Slicing specifications in general rule of processing in Chinese Pharmacopoeia from slicing development of Chinese materia medica processed product and thinking and suggestion on slicing techniques / 中国中药杂志

Slicing is critical in the processing of Chinese materia medica(CMM) processed product and the specification(thickness) is closely related to the quality of the decoction. On the basis of clarifying the concept and evolution of slicing of CMM processed product by reviewing the Chinese herbal classics of the past dynasties and general rules of local processing standards, this study discussed the development history of slicing specifications in general rules of Chinese Pharmacopoeia(2020 edition), analyzed the current situation and key problems, and proposed the thinking and suggestion on promoting the sound development of slicing of CMM processed product. Since 2000, the slicing thickness of CMM processed product in the general rules of local CMM processed product processing specifications newly revised and issued by 27 provinces, autonomous regions, and municipalities has been consistent with that in the general rules of the Chinese Pharmacopoeia(2020 edition). The standard that the thickness of extremely thin pieces is less than 0.5 mm is rarely retained, and the pieces in 0.5-1 mm thickness have not been found on the market, which is consistent with the provisions of the general rules of the Chinese Pharmacopoeia. This study can provide a historical and modern basis for the rationality of slicing of CMM processed product.

Simultaneous Determination of Six Flavonoids in Astragali Radix Directional Processed with Four Enzymes by UPLC / 中国实验方剂学杂志

Objective::To establish an UPLC method for the simultaneous determination of 6 flavonoids, and to research for the effect of Astragali Radix directional processed with four enzymes (complex enzyme, plant cellulase, snail enzyme, and β-glucosidase) on the contents of flavonoid glycosides and their aglycones in this herb. Method::Chromatographic separation was carried out on ACQUITY UPLC HSS T3 column (2.1 mm×100 mm, 1.8 μm) with the mobile phase of 0.1 mol·L-1 formic acid solution-0.1 mol·L-1 formic acid acetonitrile solution for gradient elution. The detection wavelength was set at 260 nm, the flow rate was 0.3 mL·min-1, the column temperature was 30 ℃, and the injection volume was 2 μL. Result::Calycosin-glucoside, calycosin, ononin, formononetin, 9, 10-dimethoxy-pterocarpan-3-O-β-D-glucoside and 3-hydroxy-9, 10-dimethoxy-pterocarpan showed good linear relationships within their own ranges (R2≥0.998 5), the relative standard deviations (RSDs) of precision, stability and repeatability were all <5.0%, and the average recovery was 97.62%-101.13% with RSDs of 1.4%-2.7%. In 0.5 g·L-1 level of enzyme solution, the contents of calycosin-glucoside, calycosin, ononin, formononetin, 9, 10-dimethoxy-pterocarpan-3-O-β-D-glucoside and 3-hydroxy-9, 10-dimethoxy-pterocarpan in Astragali Radix processed with complex enzyme were 0.082 0, 0.335 9, 0.055 9, 0.104 9, 0.015 0, 0.009 7 mg·g-1, the contents of them in Astragali Radix processed with plant cellulase were 0.105 7, 0.364 2, 0.070 2, 0.117 4, 0.020 8, 0.012 5 mg·g-1, their contents in Astragali Radix processed with snail enzyme were 0.031 4, 0.510 0, 0.043 5, 0.210 9, 0.013 0, 0.013 0 mg·g-1, and their contents in Astragali Radix processed with β-glucosidase were 0.085 3, 0.312 4, 0.061 5, 0.110 8, 0.005 8, 0.009 6 mg·g-1, respectively. Conclusion::After the processing of Astragali Radix by four enzymes, in addition to 9, 10-dimethoxy-pterocarpan-3-O-β-D-glucoside, the contents of calycosin-glucoside and ononin are reduced, but the contents of their three corresponding aglycones are significantly increased. The established method is simple, accurate and reproducible, and is suitable for the simultaneous determination of 6 flavonoids in Astragali Radix, which can provide a reference for this herb directional processed with enzymes.

