Radiation processing of bacterial cellulose-monolaurin wound dressing: Physicochemical effects, functional analysis, and sterilization.

A commercial bacterial cellulose-monolaurin wound dressing was investigated for changes in the chemical structure, mechanical strength, thermal degradation, morphology, and functional swelling properties after exposure to gamma and electron beam radiations at doses 15-50 kGy. Radiation-induced oxidation occurred as seen in the FT-IR peaks at 1720-1750 cm-1. Degradation of the cellulosic network was observed in tensile strength reduction and shift in degradation temperature to lower values. The SEM cross-section images of the irradiated dressings revealed a less dense nanostructure network compared to the non-irradiated samples while the XRD diffractograms indicated a change in lattice direction/plane. Despite these changes, irradiation caused no significant effect on the functional properties especially at 15-25 kGy doses where most biomedical devices are sterilized. All irradiated wound dressings exhibited physical integrity, increased exudate absorption, and water vapor transmission rate - properties beneficial to wound-healing functionality. The pre-selected sterilization dose of 15 kGy for each ionizing radiation was successfully verified and substantiated following ISO 11137-2:2016, hence ionizing radiation is a suitable sterilization modality for the product.

The Influence of Combined Sterilization Factors on the Structural and Functional Characteristics of Bone Implants.

The results of a comprehensive study of the patterns of structural and functional changes in bone tissue samples after combined (ozone + radiation) sterilization are presented. The study used a different approach to the sterilization process with selective ozone or radiation exposure and an integral, combined one, based on a combined ozone-oxygen treatment of bone samples at the first stage and radiation at the second. The methods of IR spectroscopy, scanning electron microscopy with a prefix for elemental analysis, atomic force microscopy, and mechanical analysis with determination of elastic-plastic properties (Vickers microhardness index) were used in the work. It is shown that the ozone exposure used at the first stage of the combined sterilization process of bone implants does not lead to negative consequences with respect to their properties and characteristics. The results obtained serve as a scientific and methodological basis for the further improvement and optimization of sterilization technologies (including combined). They also offer a comprehensive justification of the parameters of sterilization regimes to ensure the safety of using bone implants during reconstructive operations, minimizing structural and functional changes in bone matter, and creating effective health-saving technologies and the possibility of using them for various biomedical applications.

A Quick Laboratory Method for Assessment of Blood Penetration and Splash Resistance of PPE Fabrics During the COVID-19 Pandemic Situation.

In the current outbreak of COVID-19, healthcare facilities are hit by a shortage of supply of Personal Protective Equipments (PPE) owing to extensive local and global demands and restrictions on their import or export. To circumvent this, trials with several indigenous materials suitable to qualify for PPEs and sterilization techniques for their reuse are being carried out. Prior to their commercialisation, it is imperative to evaluate the resistance of the PPE fabrics against penetration of synthetic blood under applied pressure, 40-300 mmHg as per test standards. Generally, two types of tests are recommended, Penetration Test and Splash Resistance Test, the former being more stringent. While the final certification of PPEs is carried out by authorised agencies, a first impression quick estimate of the choice of fabric can be made using a simple laboratory set-up. This study describes setups developed in the laboratory to carry out these tests. Evaluation of the fabrics, post-gamma irradiation, was also carried out. Microscopic examinations were performed to investigate radiation-induced structural changes in fabrics showing degraded performance. This set-up is useful for selection of fabrics and to assess the feasibility of reuse of PPEs, which is the need of the hour in this pandemic situation.

Printed Low-Cost PEDOT:PSS/PVA Polymer Composite for Radiation Sterilization Monitoring.

