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Fentanyl buccal tablets place the tablet at the buccal site (above a rear molar, between the upper cheek and gum) and wait until it dissolves, but some patients may not be able to retain it due to defects of the maxillary molars. The aim of this study was to evaluate the effectiveness and safety of fentanyl buccal tablets when they were used outside the buccal site. Seven patients were treated with fentanyl buccal tablets outside the buccal site. For each of 5 episodes in which effective dose was identified, were investigated to average pain intensity assessed on a 0 to 10 numerical rating scale at 30 min postadministration and reduction in pain intensity of more than 33%. Pain intensity significantly decreased at 30 min postadministration in 5 patients with effective doses identified (p<0.001). In 92.0% of episodes treated, there was a reduction in pain intensity of more than 33%. Adverse events were somnolence and nausea with mild. However, these effects did not result in discontinuation of medication. Our findings suggested that fentanyl buccal tablets can be used effectively and safely even when patients used outside the buccal site.
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The taste is the key to the research and design for formulation prescription of traditional Chinese medicine buccal tablets( TCMBTs). TCMBTs are dissolved in the oral cavity in parallel with the release of the drug,providing a sufficient " time window" for the perception of various basic taste,tactile and retention. The overall taste is the result of competitive inhibition,comprehensive superposition and dynamic change of multiple tastes. Traditional evaluation methods rely mostly on recalled experience score,difficult to reflect the dynamic changes of taste for buccal tablets. Therefore,it is urgent to establish a new optimized model for taste evaluation and formulation prescription according to the formulation characteristics of TCMBTs. To this end,this paper proposed for the first time to construct a research method for the optimal formulation of TCMBTs based on temporal dominant description of sensations combined with multivariate statistical analysis: the sensory test of volunteers was carried out by temporal dominant description analysis method,and elements separation was conducted for the time and taste in the process of inclusion to form a temporal dominant descriptive score of multi-time points and multi-sensory attributes. Finally,the optimal formulation was obtained by multivariate statistical analysis. Taking the formulation prescription of Compound Caoshanhu Buccal Tablets as an example,the research ideas of this method were explained,and the optimal formulation prescription was obtained as follows,Glabrous Sarcandra Extract of 20. 0 g,mannitol of 24. 0 g,microcrystalline cellulose of 12. 0 g,aspartame of 1. 0%,menthol of 0. 7%,and menthol oil of 0. 7%. This study provides a new method for the taste evaluation and formulation research of TCMBTs,providing a new idea for the fine manufacturing and innovative development of TCM buccal tablets in the new era.
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Humans , Drug Compounding , Medicine, Chinese Traditional , Sensation , Solubility , Tablets , TasteABSTRACT
Objective:To prepare Lycii Fructus polysaccharide buccal tablets and investigate its immunomodulatory effect. Method:Taking the appearance, taste, hardness and disintegration time of the tablets as comprehensive evaluation index, based on single factor tests, central composite design-response surface methodology was adopted to optimize the prescription of Lycii Fructus polysaccharide buccal tablets with mass ratio of dextrin to mannitol, mass ratio of cyclamate to malic acid and dosage of sodium carboxymethyl starch (CMS-Na) as factors. Kunming mice were randomly divided into 5 groups, namely the Lycii Fructus polysaccharide buccal tablets low (100 mg·kg-1·d-1), medium (200 mg·kg-1·d-1) and high (300 mg·kg-1·d-1) dose groups, the normal group (0.9% normal saline, 300 mg·kg-1·d-1) and the positive medicine group (Cinengsu group, 300 mg·kg-1·d-1). The immunomodulatory effect of the buccal tablets were investigated by calculating immune organ index, monocyte-macrophage phagocytic index, serum hemolysin antibody level, and the voix pedis thickness difference of delayed hypersensitivity (DTH) of mice. Result:Optimal prescription for the buccal tablets was 80% of Lycii Fructus extract, 11.5% of dextrin-mannitol (1.2:1), 1% of cyclamate-malic acid (1:1), 0.5% of cream essence, 6.5% of CMS-Na, 0.5% of magnesium stearate, and appropriate amount of 80% ethanol. Under the optimal condition, the hardness of the buccal tablets was 11.83 kg, its disintegration time was 13.21 min, both of which were in line with the relevant provisions of the 2015 edition of Chinese Pharmacopoeia, and the buccal tablets had good appearance and taste. Compared with the normal group, medium and high dose groups of Lycii Fructus polysaccharide buccal tablets significantly increased thymus index, spleen index and phagocytic index of mice (PPPPPConclusion:The formulation process of the buccal tablets optimized by central composite design-response surface methodology is stable and feasible, and Lycii Fructus polysaccharide buccal tablets can improve the immune regulation function of normal mice, and this study can provide experimental basis for the development, utilization and clinical application of Lycii Fructus and Lycii Fructus polysaccharides.
