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Objective To establish a high performance liquid chromatography(HPLC)method for the determination of disodi-um edetate(EDTA-2Na)in nalmefene hydrochloride injection. Methods Content of EDTA-2Na in nalmefene hydrochloride injection was determined by HPLC. C18 Column was used. The mobile phase consisted of 0.3%tetrabutylammonium hydroxide solution-water-acetonitrile(20:45:35)with a flow rate of 1.0 ml/min,and the detection wavelength was 254 nm. The column temperature was 30℃and the injection volume was 20μl. Results The quantification limit and detection limit were 0.199 and 0.060μg/ml,respectively;the linear equation for the disodium edetate was Y=10.125X-0.216,and the calibration curves were linear within the range of 2.4593~7.3780 μg/ml(r=1.000). Each concentration of the average recovery was between 98~102%(n=9)(RSD%=0.58%). Conclusion The method can be used for the determination of EDTA-2Na in nalmefene hydrochloride injection,which is convenient,fast,sensitive and reproducible,with good precision,specificity and accuracy.
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Objective To compare the release rate and bioavailability of progesterone injection with different particle sizes. Methods The preparation of progesterone nano sized injection and micron sized injection were performed by power X-ray diffraction (PXRD)and Fourier trensform infrared spectooscory(FTIR). The dissolution rate of two preparations and progesterone was compared by dialysis Method. HPLC-MS method was used to determine the progesterone concentration of plasma in rats after intramuscular injec-tion of different preparations,and the main pharmacokinetic parameters were calculated and analyzed statistically. Results Based on the analysis of PXRD and FTIR,there were no crystal structure changes between the two preparations and progesterone. The complete release of progesterone nano sized injection and micron sized injection required 2 and 4 h in the PBS solution,respectively,while the release of progesterone required nearly 40 h. In the pharmacokinetic experiment,compared with progesterone injection,the Cmax of pro-gesterone nano sized injection and micron sized injection were increased by 1.8 and 1.7 times,respectively;the AUC0-t were increased by 2.95 and 1.63 times,respectively. The bioavailability of both was higher than that of progesterone injection. Conclusion The re-lease rate bioavailability of progesterone nano sized injection and micron sized injection is higher than that of progesterone and proges-terone injection. Bioavailability of progesterone nano sized injection is higher than that of progesterone micron sized injection.
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Objective To prepare naloxone hydrochloride nasal spray and evaluate the ciliotoxicity and pharmacokinetics of the formulation. Methods The stability of naloxone hydrochloride was studied in pH3.5-5.5. Penetration promoting effects of absorp-tion enhancers on the naloxone hydrochloride were evaluated. Nasal ciliotoxicity studies were carried out using isolated toad palate. Rats were treated with naloxone hydrochloride solution by intramuscular injection of nasal drops to evaluate the pharmacokinetics. Results Naloxone hydrochloride solution was stable in pH3.5-5.5. Disodium ethylenediaminetetraacetic acid(0.2%,W/V)had the best penetration promoting effect on naloxone hydrochloride. Naloxone hydrochloride nasal spray did not exhibit obvious nasal ciliotox-icity compared to the negative control. The nasal spray had a faster therapeutic effect and its bioavailability was similar to that of the in-tramuscular injection. Conclusion Naloxone hydrochloride nasal spray prepared in this research is stable with no obvious nasal cilio-toxicity,has faster therapeutic effect,and good bioavailability,so may have a broad application prospect.
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Objective To develop a HPLC method for determining the dissolution of desogestrel and ethinylestradiol tablets. Methods The dissolution was determined by the second method described in Chinese Pharmacopoeia(ChP)2015. In total 500 ml of 0.05%sodium lauryl sulfate solution was used as dissolution media,and the rotation speed was 50 r/min. The dissolution time was 30 min and the dissolution was determined by HPLC. The HPLC column was Agilent SB C18 column(150 mm×4.6 mm,5μm). The mobile phase:acetonitrile as mobile phase A,acetonitrile-water(50∶50,V/V)as mobile phase B with gradient elution. The flow rate was 1 ml/min. The detection wavelength of desogestrel and ethinylestradiol was 210 nm. The column temperature was 40℃and the injection volume was 100μl. Results The average recoveries were 99.68%for desogestrel and 99.40%for ethinylestrsdiol,and the stability of work?ing solutions was acceptable in 12 h. The calibration curves were linear within the range of(0.06-0.36)μg/ml(r=0.9999)for desoges?trel,(0.012-0.072)μg/ml(r=0.9999)for ethinylestradiol,respectively. Conclusion The method is convenient and precise in the dis?solution determination of desogestrel and ethinylestradiol tablets.
