Secondary metabolites are natural compounds synthesized by plants as an adaptation to environmental factors. Humans use such components for the prevention and treatment of minor or mild conditions. Lespedeza capitata is a medicinal and melliferous plant known for its various beneficial properties (antioxidant, antiaging, antiedematous, etc.). The objectives of this study were to identify and quantify the secondary metabolites from a selective L. capitata extract. Moreover, the evaluation of the antioxidant activity was part of the present research. Material and methods: Identification and semiquantification were assessed by liquid chromatography (HPLC/MS), and the total flavonoids and polyphenols were determined by spectrophotometry according to European Pharmacop eia indications. DPPH (2,2-diphenyl-1-picrylhydrazyl) assay and iron chelation test were used to establish the antioxidant putative effects of the investigated extract. Results: Among the identified compounds different quercetin derivatives, chlorogenic acid, and rosmarinic acid were found. The total polyphenols amounted to 174.24 mg/g GAE and flavonoids measured 95.65 mg/g rutoside equivalents. The antioxidant activity showed a good capacity to sca venge free radicals and a higher potential to chelate ferrous ions. The intensity o f the effect was correlated to concentration. All in all, the investigated L. capitata extract demonstrated a polyphenol and flavonoid-rich content with good antioxidant potential.

On the basis of literatures and standards relating to Tibetan medicine, the varieties, origin, standards and efficacy of Saxifragaceae plant used in Tibetan medicine were summarized. According to the findings, 75 species(including varieties) in 8 genera of Saxifragaceae plants, involving 21 varieties, are used in Tibetan medicine. Among them, 9 commonly used varieties, namely Songdi, Sedi, Yajima, Aoledansaierbao, Jiansidawu, Saiguo, Katuer, Sangdi, Maoqinghong, are recorded in Chinese Pharmacopoeia, Ministry Standards for Tibetan Medicine, Tibetan Medicine Standards and other local standards, accounting for 42.9% of the total number of varieties. Tibetan names, Tibetan translation of Chinese names, as well as original plant of Tibetan medicine varieties are quite different in relevant Tibetan medicine standards and literatures, which resulted in common phenomena of synonym and homonym. The standards of most varieties only involve characters, and microscopic, physical and chemical identification, with low quality standards. Based on the results of the analysis, this paper suggests strengthening surveys on herbal textual research, resources and current utilization of Saxifragaceae plants used in Tibetan medicine, summarizing the varieties, establishing improved quality standards, and perfor-ming a comparative study on therapeutic material basis and biological activity of different original plants, in order to promote rational use of these medicinal plant resources, and ensuring the accuracy, safety, and effectiveness of clinical medication.

Insulin human, containing 51 amino acids, is a small polypeptide hormone that regulates blood glucose homeostasis. Patients with insulin-dependent diabetes mellitus require insulin therapy through the administration of exogenous insulin to avoid ketoacidosis. Utilizing various genetic engineering techniques, pharmaceutical companies have developed a variety of rapid- or long-acting insulin analogues. Analytical methods for various types of insulin and insulin analogues are gradually being included in the United States Pharmacopeia (USP) and the European Pharmacopeia (Ph. Eur.), but not yet in the Chinese Pharmacopeia. Usually these insulin analogues only differ by 1 to 3 amino acids, which is too subtle to distinguish by most of analytical methods currently available. In this study a peptide mapping technique was employed to screen insulin analogues for quality assessment. Peptide mapping is capable of identifying single amino acid changes resulted from events such as errors in the reading of complementary DNA sequences or point mutations. Here we analyzed 6 insulin preparations including insulin human, insulin lispro, insulin aspart, insulin detemir, insulin glargine and insulin glulisine using peptide mapping analysis. The peptide fingerprints of the insulin products we tested all corresponded well to those of the standard materials. Our peptide mapping method is more accurate in identifying the subtle differences between the insulin analogues than chromatography is. We concluded that peptide mapping is a valuable initial screening tool for quality assessment of insulin analogues. In the future, we intend to continue to develop this technology for post-marketing surveillance of other biopharmaceuticals and biosimilars, such as somatropin, erythropoietin and G-CSF.