Analysis on Mechanism of Adenine-induced Kidney-Yang Deficiency Rats Treated with Different Processed Products of Curculiginis Rhizoma / 中国实验方剂学杂志

Objective:To study on the mechanism of invigorating kidney and strengthening Yang of different processed products of Curculiginis Rhizoma aqueous extracts in rats with kidney-Yang deficiency induced by adenine. Method:Taking Guifu Dihuang pills as the positive drug group (the dosage of 2.466 g·kg-1), after intragastric administration for 4 weeks, enzyme-linked immunosorbent assay (ELISA) was used to compare the effects of different processed products of Curculiginis Rhizoma aqueous extracts (the dosage of 2.742 g·kg-1) on the levels of thyroid stimulating hormone (TSH), 17-hydroxycorticosteroids (17-OHCS), estradiol (E2), testosterone (T), triiodothyronine (T3), thyroxine (T4) and cortisol (COR) in serum of rats with kidney-Yang deficiency induced by adenine. The activity of cytochrome P450 3A (CYP3A) in rat liver and kidney microsomes was determined by Nash colorimetry. Result:All the processed products aqueous extracts could improve the function of hypothalamus-pituitary-target gland axis in rats with kidney-Yang deficiency induced by adenine, and the total score was in the order of Euodiae Fructus juice-processed products (29 points)>salt-processed products (25 points)>rice wine-processed products (23 points)>raw products (17 points)>Zingiberis Rhizoma juice-processed products (11 points). And the different processed products of Curculiginis Rhizoma could increase CYP3A activity of liver and kidney microsomes of kidney-Yang deficiency rats, especially the Euodiae Fructus juice-processed products and salt-processed products. Conclusion:All the processed products of Curculiginis Rhizoma can effectively treat the syndrome of kidney-Yang deficiency in rats, among them, Euodiae Fructus juice-processed products and salt-processed products have more significant effect on invigorating kidney and strengthening Yang.

Relationship Between Characters and Main Components of Chelidonii Herba Pieces / 中国实验方剂学杂志

Objective::To determine the relationship between the characters and the main components of Chelidonii Herba pieces. Method::The main components of the samples were determined by HPLC, and the characters of Chelidonii Herba Pieces were evaluated by sensory evaluation. The correlation between the characters and components was calculated by correlation formula. Result::The content of 6 components, such as chelidonine, was determined by HPLC. Based on the result of sensory evaluation, there was a certain correlation between the characters and the components. Character descriptions that " some have visible white powder, some have white pubescence, and sometimes they have visible yellow florets" had a very low similarity with total alkali, indicating that these characters and total alkali content was not related. The similarity between the description of " hollow stem" had a high similarity with total alkali content, indicating that the amount of stem was related to the total alkali content. The character description of " more broken leaves" was negatively correlated with total alkaloids in the similarity, which indicated that the content of total alkaloids was less when there were more leaves(or more broken leaves), otherwise, the content of total alkaloids was relatively higher. Conclusion::The established HPLC method is simple and feasible. This study objectively quantifies the descriptions of Chelidonii Herba pieces characters, correlates them with the main components of Chelidonii Herba pieces, and then preliminarily judges the quality of Chelidonii Herba pieces according to the appearance of the characters, which provides a theoretical basis for the identification of Chelidonii Herba pieces in the market by experience, and ideas for the study of the characters of other traditional Chinese medicines.

Metabolomics analysis and rapid identification of changes in chemical ingredients in crude and processed Astragali Radix by UPLC-QTOF-MS combined with novel informatics UNIFI platform / 中国天然药物

Astragali Radix, the root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., is widely used as a tonic decoction pieces in the clinic of traditional Chinese medicine (TCM). Astragali Radix has various processed products with varying pharmacological actions. There is no modern scientific evidence to explain the differences in pharmacological activities and related mechanisms. In the present study, we explore the changes in chemical components in Astragali Radix after processing, by ultra-high performance liquid chromatography quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) combined with novel informatics UNIFI platform and multivariate statistical analysis. Our results showed that the crude and various processed products could be clearly separated in PCA scores plot and 15 significant markers could be used to distinguish crude and various processed products by OPLS-DA in UNIFI platform. In conclusion, the present study provided a basis of chemical components for revealing connotation of different processing techniques on Astragali Radix.

