OBJECTIVE To prepare the Eriodictyol chewable tablet and to evaluate its quality. METHODS The chewable tablet was prepared by the wetting granulation method by using microcrystalline cellulose （MCC） and mannitol as fillers， polyvinylpyrrolidone （PVP） as adhesive， citric acid and sucralose as flavor correction agents， magnesium stearate as lubricant. The comprehensive evaluation was conducted on Eriodictyol chewable tablets with the dosage of each excipient as a factor using the appearance， taste， flavor and texture as indicators. The ratio of excipients was optimized by orthogonal test， and the quality of Eriodictyol chewable tablets prepared by optimized formulation was evaluated in terms of appearance， weight difference， hardness， fragility， eriodictyol content， dissolution and content uniformity. RESULTS The optimal formulation was as follows： 26.4% eriodictyol （50 mg each piece）， 45% mannitol， 25% MCC， 0.3% citric acid， 0.3% sucralose， 1% magnesium stearate， 2% PVP （preparing 5% solution using purified water）. The scores of 3 batches of Eriodictyol chewable tablets in the validation test were 8.76， 8.75 and 8.80 （RSD＝0.30%， n＝3）， respectively. The Eriodictyol chewable tablet had a complete appearance and a smooth surface； the average tablet weight was 192.57 mg， the average hardness was 57.36 N， the fragility was 0.09%， the average content of eriodictyol per tablet was 50.74 mg， the cumulative dissolution within 30 min was exceeding 80%， and the content uniformity was 5.51. CONCLUSIONS Eriodictyol chewable tablet prepared by optimal formulation conforms to the requirements of the 2020 edition of Chinese Pharmacopoeia.

Objective:A gas chromatography analysis system for fatty acid compositions of hydrogenated palm glycerides was established to provide a reference for quality standards of hydrogenated palm glycerides.Methods:In this test,a DB-WAX(30 m ×0.53 mm,1.0 μm)strong polarity gas chromatographic column was employed with an injection volume of 1 μL and a split ratio of 120∶1.The initial column temperature was 70℃,sustained for 2 min,ramped up to 230 ℃ at a rate of 5 ℃ per minute,and maintained for 10 min,with the inlet temperature of 250 ℃ and the detector temperature of 250 ℃.Results:In this experiment,the gas chromatograph-ic method was established successfully to determine fatty acid compositions of hydrogenated palm glycerides.The validated results indicated that the method exhibited well-suited system applicability,specificity and precision,and the RSD(％)fulfilled the requirements.The limit of detection(LOD)and limit of quantification(LOQ)values of nine fatty acid methyl esters were defined,and fatty acid compositions of seven batches of samples were checked successfully.Conclusion:The GC methodology developed in this study is suitable for the analysis and determina-tion of fatty acid compositions in hydrogenated palm glycerides,which can serve as a reference for the quality control of this pharmaceutical excipient and the establishment of quality standards.

Objective:To investigate the effect of Qideng Mingmu capsule on the formation and remodeling of retinal neovascularization in mice with oxygen-induced retinopathy (OIR).Methods:Thirty-six postnatal day 7 (P7)SPF grade C57BL/6J pups were divided into normal group, OIR group, Qideng Mingmu capsule group and apatinib group by random number table method, with 9 mice in each group.The mice in the normal group were raised in normal environment.The mice in the other three groups were fed in hyperoxic environment of (75±2)% oxygen concentration for 5 days from P7 to P12 and then were fed in normal environment for 5 days from P12 to P17 to establish the OIR model.From P12, mice in Qideng Mingmu capsule group and apatinib group were given intragastric administration of Qideng Mingmu capsule (900 mg/kg) and vascular endothelial growth factor receptor 2 inhibitor apatinib (70 mg/kg) respectively, once a day for 5 consecutive days.On P17, paraffin sections of mouse eyeballs were made and stained with hematoxylin-eosin to count the number of vascular endothelial cells that broke through the internal limiting membrane.The retinal slices were prepared and stained with FITC-dextran to quantify the retinal non-perfusion area, neovascularization density and total vascular density.The distribution and fluorescence intensity of retinal vascular endothelial cell marker CD31 and pericyte marker α-smooth muscle actin (α-SMA) were observed by double immunofluorescence staining.Immunohistochemical staining was used to detect the expression and distribution of retinal hypoxia inducible factor-1α (HIF-1α) and vascular endothelial cadherin (VE-cadherin).The use and care of animals were in accordance with the Regulations on the Management of Laboratory Animals issued by the Ministry of Science and Technology.This study was approved by the Animal Ethics Committee of Chengdu University of Traditional Chinese Medicine (No.2019-30).Results:The number of vascular endothelial cells breaking through the internal limiting membrane in normal group, OIR group, Qideng Mingmu capsule group and apatinib group were (2.83±4.40), (37.33±5.43), (23.83±6.79) and (14.00±9.34), respectively, with a statistically significant overall difference ( F=28.313, P<0.001).There were more vascular endothelial cells breaking through internal limiting membrane in OIR group than in normal group, Qideng Mingmu capsule group and apatinib group, showing statistically significant differences (all at P<0.05).In the observation of mouse retinal slices, there were large non-perfusion areas, neovascularization buds and disordered distribution of blood vessels in OIR group.The distribution of blood vessels was more uniform and the areas of non-perfusion and neovascularization were smaller in Qideng Mingmu capsule group and apatinib group than in OIR group.The relative area of central retinal non-perfusion area and neovascularization density were significantly lower in normal group, Qideng Mingmu capsule group and apatinib group than in OIR group (all at P<0.05).The immunofluorescence intensity of CD31 and the absorbance value of HIF-1α were significantly lower, and the immunofluorescence intensity of α-SMA and the absorbance value of VE-cadherin were significantly higher in normal group, Qideng Mingmu capsule group and apatinib group than in OIR group (all at P<0.05). Conclusions:Qideng Mingmu capsule can inhibit retinal neovascularization formation, increase vascular pericyte coverage, relieve retinal hypoxia and increase vascular integrity in OIR mice.It can protect the retinal vessels of OIR mice.