Leaves ciplukan Physalis angulata L. is often utilized by people because it has many benefits as a traditional medicine standardization that needs to be done to get a good simplicia. Penetapkan standard parameters ciplukan leaf botanicals that include non-specific parameters and specific parameters taken from the Jambi to circumstances where grown black sandy soil and Riau area with clay soil conditions to grow black spot. Organoleptic form of powder, aromatic odor / typical, bitter taste, but memiliiki sample the color difference is a brownish green Jambi, Riau sample brownish-green. Levels of water-soluble compounds, sample Jambi Riau 20.65% and 22.01%, solute ethanol, 19.42% of samples Jambi and Riau sample of 19%. Simplicia leaves Jambi and Riau ciplukan samples containing alkaloids, steroids, flavonoids and saponins. The water content of the sample Jambi Riau 9.12% and 9.24%.Sample drying shrinkage Jambi Riau 9.38% and 9.76%.The ash content of 13.5% of the total sample Jambi and Riau 13.6%. Acid insoluble ash content samples Riau Jambi 2% and 2.1%. Metal contamination of lead (Pb) samples Jambi 0.0530 mg / g and Riau 0.07795 mg / g. So the test-specific and non-specific parameters simplisia sample Jambi and Riau region meet Indonesian Herbal Pharmacopoeia standards.

Through consulting the ancient herbs and medical books, combining with modern literature, this paper makes textual research on herbal medicine, and textual research on the name, origin, position and harvest and processing changes of the medicinal herbs in ancient classical prescriptions. According to research, Cinnamon medicinal materials were first listed in the Shennong's Herbal Classic, as the name of "Jungui" and "Mugui". Among them, Jungui has undergone the evolution of "Qungui-Jungui-Tonggui-Jungui". After the Northern and Southern Dynasties, a half-volume fatty "Gui" was added, but the usage of the three was no different. The names of Cinnamomi Ramulus and Cinnamomi Cortex did not appear until the Tang Dynasty, and they were preferably thick-skinned and with no cork cambium, and they were mostly used in the name of "Guixin"; Since the Song and Yuan Dynasties, the medicinal parts of cassia have gradually separated. Cinnamomi Cortex is the trunk bark of sapling or branch bark, the twig is Cinnamomi Ramulus, and the tenderest twig is Liugui, Song Dynasty unified the name as "Guizhi"; After the Ming and Qing Dynasties, Cinnamomi Cortex was used as the trunk bark, and Cinnamomi Ramulus was used as the tender twig; In modern times, the Chinese Pharmacopoeia stipulates that the Cinnamomi Ramulus is the young branch of C. cassia, which is Cinnamomum, and Cinnamomi Cortex was the dried trunk bark. From the plant morphology recorded in the previous herbals and the drawings, combined with the distribution of the origins described in the previous herbals, the mainstream plant used as a medicine in the past generations should be C. cassia, but there are other sect. Cinnamomum plants that are also used in medicine everywhere, such as C. chekiangensis, C. bejolghota, C. wilsonii, etc. Throughout the ages, different plant morphologies and medicinal traits have been used to distinguish different categories. The origins of the past dynasties are mostly present in Guangdong, Guangxi province and Vietnam, and are regarded as authentic. The methods for the harvest and processing of cinnamon medicinal materials are basically the same from ancient to modern times.

Objective To compare the stability and compatibility of sterilized water for injection packaged in penicillin bottle and prefilled syringes. Methods Three batches of sterilized water for injection were continuously produced with two packaging forms, respectively. The products were assessed for accelerated stability and compatibility according to standards in National Standards for Pharmaceutical Packaging Materials 2015 edition and Chinese pharmacopeia 2015 (VolumeⅡ). Results All test items of six batches of sterilized water for injection met the requirements. Products in forms of penicillin bottle (pH: 6.1-6.7, conductivity: 4-7 μS/cm)and prefilled syringes (pH: 6.1-6.7, conductivity: 1-5 μS/cm) showed similar results. The migration levels of substances tested were all within the safe range, and there was no significant delamination of glass materials. Conclusion Sterilized water for injection in prefilled syringes has similar stability and compatibility with that in penicillin bottle, thus prefilled syringes can be used as packaging materials for sterilized water for injection. Key words: Materials testing; Penicillin bottle; Prefilled syringes

