细菌内毒素检查法测定硫酸卡那霉素注射液的热原

参照《中国兽药典》2000版收载的细菌内毒素检查法，验证了硫酸卡那霉素注射液的细菌内毒素检查法。通过干扰试验证明，硫酸卡那霉素注射液对鲎试剂的凝集反应无干扰作用，用灵敏度为0．25EU／mL的鲎试剂检查细菌内毒素的方法可行、有效。可以用细菌内毒素检查法替代家兔热原检查法来检测硫酸卡那霉素注射液的热原。     

安乃近注射液细菌内毒素检验方法的建立

本实验对安乃近注射液的细菌内毒素检查方法进行研究,建立快速准确的细菌内毒素检查法。按《中国药典》2010版附录XIE细菌内毒素检查方法进行。利用不同厂末生产的鲎试荆进行干扰试验,全面考察安乃近注射液对细茼内毒素控查的干扰作用,以确定最佳试验条件。安乃近注射液可以采用稀释方法排除干扰。本细茵内毒素检查结果安全、可靠。     

安乃近注射液细菌内毒素检验方法的建立

本实验对安乃近注射液的细菌内毒素检查方法进行研究,建立快速准确的细菌内毒素检查法。按《中国药典》2010版附录XIE细菌内毒素检查方法进行。利用不同厂末生产的鲎试荆进行干扰试验,全面考察安乃近注射液对细茼内毒素控查的干扰作用,以确定最佳试验条件。安乃近注射液可以采用稀释方法排除干扰。本细茵内毒素检查结果安全、可靠。     

双黄连注射液细菌内毒素检查及其限值的确定

本实验对双黄连注射液的细菌内毒素检查方法进行研究,建立快速准确的细菌内毒素检查法。按《中国药典》2010版附录XIE细菌内毒素检查方法进行。利用不同厂末生产的鲎试荆进行干扰试验,全面考察双黄连注射液对细茼内毒素控查的干扰作用,以确定最佳试验条件。双黄连注射液可以采用稀释方法排除干扰。本方法结果安全、可靠。     

辅酶Q10注射液热原标准的研究

目的 :探讨细菌内毒素检查法测定辅酶Q10注射液中细菌内毒素含量的可行性,并以此建立辅酶Q10注射液热原的质量标准。方法:按照《中国药典》2010版二部XIE进行。结果:细菌内毒素法能够用于辅酶Q10注射液的细菌内毒素的测定,检测结果与家兔法一致,其质量内控指标为:将样品稀释400倍后,按《中国药典》2010版二部细菌内毒素法测定,应符合规定。结论:细菌内毒素法质量内控指标可用于辅酶Q10注射液生产中的质量控制。     

细菌内毒素检测法与家兔法检测葡萄糖酸钙注射液热原的比较探讨

目的：考察细菌内毒素检查法对葡萄糖酸钙注射液进行检查的可行性。方法：用细菌内毒素检测法对家兔热原试验的葡萄糖酸钙注射液进行比较试验。结果：供试品对鲎试剂与内毒素的反应无干扰作用。家兔热原检查法结果与细菌内毒素检查法结果相吻合。结论：用细菌内毒素检查法检测葡萄糖酸钙注射液热原是可行的。     

转移因子注射液中细菌内毒素检测方法研究

为检测转移因子(TF)注射液中细菌内毒素,本研究采用鲎试剂与细菌内毒素产生凝集反应的凝胶法对国内1个生物制品厂的TF注射液样品进行了检测,实验结果表明当TF注射液稀释至0.025 mg/mL时,对鲎试剂的凝集反应无干扰作用.因此,该方法适用于TF注射液中细菌内毒素检测,并可以用于该项生物制品的质量监控.     

头孢喹肟注射液的细菌内毒素检查

参照《中国兽药典》2000年版一部附录细菌内毒素检查法进行试验,研究了头孢喹肟注射液细菌内毒素检查法的干扰情况。结果表明,供试品在0.78125 mg/mL稀释液的浓度下对细菌内毒素无干扰作用。通过实验研究,建立了该品种的细菌内毒素限量检查法。     

抗氧剂硫脲对兽用维生素B1注射液含量测定的影响

本文探讨了以硫脲(CH4N2S)作为维生素B1注射液的抗氧剂,对维生素B1注射液含量测定的影响,结果表明硫脲可干扰含量测定的结果,导致含量测定结果偏高。为维生素B1注射液的生产及检验提供参考。     