Metabolomics analysis and rapid identification of changes in chemical ingredients in crude and processed Astragali Radix by UPLC-QTOF-MS combined with novel informatics UNIFI platform / 中国天然药物

Astragali Radix, the root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., is widely used as a tonic decoction pieces in the clinic of traditional Chinese medicine (TCM). Astragali Radix has various processed products with varying pharmacological actions. There is no modern scientific evidence to explain the differences in pharmacological activities and related mechanisms. In the present study, we explore the changes in chemical components in Astragali Radix after processing, by ultra-high performance liquid chromatography quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) combined with novel informatics UNIFI platform and multivariate statistical analysis. Our results showed that the crude and various processed products could be clearly separated in PCA scores plot and 15 significant markers could be used to distinguish crude and various processed products by OPLS-DA in UNIFI platform. In conclusion, the present study provided a basis of chemical components for revealing connotation of different processing techniques on Astragali Radix.

Research on Current Situation and Development Strategies of TCM Cultural Tourism in Jiangsu Province / 中国中医药信息杂志

At present, the tourism industry has risen into a national strategic pillar industry. The development of the TCM industry has been included in the national strategy. The integration of the two major industries, TCM culture and tourism, is of great significance in promoting the development of the tourism industry and structural transformation. Jiangsu Province has a wealth of TCM cultural tourism resources, with unique industrial development advantages. Based on the analysis of the advantages and current situation of TCM cultural tourism in Jiangsu Province, this article put forward some suggestions for the development of TCM cultural tourism in order to provide a reference for promoting the integration and development of TCM culture and tourism industry.

Impact of Dentinal Tubule Orientation on Dentin Bond Strength / 华中科技大学学报（医学）（英德文版）

This study aimed to determine the impact of dentinal tubule orientation on dentin bond strength to provide a reference for clinical cavity preparation in resin-bonded restoration.Patients aged 13-16 years were selected,including 18 males and 21 females.Forty-eight human maxillary first premolars from orthodontic extractions were chosen to prepare the test models with the dentinal tubule orientations perpendicular and parallel to the bonding substrate.The test models in the vertical and parallel groups were divided into three groups:total-etching with 20％ phosphoric acid,total-etching with 35％ phosphoric acid and self-etching,with the dentinal tubule surfaces bonded with composite resin blocks in each group.After the standard test models of dentinal tubule-composite resin blocks were placed in distilled water and stored at 37℃ for 24 h,shearing tests were performed using a universal material testing machine at a crosshead speed of 0.5 mm/min.The bond strength values in the vertical group were 19.33±1.59 MPa for the 20％ phosphoric acid group,21.39±2.34 MPa for the 35％ phosphoric acid group,and 16.88±1.54 MPa for the self-etching group.The bond strength values in the parallel group were 24.53±1.99MPa for the 20％ phosphoric acid group,25.16±2.88 MPa for the 35％ phosphoric acid group,and 20.83±1.99 for the self-etching group.After using same total-etching adhesive,the shear bond strength of the parallel group was higher than that of the vertical group,and the difference was statistically significant (P＜0.05).Regardless of vertical group or parallel group,the difference in the bond strength value between the total-etching groups and the self-etching group was statistically significant (P＜0.05).It was concluded that the dentin bonding substrate which was parallel to the direction of the dentin tubule achieved an improved bond strength;the total-etching adhesives achieved higher bond strengths in dentin bond than the self-etching adhesives.