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Objective To prepare paliperidone palmitate injection,establish the testing method for its release rate,and vali?date the methodology. Methods Wet grinding was used to prepare paliperidone palmitate injection,high performance liquid chroma?tography was adopted to establish release rate detection,and validate its methodology. Results The average particle diameter of home-made agent was about 1μm,and it was an irregular bulk observed under transmission electron microscope;the precision of es?tablished release rate detection was 1.5%,recovery rate was 100.70%and stability RSD was 0.33%. The average release rate in vitro of home-made agent in three batches was:8.00%in 1.5min,62.26%in 20 min,and 85.44%in 45 min. Conclusion The particle size distribution and release rate of prepared sustained-release injection are consistent with those of original research,and the testing method of release rate is simple,sensitive and accurate,which could effectively monitor the product quality. The average release rates of agent in three batches are within the scope of quality standards.
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Objective To determin the dissolution of testosterone undecanoate capsule in vitro with an established HPLC method. Methods The dissolution was determined by the second method described in China(ChP)2015,Pharmacopoeia. Totally 900 ml of 0.25%sodium lauryl sulfate solution with pH 6.8 phosphate buffer were used as dissolution media,and the rotation speed was 75 r/min. The dissolution time was 120 min and the dissolution was determined by HPLC. The HPLC column was phenomenex@C18 column(250 mm×4.6 mm,5μm). The mobile phase was 2-propanol-acetonitrile-water(45∶45∶10,V/V/V)with a flow rate of 1.0 ml/min and the detection wavelength of 240 nm. The column temperature was 40℃and the injection volume was 20μl. Results The average recovery of the method was about 100.55%(n=9). The calibration curves showed good linearity(r2=0.9999,n=7)within ranges of 1-50μg/ml. Conclusion The method is convenient and sensitive in the dissolution determination of testosterone undecanoate capsule.
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Objective To establish a high performance liquid chromatography(HPLC)method for determining the content and dissolution of soluble guanylate cyclase(sGC)-003 tablets. Methods Content and dissolution of sGC-003 tablets were deter?mined by HPLC. Phenomenex Luna C18 column(250 mm×4.6 mm,5μm)was used. The mobile phase was acetonitrile-water(40∶60,V/V), with a flow rate of 1.0 ml/min,and the detection wavelength was set at 214 nm. The column temperature was 40℃and the injection volume was 20μl(injection volume of dissolution was 80μl). Dissolution of sGC-003 tablets was determined by the second method described in Chinese Pharmacopoeia(ChP)2015. 900 ml of pH 4.5 acetic acid buffer,pH 6.8 phosphoric acid buffer and water were used as dissolution media at the rotation speeds of 50 and 75 r/min to select the dissolution condition. Results This method had high specificity. The average recovery was about 99.58%(RSD=0.75%,n=9). And the working solution was stable within 12 h. The calibra?tion curves were had good linearity(R2=1)within the concentration range of 0.25-50μg/ml. The method of dissolution tests for sGC-003 tablets was established that 900 ml pH 6.8 phosphoric acid buffer was used as dissolution medium and paddle rotation speed was 50 r/min. The dissolution would be 80%at 30 min. Conclusion The dissolution condition can be used to determine the dissolution of sGC-003 tablets. The HPLC method is convenient,fast,sensitive and accurate in determining the content and dissolution of sGC-003 tablets.
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The etiology of depression is complex, and its incidence is related to many factors, such as social factors, genetic factors, endocrine and central nervous system functions. Antidepressant treatment effect by affecting one or more factors of the depression regulation system. This paper, based on the various hypotheses on the pathogenesis of depression proposes that the depression pathogenesis may involve central monoamine neurotransmitter systems, neural nutrients, neuro-endocrine system, nervous system and the immune system, and central nervous system tissue morphology changes, and summarizes the antidepressant drug research progress.
