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Objective To investigate the stability of 8 commonly used reference solutions and determine the validity period of internal control. Methods The storage solutions of reference substances were prepared and stored in the refrigerator at 2 to 10 ℃. The content of the storage solutions and the newly prepared reference solutions were determined by HPLC on days 0, 1, 4, 7, 10, 14, 21, 28 and 35, and their change values of the content were calculated. Results During the inspection period, the appearance of each reference solution was consistent with the newly prepared reference solution. There was no significant impurity peak in the chromatography. For mixed references of metronidazole, chloramphenicol and salicylic acid stored for 7 days, vitamin E, mixed references of tinidazole and chlorhexidine acetate, sulfadiazine, dexamethasone phosphate for 35 days, their contents met the requirements. Conclusion Stored in the refrigerator at 2 to 10 ℃, the effective time period of vitamin E reference solution, mixed references solution of tinidazole and chlorhexidine acetate, sulfadiazine reference, dexamethasone phosphate reference solution can be 35 days, and the mixed references solution of metronidazole, chloramphenicol and salicylic acid defined can be 7 days.
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Objective: To study fixed-dose combinations (FDC) of antibacterial and antiprotozoal products (ofloxacin and azoles), prescribed for the treatment of diarrhea. Methods: Rationality of these FDC products was verified by assessing parameters such as drug content and release by assay and dissolution tests, respectively mentioned in the Indian Pharmacopoeia (IP). Amount of drug solubilized and permeated as per the Biopharmaceutics Classification System (BCS) was determined. Ex vivo permeation study was performed on the gut of goat using the everted gut sac technique. Antimicrobial efficacy in terms of minimum inhibitory concentration (MIC) was assessed using agar well diffusion method against Shigella boydii, the causative agent for diarrhea. Comparative studies were performed on an individual as well as combination doses of antibacterial and antiprotozoal products for the synergistic effects to assess the rationale of these FDC. Results: The BCS solubility of ciprofloxacin (CPX), norfloxacin (NFX) and tinidazole (TNZ) was high in acidic medium (pH 1-5) and decreased at pH above 5. The assay studies showed that the individual drug contents of FDC were within the IP limits. In vitro dissolution results for both, individual drugs and their combination illustrated 99 % drug release within 30 min in 0.01N HCl. Ex vivo permeation of TNZ was higher than CPX and NFX in individual drugs. No significant change in the permeation rate was observed for individual drugs and their FDC. CPX and NFX exhibited more antimicrobial activity in terms of inhibitory zones than their FDC with antiprotozoal TNZ, above 2.5 µg/ml MIC. The pharmaceutical, biopharmaceutical and antimicrobial evaluation study showed the similarity of FDC with the individual drugs. Conclusion: The study showed no significant data to justify the therapeutic advantage of FDC over individual drugs.
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Bacterial Vaginosis (BV) is the leading cause of vaginal discharge. Because of its big surface area, wealthy blood supply, avoidance of the first-pass effect and high permeability to many drugs, the vagina offers a promising location for local impact as well as systemic drug delivery. In situ gels give several benefits, such as ease of administration in the respective body cavities, elevated spreadability at certain temperatures, reduced administration frequency, improved patient compliance and comfort compared to standard dosage forms. Tinidazole (TNZ) can give effective treatment over the BV. In situ gel of TNZ containing polaxomer 407and HPMC E100 or carbopol 941NF was optimized on the basis of various evaluation parameters. Gelation temperature (Tgel) and pH of all batches was found in range of 36.6 to38.0 ºC and 4.20 to 5.03, viscosity was found in range of 1100-2050 cps at 25ºC and 4800-6530 cps at 37ºC. The Spredability was found in range of 16-20 cm. From these evaluation parameters we selected best combination for the mucoadhesive property, antimicrobial study, in vitro drug release and for HET CAM irritation study. The optimized formulation gives satisfactory results. In this study we also compare the performance of two mucoadhesive polymer. Based on maximum desirability and cost effectiveness, in situ vaginal gel containing 20% polaxomer and 0.5% HPMC E100 could be considered as a highly promising treatment for bacterial vaginosis.