Objective To prepare the 4-valent influenza virus subunit vaccine. Methods Four strains of virus were inoculated into the allantoic cavity of healthy chicken embryo which were 9 to 11 days old. After incubated at 33-35 ℃ for 48-72 h, the embryos were cooled and the allantoic fluid was harvested. Following virus inactivation, lysis and purification, sterilization and filtration were applied to prepare a monovalent vaccine stock solution; polyacrylamide gel electrophoresis (SDS-PAGE) was used to analyze the purity. The harvested four monovalent stocks are mixed to prepare a tetravalent influenza virus subunit vaccine. Finally, the finished product vaccine was fully verified according to the Pharmacopoeia of the People’s Republic of China (2015 edition). Results The tetravalent influenza virus subunit vaccine was successfully prepared, among which hemagglutinin accounted for 91.4% of the total protein. The hemagglutinin of the four vaccine strains were H1N1 for 30 µg/ml, H3N2 for 34 µg/ml, B1 for 36 µg/ml, and B2 for 30 µg/ml, respectively. Conclusion The four-valent influenza subunit vaccine produced meets the requirements of production and verification. Key words: Tetravalent influenza virus subunit vaccine; Influenza; Vaccine; Type B influenza virus

Objective The present study aimed to explore the rationality of peeling process of Pruni semen through the determination of amygdalin. Methods The content of amarogentin in seed coat, seed kernel and total seed of Pruni semen, respectively, were determined by HPLC according to the methods of content determination under Pruni semen in Chinese Pharmacopeia (2015). The chromatographic column was Inertsil ODS-SP C18 (4.6 mm×150 mm, 5 μm). The gradient elution with acetonitrile-water as mobile phase was performed. The flow velocity was 0.6 ml/min, the column temperature was 40 ℃, and the wavelength was 210 nm. Results The average recovery rate (n=6) was 98.26%. The sample was stable within 24 h, and the RSD (n=6) was 1.12%. The quality of control products was good in the range of 0.02-0.40 μg. The analysis indicated that there is no significant differences (P>0.05) in the contents of amygdalin in seed coat, seed kernel and total seed of Pruni semen. Conclusions With the content of amygdalin as the index of evaluation, the Pruni semen had better not be peeled. Key words: Pruni semen; Processing (TCD); Amygdalin; Assay (TCD)

We evaluated the applicability of SLA 3DP in making pharmaceutical tablets. Adding alizarin dye in the printing polymers improved print resolution through minimizing light scattering. 3DP tablets were evaluated for weight deviation, uniformity in drug content and dissolution profiles. 3DP tablets were determined to be uniform in weight and drug content based on European Pharmacopoeia criteria. Tablets with different sizes and shapes were printed with consistency. A lower PEGDA to PEG ratio, addition of xylitol as disintegrant and change in tablet design to improve the surface area-to-volume ratio, were explored to improve rate of drug release from 3DP tablets.

Objective To observe the stability of a domestic influenza vaccine (split virion), inactivated (Flu-sp vaccine). Methods Fifty-eight lots of Flu-sp produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP) in 2011—2018 were tested according to Flu-sp vaccine registration standards approved by China Food and Drug Administration and related regulations in Chinese pharmacopoeia. The full tests were performed in months 0 and 12. The hemagglutinin content test was performed in months 3, 6 and 9. Results All testing results of Flu-sp vaccine met registration standards and relevant regulations within the period of validity. The hemagglutinin content of all influenza virus strains were 80%-120% of the formulated amounts. Conclusion The Flu-sp vaccine produced by SIBP has stable quality. Key words: Influenza vaccines; Drug stability; Hemagglutinins, viral

Objective To investigate the contamination of aflatoxin B1 in traditional Chinese medicine decoction pieces.and to provide evidence for the development of sdandards and scientific management. Methods Immunoaffinity column and post-column photochemical derivatization were used to detect and quantify aflatoxin B1 in 35 traditional Chinese medicines. Results A total of 48.57%(17 out of 35 batches) traditional Chinese medicine were contained aflatoxin B1. The contents of aflatoxin B1 in all contaminated varieties were less than 1μg/kg, except for Sterculia lychnophorae Semen, Foeniculi Fructus, Corydalis Rhizoma, which exceeded the standard. Conclusions The tested traditional Chinese medicine are highly contaminated of aflatoxin, it is necessary to further study the increase of aflatoxin content under the examination of Chinese Pharmacopoeia Foeniculi Fructus and Corydalis Rhizoma to better control its quality. The degree of aflatoxin B1 pollution is reated to the site of drug use and the place of origin. Key words: Assay (TCD); Aflatoxin B1; Immunoaffinity column; Photochemical derivatization

