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OBJECTIVE@#To observe the clinical efficacy of Miao medicinal crossbow acupuncture therapy as adjuvant treatment for lung cancer pain based on oxycodone hydrochloride extended-release tablet.@*METHODS@#A total of 60 patients with lung cancer pain were randomized into an observation group (30 cases, 1 case dropped off) and a control group (30 cases). In the control group, oxycodone hydrochloride extended-release tablet was given orally, 10 mg a time, once every 12 hours. On the basis of the treatment in the control group, Miao medicinal crossbow acupuncture therapy was applied once every other day in the observation group. The treatment of 14 days was required in the two groups. Before and after treatment, the numerical rating scale (NRS) score, number of break-out pain and Karnofsky performance status (KPS) score were observed in the two groups. The equivalent oxycodone consumption and rate of adverse reactions were recorded, the analgesic effect was evaluated in the two groups.@*RESULTS@#Compared before treatment, the NRS scores and number of break-out pain were decreased while the KPS scores were increased after treatment in the two groups (P<0.01). After treatment, the NRS score and number of break-out pain in the observation group were lower than the control group (P<0.01), the KPS score in the observation group was higher than the control group (P<0.05). The equivalent oxycodone consumption of whole course and the rate of adverse reactions i.e. constipation, drowsiness, nausea and vomiting in the observation group were lower than the control group (P<0.05). The analgesic effect rate was 93.1% (27/29) in the observation group, which was superior to 63.3% (19/30) in the control group (P<0.05).@*CONCLUSION@#On the basis of oxycodone hydrochloride extended-release tablet, Miao medicinal crossbow acupuncture therapy as adjuvant treatment can effectively relieve the pain degree, reduce the number of break-out pain and improve the health status and quality of life in patients with lung cancer pain, enhance the efficacy of medication and reduce its adverse reactions.
Subject(s)
Humans , Cancer Pain , Oxycodone , Quality of Life , Lung Neoplasms , Pain , Acupuncture Therapy , Adjuvants, Immunologic , Lung , AnalgesicsABSTRACT
OBJECTIVE: To investigate the effects of alcohol on release characteristics of metformin hydrochloride extended-release tablets in vitro and in vivo. METHODS: The release behaviors and swelling of self-made metformin hydrochloride extended-release tablets and commercial products Glucophage XR in different release media including water, 5% alcohol, 20% alcohol and 40% alcohol were investigated and similar factor method was used to evaluate the similarity of release. Based on results in vitro, water and the alcoholic medium with significant differences were selected for Beagle dogs experiments to investigate further the effects of alcohol on release characteristics of metformin hydrochloride extended-release tablets in vivo. RESULTS: Along with the increase of the alcohol concentration in the release media, both formation rate of the gel layer became slower and the penetration of the solvents became less in the swelling process, only dissolving a small amount of drug, so the release of self-made tablets and Glucophage XR gradually decreased in vitro. Both release in 40% alcohol produced a significant difference compared with that in water (f2<50), but the release of self-made tablets was greatly similar to Glucophage XR in the same media.In vivo studies of Beagle dogs revealed that an initial low release of both preparations was observed in 40% alcohol which was consistent with the vitro, while a certain increase was observed later, but the overall release was not statistically different from that of the water supply group. Moreover,the main pharmacokinetic parameters of the self-made tablets and Glucophage XR between the water-supply group and the 40% alcohol-supply group had no statistical difference. CONCLUSION: Alcohol has the same effects on the release characteristics of self-made metformin hydrochloride extended-release tablets and Glucophage XR in vitro and in vivo. High concentration of alcohol has a significant effect on the release characteristics in vitro, but it has no significant effect on the overall release in vivo.
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OBJECTIVE: To establish an LC-MS/MS method for the determination of levetiracetam to investigate the pharmacokinetics of levetiracetam extended-release tablets at fasted and fed states. METHODS: The separation was achieved on a Waters Symmetry C18 column (3.9 mm×150 mm, 5 μm) with mobile phase consisting of acetonitrile-5 mmol·L-1 ammonium acetate and 0.3% formic acid aqueous solution (10/90, V/V). Two subjects were randomly assigned to receive single oral dose of levetiracetam extended-release tablets 1 000 mg after being fasted and fed by a randomized crossover design. The plasma concentrations of levetiracetam were measured by LC-MS/MS. RESULTS: The calibration curve of levetiracetam in human plasma was linear over the concentration rang of 0.100 0-80.00 μg·mL-1. Under fasted and fed conditions, the main pharmacokinetic parameters of levetiracetam were as follows:ρmax were 20.50 and 19.09 μg·mL-1, AUC0-48 h were 345.4 and 336.3 μg·h·mL-1, tmax were 4.5 and 7.0 h, respectively. CONCLUSION: The method is proved to be convenient, accurate and sensitive, and suitable for the pharmacokinetic study of 1 000 mg levetiracetam extended-release tablets in healthy Chinese volunteers after being fasted and fed. The result suggests that high fat and calories diet has effect on the pharmacokinetics of levetiracetam extended-release tablets, with tmax being delayed.
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Objective To study the bioequivalence of two kinds of levetiracetam extended‐release tables including the ref‐erence product of Keppra XR in Beagle dogs .Methods Dogs were administrated orally with single dose of levetiracetam tablets (1 000 mg) .The concentration of levetiracetam in dog plasma was detected by LC‐MS/MS .All parameters of pharmacokinetics were performed by WinNonlin 5 .2 software .Results Main pharmacokinetic parameters of test and reference tablets were as follow :tmax were 1.67 h and 3 .0 h ,Cmax were 89 .50 μg/ml and 71 .18 μg/ml ,t1/2 were 3 .68 h and 3 .50 h ,AUC(0‐48) were 826 .57 μg?h/ml and 757 .84 μg?h/ml ,AUC(0‐∞ )were 826 .68 μg?h/ml and 757 .93 μg?h/ml .The relative bioavailability of test tablets was 109 .07% to reference products of Keppra XR .Conclusion Therefore ,the two kinds of levetiracetam extended‐release tablets were bioequivalent in Beagle dogs .
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OBJECTIVE: To develop a unified and discriminative method for the characterization of different diclofenac sodium extended release tablets. METHODS The flow-through cell method was employed to investigate the dissolution characteristics of all the samples at different flow rates and in different dissolution media. The dissolution data under the finally selected dissolution condition was also used to analyze the similarity of dissolution curves and statistical significance of Weibull parameters. RESULTS: The dissolution behaviors of the samples were not significantly influenced by flow rates in the selected range. The dissolution at a flow rate of 4 mL · min-1 and in hydrochloric acid (0.1 mol · L-1) for one hour followed by water for another seven hours was satisfactory to discriminate the samples, which was demonstrated by f2 and Weibull parameters analysis. CONCLUSION: This method can be used for dissolution tests of diclofenac sodium extended release tablet samples from the manufacturers in this study with meanings in guiding both comprehensive investigation on the dissolution of diclofenac sodium extended release tablets and quality improvement of generic drugs.