Objective　To study whether covering ice on head can abate headache produced by using nitroglycerin.Method　64 cases were collected from the patients who used nitroglycerin and were randomly divided into one contrasting group (group A) and one experimental group (group B).For the patients of group A,the state of headache produced by using nitroglycerin should be observed.For the patients of group B,covering ice on their head was adopted when they used nitroglycerin,and the state of headache should also be observed.Results　There were obvious difference between the two groups (P<0.001).Conclusion　Covering ice on head is a good method which can abate headache produced by using nitroglycerin.

AIM: To establish the quality standard of Agui Yangxue Tablets (Radix Angelicae sinensis, Radix Codonopsis, Rhizoma Atractylodis macrocephalae, etc.) METHODS: Radix Astragali, Radix et Rhizoma Glycyrrhizae and Radix Rehmanniae praeparata were identified by TLC. The content of ferulic acid and paeoniflorin was determined by HPLC. The HPLC condition of ferulic acid was as follows: column was Diamonsil~ TM C_ 18 (4.6 mm?200 mm,5 ?m), the mobile phase consisted of acetonitrile -0.085% phosphoric acid (22 ∶ 78), the UV detection wavelength was at 322 nm, the flow rate was 1.0 mL/min with column temperature at 35 ?C . The HPLC condition of paeoniflorin was as follows: column was Diamonsil~ TM C_ 18 (4.6 mm?200 mm,5 ?m), the mobile phase consisted of acetonitrile -0.1% phosphoric acid (15 ∶ 85), the UV detection wavelength was at 229 nm, the flow rate was 1.0 mL/min with column temperature at 25 ?C . RESULTS: The developed TLC spots were quite clear. The calibration curve of ferulic acid was linear with 0.012 9-0.154 8 ?g(r=0.999 7). The average recovery was 99.32% with RSD of 1.74% (n=9). The calibration curve of paeoniflorin was linear with 0.106 8-1.602 0 ?g(r= 0.999 9). The average recovery was 98.68% with RSD of 0.98 (n=9). CONCLUSION: The established TLC and HPLC methods are exclusive, reproducible and suitable for the quality control of Agui Yangxue Tables.

Objective To investigate tissue distribution of Hylotelephin in Beagle dogs and excretion of Hylotelephin in rats. Methods A high performance liquid chromatography (HPLC) with UV detection was developed to study the concentrations of Hylotelephin in biological samples, taking anthracene as an internal standard, Benzoyl chloride as the pre-column derivatization of Hylotelephin and methanol-water as the mobile phase. Results After a single intravenous dose of 10.6 mg/kg Hylotelephin in beagle dogs, parent drug was widely distributed to virtually all tissues in 5 min and the concentration of Hylotelephin in most tissues at 90 min were lower than those at 5 min obviously. Hylotelephin was mainly distributed in kidney, liver and spleen, secondly in heart, lung and intestine. The parent drug concentration in kidney, liver and spleen was similar to that in blood at the same time point. After a single intravenous dose of 36 mg/kg Hylotelephin in rats, the excretion of the parent drug in urine, feces and bile amounted to 88.45%, 0.61% and 1.08% of the dose, respectively. The parent drug excretion amounted to 67% of the dose in 3 h. Conclusion Hylotelephin was distributed and eliminated in Beagle dogs rapidly. It was mostly distributed in kidney, liver, spleen and plasma. The parent drug excretion was 88% via urine.

OBJECTIVETo compare the influence on the dissolution of tanshinone IIA (TS IIA) solid dispersions in complex carriers and single, which used in preparation of TS IIA solid dispersions, and further enhance the dissolution of TS IIA.

METHODThe TS IIA solid dispersions were prepared by solvent technique with polyvinylpyrrolidone K30 (PVPK30), poloxamer188 (F68) and combination of PVPK30 and F68 as carriers, respectively. The physical characteristics of TS IIA solid dispersions was studied using differential scanning calorimetry (DSC). Dissolution rates were studied using small cup method (CHP XC III). The solubility of TS IIA with the solid dispersions and pure drug form were determined by HPLC method.

RESULTThe DSC analysis suggested that TS IIA was dispersed as an amorphous form in the combination of PVPK30 and F68. Dissolution profile of the prepared solid dispersions could be described by Weibull equation (R>0.99). For tested three carries, Td value (calculated time to 63.2% of total drug release according to Weibull equation) were (90.40 +/- 2.82) min, (204.5 +/- 8.20) min and (25.83 +/- 0.13) min, respectively. The PVPK30/F68-TS IIA solid dispersion resulted in a significant increase of TS IIA solubility compared with prepared PVPK30-TS IIA and F68-TS IIA solid dispersions (P<0.01).