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Five components in the impurity profile of tinidazole glucose injection were detected and identified by UPLC-Q Exactive quadrupole-electrostatic field orbitrap high resolution mass spectrometry, in combination with retention time references, organic reaction mechanisms and UV spectral analysis. They are 2-methyl-5-nitroimidazole (impurity 1), 5-hydroxymethylfurfural (impurity 2), 1-(2-(ethylsulfonyl)ethyl)-2-methyl-4-nitro-1H-Imidazole (impurity 5), 1-(2-(ethylthio)ethyl)-2-methyl-5-nitro-1H-imidazole (impurity 6) and 1,4-di-N-oxo-2-methyl-5-nitro-1H-imidazole (impurity 8) respectively, of which impurities 6 and 8 are identified for the first time. These results and detection methods are useful for monitoring the manufacturing process and quality control of tinidazole and glucose injection solution.
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Objective To analyze the curative effect of teprenone capsule combined with quadruple therapy in the treatment of chronic atrophic gastritis.Methods From June 2013 to June 2017,one hundred and fifty patients with chronic atrophic gastritis admitted to the First Hospital of Ninghai County were retrospectively selected.According to different treatment schemes,they were divided into control group and observation group,with 75 patients in each group.The control group was treated with routine quadruple therapy, and the observation group was treated with teprenone capsule combined with quadruple therapy.The effective rate of the two groups was compared.Results The total effective rate of the observation group was 97.33% ,which was higher than 85.33% of the control group,the difference between the two groups was statistically significant(χ2 =3.197,P<0.05).After treatment,the levels of interleukin-8 and tumor necrosis factor - alpha in the observation group were ( 7.04 ± 1.03 ) ng/L, ( 41.02 ± 1.72)ng/L,respectively,which in the control group were (10.81 ± 1.63)ng/L,(57.35 ± 2.95) ng/L,respectively, the differences between the two groups were statistically significant (t=6.028,7.281,all P <0.05).The gastric mucosa score and the gastrin concentration in the observation group were (1.13 ± 0.32)points,(8.97 ± 2.33)pmol/L, respectively,which in the control group were ( 1. 82 ± 0. 61 ) points, ( 5. 36 ± 1. 52 ) pmol/L, respectively, the differences between the two groups were statistically significant ( t =5. 661, 6. 024, all P <0. 05 ). Conclusion Teprenone capsule combined with quadruple therapy can improve the clinical efficacy and reduce the degree of inflammation in patients with chronic atrophic gastritis,which is worthy of clinical application.
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Resumen Introducción: En México la seroprevalencia de la Entamoeba histolytica es del 8.4%. La amebiasis intestinal en pacientes con leucemia aguda de novo posterior al inicio de quimioterapia (QT), en el Servicio de Hematología del CMN 20 de Noviembre, es del 12%, aún si muestran test coprológico negativo basal. Objetivo: Averiguar si la administración de tinidazol, en pacientes con leucemia aguda y coprológico negativo, al principio de la QT, disminuye la incidencia de colitis amebiana durante la inducción a la remisión. Método: Prospectivo y no comparativo. Enfermos con diagnóstico de leucemia aguda de novo que inician QT de inducción y coprológico inicial. Se indicó tinidazol, 2 g/día durante 5 días en la primera semana de comenzada QT. Se vigilaron hasta que la inducción concluyó y se inició la recuperación hematopoyética. Resultados: 38 pacientes, 15 mujeres y 23 hombres con edad media de 44 años (16-72). Con leucemia aguda linfoblástica 19, con mieloblástica 16 y con promielocítica 3. Casos sin y con amebiasis intestinal, 35 y 3, respectivamente. Los pacientes con amebiasis solo recibieron tinidazol durante 3 días y se dio después de 2 días de empezada la QT. Conclusión: El tinidazol, en pacientes con leucemia aguda de novo que inician QT de inducción, es efectivo en la prevención de la amebiasis intestinal, durante la etapa de inducción, si se administra a 2 g/día, durante cinco días, a partir del día 1 de la QT.
