盐酸头孢噻呋注射液^(60)Co-γ辐照灭菌的研究

研究旨在探讨盐酸头孢噻呋注射液使用辐照灭菌的可能性。试验采用不同辐照剂量(8、16、24、32、40 kGy)对盐酸头孢噻呋注射液样品进行辐照,辐照前后样品进行沉降体积比、含量、有关物质及无菌等项目的检测,并将辐照后的样品进行40℃加速稳定性试验。结果显示,与辐照前相比,样品的沉降体积比无明显变化,不同的辐照剂量辐照后均能够保证产品无菌。随着辐照剂量的增加,样品的含量有所降低,杂质有所升高;当辐照剂量为32、40 kGy时,样品性状发生改变。在40℃加速条件下,随着加速时间延长,辐照剂量为8~16 kGy的样品含量略有降低,有关物质略有增加,加速6个月后各检测项均在合格范围内。研究表明,盐酸头孢噻呋注射液样品可采用辐照灭菌,根据产品的加速稳定性结果,初步筛选最佳辐照剂量为8~16 kGy。

^(60)Co辐射灭菌对紫草油质量的影响

目的:考察三批次不同剂量^(60)Co辐射灭菌对院内制剂紫草油的性状、定性鉴别、含量测定、微生物限度检查等质量控制指标的影响,为紫草油实现最终灭菌提供参考。方法:根据2020版《中华人民共和国药典》、四川省药品监督管理局批准的质量标准SZBZ20081112要求,观察紫草油性状变化;采用薄层色谱法对紫草油与紫草对照药材进行定性鉴别;采用紫外分光光度法,检测羟基萘醌总色素含量,在520 nm波长处测定吸光度,按左旋紫草素(C6H16O5)的吸收系数(E1%1 cm)为242计;采用微生物计数法,进行需氧菌总数、霉菌和酵母菌总数、控制菌检查(金黄色葡萄球菌、铜绿假单胞菌)等微生物限度检测。结果:3 kgy、5 kgy、6 kgy辐射灭菌后的制剂均符合质量标准的要求,10 kgy、20 kgy辐射灭菌后的制剂不符合质量标准的要求。结论:^(60)Co辐射灭菌,具有灭菌作用显著、穿透力强、不需升高温度、无化学残留物、可实现带包装最终灭菌、操作简便等特点,能达到灭菌的效果,不影响紫草油质量,有实用价值。

Effects of sterilization treatments on the analysis of TOC in water samples

Decomposition experiments conducted with and without microbial processes are commonly used to study the effects of environmental microorganisms on the degradation of organic pollutants.However,the effects of biological pretreatment （sterilization） on organic matter often have a negative impact on such experiments.Based on the principle of water total organic carbon （TOC） analysis,the effects of physical sterilization treatments on determination of TOC and other water quality parameters were investigated.The results revealed that two conventional physical sterilization treatments,autoclaving and 60 Co γ-radiation sterilization,led to the direct decomposition of some organic pollutants,resulting in remarkable errors in the analysis of TOC in water samples.Furthermore,the extent of the errors varied with the intensity and the duration of sterilization treatments.Accordingly,a novel sterilization method for water samples,0.45 μm micro-filtration coupled with ultraviolet radiation （MCUR）,was developed in the present study.The results indicated that the MCUR method was capable of exerting a high bactericidal effect on the water sample while significantly decreasing the negative impact on the analysis of TOC and other water quality parameters.Before and after sterilization treatments,the relative errors of TOC determination could be controlled to lower than 3% for water samples with different categories and concentrations of organic pollutants by using MCUR.

Preparation and characterization of iron-ore-imbedded silicone rubber materials for radiation protection

Iron-ore-imbedded silicone rubber materials were produced for radiation shielding. Samples were tested against a Co-60 gamma source, which is widely used in nuclear technology and medicine. Decreasing the particle size of iron ore resulted in better gamma radiation protection owing to more homogenous distribution. In addition, the materials had flexible properties up to the addition of 60 wt% iron ore content. Further, 0.5 mm Pb E gamma protection was provided by using 2.06-mm-thick SDT-60 as the Co-60 source. Iron ore–silicone rubber composites are candidate materials for lead-free flexible radiation protection systems owing to their relatively inexpensive and easy production.