Impact of Dentinal Tubule Orientation on Dentin Bond Strength / 华中科技大学学报（医学）（英德文版）

This study aimed to determine the impact of dentinal tubule orientation on dentin bond strength to provide a reference for clinical cavity preparation in resin-bonded restoration.Patients aged 13-16 years were selected,including 18 males and 21 females.Forty-eight human maxillary first premolars from orthodontic extractions were chosen to prepare the test models with the dentinal tubule orientations perpendicular and parallel to the bonding substrate.The test models in the vertical and parallel groups were divided into three groups:total-etching with 20％ phosphoric acid,total-etching with 35％ phosphoric acid and self-etching,with the dentinal tubule surfaces bonded with composite resin blocks in each group.After the standard test models of dentinal tubule-composite resin blocks were placed in distilled water and stored at 37℃ for 24 h,shearing tests were performed using a universal material testing machine at a crosshead speed of 0.5 mm/min.The bond strength values in the vertical group were 19.33±1.59 MPa for the 20％ phosphoric acid group,21.39±2.34 MPa for the 35％ phosphoric acid group,and 16.88±1.54 MPa for the self-etching group.The bond strength values in the parallel group were 24.53±1.99MPa for the 20％ phosphoric acid group,25.16±2.88 MPa for the 35％ phosphoric acid group,and 20.83±1.99 for the self-etching group.After using same total-etching adhesive,the shear bond strength of the parallel group was higher than that of the vertical group,and the difference was statistically significant (P＜0.05).Regardless of vertical group or parallel group,the difference in the bond strength value between the total-etching groups and the self-etching group was statistically significant (P＜0.05).It was concluded that the dentin bonding substrate which was parallel to the direction of the dentin tubule achieved an improved bond strength;the total-etching adhesives achieved higher bond strengths in dentin bond than the self-etching adhesives.

Investigation of potential toxic factors for fleece-flower root： from perspective of processing methods evolution / 中国中药杂志

In recent years, the rapid growth of reports on fleece-flower root-caused liver damages has drawn wide attention of both at home and abroad, however, there were rare literature on toxicology of fleece-flower root in ancient Chinese medicine. But why there are so many reports on toxicology of fleece-flower root now compared with the ancient literature? As a typical tonic medicine, the clinical utility of fleece-flower root was largely limited by its standardization and reliability of processing methods in ancient Chinese medicine. The ancient processing methods of fleece-flower root emphasized nine times of steaming and nine times of drying, while the modern processes have been simplified into one time of steaming. Whether the differences between ancient and modern processing methods are the potential cause of the increased events of fleece-flower root-caused liver damages. We will make deep analysis and provide new clues and perspectives for the research on its toxicity. This article, therefore, would discuss the affecting factors and key problems in toxicity attenuation of fleece-flower root on the basis of sorting out the processing methods of fleece-flower root in ancient medical books and modern standards, in order to provide the reference for establishing specification for toxicity attenuation of fleece-flower root.

Determination of four coumarin constituents before and after Angelicae Dahuricae Radix stewed with yellow rice wine and research on its mutual transformation mechanism / 中国中药杂志

To determine the contents of oxypeucedanin, oxypeucedanin hydrate, byakangelicol and byak-angelicin both before and after Angelicae Dahuricae Radix was stewed with yellow rice wine by high-performance liquid chromatography, and study the mutual transformation mechanisms of oxypeucedanin into oxypeucedanin hydrate, as well as byakangelicol into byak-angelicin. The research results indicated that the contents of oxypeucedanin and byakangelicol were decreased, but the contents of oxypeucedanin hydrate and byak-angelicin were increased after Angelicae Dahuricae Radix was processed with yellow rice wine. The contents' changes of these chemical compounds were due to the ring opening reaction of epoxy compounds, such as oxypeucedanin and byakangelicol under the weak acidity and heating conditions of yellow rice wine. This research could provide a scientific basis for the processing mechanism of Angelicae Dahuricae Radix with yellow rice wine stewing.

Comparison of anti-inflammatory activity between crude Atractylodes lancea and their processed products by stir-baking with bran in rat models of gastric ulcer / 中国中药杂志