Abstract Introduction: In Mexico, seroprevalence of Entamoeba histolytica is 8.4%. The intestinal amebiasis in patients with acute leukemia of novo, after the start of chemotherapy (CT) in the Hematology Service of the CMN 20 de Noviembre is 12%, even if patients show a negative baseline coprological test. Objective: To find out if the administration of tinidazole, in patients with acute leukemia and negative coprological test, at the beginning of the CT, decreases the incidence of amoebic colitis during the induction to remission. Method: Prospective and not comparative study. Patients with de novo diagnosis of acute leukemia who initiate induction and initial coprological CT. Tinidazole was indicated, 2 g/day for 5 days in the first week of CT started. They were monitored until the induction was concluded and hematopoietic recovery started. Results: 38 patients, 15 women and 23 men with a mean age of 44 years (16-72), with acute lymphoblastic leukemia 19, myeloblastic 16 and promyelocytic 3. Cases without and with intestinal amebiasis were 35 and 3, respectively. Patients with amebiasis only received tinidazole for 3 days and it was given 2 days after the CT started. Conclusion: Tinidazole, in patients with acute de novo leukemia who initiate induction CT, is effective in the prevention of intestinal amebiasis, during the induction stage, if administered at 2 g/day, for five days, starting on day 1 of the CT.
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Humans , Male , Female , Adolescent , Adult , Middle Aged , Aged , Young Adult , Tinidazole/therapeutic use , Colitis/parasitology , Colitis/prevention & control , Dysentery, Amebic/prevention & control , Leukemia, Myeloid, Acute/complications , Leukemia, Myeloid, Acute/drug therapy , Prospective Studies , Treatment Outcome , Colitis/complications , Dysentery, Amebic/complications , Antineoplastic Agents/therapeutic useABSTRACT
Objective:To establish a microbial counting method for pre-sterilization products of tinidazole and sodium chloride in-jection.Methods:Pre-sterilization product was taken out 100 ml, and according to the established verification test method , the test bacteria were added to the samples and the recovery rate of the tested bacteria was measured .Results: The recoveries of all the test bacteria ( Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and Aspergillus brasiliensis) in the vali-dation test were within the range of 50％-200％, and the results met the requirements of Chinese Pharmacopoeia.Conclusion: The method is effective and feasible , and can be used for the microbiological count of pre-sterilization products .
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Objective To investigate the effect of psychological intervention, combined with Concentrated Tinidazole Gargles on dental plaque and gingivitis inflammation and influence factor of life quality in elder patients. Methods The control group was given Concentrated Tinidazole Gargles treatment, the research group was given psychological intervention on the basis of Concentrated Tinidazole Gargles (as control group). Plaque index, gingivitis index and SF-36 scale changes before and after treatment were recorded between two groups of elderly patients with gingivitis. Results There was no significant difference in plaque index, gingival indexand SF-36 score compared with before treatment between two groups; Plaque index, gingivitis index and the SF-36 score were improved in the research group better than the control group after treatment (P<0.05). Conclusion There is positive significance in improving the clinical efficacy of Concentrated Tinidazole Gargles plus psychological intervention and assurance of the quality of life on gingivitis in elder patients.
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Objective To compare the clinical effect and safety of minocycline hydrochloride combined with metronidazole or tinidazole in treatment of chronic periodontitis.Methods Patients with chronic periodonitis (260 cases) accepted in Ninth Hospital of Xi'an from February 2014 to February 2016 were randomly divided into observation group and control group with 130 cases in each group.Patients in control group were given minocycline hydrochloride combined with metronidazole,and patients in observation group were given minocycline hydrochloride combined with tinidazole.Then the clinical effect,periodontal indexes and adverse reactions of two groups were compared.Results The total effective rate of observation group was 94.62％,which was obviously higher than that of control group (83.85％,P ＜ 0.05).The periodontal indexes of observation group were higher than control group (P ＜ 0.05).The adverse reaction rate of observation group was 8.46％,that of control group was 14.62％,which had no differences.The recurrence rate of observation group was 1.54％,that of control group was 6.92％,which had no differences.Conclusion Using minocycline hydrochloride combined with tinidazole has better effect in treatment of chronic periodontitis,which is safety and worthy of clinical application.