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OBJECTIVE： To study the improvement effects of Lanqian buccal tablets on scopolamine-induced learning and memory impairment of mice. METHODS： The mice were randomly divided into blank group （normal saline）， model group （normal saline）， positive group （Donepezil hydrochloride tablets， 1.52 mg/kg） and Lanqian buccal tablets high-dose， medium-dose and low-dose groups （800， 400， 200 mg/kg）， with 14 mice in each group. Once a day， 30 days after continuous intragastric administration， except for blank group， other groups were intraperitioneal injected scopolamine hydrobromide 3 mg/kg to induce learning and memory impairment model. After modeling， the learning and memory ability of mice were evaluated with step through test （latency， mistake times of entering darkroom as indexes） and Morris water maze （the time of going up on the platform， the times of crossing the platform， swimming time in target quadrant as indexes）. The levels of Ach， ChAT， AchE， SOD and MDA in cerebral tissue of mice were determined. RESULTS： Compared with blank group， latency， the times of crossing the platform， swimming time in target quadrant， the levels of ChAT， Ach and SOD were shortened or decreased significantly in model group （P＜0.05 or P＜0.01）， while mistake times of entering darkroom， the time of going up on the platform， the levels of AchE and MDA were extended or rised significantly （P＜0.01）. Compared with model group， latency （except for Lanqian buccal tablet low-dose group）， the times of crossing the platform， swimming time in target quadrant， the levels of ChAT， Ach and SOD were extended or rised significantly in positive group and Lanqian buccal tablet groups （P＜0.05 or P＜0.01）. The mistake times of entering darkroom （except for Lanqian buccal tablet low-dose group）， the time of going up on the platform （except for Lanqian buccal tablet low-dose group） and the levels of AchE and MDA （except for Lanqian buccal tablet medium-dose and low-dose group） were shortened or decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS： Lanqian buccal tablet can improve scopolamine-induced learning and memory impairment of mice by increasing the levels of ChAT， Ach and SOD and decreasing the levels of AchE and MDA.
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OBJECTIVE： To establish a method for quality control of Peony pollen buccal tablets， and to provide reference for the formulation of quality standard. METHODS： TLC method was used for qualitative identification of paeoniflorin， kaempferol and luteolin in Peony pollen buccal tablets according to 2015 edition of Chinese Pharmacopeia （part Ⅳ）. The contents of paeoniflorin and oxypaeoniflorin in Peony pollen buccal tablets were determined by dual-wavelength HPLC method [The determination was perform on Agilent TC-C18 column with mobile phase consisted of acetonitrile （A）-0.1％ phosphoric acid solution （B） with gradient elution at the flow rate of 1.0 mL/min. The detection wavelength was set at 230 nm for paeoniflorin and 258 nm for oxypaeoniflorin. Sample size was 20 μL]. RESULTS： TLC identification of paeoniflorin， kaempferol and luteolin showed that the same color characteristic spots of control chromatogram appeared in the corresponding positions of sample chromatogram without interference from negative samples. The linear range of paeoniflorin and oxypaeoniflorin were 7.2-86.4 μg/mL and 2.72-32.64 μg/mL（r≥0.999 7），respectively. The average recoveries were 99.12％ and 98.65％， and RSD were 1.54％ and 2.53％（n＝6），respectively. RSDs of precision （n＝6）， stability （n＝8） and reproducibility （n＝6） tests were all lower than 3.0％. CONCLUSIONS： The method is simple and reproducible， and can be used for quality control of Peony pollen buccal tablets.
