureus isolated from clinical specimens were subjected to D-test and antibiotic profiling.Results:Of the total 278 isolates,140(50.35%)were D-test positives and the rest were D-test negatives.Further,of 140(100%)pesitives,87(62.14%)and 53(37.85%)strains were from males and females,respectively.Of 140(100%)pesitives,117(83.57%)were methicillin resistant S.aureus and23(16.42%)were methicillin sensitive S.aureus;of 140 strains,103(73.57%)strains front persons with and 37(26.42%)were without related infections;of 140 strains,91(65%)and 49(35%)were from hospital-and community-acquired samples,respectively.In 140 strains,118(84.28%)with comorbidities and 22(15.71%)without comorbidities cases were recorded;similarly,persons with prior antibiotic uses contributed 108(77.14%)and without 32(22.85%)positive strains.These binary data of surveillance were analyzed by a univariate analysis.It was evident that the prior antibiotic uses and comorbidities due to other ailments were the determinative factors in D-test positivity,corroborated by low P values,P=0.001 1 and 0.0024,respectively.All isolates(278)were resistant to17 antibiotics of nine groups,in varying degrees;the minimum of 28%resistance for vancomycin and the maximum of 97%resistance for gentamicin were recorded.Further,of 278 strains,only42(15.1%)strains were resistant constitutively to both antibiotics,erythromycin resistant and clindamycin resistant,while 45(16.2%)strains were constitutively sensitive to both antibiotics(erythromycin sensitive,and clindamycin sensitive).Further,of the rest 191(68.7%)strains were with erythromycin resistant and clindamycin resistant,of which only 140(50.35%)strains were D-test positives,while the rest 51(18.34%)strains were D-test negatives.Conclusions:In view of high prevalence of D-test positive S.aureus strains,and equally high prevalence of multidrug resistant strains both in community and hospital sectors,undertaking of D-test may be routinely conducted for suppurative infections.

盐酸克林霉素(clindamycin)的应用研究进展

克林霉素属于洁霉素类抗生素,对革兰氏阳性菌作用较强,该药在人医临床应用广泛,兽医临床应用较少。本文对克林霉素的药理特征、制剂类型、药动学特点、不良反应、检测方法等方面进行了综述,旨在全面评估克林霉素,以便为在兽医临床上合理应用该药提供依据。

盐酸克林霉素(clindamycin)在健康猪及链球菌感染猪体内的药代动力学

盐酸克林霉素按每公斤体重 11mg单一剂量肌肉注射 ,分别观察了其在健康猪 (n=5 )和链球菌感染猪 (n =5 )体内的药代动力学。用高效液相色谱法测定盐酸克林霉素的血药浓度 ,所得血药浓度 -时间数据采用 MCPKP软件进行分析。在健康猪体内的药代动力学参数如下 :Cmax为 (2 .5 46 43± 0 .2 2 42 ) mg/ L,T1 /2 为 (3.2 10± 0 .795 3) h,AUC为(17.86 5 72± 1.2 5 46 ) m g· h/ L ,Tmax为 (2 .18796± 0 .44 37) h。在链球菌感染猪体内的药代动力学参数如下 :Cmax为(2 .5 5 6 89± 0 .12 45 ) mg/ L ,T1 /2 为 (2 .6 912 3± 0 .8895 2 ) h,AUC为 (12 .0 0 6 5 4± 3.2 5 46 ) mg· h/ L ,Tmax为(1.16 176± 0 .5 436 ) h。

Methicillin-Resistant Staphylococcus aureus May Also Be Resistant to Clindamycin and Vancomycin