Objective To explore the relationship between methylene tetrahydrofolate reductase(MTHFR)C677T gene polymorphism and serum homocysteine(Hcy)levels with postoperative restenosis in patients with lower limb arteriosclerosis obliterans(ASO)after intervention.Methods A total of 92 patients with lower limb ASO treated in Wenzhou Central Hospital from January 2021 to July 2022 were divided into non-restenosis group and restenosis group according to whether patients with postoperative restenosis.General and surgical data from all patients were collected,and preoperative neutrophils,lymphocytes,platelets,fibrinogen,D-dimer,C-reactive protein,low-density lipoprotein,homocysteine,MTHFR C677T gene polymorphism,etc were tested.x2 test and Logistic regression analysis were used to compare the relationship between lower limb ASO postoperative restenosis after intervention and MTHFR C677T gene polymorphism and serum Hey.A risk scoring system was built to predict postoperative restenosis after intervention and evaluate its effectiveness.Results There were significant differences(P＜0.05)between the two groups in terms of lesion location,stent placement,stent length,serum Hcy,and MTHFR C677T gene polymorphism.Multivariate Logistic regression analysis showed that MTHFR C677T TT type,serum Hey 17.15μmol/L,lesion location in the femoral artery,and no stent placement were independent risk factors for postoperative restenosis in lower limb ASO patients(P＜0.05).The area under the curve(AUC)of receiver operating characteristic curve of the risk scoring system constructed based on independent risk factors was 0.818(95％CI:0.731-0.905),which was significantly higher than those other independent risk factors and had high efficacy.Conclusion The MTHFR C677T gene polymorphism and serum Hcy are closely related to postoperative restenosis in lower limb ASO patients.A risk scoring system based on MTHFR C677T gene polymorphism,serum Hcy,lesion location,and stent placement can help predict the occurrence of restenosis in lower limb ASO patients.

Pharmaceutical excipients of animal origin, an important part in pharmaceutical excipients, are widely used in pharmaceutical preparations.However, compared with the pharmaceutical excipients of other origins, pharmaceutical excipients of animal origin have more special requirements in many aspects, such as raw materials, production, quality control, storage, supervision, etc.Chinese Pharmacopoeia 2020 first included the Guideline for Pharmaceutical Excipients of Animal Origin, which introduces the basic ideas and technical requirements for the life cycle quality control of pharmaceutical excipients of animal origin based on the risk management concept.This article illustrates the specificity of the pharmaceutical excipients of animal origin, and interprets the main contents of this guideline in conjunction with relevant domestic and foreign regulations and technical documents, thereby providing comprehensive reference for the implementation of the guideline.

OBJE CTIVE To investigate the clinical characteristics of a dverse drug reactions of asparaginase-associated pancreatitis（AAP），so as to provide reference for clinical safe medication. METHODS Analysis and identification were performed on a severe adverse reaction case of acute pancreatitis complicated with diabetic ketoacidosis and liver injury in a patient with acute lymphoblastic leukemia in our hospital after using pegaspargase. Retrieved from Wanfang database ，CNKI，PubMed and Embase database，case reports of AAP were collected and summarized in terms of patient demographics ，drug use ，incubation period and adverse reaction outcome. Combined with this case ，the disease characteristics and potential risk factors of AAP were analyzed and discussed. RESULTS After analysis and identification ，it was determined that AAP occurred in this patient. A total of 47 case reports were retrieved from the database ，and a total of 52 patients（including this patient ）were included in the analysis ，including 29 males and 23 females，mainly minors （65.4％）. L-asparaginase was the main asparaginase preparation that causes AAP （80.8％）. Gastrointestinal symptoms were the main prodromal symptoms （92.3％），which could be accompanied by other asparaginase related adverse reactions. AAP could occur after 1-33 times of administration ，and the median latency was 14 days after administration；compared with children ，median latency of AAP in adult patients was shortened significantly （11 d vs. 16 d，P＝ 0.049）；the median latency of AAP had longer tendency in patients treated with pegaspargase than that of L-asparaginase （17 d vs. 12.5 d，P＝0.490）. Of the cases included in the analysis ，8 patients died due to AAP ，1 of which was related to re-exposure to asparaginase preparations. CONCLUSIONS Acute pancreatitis is a serious and potentially fatal adverse drug reaction of ； asparaginase preparations. Clinical medical staff should pay attention to the characteristics of AAP ，consider the possibility ： of AAP when the patients have gastrointestinal symptoms and do a good job in patient education and pharmaceutical care to minimize the damage caused by AAP to patients.

