ABSTRACT
Enteric-soluble soft capsule is a kind of new preparation that does not disintegrate in the stomach ，but releases rapidly in the intestinal tract to play a pharmacodynamic role. It has the unique advantages of improving drug stability ，reducing drug irritation ，delivering drugs directionally to the intestinal tract ，and prolonging drug action time. In this paper ，the decomposition and release mechanism ，application advantages ，classification of enteric-soluble coating materials and preparation methods of enteric-soluble soft capsule are sorted and summarized ，in order to provide reference for further development of this type of preparation.
ABSTRACT
Objective:To evaluate the accuracy of serum surfactant protein concentration in predicting postoperative pulmonary complications (PPCs) in the patients at moderate risk for PPCs undergoing abdominal surgery.Methods:Fifty-eight patients of both sexes, with the predicted ARISCAT score of 26-44 points, scheduled for elective abdominal gastrointestinal surgery, were studied.Central venous blood samples were collected before operation (T 0), at 30 min after extubation (T 1) and at 1 day after surgery (T 2) for determination of serum surfactant protein A (SP-A) and surfactant protein B (SP-B) in serum by enzyme-linked immunosorbent assay.The occurrence of PPCs during the postoperative hospitalization was recorded.The patients were divided into PPCs group and non-PPCs group according to whether PPCs occurred. The receiver operating characteristic curve was used to analyze the accuracy of serum SP-A and SP-B concentrations in predicting PPCs. Results:Compared with the baseline value at T 0, the serum SP-B concentrations were significantly increased at T 1 in group PPCs, and the concentrations of serum SP-A and SP-B were significantly decreased at T 2 in both groups ( P<0.05). The concentrations of serum SP-A and SP-B were significantly decreased at T 2 than at T 1 in both groups ( P<0.05). Compared with non-PPCs group, the serum concentrations of SP-A at T 0 and SP-B at T 1 were significantly increased in group PPCs ( P<0.05). The area under the receiver operating characteristic curve of serum SP-B concentrations in predicting PPCs at T 1 was 0.908 (95% confidence interval 0.821-0.996), and the cut-off value was 26.3 ng/ml, sensitivity 0.90, and specificity 0.81. Conclusion:The accuracy of serum SP-B concentrations measured at 30 min after extubation in predicting PPCs is higher in the patients at moderate risk for PPCs undergoing abdominal surgery.
ABSTRACT
OBJECTIVE： To extablish the method for blood concentration determination of mitoxantrone in rats， and to study the pharamokinetics of mitoxantrone in rats. METHODS： Totally 6 SD rats were collected and given mitoxantrone 5 mg/kg via tail vein. The blood samples 0.3 mL were collected before medication and 5， 10， 20， 40， 60， 120， 240， 480， 720 min after medication. Blood samples were placed in heparinized EP tube， and the plasma was centrifuged and separated. After adding silica gel， the plasma were ground and mixed well， then added into methanol solution containing 0.5 mol/L hydrochloric acid to precipitate protein. After grinding and mixing， the supernatant was centrifuged and dried with nitrogen and then dissolved with mobile phase. HPLC method was adopted to determine the plasma concentration of mitoxantrone. The determination was performed on ZORBAX SB-C18 column with mobile phase consisted of 20 mmol/L ammonium acetate （pH adjusted to 2.0 with hydrochloric acid）-methanol （65 ∶ 35， V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 244 nm， and column temperature was 30 ℃. The sample size was 20 μL. Pharmacokinetic parameters were calculated with DAS 3.0 software. RESULTS： The linear range of mitoxantrone were 200-10 000 μg/L （r＝0.999 6， n＝6）. The lower limit of quantitation was 200 μg/L， and the limit of detection was 150 μg/L， respectively. RSDs of intra-day and inter-day precision and stability were all lower than 8.0％ （n＝5， 3， 6， respectively）. The extraction recoveries were （85.64±3.93）％-（92.31±1.68）％ （n＝3）. The recoveries of accuracy test were （93.58±1.42）％-（113.92±2.74）％ （n＝3）. The pharmacokinetic parameters of mitoxantrone were as follows as AUC0-720 min was （5 247.1±474.6.0） μg·h/L； t1 /2z was （24.88±6.94） h； CLZ was （0.46±0.09） L/（h·kg）； Vz was （11.07±2.64） L/kg. CONCLUSIONS： The method has recovery and good repeatability， and is suitable for the determination of blood concentration of mitoxantrone and its pharmacokinetic research.