During the γ-radiation sterilization process, the levels of radiation exposure to a medical device must be carefully monitored to achieve the required sterilization without causing deleterious effects on its intended physical and chemical properties. To address this issue, here we have demonstrated the development of an all-printed disposable low-cost sensor that exploits the change in electrical impedance of a semi-interpenetrating polymer network (SIPN) composed of poly(vinyl alcohol) (PVA) and poly(3,4-ethylenedioxythiophene):polystyrenesulfonate (PEDOT:PSS) as a functional polymer composite for radiation sterilization monitoring applications. Specifically, the PEDOT:PSS acts as the electrically conductive medium, while the PVA provides the ductility and stability of the printed sensors. During irradiation exposure, chain scission and cross-linking events occur concurrently in the PEDOT:PSS and PVA polymer chains, respectively. The concurrent scissoring of the PEDOT polymer and cross-linking of the PVA polymer network leads to the formation of a stable SIPN with reduced electrical conductivity, which was verified through FTIR, Raman, and TGA analysis. Systematic studies of different ratios of PEDOT:PSS and PVA mixtures were tested to identify the optimal ratio that provided the highest radiation sensitivity and stability performance. The results showed that PEDOT:PSS/PVA composites with 10 wt % PVA produced sensors with relative impedance changes of 30% after 25 kGy and up to 370% after 53 kGy (which are two of the most commonly used radiation exposure levels for sterilization applications). This composition showed high electrical impedance stability with less than ±5% change over 18 days after irradiation exposure. These findings demonstrate the feasibility of utilizing a printing technology for scalable manufacturing of low-cost, flexible radiation sensors for more effective monitoring of radiation sterilization processes.

Radiation Inactivation of Coronavirus Infection Pathogen by the Example of Transmissible Gastroenteritis Virus.

In recent years, members of the Coronaviridae family have caused outbreaks of respiratory diseases (MERS, SARS, and COVID-19). At the same time, the potential of radiation-induced inactivation of this group of viruses have been little studied, although radiation technologies can be widely used both in the processing of personal protective equipment and in the sterilization of vaccines. In the present work, the effect of 10 MeV electron beams and 7.6 MeV bremsstrahlung on the coronavirus infection pathogen (transmissible gastroenteritis virus) has been studied in vitro. In the given experimental conditions, irradiation with photons turned out to be more effective. The virus-containing suspension frozen at -86°C was the most resistant to radiation: the dose required for complete inactivation of the virus in this case was from 15 kGy, while for the liquid suspension and lyophilized form the sterilizing dose was from 10 kGy. At lower radiation doses for all samples during passaging in cell culture, residual infectious activity of the virus was observed. These differences in the efficiency of inactivation of liquid and frozen virus-containing samples indicate a significant contribution of the direct effect of radiation.

Optimization of Novel Human Acellular Dermal Dressing Sterilization for Routine Use in Clinical Practice.

Gamma rays and electrons with kinetic energy up to 10 MeV are routinely used to sterilize biomaterials. To date, the effects of irradiation upon human acellular dermal matrices (hADMs) remain to be fully elucidated. The optimal irradiation dosage remains a critical parameter affecting the final product structure and, by extension, its therapeutic potential. ADM slides were prepared by various digestion methods. The influence of various doses of radiation sterilization using a high-energy electron beam on the structure of collagen, the formation of free radicals and immune responses to non-irradiated (native) and irradiated hADM was investigated. The study of the structure changes was carried out using the following methods: immunohistology, immunoblotting, and electron paramagnetic resonance (EPR) spectroscopy. It was shown that radiation sterilization did not change the architecture and three-dimensional structure of hADM; however, it significantly influenced the degradation of collagen fibers and induced the production of free radicals in a dose-dependent manner. More importantly, the observed effects did not disrupt the therapeutic potential of the new transplants. Therefore, radiation sterilization at a dose of 35kGy can ensure high sterility of the dressing while maintaining its therapeutic potential.

The effect of gamma and microwave radiation sterilization on periodontological grafts for microbiological evaluation.

Periodontological grafts are materials used in dentistry to regenerate lost gingival soft tissues or bone parts. In the case of direct contact with blood, the possibility of disease transmission from the source to the patient is high. This source can be an animal or a human. Therefore, the sterilization of grafts before implanting to the patient is of significant importance. The purpose of this study was to evaluate gamma radiation and microwave sterilization processes from microbiological and sterility perspectives and to compare the effectiveness of these two sterilization methods. Grafts were irradiated with 2, 4, 5, 10, 25 and 50 kGy doses of gamma radiation. Another group of same materials was irradiated by microwave for 1, 2, 3 and 4 min at 24,500 MHz and 900 W. Gamma radiation and microwave sterilization methods were evaluated as successful at minimum doses as 5 kGy and 3 min, respectively. Both gamma and microwave sterilization successfu lly sterilized periodontological grafts coded as PBG1, HBG1, HL1, PDG1, MBG3, MDG2 and PDG3. Moreover, microwave sterilization can be used as an alternative novel method to gamma radiation sterilization.