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Objective To study and analyze the clinical effect of clarithromycin combined with tinidazole in the treatment of HP associated gastritis in children. Abstract 100 children with HP associated gastritis were selected as the subjects. The control group was treated with 50 mg/(g?d) amoxicillin combined with 20 mg/(g?d) metronidazole, twice a day. The control group was treated with clarithromycin combined with tinidazole, 20 mg/(g?d) clarithromycin, 20 mg/(g?d) tinidazole, twice a day. The clinical efficacy, the rate of HP eradication and adverse reactions of the experimental group and the control group were compared and analyzed. Results After the corresponding treatment, 45 patients in the experimental group were radical cured. In the control group, 35 cases were radical cured. The radical cured rate of HP of the control group (90.0%) was significantly higher than that (70.0 %) in control group, which was statistically significant (P<0.05). In the control group, 15 cases were valid, and 25 cases were better effective. In the experimental group, 32 cases were better effective, and 16 cases were valid. The effective rate of the experimental group was 96.0%, which was significantly higher than that (80.0%) of the control group with statistical difference (P<0.05). In the control group, 3 cases occurred complications, in the experimental group, 2 cases occurred complications, and the incidence of complications in two groups was 6.0% and 4.0% respectively. There was no significant difference between two groups. Conclusion Clarithromycin combined with tinidazole in the treatment of pediatric HP associated gastritis has better efficacy, high safety, could significantly improve the clinical symptoms of patients, with clinical significance.
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Objective To investigate the clinical effect of moxifloxacin combined with tinidazole and psychological intervention in the treatment of pelvic inflammatory disease. Methods The control group treated with moxifloxacin combined with tinidazole,pelvic inflammatory disease,the study group patients were given pelvic inflammatory tinidazole, moxifloxacin, combined with psychological intervention treatment (tinidazole and moxifloxacin administration methods and drug sources are the same as the control group). The clinical efficacy of two groups of pelvic inflammatory disease patients treated with 12 days was recorded. Results The group of patients with pelvic inflammatory disease were successfully completed corresponding treatment, the total effective rate of the study group was 95.65%, the control group was 68.18%, study group patients with pelvic inflammatory disease clinical curative effect was significantly better than the control group (P<0.05). Conclusion The application of moxifloxacin,tinidazole and psychological intervention in the treatment of pelvic inflammatory disease can significantly improve the clinical efficacy of patients, and is conducive to the protection of their quality of life, physical and mental health.
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Objective To study and analyze the clinical effect of clarithromycin combined with tinidazole in the treatment of HP associated gastritis in children. Abstract 100 children with HP associated gastritis were selected as the subjects. The control group was treated with 50 mg/(g?d) amoxicillin combined with 20 mg/(g?d) metronidazole, twice a day. The control group was treated with clarithromycin combined with tinidazole, 20 mg/(g?d) clarithromycin, 20 mg/(g?d) tinidazole, twice a day. The clinical efficacy, the rate of HP eradication and adverse reactions of the experimental group and the control group were compared and analyzed. Results After the corresponding treatment, 45 patients in the experimental group were radical cured. In the control group, 35 cases were radical cured. The radical cured rate of HP of the control group (90.0%) was significantly higher than that (70.0 %) in control group, which was statistically significant (P<0.05). In the control group, 15 cases were valid, and 25 cases were better effective. In the experimental group, 32 cases were better effective, and 16 cases were valid. The effective rate of the experimental group was 96.0%, which was significantly higher than that (80.0%) of the control group with statistical difference (P<0.05). In the control group, 3 cases occurred complications, in the experimental group, 2 cases occurred complications, and the incidence of complications in two groups was 6.0% and 4.0% respectively. There was no significant difference between two groups. Conclusion Clarithromycin combined with tinidazole in the treatment of pediatric HP associated gastritis has better efficacy, high safety, could significantly improve the clinical symptoms of patients, with clinical significance.