Objectives: Methicillin-resistant Staphylococcus aureus (MRSA) is a global superbug widely distributed in hospitals, communities and livestock settings. This study investigated the presence and molecular characterization of MRSA co-resistance to clindamycin and vancomycin in the southeastern region of Nigeria. The susceptibility of these organisms to other selected antibiotics was also investigated. Method: Biological samples were obtained from consenting patients from three establishments in Enugu, Nigeria and cultured for isolation and purification. The pure isolates were subjected to antimicrobial susceptibility profiling using conventional antibiotics. The genomic DNAs of the pure isolates were isolated using the Promega genomic DNA purification kit while the antibiotic resistance genes (mecA) genes were identified using a multiplex polymerase chain reaction. Also, the minimum inhibitory concentration of the clindamycin and vancomycin antibiotics was determined as well as their combined activity on the MRSA isolates. Results: A large proportion (71%) of the MRSA isolates was from urine samples and then from the High Vaginal Swab (19%). All the isolates were resistant to cloxacillin while 95% were resistant to ciprofloxacin. MRSA isolates demonstrated resistance to clindamycin (with MIC of 23.44 - 250 μg/ml) and to vancomycin (with MIC of 62.5 - 250 μg/ml). The isolated MRSA also demonstrated multidrug-resistant traits. The combined effects of vancomycin and clindamycin against different species of MRSA exhibited additive, antagonistic and indifferent effects and none had a synergistic effect. Multiplex Polymerase Chain Reaction revealed that the majority of the strains were positive for the 162-bp internal fragment of the mecA gene of MRSA and basically displayed SCCmec type III, indicating that they were multidrug-resistant and hospital-acquired. Conclusion: Clindamycin and vancomycin-resistant MRSA infections are also within the Eastern region of Nigeria as found in other countries of the world. This superbug, therefore, may require drastic and urgent measures to curtail its spread and attendant healthcare challenges like outbreaks of infections. In addition, strict adherence to antibiotic policy and continuous surveillance is highly advocated.

Clindamycin Resistance among Methicillin Resistant <i>Staphylococcus aureus</i>Isolated from Human and Respective Household Swine in Greater Kabale Region—South Western Uganda

Introduction: S. aureus is recognized as the common cause of nosocomial and community-acquired infections. Macrolide-Lincosamide-Streptogramin B (MLSB) is thought to be alternative therapies against MRSA infections. Clindamycin is the most favored agent because of exceptional pharmacokinetic characteristics. However, increasing resistance to clindamycin among MRSA strains is a serious challenge. The current study investigated the profile of clindamycin resistance among MRSA isolates from Humans, and their respective livestock (in particular swine) using D-test in greater Kabale region. Materials and Methods: Three hundred phenotypic MRSA isolates previously isolated from Humans and swine were confirmed by mecA PCR. We performed D-test using erythromycin (15 μg) and clindamycin (2 μg) discs in accordance to Clinical and Laboratory Standards Institute (CLSI) protocol. Results: Of all 300 MRSA isolates, 6% (n = 18) were sensitive to Erythromycin and Clindamycin (S). The rate of inducible clindamycin resistance (iMLSB) was 42% (n = 125) and 38% (n = 115) was resistance to both Erythromycin and clindamycin (cMLSB). However, 14% (n = 42) were resistant to erythromycin but sensitive to clindamycin (MS) without “D” zone negative. Conclusion: Clindamycin resistance (both cMLSB and iMLSB) among MRSA was high and “D” test should be adopted routinely during antimicrobial susceptibility testing by disc diffusion testing to rapidly detect iMLSB and cMLSB.

Impact of Local Application of Clindamycin in Preventing Dry Socket after Third Mandibular Molar Extraction

Extraction of third mandibular tooth is one of the most commonly performed surgical procedures in oral surgery. One of the most common complications following the extraction of third mandibular molar teeth is dry socket (alveolar osteitis). Dry socket is the delayed healing of the wound of the alveolar bone after dental extractions. The purpose of this study was to determine if the intra-alveolar application of Clindamycin could reduce the incidence of dry socket following the extraction of third mandibular molar tooth. Patients who qualified for the prospective, randomized, double-masked, placebo-controlled trial were randomly divided into 2 groups, each group 30 patients. The first group (30 patients) included smokers and the second group (30 patients) included non smokers. Both groups had the mandibular third molar extracted in both sides at the same time. In total, 120 third molars were extracted. The left site was a study group in which we applied the clindamycin and the right site was a control group. The patients were also divided by gender. Dry socket occurred in 3.3% of cases for patients whom were given Clindamycin, regardless of their smoking habits, as opposed to 31.7% for those who did not receive the antibiotic. Results clearly showed that Clindamycin had a huge impact on reducing dry socket regardless of smoking habits.