Sterile Insect Technique: Successful Suppression of an Aedes aegypti Field Population in Cuba.

Dengue virus infections are a serious public health problem worldwide. Aedes aegypti is the primary vector of dengue in Cuba. As there is no vaccine or specific treatment, the control efforts are directed to the reduction of mosquito populations. The indiscriminate use of insecticides can lead to adverse effects on ecosystems, including human health. The sterile insect technique is a species-specific and environment-friendly method of insect population control based on the release of large numbers of sterile insects, ideally males only. The success of this technique for the sustainable management of agricultural pests has encouraged its evaluation for the population suppression of mosquito vector species. Here, we describe an open field trial to evaluate the effect of the release of irradiated male Ae. aegypti on a wild population. The pilot trial was carried out in a suburb of Havana and compared the mosquito population density before and after the intervention, in both untreated control and release areas. The wild population was monitored by an ovitrap network, recording frequency and density of eggs as well as their hatch rate. A significant amount of sterility was induced in the field population of the release area, as compared with the untreated control area. The ovitrap index and the mean number of eggs/trap declined dramatically after 12 and 5 weeks of releases, respectively. For the last 3 weeks, no eggs were collected in the treatment area, clearly indicating a significant suppression of the wild target population. We conclude that the sterile males released competed successfully and induced enough sterility to suppress the local Ae. aegypti population.

Sterilization process of polyester based anticancer-drug delivery systems.

Recently, growing interest in biodegradable polyesters as drug carriers in the development of innovative anticancer drug delivery systems (DDSs) has been observed. These compounds are thermally unstable, and are therefore, particularly demanding due to the limited number of available sterilization techniques. Furthermore, the DDSs sterilization process is often limited to aseptic filtration. Ensuring aseptic production is very demanding and costly, and it is therefore necessary to work on the application of new sterilization methods. In view of this, this review presents the current state of knowledge regarding the radiation sterilization process of some anticancer drugs as well biodegradable polyester carriers (such as polylactide, polyglycolide, poly(ε-caprolactone), poly(trimethylene carbonate) and co- or terpolymers of lactide, glycolide, ε-caprolactone and trimethylene carbonate). The structural changes in anticancer DDSs under the influence of ionizing radiation and the potential degradation mechanisms of both, polyester carriers and cytostatics during the sterilization process of ionizing radiation as well as their effects on the microstructure and properties of DDSs have been discussed in this paper.

Does bone marrow aspirate help enhance the integration of gamma irradiated allograft bone?

Bone allografts donated by other individuals offer a viable alternative to autograft. Risks of disease transmission are overcome by sterilizing the bone; unfortunately sterilization methods generally affect bone functional properties including osteogenic potential and biomechanical integrity. This study aimed to determine any enhancement effect when gamma sterilised allografts was impregnated with autologous bone marrow in improving the rate and quality of integration in metaphyseal-tibial defects of rabbits. Almost all subjects showed 50% of the defect being covered by new bones by the third week and smaller residual defect size in the treated group at the fifth week. Hounsfield units at the defect site showed increasing healing in all samples, with the treated group having an apparent advantage although insignificant (p > 0.05). In the histopathological score evaluating healing over cortical and cancellous bone at the fracture site showed only slight variations between the groups (p > 0.05). Therefore no enhanced healing by the autologous bone marrow was observed when added to the bone allografts in treating the unicortical defects.

The Radiation Sterilization of Ertapenem Sodium in the Solid State.

For the first time, the influence of ionising radiation on the physicochemical properties of ertapenem in solid state was studied. During our studies, we evaluated the possibility of applying radiosterilization to obtain sterile ertapenem. Spectroscopic (Fourier Transform Infrared (FT-IR)), thermal (differential scanning calorimetry (DSC), chromatography (High-Performance Liquid Chromatography (HPLC) and HPLC-MS), and X-ray powder diffraction (XRPD) studies shown that irradiation of ertapenem with the 25 kGy, the dose required to achieve sterility, does not change the physicochemical properties of the studied compound. The antimicrobial activity of ertapenem irradiated with the dose of 25 kGy was only reduced for one species. Based on the received results, we can conclude that radiostelization is a promising alternative method of obtaining sterile ertapenem. In our studies, ertapenem was also exposed to e-beam radiation with a dose of 400 kGy. It was determined that two novel degradation products that are structurally differently to degradants formed during hydrolysis and thermolysis.