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that inhibits the action of the enzyme cyclooxygenase-2 and is widely used in many countries for the treatment of pain and inflammation. It is often given on a dosage adjustment basis mainly in the elderly and children. In the present work the nimesulide tablet splitting process from three different suppliers was studied using a tablet cutter in order to verify the influence of the breakdown of the same on the content of each obtained fragment. The tests of average weight, hardness, friability, disintegration, dosage and uniformity of unit doses were performed following the official methodology established by the Brazilian Pharmacopoeia. The samples studied met the official specifications before being submitted to the partition procedure; however, after dividing the tablets, the drug content in the halves presented excessive variation, showing that this procedure should not be performed for the drug Nimesulide. In cases of need for varying administration doses of Nimesulide, it is recommended that the drug be manipulated or that another pharmaceutical form is used in order to ensure dosage in each unit of the dosage form.

Objective To optimize a method for extracting traditional Chinese medicine composition with insomnia, and to prepare the insomnia granules for quality control. Methods The optimal extraction process was screened by orthogonal test using high-performance liquid chromatography with geniposide as the evaluation index. The particle size, bulk density, angle of repose, moisture, solubility, hygroscopicity and loading difference of the insomnia granule were evaluated, and the difference between the trial test and the pilot test were analyzed to comprehensively monitor the quality of the insomnia granule. Results The best extraction process was to add 10 times of water and cooked it three times for 1.5 hours each time. The average yield rate of dry extract of the pilot test and trial test was 22.10%, 15.52%, and the average yield of powder was 84.96% and 93.12%, respectively. The conversion rate from the pilot test to the trial test is 76.97%. Both the trial test and the pilot test particles met the quality requirements of the 2015 edition of the pharmacopoeia. Conclusions The preparation method of the insomnia granules is simple and the quality is uniform. The results of the pilot scale showed that the conversion rate is high, the quality is controllable, and the technical feasibility of industrial production is obtained. Key words: Orthogonal test; Extraction; Jasminoidin; Pilot test; Assay (TCD); Quality control; Technology improving (TCD)

Atractylodis Macrocephalae Rhizoma is a common traditional Chinese medicine with huge demand. In this paper, quality standards of Atractylodis Macrocephalae Rhizoma in Chinese Pharmacopoeia, Japanese Pharmacopoeia, Korean Pharmacopoeia, European Pharmacopoeia and Hong Kong Chinese Materia Medica Standards were compared and analyzed. It aims to understand the similarities and differences of the quality standards of Atractylodis Macrocephalae Rhizoma between Chinese Pharmacopoeia and other pharmacopoeias, and learn the advantages of them to provide the reference for improving the quality standard of Atractylodis Macrocephalae Rhizoma. Key words: Atractmlodis Macrocephalae Rhizoma; Chinese Pharmacopoeia; European Pharmacopoeia; Japanese Pharmacopoeia; Korean Pharmacopoeia; Hong Kong Chinese Materia Medica Standards; Quality standard

Korean Herbal Medicine (KHM) has clinical advantages that can overcome the limitations of Western Medicine. However, the strength of KHM cannot be fully exercised without standardization. In fact, many aspects of KHM including the processing of the herbal medicines are being standardized these days. Twenty-eight methods of herbal medicine processing that were previously described in the Korean Pharmacopoeia have since been deleted. The herbal medicines processing methods significantly affect their pharmacological properties, and hence this forms an essential part of KHM. In this research, therefore, the history of processing KHM and the steps involved have been summarized and analyzed. Furthermore, the changes in the efficacy of 165 herbal medicines in the Korean Pharmacopoeia after processing were summarized. In addition, the traditional processing methods in various textbooks and the processing methods in Korean Pharmacopoeia were compared to enhance the current level of standardization. This study, therefore, suggests a new “3K formula” as the first step for standardization of herbal medicines processing. With this formula, it is possible to name the processed herbal medicines in a unified way. With the ever-increasing global demand for herbal medicines, there is a clear necessity for further future studies on the standardization of the herbal medicines processing methods.