Development and Application of a Validated HPLC Method for the Determination of Clindamycin Palmitate Hydrochloride in Marketed Drug Products: An Optimization of the Current USP Methodology for Assay

A simple efficient isocratic reversed-phase HPLC method was developed and validated for the determination of clindamycin palmitate hydrochloride (CPH) and its commercially available oral solution products. Separation was achieved on a Phenomenex Zorbax (Luna) cyano column (150 × 4.6 mm, 5 μm) with a Phenomenex cyano guard cartridge (4 × 3.0 mm) on Agilent 1050 series HPLC system. CPH and its resolution standard lincomycin were eluted isocratically at a flow rate of 1 mL/min with a simplified mobile phase (potassium phosphate buffer (5 mM, pH 3.0)—acetonitrile—tetrahydrofuran (20:75:5, v/v/v)) and detected at 210 nm. The column was maintained at 25?C. The method was validated according to USP category I requirements. Robustness and forced degradation studies were also conducted. CPH marketed drug products were obtained from a drug distributor and assayed for potency using the validated method. Validation acceptance criteria were met in all cases. The analytical range for CPH was 15 - 500 μg/mL and the linearity was r2 > 0.999 over three days. The method was determined to be specific and robust. Both accuracy (92.0% - 103.8%) and precision (0.67% - 1.52%) were established across the analytical range for low, intermediate and high QC concentrations. Method applicability was demonstrated by analyzing two marketed products of CPH, in which results showed potency >98%. The method was determined to be an enhancement over the current USP methodology for assay as a result of increased efficiency, reduced organic solvents and the elimination of matrix modifiers. This method was successfully applied for the quality assessment of: 1) currently marketed drug products and 2) will in future assess the product quality of novel dosage forms of CPH for pediatric use.

Efficacy of He-Ne Laser in Combination with Topical Clindamycin in the Treatment of Acne Vulgaris (AV)

Objective: To evaluate the efficacy of He-Ne laser in combination with topical clindamycin in the treatment of AV at 108 Military Central Hospital from Oct 2015 to Aug 2016. Subjects and Methods: 61 patients with AV were divided into 2 groups: Group 1: 31 patients were treated with He-Ne laser in combination with topical Clindamycin, Group 2: 30 patients were only treated with topical clindamycin. Laser HE-NE was applied 2 times/week for 6 weeks. Result: After 3 months of treatment Group 1: very good—51.6%, good—48.4%. Group 2: very good—30%, good—50% and moderate—20%. Conclusion: The combination of He-Ne laser with topical clindamycin shows more rapid clinical improvement compared to topical clindamycin alone in the treatment of mild and moderate AV.

Antibiosis of Cefotaxime/Clindamycin and Lactobacillus acidophilus on Related Bacteria to Diabetic Foot Ulcer

Diabetic foot complications are very common and represent a serious health problem in Mexico because of their high frequency, high costs and difficulties in handling. The treatment of choice to inhibit bacteria related to diabetic foot ulcer consists mainly of the use of cefotaxime however the problem with this treatment (antibiotics) is not always effective due to the pathophysiological condition of the patient, together with the resistance bacteria develop to the drugs. OMS has suggested the use of probiotics for research directed to the development of microbial interference therapies. This project used the Lyophilized conditioned medium with probiotics, extracellulars of probiotics, because there are reports in which wound healing in mice is observed employing probiotics. The objective of this study was to evaluate the biological activity of cefotaxime, clindamycin and thelyophilized conditioned media Lactobacillus acidophilus (LCMLa) on bacterias isolated from diabetic foot ulcer, this bioassay was performed by the turbidimetric method. The macroscopic analysis of the colonies was carried out and the morphological analysis of the bacteria was carried out using the atomic force microscope;in addition, the type of Gram and oxygen requirements for its growth were determined. From the diabetic foot ulcers, three strains were isolated, of which strain 1 and 3 whose morphology corresponds to a bacillus, was susceptible to cefotaxime and to the lyophilized conditioned medium of L. acidophilus. The potential of microbial interference that exhibits L. acidophilus on bacteria related to diabetic foot ulcer is demonstrated.