The Radiostability of Meropenem Trihydrate in Solid State.

The influence of ionising radiation on the physicochemical properties of meropenem trihydrate in solid state was studied for doses of e-beam radiation: 25 kGy and 400 kGy. In the first part of our studies, we evaluated the possibility of applying radiosterilization to obtain sterile meropenem. No changes for meropenem irradiated with a dose of 25 kGy, the dose required to attain sterility, was confirmed in the results of spectroscopic (FT-IR), thermal (DSC, TGA) and X-ray powder diffraction (XRPD) studies. The radiation dose of 25 kGy produces no more than about 1500 ppm of radical defects. The chromatographic studies of irradiated meropenem in solutions did not show any chemical degradation. Moreover, the antimicrobial activity of meropenem irradiated with the dose of 25 kGy was unchanged. Based on the received results, we can conclude that radiostelization is a promising, alternative method for obtaining sterile meropenem. In the second part of the research, meropenem was exposed to e-beam radiation at the 400 kGy dose rate. It was confirmed, that reducing of antimicrobial activity could be connected with the degradation of ß-lactam ring and changes in the trans-hydroxyethyl group. Apart from chemical changes, changes in the physical stability of irradiated meropenem (400 kGy) was also observed.

Overview on radiation and tissue banking in Latin America.

The International Atomic Energy Agency (IAEA) played an important role in the establishment of new tissue banks and the improvement of already existing ones in Latin America. The Agency strongly supported, through regional, interregional and national technical cooperation projects, providing equipment, expert missions and training for the production and application of human tissues for transplantation. From 1999 to 2005 five regional courses were given in Buenos Aires under the modality of 1-year distance learning training courses and 1-week face to face courses. The courses were organized by the IAEA, through the National Atomic Energy Commission (CNEA) and the Faculty of Medicine of Buenos Aires University as Post Graduate Specialization Course. In 2005 the Latin American countries joined with Spain and Portugal, and created the Ibero American Network Council of Donation and Transplant (Red Consejo Iberoamericano de Donación y Trasplantes-RCIDT). The objective of this network is to cooperate among twenty-one Ibero American countries in organizational and legislative aspects, training of professionals, and ethical and social issues related to the donation and transplantation of organs, tissues and cells. The members of this Network work actively to harmonize the regulations and the control of donation and transplantation of human organs, tissues and cells. At present, in Latin America, more than 220 facilities of tissues banks are operating and tissue allografts are being produced by single and multi-tissue banks. The efforts made by the governments and professionals from the region allow the tissue banks to operate under quality systems and introduce new technologies.

Influence of gamma and electron beam sterilization on the stability of a premixed injectable calcium phosphate cement for trauma indications.

Premixed calcium phosphate cements (CPC's) are becoming the material of choice for injectable cements as a result of their effective delivery to the target implantation site. For orthopaedic use, it is of vital importance that the attributes of these CPC's are not compromised by irradiation sterilization. Therefore, the aim of this study is to determine the influence of irradiation sterilization on a range of premixed CPC's, with an emphasis on improving product shelf life through the use of optimal packaging configurations and annealing steps. Electron spin resonance (ESR) confirmed the presence of free radicals in the inorganic phase of the CPC paste following irradiation. The inclusion of a 24-h annealing step was the only successful method in reducing the degree of free radical formation. Based on the results of injectability force testing, it was revealed that an annealing step greater than 24-h significantly altered the viscosity, however; at 24-h the key attributes of the CPC paste were minimally effected. Overall, it was established that vacuum packing the CPC paste, placing the contents into a foil pouch, gamma irradiating at the minimal dose required and using an annealing step of ≤ 24-h, has the potential to extend the shelf life of the cement.