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Objective To investigate the clinical effect of moxifloxacin combined with tinidazole and psychological intervention in the treatment of pelvic inflammatory disease. Methods The control group treated with moxifloxacin combined with tinidazole,pelvic inflammatory disease,the study group patients were given pelvic inflammatory tinidazole, moxifloxacin, combined with psychological intervention treatment (tinidazole and moxifloxacin administration methods and drug sources are the same as the control group). The clinical efficacy of two groups of pelvic inflammatory disease patients treated with 12 days was recorded. Results The group of patients with pelvic inflammatory disease were successfully completed corresponding treatment, the total effective rate of the study group was 95.65%, the control group was 68.18%, study group patients with pelvic inflammatory disease clinical curative effect was significantly better than the control group (P<0.05). Conclusion The application of moxifloxacin,tinidazole and psychological intervention in the treatment of pelvic inflammatory disease can significantly improve the clinical efficacy of patients, and is conducive to the protection of their quality of life, physical and mental health.
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90 extracted single rooted human teeth were inoculated with E.faecalis.The cannals of the teeth were irrigated with MTAD, 5.25% NaClO,compound chlorhexidine gargle,tinidazole mouthwash,distilled H2 O(infection control)and autoclave followed by distilled H2 O(autoclaving control),respectively(n =1 5).Then E.faecalis infection of the samples were examined.The results showed that MTAD had significantly greater antibacterial effects than 5.25% NaClO,tinidazole mouthwashes,compound chlorhexidine gargle and tinidazole mouthwash(P <0.05).There was no significant difference between each 2 of the other 3 irrigants.
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Objective:To study the in vitro and in vivo transdermal enhancement of one kind of arginine oligomer-chitosan ( CS-R9). Methods: In vitro mouse skin as the barrier, Franz diffusion cells were used to study the transdermal property of tinidazole ( TNZ) solution in vitro enhanced by CS-R9 using TNZ solution as the negative control and TNZ solution with Azone as the positive control. The rats were randomly divided into three groups, TNZ solution group ( the negative group) , TNZ solution with Azone group (the positive group) and TNZ solution with CS-R9 group. At the predetermined time intervals, 0. 5 ml blood was withdrawn from the rats and TNZ concentration was detected by HPLC to evaluate the enhancement of CS-R9 on TNZ in vivo. Results:Compared with the negative group, CS-R9 had significant enhancement on TNZ trandermal penetration in vitro(P 0. 05). The in vivo results showed CS-R9 exhibited similar transdermal enhancement on TNZ as Azone at the same concentration (P>0. 05), and CS-R9 had sustalned-release property. Conclusion: CS-R9 has promising transdermal en-hancement on TNZ, which is valuable to be studied further.
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Objective To investigate the clinical effect of longxuejie capsule in combination with tinidazole in the treatment of chronic cervicitis and its effects on levels of immunoglobulin.Methods 90 cases in our hospital from January 2013 to June 2014, with chronic cervicitis meeting the inclusion critera were randomly divided into 2 groups by method of stratified randomization equally.Control group (n=45) was treated with tinidazole and conventional treatments, while observation group ( n =45 ) was treated with tinidazole and longxuejie capsule.Then, the curative efficacy, scale of symptoms and levels of immunoglobulin were observed and compared.Results The therapeutic efficiency ratio of observation group was 95.6%, which was significantly higher than that of control group ( 80.0%, P<0.05 ).After the treatment, in comparison with the control group, scale of cervical secretion and severity of cervical lesion was statistically lower respectively than observation group ( P<0.05 ).As to immunological function, concentrations of IgG, IgM, IgA in observation group were statistically higher than that in control group after the treatment (P<0.05).The control group and observation group respectively in 2 cases and 3 cases of abdominal pain, alleviated by themselves without treatment.Conclusion longxuejie capsule combined with tinidazole is effective and reliable for patients with chronic cervicitis, which significantly improves symptoms and elevates levels of immunoglobulin.