Clindamycin-induced acute cholestatic hepatitis

我们为牙齿的感染在 clindamycin 的管理以后在一个 42 岁的女人报导尖锐 hepatotoxicity 的一个案例。在治疗的 6 d 以后，她有疲劳，恶心，呕吐，厌食，瘙痒和黄疸。她的实验室分析显示出丙氨酸 aminotransferase (中高音) ， 1795 IU/L (正常范围 0-40 ) ；aspartate aminotransferase (著名计算机生产厂商) ， 1337 IU/L (正常范围 5-34 ) ；硷性磷酸酯酶(高山) ， 339 IU/L (正常范围 40-150 ) ；gamma-glutamyl transpeptidase (GGT ) ， 148 IU/L (正常范围 9-64 IU/L ) ；全部的胆红素， 4.1 mg/dL；直接胆红素， 2.9 mg/dL 和前凝血酶时间(磅) ， 13.5 s 与国际规范的比率(INR ) ， 1.04。她被就医，与立即的药中止。她的肝活体检视标本显示出混合类型(肝细胞和胆汁郁积的) 肝的损害，与导致药的肝炎的诊断兼容。用 Naranjo 概率规模的一个客观诱发性评价建议 clindamycin 是尖锐肝炎的可能的原因。在易受影响的个人， clindamycin 使用可以导致尖锐混合类型肝毒性。如果在严重肝损伤被建立以前，这药被中止，完全的恢复可能是可能的。

Pharmacokinetics after single and multiple intravaginal application of clindamycin phosphate vaginal gel in Chinese female volunteers

Objective:To investigate the pharmacokinetics of clindamycin phosphate vaginal gel in healthy Chinese female volunteers.Methods:Ten healthy Chinese female volun- teers were intravaginally given with 5.0g of clindamycin phosphate vaginal gel (equivalent to 100mg of clindamycin) once for single dose treatment,and 5.0g,once a day for 3 days,for mul- tiple dose treatment.The serum concentration of clindamycin were determined by HPLC-MS method and its pharmacokinetic parameters of clindamycin were calculated by DAS 1.0 soft- ware.Results:The main pharmacokinetic parameters of clindamycin for single dose and multiple doses were as follows:t_(1/2) were (15.30±2.62) hours and (14.78±2.49) hours,Tmax were (4.88±0.94) hours and (4.70±0.59) hours,Cmax were (38.30±22.77) ng/ml and (44.87±26.71) ng/ml,AUC0_(-∞) were (783.45±351.19) ng·ml^(-1)·h^(-1) and (1015.68±456.95) ng·ml^(-1)·h^(-1),respectively.Conclusion:The Cmax of clindamycin phosphate vaginal gel after a single dose and multiple doses are obviously lower and t_(1,2) are longer than that of clindamycin phosphate oral preparations,which suggests that clindamycin phosphate vaginal gel acts locally and can be slowly absorbed to circulation for systemic actions.

Efficacy and Tolerability of 0.1%Adapalene With 1%Clindamycin Versus 0.1%Adapalene With 2.5%Benzoyl Peroxide on Acne Vulgaris:A Case Control Study

Objective:Combination therapy is currently the preferred acne treatment.We conducted this study to compare the efficacy and tolerability of 0.1%adapalene with 1%clindamycin versus 0.1%adapalene with 2.5%benzoyl peroxide(BPO)in the treatment of acne vulgaris.Methods:This study was conducted over a period of 1 year from September 2014 to September 2015.One-hundred patients aged 14 to 30 years with mild to moderate acne vulgaris were included.The patients were randomly allocated to 2 equal groups(n=50 in each group),and received a topical combination of 0.1%adapalene with 1%clindamycin andtopical combination of 0.1%adapalene with 2.5%BPO,respectively).The efficacy and tolerability of two treatments were compared.The unpaired studentt test was used to compare the difference in continuous variables between 2 groups,while the chi-square test or Fisher exact test was used for categorical variables.Results:One-hundred patients with mild to moderate acne vulgaris were randomly allocated to 2 equal groups(n=50 in each group).After 12 weeks of treatment,there were no significant differences between the adapalene-clindamycin and adapalene-BPO in the mean reductions in the numbers of non-inflammatory lesions(11.16±8.01 and 11.12±8.62,respectively),inflammatory papules(49.78±37.57 and 50.48±36.57,respectively),and total lesions(67.50±44.59 and 70.12±46.83,respectively).The incidence of a burning sensation was significantly greater in the adapalene-BPO group than the adapalene-clindamycin group(32%vs.6%;P=0.002).Conclusion:Topical adapalene plus clindamycin and adapalene plus BPO had similar efficacies in the treatment of acne.Adapalene with clindamycin was better tolerated than adapalene with BPO.