CONCLUSIONAs compared to single use of PVPK30 or F68, the combination of PVPK30 and F68 improve the dissolution rate and solubility of TS IIA significantly in the prepared solid dispersions (P<0.01). The application of complex carriers in solid dispersion technology should be paid more attention to improvement of poorly soluble drugs dissolution in the future.

Diterpenes, Abietane ; Phenanthrenes ; chemistry ; Solubility ; Temperature

Objective:To assess the clinical effectiveness and safety of Omalizumab for treating pediatric allergic asthma in real world in China.Methods:The clinical data of children aged 6 to 11 years with allergic asthma who received Omalizumab treatment in 17 hospitals in China between July 6, 2018 and September 30, 2020 were retrospectively analyzed.Such information as the demographic characteristics, allergic history, family history, total immunoglobulin E (IgE) levels, specific IgE levels, skin prick test, exhaled nitric oxide (FeNO) levels, eosinophil (EOS) counts, and comorbidities at baseline were collected.Descriptive analysis of the Omalizumab treatment mode was made, and the difference in the first dose, injection frequency and course of treatment between the Omalizumab treatment mode and the mode recommended in the instruction was investigated.Global Evaluation of Treatment Effectiveness (GETE) analysis was made after Omalizumab treatment.The moderate-to-severe asthma exacerbation rate, inhaled corticosteroid (ICS) dose, lung functions were compared before and after Omalizumab treatment.Changes in the Childhood Asthma Control Test (C-ACT) and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) results from baseline to 4, 8, 12, 16, 24, and 52 weeks after Omalizumab treatment were studied.The commodity improvement was assessed.The adverse event (AE) and serious adverse event (SAE) were analyzed for the evaluation of Omalizumab treatment safety.The difference in the annual rate of moderate-to-severe asthma exacerbation and ICS reduction was investigated by using t test.The significance level was set to 0.05.Other parameters were all subject to descriptive analysis.A total of 200 allergic asthma patients were enrolled, including 75.5% ( n=151) males and 24.5% ( n=49) females.The patients aged (8.20±1.81) years. Results:The median total IgE level of the 200 patients was 513.5 (24.4-11 600.0) IU/mL.Their median treatment time with Omalizumab was 112 (1-666) days.Their first dose of Omalizumab was 300 (150-600) mg.Of the 200 cases, 114 cases (57.0%) followed the first Omalizumab dosage recommended in the instruction.After 4-6 months of Omalizumab treatment, 88.5% of the patients enrolled ( n=117) responded to Omalizumab.After 4 weeks of treatment with Omalizumab, asthma was well-controlled, with an increased C-ACT score [from (22.70±3.70) points to (18.90±3.74) points at baseline]. Four-six months after Omalizumab administration, the annual rate of moderate-to-severe asthma exacerbation had a reduction of (2.00±5.68) per patient year( t=4.702 5, P<0.001), the median ICS daily dose was lowered [0 (0-240) μg vs. 160 (50-4 000) μg at baseline] ( P<0.001), the PAQLQ score was improved [(154.90±8.57) points vs. (122.80±27.15) points at baseline], and the forced expiratory volume in one second % predicted (FEV 1%pred) was increased [(92.80±10.50)% vs. (89.70±18.17)% at baseline]. In patients with available evaluations for comorbidities, including allergic rhinitis, atopic dermatitis or eczema, urticaria, allergic conjunctivitis and sinusitis, 92.8%-100.0% showed improved symptoms.A total of 124 AE were reported in 58 (29.0%) of the 200 patients, and the annual incidence was 0(0-15.1) per patient year.In 53 patients who suffered AE, 44 patients (83.0%) and 9 patients (17.0%) reported mild and moderate AE, respectively.No severe AE were observed in patients.The annual incidence of SAE was 0(0-1.9) per patient year.Most common drug-related AE were abdominal pain (2 patients, 1.0%) and fever (2 patients, 1.0%). No patient withdrew Omalizumab due to AE. Conclusions:Omalizumab shows good effectiveness and safety for the treatment of asthma in children.It can reduce the moderate-to-severe asthma exacerbation rate, reduce the ICS dose, improve asthma control levels, and improve lung functions and quality of life of patients.