To compare the anti-inflammatory activity of the crude Atractylodes lancea (AL) and AL processed products by stir-baking with bran in rat models of gastric ulcer, and preliminarily explore the anti-ulcer mechanisms of AL, the model of gastric ulcer was imitated by local acetic acid injection into gastric mucosa in rats by surgery according to the modified Okabe method. All rats were randomly divided into the following 10 groups： sham-operation group, model group, omeprazole group, Sanjiu Weitai granule group, crude AL low dose group, crude AL middle dose group, crude AL high dose group, processed AL low dose group, processed AL middle dose group, and processed AL high dose group. Rats were administered via intragastric (ig) two times each day, for 10 consecutive days. Blood was collected from the abdominal aorta, serum was separated, and the ulcer tissues were taken. The levels of inflammatory factors interleukin 6, 8 (IL-6, 8), tumor necrosis factor-α (TNF-α), and prostaglandin E2 (PGE2) in serum and gastric tissues were determined by enzyme-linked immunosorbent assay (ELISA), and the mRNA expressions of TNF-α and IL-8 in gastric tissues were detected by quantitative real-time reverse transcription polymerase chain reaction (RT-PCR). The protein expressions of TNF-α and IL-8 in gastric tissues were detected by immunohistochemistry. Compared with sham-operation group, the levels of TNF-α, IL-8, IL-6, PGE2 as well as the mRNA expressions and protein expressions of TNF-α, IL-8 in gastric tissues were significantly higher in model group. The above levels were reduced in different degrees in all treatment groups. Compared with the crude AL, same dose of processed AL was more effective in decreasing the levels of TNF-α, IL-8, IL-6, PGE2 in serum and gastric tissues and down-regulating the mRNA expressions of TNF-α and IL-8 in gastric tissues, with significant difference in middle dose groups and high dose groups. The results showed that AL had potent anti-inflammatory effects in rat models of gastric ulcer induced by acetic acid, and the processed AL had more obvious effect. The anti-ulcer action of AL could be attributed partly to down-regulating the levels of TNF-α, IL-8, IL-6 and PGE2.

Study on protective effect of Sijunzi decoction (red/white ginseng) on H2O2-induced H9c2 cardiomyocytes apoptosis / 中国中药杂志

In this study, efforts were made to screen out the drug concentration of Sijunzi decoction (red ginseng) for in vitro intervention of H9c2 cardiomyocytes, select high, medium and low groups for subsequent experiments, establish the H2O2-induced myocardial cell apoptosis to investigate the protective effect of Sijunzi decoction (white/red ginseng), provide reference ginseng ingredients in Sijunzi decoction used to treat ischemic heart disease and reflect its curative effect, and observe its impacts on SOD, MAD, LDH and other indexes to preliminarily define the action mechanism. According to the results, red ginseng in Sijunzi decoction showed a better protective effect on H2O2-induced myocardial cell injury than that of white ginseng. Both of them could enhance SOD activity and reduce MDA production and LDH release, so as to significantly reduce the amount of apoptotic myocardial cells and play protective role.

A new saikogenin from the roots of Bupleurum bicaule / 中国天然药物

AIM@#To study the chemical constituents from the roots of Buleurum bicaule Helm (Apiaceae).@*METHOD@#Silica gel, Sephadex LH-20, MPLC Rp-C18 column chromatography, and HPLC were used for isolation of compounds. The structures were elucidated on the basis of 1D- and 2D-NMR technology and HRESI-MS. Compounds were evaluated in vitro for their inhibitory ability against the proliferation of rat mesangial cells by the MTT method.@*RESULTS@#Twelve compounds were isolated, and their structures were identified on the basis of their spectroscopic and physico-chemical properties as 13, 28-epoxy-olean-11-en-3-one (1), saikogenin E (2), saikogenin G (3), 11α-methoxy-3β, 16β, 23, 28-tetrahydroxyolean-12-ene (4), saikogenin D (5), prosaikogenin F (6), prosaikogenin A (7), prosaikogenin G (8), prosaikogenin D (9), laccaic acid (10b), methyl gallate (11), and ethyl gallate (12). Compounds 1, 2, 7, 8, and 10 were observed to have inhibitory activity against mesangial cell proliferationin to different degrees.@*CONCLUSION@#Compound 1, 8, and 10 exhibit significant inhibitory effects on rat mesangial cell proliferation induced by Ang II.