盐酸克林霉素棕榈酸酯联合西地碘对慢性牙周炎患者的应用效果

目的探究盐酸克林霉素棕榈酸酯与西地碘联合治疗慢性牙周炎(CP)的效果。方法回顾性选取新乡医学院第一附属医院2021年5月至2022年3月收治的CP患者,以1∶1原则根据不同治疗方案将68例患者分为2组,各34例。对照组接受西地碘治疗,联合组接受盐酸克林霉素棕榈酸酯+西地碘治疗。对比两组疗效、牙周指标[菌斑指数(PLI)、牙龈指数(GI)、牙周袋探诊深度(PD)、牙齿附着丧失(AL)]、疼痛程度[视觉模拟评分法(VAS)评估]、生活质量[CP口腔健康影响程度量表(OHIP-CP)]、血清因子水平[人髓系细胞触发受体-1(TREM-1)、高迁移率族蛋白B-1(HMGB-1)、瘦素、内脂素]、不良反应及复发率。结果联合组总有效率(97.06%)高于对照组(76.47%)(P<0.05);治疗后联合组PD、AL、PLI、GI、VAS及OHIP-CP评分低于对照组(P<0.05);治疗后联合组TREM-1、HMGB-1、内脂素低于对照组,瘦素高于对照组(P<0.05);联合组复发率(12.12%)低于对照组(34.61%)(P<0.05);两组不良反应发生率相比,差异无统计学意义(P>0.05)。结论盐酸克林霉素棕榈酸酯联合西地碘治疗CP效果显著,可改善牙周状况,减轻痛感,提高生活质量,降低复发率,安全可靠。

甘草查尔酮A与三种抗生素联用对产气荚膜梭菌感染小鼠的治疗作用

本研究旨在研究中药单体与抗生素联用对产气荚膜梭菌(Clostridium perfringens,CP)感染小鼠的影响。本试验以甘草查尔酮A(licorice chalcone A,LCA)为代表药物,探究LCA与抗生素联用的体外和体内治疗效果,通过联合药敏试验确定与中药单体LCA有协同作用的抗生素,测定了产气荚膜梭菌在不同浓度药物作用下的杀菌曲线、溶血试验、滑动试验以及对小鼠的气性坏疽治疗效果,比较不同种抗生素在不同浓度下与LCA联用的治疗作用。结果表明,克林霉素(clindamycin,CLDM)、四环素(tetracycline,TCN)、替米考星(tilmicosin,TMS)三种抗生素与LCA有协同作用。根据杀菌曲线结果显示,8μg·mL^(-1)LCA和16μg·mL^(-1)TMS几乎可以完全杀灭产气荚膜梭菌;2μg·mL^(-1)LCA与2μg·mL^(-1)TMS联合使用可显著降低细菌的溶血性,溶血几乎完全被抑制(溶血定量为9.08%)。值得注意的是,LCA对细菌的迁移力有一定的促进作用,能够提高菌毛介导的运动性,与TMS联用后其促进作用显著提升。动物体内试验结果表明,CLDM单独使用时对产气荚膜梭菌具有较好的抑制作用,治疗效果显著;TCN和TMS分别与LCA联合使用时表现出协同作用(FIC指数为0.375),同时治疗时也表现出较好的增效效果。因此,在治疗产气荚膜梭菌感染时,TMS与LCA联合作用,可以降低药物使用量并提高治疗效果。