Effect of 60Co Irradiation on 3 Active Ingredients in Compound Hemostatic Capsules / 中国药师

Objective: To establish an HPLC method for the simultaneous determination of 3 active components in compound he-mostatic capsules and investigate the content changes before and after 60Co-γ ray irradiation. Methods: An Agilent-C18column (250 mm×4. 6 mm, 5 μm) was adopted and the flow rate was 1. 0 ml·min-1. The mobile phase consisted of acetonitrile-0. 5% phosphor-ic acid solution (triethylamine was used to adjust pH to 6) with gradient elution, the detection wavelength was 254 nm (0-35 min) and 281 nm (35-55 min), and the column temperature was 35℃. The compound hemostatic capsules were irradiated at 5, 8 and 10 kGy, respectively, and the contents of the 3 active components in compound hemostatic capsules were compared before and after the radia-tion,and the t-test was applied to investigate the significance. Results: Typhaneoside,isorhamnetin-3-O-neohesperidin and tetrahydro-palmatine respectively within the concentration range of 0. 018-0. 11 mg·ml-1,0. 020-0. 120 mg·ml-1and 0. 011-0. 066 mg·ml-1 showed a good linear relationship with the peak area. The average recovery was 97. 7% , 98. 7% and 99. 3% with the RSD of 0. 9% , 0. 9% and 0. 5% , respectively (n=6). After the irradiation, the contents of the three active components in compound hemostatic capsules all showed changes. Under the dose of 8 kGy, the content changes of typhaneoside and isorhamnetin-3-O- neohesperidin showed no statistical significance (P>0. 05),and when the dose increased to 10 kGy,the content of tetrahydropalmatine exhibited sig-nificant difference (P<0. 05). Conclusion: The established determination method for compound hemostatic capsule shows such ad-vantages as high recovery, good repeatability, simple operation and promising separation, which can be used as a quality control meth-od for compound hemostatic capsules. The sterilization effect of 60Co-γ ray irradiation on compound hemostatic capsules is significant without notable changes in the active components. When the irradiation dose is equal to or below 5 kGy,the change of each component is not obvious,which can provide reference for the radiation sterilization of compound hemostatic capsules.

Comparison of the Effects of Different Sterilization Methods on the Contents of Index Components in Baras / 中国药学杂志

OBJECTIVE: To compare the contents of the index components in Baras treated by different sterilization methods for choosing the best sterilization method.METHODS: The mixed medicinal powder of Baras were treated by autoclave sterilization, circulating steam sterilization, dry heat sterilization and 60Co radiation sterilization, respectively. The contents of iso-chlorogenic acid A, iso-chlorogenic acid C, quercetin and piperine were determined by HPLC. The influence on the contents of the index components and microbe limitation were analyzed.RESULTS: The total number of bacteria and the counts of mold, yeast count and Escherichia coli in the samples treated by the four sterilization methods were all in compliance with the requirements of Chinese Pharmacopoeia. The total content of four kinds of index components in the samples treated by 60Co radiation sterilization method at dose of 4 kGy was slightly higher than that of others, with a loss rate of 1.21%.CONCLUSION: The 60Co radiation sterilization method is suitable for Baras drying with simple process, short drying time, and the ability to effectively retain all index components.

Raman spectral markers of collagen denaturation and hydration in human cortical bone tissue are affected by radiation sterilization and high cycle fatigue damage.

BACKGROUND: Thermal denaturation and monotonic mechanical damage alter the organic and water-related compartments of cortical bone. These changes can be detected using Raman spectroscopy. However, less is known regarding Raman sensitivity to detect the effects of cyclic fatigue damage and allograft sterilization doses of gamma radiation. OBJECTIVE: To determine if Raman spectroscopic biomarkers of collagen denaturation and hydration are sensitive to the effects of (a) high cycle fatigue damage and (b) 25kGy irradiation. METHODS: Unirradiated and gamma-radiation sterilized human cortical bone specimens previously tested in vitro under high-cycle (> 100,000 cycles) fatigue conditions at 15MPa, 25MPa, 35MPa, 45MPa, and 55MPa cyclic stress levels were studied. Cortical bone Raman spectral profiles from wavenumber ranges of 800-1750cm-1 and 2700-3800cm-1 were obtained and compared from: a) non-fatigue vs fatigue fracture sites and b) radiated vs. unirradiated states. Raman biomarker ratios 1670/1640 and 3220/2949, which reflect collagen denaturation and organic matrix (mainly collagen)-bound water, respectively, were assessed. One- and two-way ANOVA analyses were utilized to identify differences between groups along with interaction effects between cyclic fatigue and radiation-induced damage. RESULTS: Cyclic fatigue damage resulted in increases in collagen denaturation (1670/1640: 1.517 ± 0.043 vs 1.579 ± 0.021, p < 0.001) and organic matrix-bound water (3220/2949: 0.109 ± 0.012 vs 0.131 ± 0.008, p < 0.001). Organic matrix-bound water increased secondary to 25kGy irradiation (3220/2949: 0.105 ± 0.010 vs 0.1161 ± 0.009, p = 0.003). Organic matrix-bound water was correlated positively with collagen denaturation (r = 0.514, p < 0.001). CONCLUSIONS: Raman spectroscopy can detect the effects of cyclic fatigue damage and 25kGy irradiation via increases in organic matrix (mainly collagen)-bound water. A Raman measure of collagen denaturation was sensitive to cyclic fatigue damage but not 25kGy irradiation. Collagen denaturation was correlated with organic matrix-bound water, suggesting that denaturation of collagen to gelatinous form may expose more binding sites to water by unwinding the triple alpha chains. This research may eventually be useful to help identify allograft quality and more appropriately match donors to recipients.