Study on decoction's effect of different processed rhizomes of Cibotium barometz on retinoic acid induced male rats osteoporosis / 中国中药杂志

This study compared the decoction's HPLC figures of the different processed rhizomes of Cibotium barometz including the raw, the sand-baked, the wined, the steamed and the salted, on the basis of which, with the sand-baked Drynaria fortunei decoction as the positive control group, comparingall groups' decoction, concentration of which was 104.2 g x L(-1), for 4 weeks, by their effects (s-TRAP and total scores of OPG, Ca, P, IL-6, TNF-alpha and IL-1) on retinoic acid induced male rats osteoporosis. The experiment results showed the sand-baked and the wined were better than the steamed, the salted and the raw;in the processing methods' selection, the sand-baked was a better heating method than the steamed and the rice wine was the better excipient than the salt. It provided a reference to explain the processing principle of rhizomes of C. barometz and work mechanism of anti-osteoporosis.

Determination of amino acids in Galli Gigerii endothelium corneum by HPLC with pre-column derivatization / 中国中药杂志

Hydrolytic amino acids were extracted by acid hydrolysis method, then derivatized with phenyl isothiocyanate (PITC). And the samples were analysed by HPLC on an Ultimate Prime C18 (4.6 mm x 250 mm, 5 microm) column with gradient elution of 0.1 mol x L(-1) sodium acetate buffer solution (adjusted to pH 6. 5)-acetonitrile (93:7) (A) and acetonitrile-water (8:2) (B) at a flow rate of 1.0 mL x min(-1). Column temperature was 40 degrees C and the detected wavelength was 254 nm. Amino acids derivative solution remained stable in 36 hours. The response was linear for 16 amino acids with a correlation coefficient r > 0.999 5. The average recoveries were 98.01% -101.8%. The method is reliable with good accuracy and repeatability, which is useful for the determination of amino acids in Galli Gigerii Endothelium Corneum.

Metabolomics analysis revealing multiple compounds changed in rhubarb after processing / 中国中药杂志

Untargeted metabolomics analysis of rhubarb and stewed rhubarb samples shows that the determined samples clearly clustered in to two groups, indicating that the processing procedures caused changes in the composition and/or content of components in rhubarb. Ten components were identified by UHPLC-Q-TOF-MS/MS and references, which intensity declined in rhubarb after processing. Targeted metabolomics analysis of rhubarb and stewed rhubarb samples indicated that aloe-emodin, rhein, emodin and physcion were detected with lower intensity in stewed rhubarb samples than in rhubarb samples. Metabolomics analysis of rhubarb and stewed rhubarb indicated the various components of rhubarb changed after processing.

New hydrolysable tannin from Cibotium barometz / 中国中药杂志

<p><b>OBJECTIVE</b>To study the chemical constituents from Cibotium batometz.</p><p><b>METHOD</b>Column chromatograph and HPLC were used to isolate and purify the compound, and the structure was elucidated on the basis of MS and NMR spectroscopic methods.</p><p><b>RESULT</b>A new phenolic compound, 4-O-caffeoyl-D-glucopyranose, has been isolated from the rhizome of C. barometz. The structure of the new compound was elucidated on the basis of chemical and spectroscopic methods, including intensive 1D, 2D NMR and ESI-MS data analysis.</p><p><b>CONCLUSION</b>4-O-caffeoyl-D-glucopyranose was a new phenolic compound.</p>

Immunogenicity and safety of a booster dose of inactivated polio vaccine / 中华预防医学杂志