综合性医院门诊克林霉素使用情况专项处方点评的研究

克林霉素是林可霉素衍生物,也是临床常用的抗生素类型,可通过抑制敏感菌株蛋白质合成,发挥抗感染效果。克林霉素的抗菌活性较强,但是不良反应较多,需要进一步提升其临床用药合理性,保障患者临床治疗有效性和安全性。当前,针对克林霉素临床应用的处方点评管理规范逐渐完善,处方点评工作有序开展,但是仍需进一步明确该类抗生素使用中存在的问题,进而制定相应的干预对策,以保证克林霉素临床应用的安全性和有效性。为此,文章对综合性医院门诊克林霉素使用情况专项处方点评情况进行了现状分析,并总结了克林霉素处方点评中发现的问题,针对问题汇总了提升克林霉素用药合理性的相关建议。

Synergistic effect of α-mangostin on antibacterial activity of tetracycline, erythromycin, and clindamycin against acne involved bacteria

Objective:To evaluate the synergistic effect ofα-mangostin with tetracycline,erythromycin,and clindamycin against bacteria involved in acne production.Methods:A broth microdilution method was used to determine the minimum inhibitory concentration(MIC)ofα-mangostin and a range of antibiotics.Synergistic effects on antibacterial activity were determined based on their own MIC,and then using a checkerboard method and a time-kill assay at 37°C for24 h.Results:α-Mangostin exhibited antibacterial activity against Propionibacterium acnes,Staphylococcus aureus,S.epidermidis and S.pyogenes with MIC values of 0.78,3.13,0.78,and 6.25μg/m L,respectively.The results of the checkerboard assay showed thatα-mangostin produced synergistic effects with tetracycline,erythromycin,and clindamycin against all tested bacteria,with a fractional inhibitory concentration index(FICI)between 0.09 and 0.32.Moreover,time-kill curve data indicated thatα-mangostin increased the antibacterial activity of tetracycline,erythromycin,and clindamycin.Conclusion:These findings suggested thatα-mangostin may be used to enhance the antibacterial activity of some antibiotics against bacteria involved in acne production.

β-溶血性链球菌对红霉素、克林霉素耐药性及对大环内酯类抗生素耐药机制研究

目的探讨BHS的耐药性及耐药基因携带情况。方法采用药敏纸片法测定BHS对红霉素、克林霉素的药物敏感性,应用PCR法检测其对大环内酯类药物耐药基因ermB、mefA。结果BHS群对红霉素及林可酰胺类药物克林霉素的耐药率较高。ermB基因阳性率为84.4%,其中GCS、GFS对该基因携带率最高均为100%,7株红霉素敏感菌株中检测出ermB基因,与耐药表型不符。mefA基因阳性率为3.1%,均在红霉素耐药菌株中检出。有1株同时携带ermB、mefA基因。结论BHS群对大环内酯类药物及林可酰胺类药物耐药率较高,其对红霉素耐药主要与核糖体糖蛋白甲基化有关。

克林霉素甲硝唑搽剂原料甲硝唑供应商变更质量研究

目的:克林霉素甲硝唑搽剂变更原料甲硝唑供应商,为评估原料供应商变更对制剂质量的影响,对变更前后供应商原料甲硝唑进行质量对比研究;对变更前后制剂杂质进行对比研究;对变更前后制剂产品进行质量稳定性研究。方法:采用粉末X射线衍射法、激光粒度分析法、高效液相色谱法,对原料甲硝唑进行晶型、粒度分布、杂质、含量对比研究,对制剂产品进行杂质及质量对比研究,开展稳定性试验研究。结果:变更前后供应商原料甲硝唑质量对比,为同一晶型原料药,粒度分布基本一致,杂质及含量无明显差异;甲硝唑变更前后制剂杂质及质量对比无明显差异;甲硝唑变更前后生产产品经稳定性对比试验,各项检测结果均无明显变化,质量稳定。结论:变更原料甲硝唑供应商,原料甲硝唑质量无明显差异,未对产品质量产生不良影响。