Effect of irradiation on temperature performance of dispersioncompensation no-core cascade optical-fiber sensor coated with polydimethylsiloxane film

A temperature measurement device can produce data deviations and can even be damaged in a high-dose radiation environment.To reduce the radiation damage to such a device and improve the temperature measurement accuracy in a radiation environment,a temperature sensor based on optical-fiber sensing technology is proposed.This sensor has a cascade structure composed of a single-mode fiber(SMF),a dispersion-compensation fiber(DCF),a nocore fiber(NCF),and another SMF(SDNS).The DCF and NCF are coated with a polydimethylsiloxane(PDMS)film,which is a heat-sensitive material with high thermal optical and thermal expansion coefficients.In experiments,PDMS was found to produce an irradiation crosslinking effect after irradiation,which improved the temperature sensitivity of the SDNS sensor.The experimental results showed that within a range of 30–100℃,the maximum temperature sensitivity after irradiation was 62.86 pm/℃,and the maximum transmission sensitivity after irradiation was 3.353×10^(-2)dB/℃,which were 1.22 times and 2.267 times the values before irradiation,respectively.In addition,repeated temperature experiments verified that the SDNS sensor coated with the PDMS film had excellent temperature repeatability.Furthermore,it was found that with an increase in the irradiation intensity,the irradiation crosslinking degree of PDMS increased,and the temperature sensitivity of the sensor was improved.The proposed sensor could potentially be applied to temperature measurement in a nuclear-radiation environment.

Preliminary Research on Radiation Breeding of Pteroceltis tatarinowii Maxim.

In order to explore the effect of radiation breeding on new germplasm innovation of Pteroceltis tatarinowii,the dry seeds of P.tatarinowii from Lingyan Temple were used as test materials in this study,which were irradiated by ^(60)Co-γ rays with different radiation doses.The results showed that the emergence rate decreased with the increase of radiation dose,the emergence rate of low dose below 200 Gy decreased slowly,and the emergence rate of high dose above 200 Gy decreased sharply;when the radiation dose ranged from 100 to 200 Gy,the mutagenic effect of P.tatarinowii seeds was the best;and radiation obviously affected the leaf color and leaf shape of seedlings.This study provides original materials for the cultivation of new P.tatarinowii varieties and the study of color-changing mechanism.

^（60）Co─γ射线辐照香味蒜蓉对某些营养素含量的影响

本文提出了香味蒜蓉￣（６０）Ｃｏ－γ射线辐照杀菌单元操作方法，通过对辐照杀菌化学效应的研究，建立了１７种人体必需氨基酸含量及氨基酸总量与辐照剂量的数学模型和大蒜素、维生素Ｃ、蛋白质、总糖、脂肪、总酸、水分等成分与辐照剂量的关系模型。

钴-60辐照灭菌医用手套质量和包装材料的研究

医用手套包装用的纸塑复合材料具有良好的防菌、防潮与抗低温性能,经钴-60照射后,虽透气度有所增加,抗性强度下降,但仍优于单层纸包装材料。手套经25kGy照射后,抗拉质量仍符合国家标准。

^（60）CO－γ射线辐照消毒大鼠与小鼠饲料的效果

对^（６０）ＣＯ－γ射线辐照大鼠与小鼠颗粒饲料的有效灭菌剂量和辐照后饲料的营养成分。有效保存期及饲喂效果进行了研究。结果表明，ＳＰＦ级动物饲料的有效灭菌剂量为２５ｋＧｙ，辐照灭菌后的有效保存期至少为９０ｄ，而以３０ｋＧｙ辐照剂量灭菌的饲料可以保存１８０ｄ．饲料经辐照灭菌后，仅维生素Ｂ１减少２０％左右，其余营养成分无明显损失。而以高压蒸汽法（１２１℃，３０ｍｉｎ）灭菌的饲料其粗蛋白和维生素等均有不同程度的损失，尤其是维生素Ｂ１损失约５０％。以两种不同方法灭菌的饲料分别饲喂裸小鼠，结果：辐照饲料组裸鼠的体重显著高于高压灭菌组（Ｐ＜０．０５）。

超声波协同钴-60对蕃茄酱的灭菌效果研究

用一定频率的超声波协同60Co辐射对番茄酱进行处理,通过二次旋转实验设计,采用不同的超声波功率、处理时间及辐射剂量,以细菌总数及乳酸杆菌两个微生物指标来考察其协同杀菌能力.结果表明,经过超声波处理的番茄酱,再以较低的辐射剂量处理,可获得令人满意的杀菌效果.当超声波功率为120 W,超声波作用时间为20.8 min,辐射剂量为7.05 kGy时,细菌总数的减少率可以达到99%;当超声波功率为120 W,超声波作用时间为16 min,辐射剂量为7.11 kGy时,乳酸杆菌的减少率可以达到98%.