<p><b>OBJECTIVE</b>To evaluate the immunogenicity and safety of a boost dose of inactivated polio vaccine (IPV) among children aged 18 months who had been administered with primary doses of IPV.</p><p><b>METHODS</b>Form 2011 to 2012, a total of 97 children were enrolled in the present study who were vaccinated with IPV at 2, 3, 4 months of age and boosted with the same vaccine at 18 months of age. Anti-poliovirus neutralizing antibody titers in serum were measured before and after booster vaccination, geometric mean titers (GMT) and seroprotection rate were calculated. Adverse events occurring within 30 days after booster vaccination were observed, including pain, redness/swelling and induration at the injection site, fever, vomit, abnormal crying, drowsiness, loss of appetite, irritability, and all other physical discomfort and related medications were also recorded. A descriptive analysis was performed for the safety assessment.</p><p><b>RESULTS</b>Immunogenicity was assessed in 84 subjects. The pre-booster seropositivity rates of neutralizing antibody against poliovirus type 1, 2, 3 before booster were all 100% (84/84) and the corresponding GMT (95% CI) was 1: 148.5 (116.49-189.29) , 1: 237.68 (178.39-316.67) and 1: 231.87 (181.27-296.58) , respectively. The seropositivity rates of neutralizing antibody against the three types of poliovirus after booster were all 100% (84/84) and the corresponding GMT (95% CI) was 1: 1612.14 (1470.57-1767.34) , 1: 1854.92 (1715.83-2005.29) and 1: 1625.50 (1452.12-1819.58) , respectively. The pre-booster titer of neutralizing antibody against poliovirus type 1, 2, 3 mainly ranged 1: 128-1: 512, which accounted for 65% (55/84) , 55% (46/84) , 74% (62/84) in each type. After the booster immunization, titers of neutralizing antibody against type 1, 2, 3 were increased as subjects with titer ≥ 1: 1024 accounted for 94% (78/84) , 95% (80/84) , 92% (77/84) , respectively.Safety was evaluated in 96 subjects, of which 16 subjects reported adverse events with the rate of 17%. The observed local events were mainly tenderness 3% (3/96) , redness/swelling and induration were not reported. The systemic adverse events included loss of appetite (8%, 8/96) , irritability (8%, 8/96) , fever (7%, 7/96) , abnormal crying (6%, 6/96) , drowsiness (6%, 6/96) and vomit (1%, 1/96) . All reported adverse events were mild or moderate. All of the local events occurred in the day of vaccination and lasted for 1-2 days, while systemic events almost developed within 2 days after vaccination and last less than 3 days.</p><p><b>CONCLUSION</b>IPV booster dose has good immunogenicity and safety profile, which provides effective protection against poliovirus.</p>

Safety of different sequential immunization schedules of inactivated poliovirus vaccine and oral poliovirus vaccine primary vaccination / 中华预防医学杂志

<p><b>OBJECTIVE</b>To evaluate safety of different sequential immunization schedules of inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) primary vaccination.</p><p><b>METHODS</b>Infants of 2 months old (60-89 days) selected in Beijing, were assigned to four groups, 1 dose IPV plus 2 doses OPV (I-O-O), 2 doses IPV plus 1 dose OPV(I-I-O), 3 doses IPV (I-I-I), and 3 doses OPV (O-O-O), and were vaccinated at the age of 2, 3, 4 months, from 2009 to 2011. The frequencies of systemic as well as local injection site reactions after every dose were recorded and calculated. A total of 553 infants were enrolled in the study and 89 infants were quit, 1492 diseases were observed.</p><p><b>RESULTS</b>The incidence of adverse events in I-O-O, I-I-O, I-I-I, O-O-O were 22.9% (94/410), 18.4% (60/327), 22.0% (78/354) and 17.7% (71/401) with no statistical differences (χ(2) = 4.84, P = 0.184). Dose 1 (22.7% (32/141)-35.3% (54/153) ) was more frequently than dose 2 and dose 3. No serious adverse events (SAE) were reported during the study. The incidence of systemic adverse reactions in I-O-O, I-I-O, I-I-I, O-O-O were 21.5% (88/410), 17.7% (58/327) , 20.1% (71/354) and 17.7% (71/401) with no statistical differences (χ(2) = 2.53, P = 0.472). Abnormal crying were the most frequency reactions (7.2% (29/401)-11.3% (37/327) ) in 4 groups. Rarely severe reactions were observed of abnormal crying, somnolence, irritability and mild or medium reactions occurred in other symptoms. Local adverse reactions such as injection site pain, scleroma and swelling were reported by 2.2% (5/229)-5.6% (22/393) ,0-0.9% (2/229) and 0-1.0% (4/393) in I-O-O,I-I-O and I-I-I, and most reactions were mild.</p><p><b>CONCLUSION</b>Three IPV immunization and IPV/OPV sequential immunization as well as three OPV immunization demonstrated safe.</p>