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Objective To explore the differences in the pharmacokinetics of Glutathione Buccal Tablets and tablets. Methods 20 volunteers received pharmacokinetic experiments, using single dose crossover parallel mode of administration, the HPLC method for the determination of plasma concentration time parameters to evaluate the pharmacokinetics. Results The difference was statistically significant the blood concentration of subjects after taking 0.25 to 5 h during the same time point of two forms of group, GSH tablet drug stability is better than that of GSH (P<0.05). GSH tablets into tablets Cloth (t1/2) 1.56 h, the half-life was significantly lower than that of GSH (P<0.05). GSH tablets tablets glutathione concentration peak time (tmax) of 1.75h was significantly higher than that of GSH (P<0.05) GSH tablets, tablets of glutathione concentration peak (Cmax) of 11.077, significantly higher than that of GSH tablets (P<0.05). Conclusion The peak plasma concentration of GSH tablets higher. Reach the peak concentration time and time longer, the pharmacokinetics of GSH tablets is better than that of GSH tablet, which has broad application prospect.
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Objective To explore the differences in the pharmacokinetics of Glutathione Buccal Tablets and tablets. Methods 20 volunteers received pharmacokinetic experiments, using single dose crossover parallel mode of administration, the HPLC method for the determination of plasma concentration time parameters to evaluate the pharmacokinetics. Results The difference was statistically significant the blood concentration of subjects after taking 0.25 to 5 h during the same time point of two forms of group, GSH tablet drug stability is better than that of GSH (P<0.05). GSH tablets into tablets Cloth (t1/2) 1.56 h, the half-life was significantly lower than that of GSH (P<0.05). GSH tablets tablets glutathione concentration peak time (tmax) of 1.75h was significantly higher than that of GSH (P<0.05) GSH tablets, tablets of glutathione concentration peak (Cmax) of 11.077, significantly higher than that of GSH tablets (P<0.05). Conclusion The peak plasma concentration of GSH tablets higher. Reach the peak concentration time and time longer, the pharmacokinetics of GSH tablets is better than that of GSH tablet, which has broad application prospect.
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OBJECTIVE:To observe analgesic effect and safety of Shixin buccal tablets on pericoronitis of wisdom tooth. METHODS:120 patients with pericoronitis of wisdom tooth were randomly divided into control group and observation group with 60 cases in each group. Control group received periodontal pocket irrigation combined with metronidazole;observation group was additionally given Shixin buccal tablets on the basis of control group,1 tablet/time,4 times/d. Clinical efficacy,medication compli-ance,pain score and ADR were compared between 2 groups. RESULTS:The effective rate of observation group(95.00%)was sig-nificantly higher than that of control group(73.33%),with statistical significance(P0.05);the pain score of observation group was significantly lower than that of control group,with statistically significant difference(P<0.05). No serious ADR was found in 2 groups. CONCLUSIONS:Shixin buccal tablets significantly alleviate the pain caused by pericoronitis of wisdom tooth.
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Objective:To prepare old tea buccal tablets using wet granulation method and optimize the preparation technology. Methods:The amount of each adjuvant was studied by single factor experiments, and the formula of the buccal tablets was optimized by the orthogonal experiments using taste and disintegration time as indices. Results:The optimal formula was composed of old tea ex-tract 30 g,mannitol 60g,PEG6000 20 g,aspartame 10 g,citric acid 10 g and menthol crystal 1 g. All the tested indices including ap-pearance, hardness and disintegration time met the requirements described in Chinese pharmacopeia. Conclusion: The preparation technology is reasonable and feasible for the industrial production.
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To prepare oroxylum indicum ( OLI) buccal tablets. Methods:The extract of oroxylum indicum as the main component, the buccal tablets were prepared using a wet granulation compression method. According to the results of single factor ex-periments, an orthogonal design was used to select the optimal formula based on the appearance, taste, disintegration time and friabili-ty. The average weight variation and average disintegration time were tested to evaluate the quality of three batches of the buccal tablets with the optimized formula. Results:The optimal formula was composed of 50%mannitol, 5%sucrose-stevioside (100∶1), 5% pep-permint oil and 35%PVP-K30-85% ethanol (6∶10). For the three batches of the buccal tablets with the optimized formula, the aver-age weight variation was (1. 83 ± 0. 29) % and the average disintegration time was(14. 7 ± 0. 6) min, which met the requirements of quality control on buccal tablets in Chinese pharmacopoeia. Conclusion:The optimal formula and process of OLI buccal tablets show fine reproducibility and stability.