不同灭菌方法对实验动物配合颗粒饲料营养成分的影响

探讨不同的灭菌条件,对实验动物配合颗粒饲料(鼠料)中营养成分的影响。采用不同时间的高压蒸汽(121℃、0.14 MPa)(蒸汽灭菌)和不同剂量的60 Co-γ射线照射(照射灭菌)对鼠料灭菌,依据国标做细菌培养,观察灭菌条件及效果,并对鼠料进行营养成分的测定。结果表明,20 min蒸汽灭菌和20.0 kGy剂量60 Co-γ射线照射时细菌培养为阴性;蒸汽灭菌比照射灭菌更容易造成营养成分的破坏,两种方法差异显著(P<0.05),且不同时间下水分、粗蛋白、粗脂肪、赖氨酸、蛋氨酸、胱氨酸、苏氨酸、异亮氨酸及维生素的损失都有显著差异(P<0.05),矿物质除铁外损失无显著差异(P>0.05);不同剂量照射下,各种营养成分的损失差异不显著(P>0.05)。鼠料消毒灭菌的适宜条件为20 min蒸汽灭菌或20.0 kGy照射灭菌;蒸汽灭菌对鼠料的营养成分影响较大,而照射灭菌则影响较小。

对藻酸钠消毒方法的研究

经对４种消毒方法比较，对作为动物细胞微囊重要材料之一的藻酸钠以用流通蒸汽消毒效果最好。该法作用３０ｍｉｎ对枯草杆菌黑色变种芽胞的杀灭率达１００％，对藻酸钠粘度影响小，制成的微囊破损率为１８５％。

不同灭菌方法对桑叶超微粉中芦丁含量的影响

目的探讨不同灭菌方法对桑叶超微粉中芦丁含量的影响。方法对同批桑叶超微粉分别采用干热灭菌、湿热灭菌、^(60)Co辐照灭菌、微波灭菌、臭氧灭菌和环氧乙烷气体灭菌方法灭菌;采用高效液相色谱法测定灭菌前后的样品中芦丁含量,色谱柱为Thermo Hypersil ODS C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.5%磷酸溶液(梯度洗脱),流速为1.0 m L/min,检测波长为358 nm,柱温为25℃,进样量为10μL。结果6种灭菌方法均可达到灭菌效果,但不同灭菌方法对桑叶超微粉中芦丁含量的影响不同。湿热灭菌的桑叶超微粉色泽差,呈深黄绿色且结块;^(60)Co辐照灭菌和微波灭菌的桑叶超微粉中芦丁含量分别为0.1554%和0.1528%,RSD分别为1.86%和1.62%。结论不同灭菌方法对桑叶超微粉中的芦丁含量均有影响,^(60)Co辐照灭菌和微波灭菌方法对芦丁含量影响较小,结合实际生产,宜采用微波灭菌方法对桑叶超微粉进行灭菌。

SWELLING BEHAVIOR OF ACRYLAMIDE HYDROGEL IN DIFFERENT SOLVENTS AND pHs

Swelling property of acrylamide hydrogels,prepared from aqueous solutions of acrylamide monomer havingconcentrations in the range of 10-60 wt% by ray irradiation method using a Co-60 gamma radiation source at dosesranging 1-30.0 kGy,has been investigated under various swelling media.These swelling media were basically solvents(solutions),produced by dissolving methanol,ethanol,glucose,sucrose,sodium chloride and sodium persulfate individuallywith distilled water,and solutions prepared with pHs=3,7 and 10.The investigation was performed in order to observe theeffect of these solvents and pHs as well as the influence of monomer concentrations,radiation doses and times on swellingbehavior of hydrogels.Swelling values were found higher for hydrogels prepared with lower monomer concentrations(ca.20 wt%)and radiation doses(ca.5 kGy)and showed a leveling off tendency within 24 h.The glucose solvent and the buffersolution of pH=10 revealed significant increase of swelling of hydrogels as compared to other solutions.Results areexplained based on crosslinking density in hydrogel,polymer-solvent/polymer-polymer interactions in solutions,permeability of molecules in solutions and ionization capacity of hydrogel in pH.