Information-based teaching was applied in the experimental teaching of nuclear protection medicine based on its own features.The teaching content was sent to students as micro-video via an information platform before class for preview;during the class,the teaching was performed in the form of lectures by students and experiments in groups;after class,students were required to submit reports of experimental improvement or innovative experimental design.A comprehensive assessment was performed for preview,classroom operation,question answering in class,and experimental reports.The results of teaching practice showed that this teaching mode can effectively stimulate the students' interests in learning,enhance their research and innovation abilities,and improve the experimental teaching effect of nuclear protection medicine.

OBJECTIVE:To study the spectrum-effect relationship of the antipyretic effect of Radix Bupleuri injection. METH-ODS:HPLC method was used to establish the fingerprint of Radix Bupleuri injection. The antipyretic effect of 10 batches of Radix Bupleuri injection on fever rats induced by dried yeast were determined respectively. The fingerprint peaks were screened,along with the temperature value of different time points(0,10,15,30,40,55,70 min). The principal components were extracted by principal component method and the indirect relationship between the fingerprint and antipyretic effect was analyzed,depending on the principal component correlation coefficient matrix. RESULTS:There were 39 common peaks in fingerprint(similarity>0.85), No. 8,12,14,19,26,31,34,35 and 39 common peaks with large peak area were included in the study. Four principal compo-nents were extracted by principal component analysis(87% of total variant). First principal component showed that the active com-ponents of the 12th peak may be related to the antipyretic effect of 6 to 13 hours. The second principal component showed that the active components of the 26th peak may be related to the antipyretic effect of 0.5 to 5 hours. The third principal component showed that the similar effect of the active components could be caused by 34th,35th and 39th peaks. The fourth principal component sug-gested that there were some similarities between the 14th and the 31st peaks. CONCLUSIONS:Radix Bupleuri injection have obvi-ous improvement for fever rats. There is certain corresponding relation between HPLC fingerprint and antipyretic effect of Radix Bu-pleuri injection .

Objective To study the characteristics of cell engraftment in mice at a lower dose under nonlethal radiated condition.Methods A syngeneic C57BL/6 mouse model,transplanted with 1 × 107 bone marrow cells and exposed to 2.5 Gy whole body irradiation (WBI),was selected to study the chimerism of cells from green fluorescent protein positive (GFP +) transgenic mice.The control group was injected with GFP + cells without receiving irradiation.In addition,an allogenic transplantation model of BALB/c mice was also investigated which was infused by GFP + cells from C57BL/6 mice.The engraftment of bone marrow-derived cells (BMDCs) was detected by immunohistochemistry in bone marrow,liver,lung,small intestine and spleen.Results The transplanted bone marrow cells successfully grafted in the haematopoietic tissues from syngeneic GFP transgenic mice.The transplanted GFP+ cells were also detected in the non-haematopoietic tissues,such as the small intestine,liver,spleen and lung,after irradiation.However,a lethal dose irradiation of 8 Gy was required to establish successful chimerism in allogeneic transplantation model by infusing the bone marrow cells from C57BL/6 mice to BALB/c mice.Conclusions Bone marrow-derived cells can be successfully grafted into various recipient tissues receiving a 2.5 Gy dose of radiation in syngeneic mice,but not in allogeneic mice.This nonlethal model may help to further study the plasticity and mechanism of bone marrow-derived cells in tissue repair and regeneration after radiation injury.

Objective To explore the prothrombotic state of patients with ulcerative colitis(UC) and the relationship with phase,severity and Truelove classification.Methods 97 patients with UC were grouped by non-active phase and active phase;The latter were subdivided into mild,moderate and severe degree by clinical manifestation and TrueloveⅠ,Ⅱ,Ⅲ via endoscopy,vWF activity,fibrinogen and D-dimer were detected in all patients.Results vWF activity,fibrinogen and D-dimer were markedly higher in active phase than in non-active phase(t=14.137,3.435,3.625,respectively).There were no significant difference in vWF activity,fibrinogen and D-dimer between mild,moderate and severe degree and Truelove Ⅰ,Ⅱ,Ⅲ.Conclusion Prothrombotic state including hypercoagulation and secondary fibrinolysis correlates with the clinical phase of UC significantly.