A new sensitive, specific, precise and accurate stability indicating reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of related substances of telmisartan drug substance. The method was developed to separate possible degradation and process related impurities. The method was developed on symmetry shield RP 8 (150 mm x 4.6 mm, 3.5 µm) column using 0.05% trifluoroacetic acid and acetonitrile as mobile phase in gradient elution. The eluents were monitored at 230 nm by UV-Visible detector. Telmisartan and its eleven impurities were well resolved by using these conditions. The limit of detection (LOD) for telmisartan and each of its impurities (Impurity-II, Impurity-III, Impurity-IV, Impurity-V, Impurity-VI, Impurity-VII, Impurity-IX, Impurity-X, Impurity-XI) were 0.01 (% w/w) and that of Impurity-I, Impurity-VIII were 0.02 (% w/w). The limit of quantitation (LOQ) for telmisartan and each of its impuries (Impurity-II, Impurity-III, Impurity-IV, Impurity-V, Impurity-VI, Impurity-VII, Impurity-IX, Impurity-X, Impurity-XI) were 0.03 (% w/w) and that of Impurity-I and Impurity-VIII peaks were 0.05 (% w/w). Forced degradation studies were performed and mass balance was established for acid, base, oxidative, photolytic, thermal and temperature and humidity degradation conditions. The method was validated as per international conference on harmonization of technical requirements for pharmaceuticals for human use (ICH) guidelines. The impurities (Impurity-VI to Impurity XI) were related to route of synthesis and the developed method was capable to quantify these impurities along with impurities (Impurity-I to Impurity-V) as per United States, European pharmacopeia.

Dermatitis atopik merupakan peradangan kulit berupa dermatitis kronis residif, disertai rasa gatal, dan dapat mengenai atau menyerang bagian tubuh tertentu. Anak-anak lebih sering terkena dermatitis atopik dan 50% menghilang saat remaja tetapi terkadang menetap dan muncul saat dewasa, atau bahkan baru mulai muncul saat usia dewasa. Tujuan penelitian ini untuk mengetahui profil kelainan kulit pada pasien dermatitis atopik anak dan dewasa.
 Penelitian ini merupakan penelitian deskriptif observasional dengan desain retrospektif. Sampel penelitian ini yaitu pasien anak dan dewasa yang didiagnosis dermatitis atopik di URJ Kulit dan Kelamin RSI Jemursari Surabaya tahun 2014-2015. Pengumpulan data dilakukan dengan menggunakan data sekunder yang diperoleh dari rekam medis pasien.
 Hasil yang diperoleh pada penelitian ini adalah 44 orang (15 pasien anak, 29 pasien dewasa pada pasien anak didapatkan 10 tempat predileksi lesi dan total yang didapatkan yaitu 22 tempat predileksi dengan tempat predileksi lesi yang paling banyak pada kaki (27,3%). Sedangkan pada 29 sampel pada pasien dewasa, didapatkan 22 tempat predileksi lesi dan total yang didapatkan yaitu 52 tempat predileksi dengan tempat predileksi lesi yang paling banyak adalah Lengan sebanyak 7 orang (13,5%)
 Pasien Anak yang mengalami Dermatitis Atopik didapatkan hampir setengahnya tempat predileksi lesi pada kaki dan jenis lesinya macula eritema. Sedangkan pada pasien Dewasa sebagian kecil tempat predileksi lesi pada lengan dengan jenis lesi pada macula eritema.

