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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.
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OBJECTIVE: To study the in vitro dissolution and permeation process of montelukast sodium chewable tablets, and establish the in vivo-in vitro correlation models to predict the bioequivalence of the generic preparations. METHODS:The Macro Flux drug dissolution absorption test system was used, and the satiety intestinal simulated liquid ( pH 5. 0) was used as the medium to compare the penetration of the reference preparation and test preparation. The rate, release and absorption process of the drug were examined by the quality parameters, and the bioavailability of the test preparation was predicted, thereby predicting whether the preparation was bioequivalent. RESULTS: In the satiety small intestine simulating solution, the permeation rate, ρmax and AUC0-t of the test preparation and the reference preparation were basically the same. The bioavailability was approximately 97% of the reference formulation. CONCLUSION: It is preliminarily predicted that the test preparation of montelukast sodium chewable tablets is bioequivalent with the reference preparation.
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Objective To develop a new type of anti-fatigue nutrient chewable tablet and to explore its anti-fatigue effect in mice. Methods Ginseng polysaccharide, acanthopanax extract and taurine were mixed together in a proportion of 6 : 8 : 1 as remedium cardinale, mannitol was used as filler, sucrose as a correctant and magnesium stearate as a lubricant. Hardness, appearance and taste were utilized as score indexes, the dosage of mannitol, sucrose, and magnesium stearate were used as study factors. The orthogonal test was applied to screen the best proportion of raw materials to create the formulation according to the mouse behaviors. A total of 60 male mice were randomly divided into control group (normal saline) and three doses of Shenjia chewable tablet groups (200, 600 and 1 800 mg kg). Lavage administration was lasted for 7 days. We then carried out the weight loading swimming test to record the swimming lime of mice, and also recorded the body mass and the serum biochemical indexes, including adenosine triphosphate (ATP), lactic acid (Lac), free triiodothyronine (FT3). free thyroid hormone (FT4). cortisol and melatonin (MT). Results The formulation was optimized as 30% ginseng polysaccharide, 40% acanthopanax extract, 5% taurine. 19% mannitol, 5% sucrose, and 1. 0% magnesium stearate. The Shenjia chewable tablet tasted cool and sweet, round in shape, yellow in color and smooth in appearance. Compared with the control group, there were significant increases in the loaded-swimming time in the three doses groups (P<0. 01), in the levels of ATP, FT3, FT4 and MT in middle and high dosage groups (P<0. 05, P<0. 01), and in Lac level in high dosage group (P
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Objective To investigate the clinical efficacy and mechanism of montelukast sodium chewable tablet in the treatment of children with bronchial asthma.Methods A total of 180 children with bronchial asthma were selected from March 2015 to June 2016 in Suizhou Maternal and Child Health Hospital.The children were divided into montelukast group (n =120) and control group (n =60) according to the therapeutic method.The children in the control group were treated with conventional treatment,including budesonide atomization,expectorant,maintaining electrolyte and acid-base balance,anti-infective therapy,β-agonists and so on.The children in the montelukast group were treated with montelukast sodium chewable tablet on the basis of conventional treatment.The children in the two groups were treated for 14 days.The clinical effect,lung function and the levels of serum nuclear factor-κB (NF-κB) and interleukin-8 (IL-8) were compared between the two groups.Results There was no significant difference in serum NF-κB and IL-8 levels between the two groups before treatment (P ＞ 0.05).The levels of serum NF-κB and IL-8 after treatment were significantly lower than those before treatment in the two groups (P ＜ 0.05).The levels of serum NF-κB and IL-8 in the montelukast group were significantly lower than those in the control group (P ＜ 0.05).There was no significant difference in the forced expiratory volume in first second (FEV1),peak expiratory flow (PEF) and percentage of FEV1 to forced vital capacity (FEV1％) between the two groups before treatment (P ＞ 0.05).The FEV1,PEF and FEV1％ after treatment were significantly higher than those before treatment in the two groups (P ＜ 0.05).The FEV1,PEF and FEV1％ in the montelukast group were significantly higher than those in the control group after treatment (P ＜ 0.05).The total effective rate in montelukast group and control group was 95.83 ％ (115/120) and 71.67 ％ (43/60) respectively,the total effective rate in montelukast group was significantly higher than that in control group (x2 =6.989,P ＜ 0.05).The incidence of adverse reactions in montelukast group and control group was 10.83％ (13/120) and 11.67％ (7/60) respectively,there was no significant difference in the incidence of adverse reactions between the two groups (x2 =0.345,P ＞ 0.05).There was no serious adverse reaction in the two groups during the treatment.Conclusion Montelukast sodium chewable tablet can significantly reduce the respiratory tract inflammatory reaction,improve the lung function,improve the clinical symptoms and have better safety in children with bronchial asthma.