鲎试验检测脂肪乳注射液中细菌内毒素的研究

目的:验证鲎试验检查脂肪乳注射液中细菌内毒素的可行性。方法:按照2010年版《中国药典》细菌内毒素检查方法,用2个厂家的鲎试剂对脂肪乳注射液进行研究。结果:用λ为0.5EU/ml的鲎试剂检测细菌内毒素可行、有效。结论:细菌内毒素检查法(凝胶法)可代替兔热原法控制脂肪乳注射液的产品质量。     

注射用硫酸链霉素细菌内毒素检查法的探讨

按照《中国兽药典》二○○五年版一部[1]中注射用硫酸链霉素细菌内毒素检查法对样品复核检验,试验表明该方法是可行的;并与《美国药典》进行了比较,结果说明《中国兽药典》注射用硫酸链霉素细菌内毒素检查法对细菌内毒素的限值表达比《美国药典》29版[2]更合理、更科学。     

氯化氨甲酰甲胆碱注射液细菌内毒素检查方法研究

建立氯化氨甲酰甲胆碱注射液的细菌内毒素检查方法。按《中国兽药典》2005年版一部收载的细菌内毒素检查法进行试验。试验结果表明,当氯化氨甲酰甲胆碱稀释成0.01 mg/mL时,对鲎试剂的凝集反应无抑制作用。可以用细菌内毒素检查法检查氯化氨甲酰甲胆碱注射液的细菌内毒素。     

Studies onEscherichia coli vaccines: Estimation of endotoxins in veterinary vaccines

Fifteen batches ofE. coli vaccines for pigs, from three different manufacturers, were subjected to a quantitative form of the in vitro Limulusamoebocyte-lysate (LAL) test for their free endotoxin content. A batch of vaccine associated with abortions in pregnant sows was found to contain a much higher level of free endotoxin than batches of vaccine not associated with abortion. The evidence of these assays suggests that they will be useful in the quality control ofE. coli vaccines.     

Comparison of the amounts of endotoxin released from Escherichia coli after exposure to antibiotics and ozone: an in vitro evaluation

Antibiotic therapy administered for treatment of gram-negative bacterial infections can exert a negative effect in the form of endotoxin shock. Therefore, a sterilization method that releases little endotoxin is required. This in vitro study aimed to compare the amounts of endotoxin released from Escherichia coli exposed to antibiotics (aminobenzylpenicillin, kanamycin, oxytetracycline, sulfadimethoxine and enrofloxacin) or ozone. The bacterial growth and amount of endotoxin released were measured at specific time points. Compared with antibiotic treatment, ozone sterilization induced release of smaller amounts of endotoxin from the bacteria. Moreover, no major differences were observed when ozone was used against the purified endotoxin. We conclude that compared with antibiotic treatment, ozone sterilization may release smaller amounts of endotoxin.     

鸭瘟活疫苗外源病毒检验方法（鸡检查法）的修订

对二〇〇五年版《中华人民共和国兽药典》中鸭瘟活疫苗外源病毒检验的鸡检查法进行了修订,确定选用9-12周龄SPF鸡,在原药典规定方法的基础上增加低剂量基础免疫程序,并用该外源病毒检验方法对5批鸭瘟活疫苗进行了验证,结果表明修订后的鸭瘟活疫苗外源病毒检验方法可靠,可操作性强。     

硫酸链霉素细菌内毒素定量测定法的研究

应用鲎试剂动态浊度法，将硫酸链霉素制备成4、2、1、0．5mg／mL溶液，定量添加标准内毒素进行干扰预试验，计算回收率，确定不干扰浓度为0．5—2mg／mL。从中选出1mg／mL为最佳浓度，然后进行3个批次硫酸链霉素正式干扰试验。在供试品中定量添加标准内毒素，其回收率分别为125．8％、126．1％、127．3％，均在50％-200％之间，说明此浓度的供试品对鲎试剂反应无干扰作用。因此，内毒素含量在0．015—1EU／mL范围内，将硫酸链霉素制备成浓度为1．0mg／mL的溶液，可用于细菌内毒素的定量检测。     

乳粉生产过程中营养素损失率的研究

随机选取某段婴幼儿乳粉同一生产周期各生产阶段的前、中、后三个批次的样品,对部分营养素(维生素B1、B2、C、A、E和微量元素Ca、Fe、Zn)含量进行检测,并计算其损失率。结果表明,在生产过程中,维生素C含量的变化受各方面因素影响最明显(损失率分别为32.33%和29.05%);Fe的含量在前处理工段到浓缩工段受到影响较明显(损失率为16.07%);其他营养素含量变化不明显。     