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Objective To establishe an HPL C method to determine the dissolution of progesterone nanocrystal capsule. Methods The dissolution was determined by the first method described in Chinese pharmacopoeia (ChP) 2010. Totally 900 ml of 0.25% sodium lauryl sulfate solution were used as dissolution media, and the rotation speed was 75 r/min. The dissolution time was 45 min and the dissolution was determined by HPLC. The HPLC column was Agilent TC C18 column (150 mm×4.6 mm,5μm). The mobile phase was methanol-acetonitrile-water (35∶40∶25,V/V/V), with a flow rate of 1.0 ml/min and the detection wavelength of 241 nm. The column temperature was 25℃and the injection volume was 20 μl. Results The average recovery of the method was about 100.02%(n=15 ), and the stability of working solutions was acceptable in 24 h (RSD=0.92%,n=8). The calibration curves showed good linearity (r=1,n=6) within ranges of 2.78-66.7 μg/ml. Conclusion The method is convenient and sensitive in the dissolution determination of progesterone nanocrystal capsule.
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Objective To establish an HPLC method for the determination of metoclopramide (MCP) and its related substances in MCP nasal spray .Methods Chromatographic separation was performed on an Agilent TC-C18 column (250 mm ×4.6 mm,5 μm) using acetonitrile and phosphate buffer solution (0.05 mol/L potassium dihydrogen phosphate solution, added with 5 ml of triethylamine and adjusted to pH 4.0 with phosphoric acid)(19∶81) as the mobile phase at 1.0 ml/min.The detection wavelength was 275 nm and the column temperature was set at 30℃.Results and Conclusion Related substances were completely separated from MCP .For MCP,the linearity of determination was over the range of 10-200 μg/ml and the recovery of the method ranged from 100.3%to 101.6%.The relative standard deviation was 0.68%(n=9).The method is accurate, reliable, repeatable, and could be readily utilized as a quality control method for MSP nasal spray .
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Objective To establish a method for determination of the content and related substances in caffeine chewable tablets. Methods Agilent TC - C18 column(250 mm×4.6 mm;5μm)was used. The mobile phase was methanol- sodium dihydrogen phosphate buffer solution(10mmol/L,adjusted to pH 3.0 with phosphoric acid )(75:25,V/V),with a flow rate 1.0 ml/min,and the detection wavelength was 273 nm. The column temperature was 30℃ and the injection volume was 20 μl. Results The calibration curves showed good linearity(r=1,n=7)within ranges of 1-400 μg/ml. The average recovery of the method was about 100.04%(RSD=0.12%,n=9),and the stability of working solutions was acceptable in 24 h (RSD=1.07%,n=8). Conclusion The results indicated that the developed method could be readily utilized as a method for the quality control,including contents determination, intermediate products and stability study.
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Objective To establish a simple, feasible and precise quality control method for the determination of contents and related substances of demethyl levophencynonate hydrochloride (L-LPC)tablets.Methods The mobile phase consisted of methanol,acetonitrile and sodium acetate buffer solution(pH 5.0),at a ratio of 4∶3∶3,at a flow rate 1.0 ml/min and a detection wavelength of 220 nm.Samples were injected 100 μl and determined at room temperature.Results The calibration curves showed good linearity (R2 =1) within the test range of 0.1-50μg/ml.The recovery of the method was about (100.15 ±0.73)%, and the stability of working solutions was acceptable in 8 h (RSD=0.36%).Conclusion The results indicated that the developed method can be readily used as a quality control method.
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OBJECTIVE:To Evaluate the characteristics of national essential drugs on the view of pharmaceutics.METHODS:Referring to related literatures,the characteristics of national essential medicines were analyzed and summarized on the basis of pharmaceutics.The national essential drugs list was compared with that of WHO's.RESULTS:In the equipment part of primary healthy care institution national essential drugs list (2009 edition),chemical and biological medicines had 205 species which included 270 formulations,were classified as 21 kinds of dosage forms.Chinese traditional medicines had 102 species which included 188 formulations,were classified as 13 kinds of dosage forms.The ration of the amount of dosage forms to species is 1.49,a little higher than WHO(1.31) now.CONCLUSION:The dosage forms of national essential drugs were abundant and enable to meet the clinical requirement.But should optimize the breed and add in many species of dosage form to satisfy the needs of medicines useage from urban to rural.