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OBJECTIVE:To establish a method for the determination of related substances in Levo-cetirizine hydrochloride chewable tablet. METHODS:RP-HPLC was performed on the column of Venusil XBP-CN with mobile phase of acetonitrile-0.05 mol/L Sodium dihydrogen phosphate solution(pH value adjusted to 3.0 by phosphoric acid)(60∶40,V/V)at a flow rate of 1.0 ml/min, the detection wavelength was 230 nm,column temperature was 25 ℃,and volume injection was 20 μl. RESULTS:Levo-cetirizine hydrochloride chewable tablet showed good separation with related substances;the linear range of levo-cetirizine hydrochloride was 1.2-2.8 μg/ml(r=0.999 9);the quantification limit and detection limit was 1.4 ng/ml and 0.3 ng/ml,respectively;RSDs of preci-sion,stability and reproducibility tests were lower than 1%;recovery was 96.3%-105.0%(RSD=1.7%,n=9);the contents of re-lated substances were no more than 0.17%. CONCLUSIONS:The method is simple,sensitive,reproducible,accurate and reli-able,and can be used for the determination of related substances in Levo-cetirizine hydrochloride chewable tablet.
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OBJECTIVE:To establish the quality standard for Anti-virus chewable tablet. METHODS:TLC was used for the qualitative identification of Forsythia suspensa,Anemarrhena asphodeloides and Pogostemon cablin in Anti-virus chewable tablet, and HPLC was conducted to determine the content of forsythin in F. suspensa. The column was Diamonsil C18 with mobile phase of acetonitrile- water (20∶80,V/V) at the flow rate of 1.0 ml/min,the detection wavelength was 230 nm,column temperature was 25℃,and injection volume was 10μl. RESULTS:The test sample and the reference sample displayed same color spots on the cor-responding position in TLC diagram. The linear range of forsythin was 0.053 5-2.675 μg(r=0.999 9);RSDs of precision,stabili-ty and reproducibility tests were no more than 1.74%;average recovery was 98.94%(RSD=1.84%,n=6). CONCLUSIONS:The method is simple,rapid,accurate,reliable and reproducible,and can be used for quality control of Anti-virus chewable tablet.
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OBJECTIVE:To establish the quality standard of Kouyanqing chewable tablet.METHODS: Flos Lonicerae Japonicae, Radix Scrophulariae and Radix Et Rhizoma Glycyrrhizae in the tablet were identified by TLC. The content of Chlorogenic acid was determined by HPLC. The chromatographic separation was performed on Hypersil ODS column (150 mm?4.6 mm,5 ?m) with mobile phase consistd of methanol-0.8%phosphoric acid solution(19∶81) with a flow rate of 0.8 mL?min-1. The detection wavelength was set at 327 nm. RESULTS: The TLC spots were clear and concentrated. There was a good linear relationship for Chlorogenic acid within the range of 11.3～101.7 ?g?mL-1(r=0.999 1). The average recovery was 99.04%(RSD=1.31%,n=9). CONCLUSION: This method is sensitive, accurate, reproducible and specific, and it can be used for the quality control of Kouyanqing chewable tablet.