Radiolytic studies of cefozopran hydrochloride in the solid state

Background: The radiation sterilization is one of the best methods for sterilizing vulnerable degradation drugs like cefozopran hydrochloride. Results: Chemical stability of radiosterylized cefozopran hydrochloride, was confirmed by spectrophotometric and chromatographic methods. EPR studies showed that radiation has created some radical defects whose concentration was no more than several dozen ppm. The antibacterial activity of cefozopran hydrochloride irradiated with a dose of 25 kGy was unaltered for Gram-positive bacteria but changed for two Gram-negative strains. The radiation sterilized cefozopran hydrochloride was not in vitro cytotoxic against human CCD39Lu normal lung fibroblast cell line. Conclusions: Cefozopran hydrochloride in solid state is not resistant to radiation sterilization and this method cannot be used for sterilization of this compound.

Nano drug delivery systems and gamma radiation sterilization.

In recent years, drug delivery systems such as liposomes and microparticles have been used in clinic for the treatment of different diseases and from a regulatory point of view, a parenterally applied drug and drug delivery systems must be sterile and pyrogen free. Radiation sterilization is a method recognized by pharmacopoeias to achieve sterility criteria of parenterals. It has the ability to kill microorganisms in therapeutic products. The ability of, however, irradiation might also affect the performance of drug delivery systems. One of the most critical points is irradiation dose, because certain undesirable chemical and physical changes may accompany with the irradiation, especially with the traditionally applied dose of 25 kGy. Its ionizing property may cause fragmentation of covalent bond. The care must be paid to the applied dose. In this research, the effects of gamma irradiation on different drug delivery systems such as chitosan microparticles, liposomes, niosomes and sphingosomes were investigated. According to the experimental data, it can be concluded that gamma irradiation can be a suitable sterilization technique for liposome, niosome and sphingosome dispersions. When all irradiated drug carrier systems were taken into consideration, chitosan glutamate microparticles were found as the most radioresistant drug delivery system among the others.

Influence of Gamma-rays Radiation Sterilization on the Content and Fingerprint Chromatography of Effec-tive Constituents in Simiao Junyi Ointment / 中国药师

Objective:To explore the degradation effect of gamma-rays radiation sterilization on the effective constituents in Simiao Junyi ointment and study the changes of fingerprint chromatography before and after the sterilization to provide basis for the feasibility of gamma-rays radiation sterilization for Simiao Junyi ointment. Methods:The contents of tetrahydropalmatine and PNS ( Panax Notogin-seng saponins) in Simiao Junyi ointment were determined by HPLC, and the fingerprint chromatography was established. The content changes of tetrahydropalmatine and PNS in Simiao Junyi ointment before and after the gamma-rays radiation sterilization were compared among the same batch and various batches, and the relative retention time and relative peak area in the fingerprint chromatography were also compared. Results:The content of tetrahydropalmatine had no change basically before and after the gamma-rays radiation steriliza-tion(P >0. 05), and there was no change in the total content of PNS (P >0. 05). Comparing the HPLC fingerprint chromatography at 280 nm, the relative retention time had statistically significant change after the gamma-rays radiation sterilization ((P 0. 05). The number of characteristic peaks reduced by one, namely the C8 characteristic peak disappeared in the pasteurized chromatography, and the areas of C6, C9 and C14 peak decreased significantly, while that of C12 increased. Conclusion:Gamma-rays radiation sterilization have no notable effect on the content of tet-rahydropalmatine and PNS in Simiao Junyi ointment, it can be used for the sterilization of Simiao Junyi ointment.