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Objective To establish a method for the determination of hesPeridin and cinnamaldehyde in siweiqing buccal tablets. Methods A high Performance liquid chromatograPhy ( HPLC) method was established. The chromatograPhic conditions were as follows: the chromatograPhic column Inertsil ODS_SP ( 4. 6 mmí150 mm, 5 μm ) with the mixture of acetonitrile and water as mobile Phase in gradient mode,the detection waVelength of 290 nm,the flow rate of 1. 0 mL·min-1 ,the column temPerature of 30℃,the theoretical Plate number no less than 3 000. Results The linear relationshiP between content and Peak area was obtained in the range of 0. 025-0. 500 μg for cinnamaldehyde and 0. 10-2. 00 μg for hesPeridin. RSD of the Peak area of cinnamaldehyde and hesPeridin for the Precision test,the stability test and the rePeatability test were 1. 16%and 1. 03%,1. 27%and 1. 08%,1. 23%and 1. 28%,resPectiVely. The aVerage recoVery of cinnamaldehyde was 99. 24%with RSD of 1. 65%(n=9). The aVerage recoVery of hesPeridin was 99. 39%with RSD of 1. 85%(n=9). Conclusion The method can be aPPlied to quantitatiVe assay of cinnamaldehyde and hesPeridin in siweiqing buccal tablets with good reProducibility and sPecificity. The recoVery result met the accePtance criteria. The method can effectiVely control the quality of siweiqing buccal tablets with good sPecificity,reProducibility and stability,and can be aPPlied to the quality control of siweiqing buccal tablets.
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Objective:To investigate the effects of cetylpyridinium chloride buccal tablets(CCBT)on dental plaque control.Meth-ods:60 patients with gingivitis,mild or moderate,or chronic periodontitis were divided into control group(without drug treatment), CCBT group (treated with CCBT)and CHX group (treated with compound chlorhexidine gargle)according to the randomized con-trolled single-blind principle.Quigley-Hein plaque index (PI)and bleeding index (BI)of the subjects were recorded,tumor necro-sis factor (TNF-α)and interleukin (IL-1β)in gingival crevicular fluid (GCF)were measured by ELISA before and after 2 weeks'trial.Results:After 2-week treatment,PI and BI in CCBT and CHX groups decreased(P0.05). In control group PI was decreased(P005).Conclusion:CCBT is effective in inhibiting plaque accumulation and decreasing GCF TNF-αlevel.
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OBJECTIVE: To optimize the formulation and manufacturing process of Dendrobium officinale buccal tablets. METHODS: Dendrobium officinale buccal tablets was prepared by ethanol granulating method. The formulation and manufacturing process were optimized by using orthogonal design with dissolution rate, qualified rate of tableting, the flowability of granules, and the taste of the tablets as indices. RESULTS: The optimized formulation contained Dendrobium, officinale powder, mannitol, microcrystalline cellulose, glucosum anhydricum, and sodium carboxymethyl starch in the ratios of 2:1:2:0.3:0.16. The granulation was performed with ethanol at an amount of 60% of inventory. The products showed rapid dissolution rate, stable quality, and good shape and taste. CONCLUSION: The optimized formulation and manufacturing process are successful to prepare Dendrobium officinale buccal tablets.
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OBJECTIVE:To establish the quality standard of Compound niubangzi buccal tablets.METHODS:Lonicerae japonica and Paeonia suffruticosa in the formulation were identified by TLC,and the content of arctiin in the tablets was determined by HPLC.RESULTS:The TLC spots were clear,well-isolated and distinctive.The linear range of arctiin was 0.586～5.274 ?g(r=0.999 9)and its average recovery was 98.94%(RSD=1.68%,n=9).CONCLUSION:The established quality standard can be used for the quality control of Compound niubangzi buccal tablets.
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AIM: To study the analgesic effect of qingyan lihou buccal tablets. METHODS: The analgesic effect in mice was observed by hot plate and body torsion induced by antimony potassium tartrate. RESULTS: The experiments proved that the buccal tablet could significantly raise pain threshold, prolonged the latency and reduced the writhe number per ten minutes of mice model by antimony potassium tartrate. CONCLUSION: Qingyan lihou buccal tablets show better analgesic effects.