酱油辐射灭菌的初步研究

以纯天然发酵淡色龙牌酱油和深色龙牌酱油为试验对象。结果表明 :γ射线具有良好的杀菌作用。剂量 6 0万拉德能使酱油灭菌率接近 90 % ,90万拉德剂量能使酱油灭菌率在 96 %以上 ,而各个剂量的γ射线对酱油总酸、氨基酸态氨的数值及感官指标几乎没有影响。

心脉康片灭菌工艺优选及其稳定性考察

目的优选心脉康片的灭菌工艺;并对制剂的稳定性进行考察,预测其有效期。方法采用单因素实验设计,以莪术醇含量和微生物限度检查为指标,优选灭菌工艺;采用影响因素试验、加速试验和长期稳定性试验考察心脉康片的稳定性。结果采用钴-60辐射灭菌法处理后,莪术醇的含量较其他灭菌方法高;强光对心脉康片的性状、崩解时限、莪术醇含量和微生物限度基本没有影响,温度和湿度对其有影响。结论钴-60辐射灭菌法,辐射剂量6 KGy为最佳灭菌工艺;湿度对心脉康片质量影响较为明显,提示包装、贮藏及运输时要保持密封干燥的环境;心脉康片的有效期暂定为18个月。

辐照灭菌工艺对熟地黄中梓醇含量的影响

目的 考察60Co-γ辐照灭菌工艺对熟地黄中梓醇含量的影响.方法 采用HPLC法对熟地黄中的梓醇进行定性鉴别及含量测定,流动相：乙腈-甲醇-0.1%磷酸溶液（10：90：1）;柱温：30℃;检测波长：215nm;流速：1.0mL·min-1.结果 梓醇在5～100μg·mL-1范围内呈良好线性关系（r=0.9998）,辐照前后样品中梓醇的含量变化在95.07%～98.86%之间.结论 60Co-γ辐照灭菌工艺对熟地黄中梓醇含量无明显影响,可用于熟地黄的灭菌.

不同灭菌方法对蜈蚣含氮量的影响研究

目的:分析乙醇灭菌及钴-60辐射灭菌对蜈蚣含氮量的影响。方法 :处理蜈蚣的各个阶段,检测含氮量和微生物。结果:处理蜈蚣各个阶段的含氮量均没有明显变化。结论:蜈蚣乙醇灭菌及钴-60辐射灭菌的方法均有效可行。

不同辐照方法对苦参及制剂中生物碱类成分的影响

目的考察电子束辐照和^(60)Co辐照对苦参药材、苦参中间体提取物及痢泻灵片中4种苦参碱类成分含量的影响。方法用电子束辐照和^(60)Co辐照2种辐照方法,分别以0、1.5、3、5、7、10、20、30、40 kGy剂量对苦参、苦参中间体提取物及痢泻灵片进行辐照,采用HPLC法测定其氧化苦参碱、氧化槐果碱、苦参碱、槐果碱含量,并比较辐照前后成分含量变化。结果氧化苦参碱、氧化槐果碱、苦参碱、槐果碱分别在0.0469~0.9374μg、0.0205~0.4104μg、0.0989~1.9779μg、0.0487~0.9731μg范围内线性关系良好,平均回收率分别为98.1%、100.1%、100.5%、96.6%,RSD分别为1.69%、2.03%、3.14%、1.10%。电子束辐照和^(60)Co辐照2种辐照方法对苦参药材中氧化苦参碱、氧化槐果碱、苦参碱、槐果碱含量基本无影响,对苦参中间体提取物和痢泻灵片4个成分含量有影响。结论所建立的苦参碱类成分测定方法准确、重复性好、简单实用,可作为痢泻灵片质控方法。辐照对苦参药材苦参碱类成分含量影响不显著,高剂量辐照对苦参中间体及成药有影响,可为企业质量控制及灭菌辐照提供依据。

比较不同灭菌工艺对白热斯中指标成分含量的影响

目的考察不同灭菌方法对白热斯灭菌效果及其活性成分含量的影响,选择最适宜的灭菌方法。方法分别采用热压灭菌、流通蒸气灭菌、干热灭菌、60Co辐射灭菌4种不同的灭菌方法对白热斯药材粉末进行灭菌处理,采用HPLC测定白热斯中胡椒碱、异绿原酸A、异绿原酸C、槲皮素4种指标性成分的含量。比较不同灭菌方法对白热斯中4种指标性成分含量及微生物限度的影响。结果 4种灭菌方法所检测的细菌总数、霉菌、酵母菌和大肠埃希菌均符合《中国药典》的要求。60Co辐照灭菌,辐射剂量为4 k Gy时,4种指标性成分总含量高于其他灭菌方法,损失率为1. 21%。结论白热斯灭菌方法选用60Co辐射灭菌技术,工艺简单,干燥时间短,且能有效保留各指标成分。