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OBJECTIVE:To observe the efficacy and safety of minocycline hydrochloride combined with tinidazole in the treat-ment of chronic periodontitis. METHODS:100 patients with chronic periodontitis were randomly divided into observation group 1, observation group 2,observation group 3 and control group. Patients in control group were given full-mouth dental scalers and sub-gingival clean scraping,then 0.9% Sodium chloride injection and 3% hydrogen peroxide were used to alternately wash periodontal pocket bottom. Based on the treatment,observation group 1 was injected Minocycline hydrochloride ointment to periodontal pocket bottom until slight overflow after saliva isolation and desiccation,once a week;observation group 2 was given Tinidazole buccal tablet 1 tablet in the buccal middle gingival surface,twice a day,observation group 3 was given Minocycline hydrochloride oint-ment+Tinidazole buccal tablets(the usage and dosage was the same with above-mentioned 2 groups). The treatment course was 4 weeks. The clinical efficacy,PLI,PAL,PPD,MD,GI before and after treatment and incidence of adverse reactions were observed. RESULTS:The total effective rate in observation group 3>observation group 1 and observation group 2>control group(P0.05). After treatment, PLI,PAL,PPD,MD and GI in all groups were significantly lower than before,and observation group 30.05). There were no obvious adverse reactions during treatment. CONCLUSIONS:Minocycline hy-drochloride combined with tinidazole has better efficacy than minocycline hydrochloride or tinidazole in the treatment of chronic periodontitis,with good safety.
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A simple, specific, accurate, precise and sensitive Reverse Phase High Performance Liquid Chromatographic method has been developed for the quantitation of Tinidazole in both pure and pharmaceutical dosage forms. . Chromatographic separation achieved isocratically on a ODS2 reverse phase column [Use Symmetry C18, 250 X 4.6mm, 5μ] utilizing a mobile phase of Methanol. The flow rate was 0.5 ml/min and the effluents were monitored at 310 nm. The retention time was 4.610min. The linearity was in the range of 5-25μg / ml. This method was validated for linearity, precision and accuracy. Statistical analysis proves that the method is reproducible and selective for the estimation of the said drug.
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Objective To study recent clinical efifcacy and safety analysis of tinidazole and metronidazole in treatment of severe oral infection. Methods, 88 cases with severe oral infection(SOI) collected in the third people's hospital of Wenling from April 2012 to April 2013 were divided into observation group (n=45) and control group (n=43) by random number table. Control group were received metronidazole drug treatment, while observation group were treated with tinidazole medication, The efifcacy, recovery duration and adverse reactions were compared between two groups. Results The efficacy of observation group was significantly better than control group, the difference was statistically significant (P<0.05). The average duration of symptoms and wound healing in observation group were (4.8±0.4)hs and (4.3 ± 0.2)hs, which were signiifcantly less than (5.5 ± 0.2)sh and (5.6 ± 0.1)sh in control group(P<0.05).Adverse reactions in observation group were signiifcantly lower than that in control group (P<0.05). Conclusion Tinidazole has a signiifcant effect and less adverse reactions in treatment of SOI.
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A simple, rapid, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Tinidazole and Ciprofloxacin in Tabletdosage form. An Aligant Zorbax Rx-C18 5μ column having 150 x 4.6mm id in Isocratic mode with mobile phase containing Orthophosphoric acid: methanol (70:30 %v/v pH: 3.0) was used. The flow rate was 1.5ml/min and effluents were monitored at 225nm.) The retention time of Tinidazole and Ciprofloxacin was 2.3min and 7.2min respectively.The concentration curves of Tinidazole and Ciprofloxacin were linear in the concentration range of 150-450 μg/mL and 125-375μg/mL respectively. The developed method was validated for specificity, precision, linearity, accuracy, LOD,LOQ, robustness . Recovery of Tinidazole and Ciprofloxacin in formulations was found to be in the range of 97.0% -98.0% and 100%-103% respectively confirms the non-interferences of the excipients in the formulation. Due to its simplicity, rapidness and high precision, the proposed HPLC method may be used for the simultaneous determination of these two drugs in pharmaceutical dosage forms.