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Objective To establish a HPLC method for the determination of galuteolin in Qingyan buccal tablets.Methods A Phenomenex luna C18 column served as stationary phase and the mobile phase was acetonitrile-0.5 %glacial acetic acid,gradient elution with the flow rate of 1 mL?min-1.The column temperature was 25 ℃and detection wavelength was 350 nm.Results A good linearity of galuteolin was in the range of 0.077 12 ?g～0.771 2 ?g and r=0.999 6.The average recovery of galuteolin was 101.35 %and RSD=1.58 %.Conclusion This method is simple,sensitive,accurate,and will provide evidence for the determination of galuteolin in compound preparations.
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AIM: To establish a method of determining the content of total saponin of Radix et Rhizoma Notoginseng in buccal tablets by HPLC. METHODS: Chromatographic conditions are as follows:Hypersil NH_2 column(4.6 mm?200 mm,5 ?m) as the stationary phase,acetonitrile-1% phosphate buffer solution(0-10 min,20:80;10-20 min,25:75;20-25 min,45:55;25-30 min,50:50) as the mobile phase,the velocity of flow is 1.0 mL/min,the temperature of coloum is 35(?C) and the detection wavelength is 203 nm. RESULTS: The HPLC method has good linearity in determining the total saponin of Radix et Rhizoma Notoginseng content,and we can detect four saponins at the same time,linear range,ginsenoside Rg1 0.093 75-6 ?g,ginsenoside Re 0.011 72-0.75 ?g,notoginsenoside R1 0.023 44-1.5 ?g and ginsenoside Rb1 0.140 6-9 ?g,the correlation coefficient r=0.999 9. CONCLUSION: The established method in this article is simple and convenient,with good reproductivity.We can detect four saponins in the total saponin of Radix et Rhizoma Notoginseng Buccal Tablets at the same time by this method.It can be used for quality control of the total saponin of Radix et Rhizoma Notoginseng Buccal Tablets.
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AIM: To establish the quality standard for Jixiangcao Buccal Tablets(Herba Reineckea Camea, Radix Asteris, Heaba Houttugnlae, Pericarpium Papaveris, Heaba Ephedrae etc.). METHODS: TLC was used for the identification of Herba Reineckea Camea and Pericarpium Papaveris. HPLC was used for the determination of ephedrine hydrocholoride in the Buccal tablets. RESULTS: TLC identification was highly specific and the spots were clear. The linear range for ephedrine hydrocholoride was in the range of 0.404～2.02?g and its average recovery was 97.03% and RSD 2.2%, respectively. CONCLUSION: The quality standard is able to effectively control the quality of Jixiangcao Buccal Tablets.
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OBJECTIVE: To study the antibacterial actions of Qinghou buccal tablets in vivo and in vitro. METHODS: Minimal inhibitory concentration (MIC) and minimal bactericidal concentration (MBC) of Qinghou buccal tablets were determined by standard test tube doubling dilution method;And the antibacterial action of which on staphylococcus aureus in mice in vivo were monitored. RESULTS: Qinghou buccal tablets had significant in vitro antibacterial action on staphylococcus aureus, ?-hemolytic streptococcus, ?-hemolytic streptococcus, streptococcus pneumoniae and hemophilus influenza, with MIC and MBC at 0.0 625～0.50g/ml and 0.125～1.0g/ml, respectively,and which had bacteriostatic action on mice that injected i.p. with staphylococcus aureus. CONCLUSION: Qinghou buccal tablets were proved to be of bacteriostatic actions in vitro and in vivo.
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OBJECTIVE:To optimize the formula of Yanle buccal tablets. METHODS: 8 different formula were derived from L8(2)7 orthogonal design table taking 7 Chinese medicines as factors. The main outcome measures were granuloma growth inhibition test, ear swelling inhibition test and phenol red's phlegm eliminating test in mice. RESULTS: The results showed that that Radix et Rhizoma Slycyrrhizae and Flos Lonicerae Japonicae had significant impact on mice's granuloma growth inh-ibition test Result;Radix Ophiopogonis,Rhizome,Belamcandae,Semen Oroxyli,and Flos Lonicerae Japonicae had significant impact on mice's ear swelling inhibition test result; and Radix et Rhizoma Slycyrrhizae and Radix Platycodi had great impact on phenol red's phlegm eliminating test result in mice, suggesting that every Chinese medicine (factor) had effect on certain pharmacodynamic action. CONCLUSION: The original formula is the reasonable and optimum one.