Air microorganisms in animal housing--4. Airborne gram-negative bacteria and airborne endotoxin in pig houses

The species composition of airborne gram-negative bacteria and the relationship between inhalable endotoxin, inhalable dust and airborne bacteria were studied in 4 pig houses. The airborne gram-negative bacterial flora was dominated by Enterobacteriaceae. Within the Enterobacteriaceae the species E. coli and Enterobacter agglomerans were predominant. Significant correlation were found between the concentration of inhalable dust and inhalable endotoxin as well as between the concentration of airborne gram-negative bacteria and inhalable endotoxin. However these correlation were not very strong. With respect to the characterization of the potential hazard of organic dust exposure, measurements of the concentration of airborne dust or airborne bacteria should not be used for the estimation of the concentration of airborne endotoxin.     

Ophthalmic viscoelastics commonly used in cataract surgery: A microbiota investigation

Purpose

To survey commonly used, sterile ophthalmic viscoelastic materials used during routine cataract surgery for the presence of bacterial DNA and/or viable bacteria and endotoxin quantification.

Methods

Samples from three different ophthalmic viscoelastic manufacturers and three different production lots per manufacturer were collected for 16 S ribosomal ribonucleic acid (rRNA) sequencing and conventional aerobic and capnophilic bacterial culture. Other samples of viscoelastic material from the same three manufacturers were collected for endotoxin quantification using a commercially available Limulus amebocyte lysate (LAL) assay. Statistical analysis was performed using Sigma Plot 14.0, and R v4.0.2.0. Differences (p ≤ .05) between sample collection sites in total DNA concentration, microbial richness, mean intra-group distances, and endotoxin quantification alongside reagent controls were evaluated.

Results

Culture yielded two isolates, identified as Staphylococcus epidermidis and Bacillus megaterium. 16 S rRNA sequencing revealed no differences between brands in richness or overall composition. The most common bacterial DNA detected across all brands was Staphylococcus sp., Cutibacterium sp., Flavobacterium sp., and Lactobacillus sp. A significant difference was found between the median endotoxin concentration between Anvision and Hyvisc® viscoelastic (Anvision: 0.171 EU/mL, Hyvisc®: 0.03 EU/mL; p < .001).

Conclusions

No brand-specific differences in bacterial DNA were detected in the viscoelastic materials. Staphylococcus, Cutibacterium, Flavobacterium, and Lactobacillus were the dominant contributors to the bacterial DNA detected. Although Anvision viscoelastic samples contained significantly more endotoxin than Hyvisc® viscoelastic samples, endotoxin concentrations were below the FDA limit of 0.2 EU/mL for both manufacturers. These data further the understanding of inflammatory outcomes following cataract surgery.     

Evaluation of in vitro properties of di-tri-octahedral smectite on clostridial toxins and growth

REASONS FOR PERFORMING STUDY: Clostridial colitis and endotoxaemia of intestinal origin are significant causes of morbidity and mortality in horses. Intestinal adsorbents are available for treatment of these conditions; however, little information exists supporting their use. OBJECTIVES: To evaluate the ability of di-tri-octahedral smectite to bind to Clostridium difficile toxins A and B, C. perfringens enterotoxin and endotoxin, inhibit clostridial growth and the actions of metronidazole in vitro. METHODS: Clostridium difficile toxins, C. perfringens enterotoxin and endotoxin were mixed with serial dilutions of di-tri-octahedral smectite, then tested for the presence of clostridial toxins or endotoxin using commercial tests. Serial dilutions of smectite were tested for the ability to inhibit growth of C. perfringens in culture broth, and to interfere with the effect of metronidazole on growth of C. perfringens in culture broth. RESULTS: Clostridium difficile toxins A and B, and C. perfringens enterotoxin were completely bound at dilutions of 1:2 to 1:16. Partial binding of C. difficile toxins occurred at dilutions up to 1:256 while partial binding of C. perfringens enterotoxin occurred up to a dilution of 1:128. Greater than 99% binding of endotoxin occurred with dilutions 1:2 to 1:32. No inhibition of growth of C. difficile or C. perfringens was present at any dilution, and there was no effect on the action of metronidazole. CONCLUSIONS: Di-tri-octahedral smectite possesses the ability to bind C. difficile toxins A and B, C. perfringens enterotoxin and endotoxin in vivo while having no effect on bacterial growth or the action of metronidazole. POTENTIAL RELEVANCE: In vivo studies are required to determine whether di-tri-octahedral smectite might be a useful adjunctive treatment of clostridial colitis and endotoxaemia in horses.