Protunkevich О. О., Prisyazhnyuk K. A., Rakipov I. M., Marchenko S. I., Ponomareva L. A. OPTIMAL CONDITIONS FOR SELECTIVE EXTRACTION OF FLAVONOIDS FROM FLORES SOPHORAE JAPONICAE. Актуальні проблеми транспортної медицини / Actual problems of transport medicine / 2019;2(56):132-138. ISSN 1818-9385 DOI http://dx.doi.org/10.5281/zenodo.3251637 http://aptm.org.ua OPTIMAL CONDITIONS FOR SELECTIVE EXTRACTION OF FLAVONOIDS FROM FLORES SOPHORAE JAPONICAE О. О. Protunkevich, K. A. Prisyazhnyuk, I. M. Rakipov, S. I. Marchenko, L. A. Ponomareva Odessa National Polytechnic University E-mail: o.o.protunkevych@opu.ua Summary Rutin and quercetin are part of many phytopreparations with antioxidant and anti-inflammatory effects. Flores Sophorae japonicae contain up to 20 % rutin. The authors investigated the optimal conditions for the selective extraction of rutin and quercetin from Flores Sophorae japonicae with alkyls and alkyl acetates. Flores Sophorae japonicae was harvested according to the requirements of the State Pharmacopoeia of Ukraine. For research, the raw material was ground to particles of 3-5 mm in size. Flavonoids from Flores Sophorae japonicae were isolated with 70 % ethanol, the primary aqueous-alcoholic extract was used for further selective extraction of rutin and quercetin with organic solvents (butanol, ethyl acetate and butyl acetate). The quantitative content of total flavonoids (X %, in terms of rutin) in the extracts was determined by the photometric method according to the levels of complexation with aluminum chloride. In the primary water-alcohol extracts, the content of flavonoids was 0,132 ± 0,06 %. To evaluate the properties of alkyls and alkyl acetates, to extract rutin from primary extracts, a two-phase selective extraction was performed in a system — water-alcohol extract: organic solvent (butanol, ethyl acetate and butyl acetate). The selective properties of solvents were evaluated by the quantitative content of flavonoids in organic phases. For crystallization of flavonoids, organic phases were concentrated using a rotary evaporator. Based on experimental data for butanol, ethyl acetate and butyl acetate, quantitative extraction characteristics were calculated, such as the distribution coefficient (D) and the levels of rutin extraction (R, %). It was determined that butyl acetate showed the most pronounced ability of selective extraction (R = 82.7 %). In the ethyl acetate and butanol phases in the cold, crystallization of flavonoids was observed during the day. The precipitates were studied by TLC, IR spectrophotometry and mass spectrometry. Chromatograms showed spots with yellow-green fluorescence and corresponding Rf = 0.5 (rutin) and Rf = 0.81 (quercetin). In the infrared spectra of flavonoid precipitation, absorption bands characteristic of phenolic and alcoholic hydroxyl groups are visible (lanes 1660, 1610, 1580, 1510, 1460 cm-1) and the “fingerprint” area of 800-1200 cm-1, which confirm the presence of rutin. The mass spectrum of precipitation has a peak 60, which corresponds to the mass of glucose and a peak 302, which confirms the presence of quercetin. It was determined that butanol proved to be the optimal selective extractant of flavonoids. Key words: rutin, quercetin, flavonoids, selective extraction.

Commonly called African peach tree, the Nauclea latifolia (Sm.) of Rubiaceae family gives fruits twice a year. It is also a well known plant in sub-Saharan Africa in the traditional pharmacopoeia. The fruits of the African peach tree are one of the countless fruits of this continent which, in lethal period, are left in the nature where they rot, thus causing a big shortage to the farmers of our country and those of the sub-region West Africa. This is why the objective of this study is to promote the fruits of Nauclea latifolia (Sm.) through the bioconversion of their juice by fermentation into ethanol as biofuel. For this, different initial concentrations (1, 2, 3, 4 and 5g/l) of Saccharomyces carlsbergensis and three strains of Saccharomyces cerevisiae reference were used on the juice formulated to the proportion of 1.5L of distilled water per kilogram (1kg) of fruit. The monitoring of the parameters (pH, density and brix degree) of 4g/l urea-enriched juices, not only enriched revealed the performance of Saccharomyces carlsbergensis and Saccharomyces cerevisiae strains in the alcoholic fermentation of the Nauclea latifolia (Sm.) fruit juice. From this work, it appears that the best efficiencies of bioethanol productivity of 122.4±0.4, 119.4±0.3 and 119.2±0.2ml/kg of fruit were obtained respectively from the enriched mashes with Thermal-tolerant alcohol (2 and 3g/l) and non-enriched must to Angel super alcohol (2g/l). This study shows that Saccharomyces cerevisiae's Thermal-tolerant alcohol and Angel super alcohol are more effective in the fermentation of Nauclea latifolia (Sm.) fruit juice into bioethanol.

Objective To study the relationships between differences in tumorigenicity and immunogenetic backgrounds of nude mice. Methods According to the Chinese Pharmacopoeia, positive and negative groups were set up in both Laboratory A and B with ten nude mice in each group. Organ tissues were collected for clinicopathological analysis. Blood samples were collected and detected using flow cytometry. DNA was extracted and analyzed with 23 STR markers. Results The positive group of Laboratory B was invalid (7/10 tumor formation). The two laboratories showed no significant difference in the results of pathological analysis, but had significant differences in CD25, CD8, CD4, Th1 and Th2. There were 13 and 18 polymorphic sites respectively found in nude mice of Laboratory A and B. Further analysis of the non-tumor-bearing nude mice in Laboratory B positive group revealed that CD25, Th2, D3Mit29 and D5Mit48 were the specific indexes. Conclusion Differences in tumorigenicity might be related to the diversity of immunogenetic backgrounds of nude mice. Key words: Nude mice; Tumorigenicity; Immune; Genetics