Treatment of benign positional paroxysmal vertigo in clinical settings in India: a cross sectional pilot survey

Background: The usage pattern and effectiveness of various treatment strategies for benign positional paroxysmal vertigo (BPPV) have not been widely reported in routine clinical settings in India. The aim of the study was to understand treatment patterns and level of symptom improvement in Indian patients presenting with symptoms of BPPV in clinical practice.Methods:A cross-sectional pan-India survey was conducted with leading neurologists and otolaryngologists. A detailed questionnaire was shared with specialists which was followed by semi-structured telephonic interviews to gather a deeper understanding of their treatment practices. The obtained data was analyzed using appropriate statistical methods.Results:A total of 5 neurologists and 8 ENT specialists completed the survey. Physicians reported that age, but not gender, was an important factor when selecting appropriate treatment. Specialists reported that in their clinical practice symptom improvement is better with betahistine plus maneuvers compared to betahistine only alone (97% verses90% cure rate) and is comparable with maneuvers (97% verses98% cure rate, respectively). Dix Hallpike and supine roll test using videonystagmography were the most recommended tests used to diagnose BPPV. Betahistine plus maneuvers was the most commonly prescribed treatment for BPPV, and clinicians observed greater decrease in the severity of BPPV symptoms with betahistine plus maneuvers versus betahistine alone or maneuvers. The Visual analog scale (VAS) was the most widely usedscale for assessing severity of BPPV symptoms.Conclusions: These findings indicate that betahistine plus maneuvers provides better control over symptom severity in patients with BPPV.

Betahistine add-on therapy for treatment of subjects with posterior benign paroxysmal positional vertigo: a randomized controlled trial / Terapia adjuvante de betaistina para o tratamento de indivíduos com vertigem posicional paroxística benigna posterior: um ensaio clínico randomizado

Abstract Introduction Benign paroxysmal positional vertigo is a common vestibular disorder that accounts for one fifth of hospital admissions due to vertigo, although it is commonly undiagnosed. Objective To evaluate the effects of betahistine add-on therapy in the treatment of subjects with posterior benign paroxysmal positional vertigo. Methods This randomized controlled study was conducted in a population of 100 subjects with posterior benign paroxysmal positional vertigo. Subjects were divided into the Epley maneuver + betahistine group (group A) and Epley maneuver only (group B) group. Subjects were evaluated before and 1-week after the maneuver using a visual analog scale and dizziness handicap inventory Results One hundred subjects completed the study protocol. The Epley maneuver had an overall success rate of 95% (96% in group A; 94% in group B, p= 0.024). Groups A and B had similar baseline visual analog scale scores (6.98 ± 2.133 and 6.27 ± 2.148, respectively, p= 0.100). After treatment, the visual analog scale score was significantly lower in both groups, and was significantly lower in group A than group B (0.74 ± 0.853 vs. 1.92 ± 1.288, respectively, p= 0.000). The change in visual analog scale score after treatment compared to baseline was also significantly greater in group A than group B (6.24 ± 2.01 vs. 4.34 ± 2.32, respectively, p= 0.000). The baseline dizziness handicap inventory values were also similar in groups A and B (55.60 ± 22.732 vs. 45.59 ± 17.049, respectively, p= 0.028). After treatment, they were significantly lower in both groups. The change in score after treatment compared to baseline was also significantly greater in group A than group B (52.44 ± 21.42 vs. 35.71 ± 13.51, respectively, p= 0.000). Conclusion The Epley maneuver is effective for treatment of benign paroxysmal positional vertigo. Betahistine add-on treatment in posterior benign paroxysmal positional vertigo resulted in improvements in both visual analog scale score and dizziness handicap inventory.

Resumo Introdução A vertigem posicional paroxística benigna é um distúrbio vestibular comum, responsável por um quinto das internações hospitalares por vertigem, embora seja comumente não diagnosticada. Objetivo Avaliar os efeitos da terapia adjuvante com betaistina no tratamento de indivíduos com vertigem posicional paroxística benigna posterior. Método Este estudo randomizado controlado foi feito em uma população de 100 indivíduos com vertigem posicional paroxística benigna posterior. Os indivíduos foram divididos nos grupos: manobra de Epley + betaistina (grupo A) e manobra de Epley apenas (grupo B). Os indivíduos foram avaliados antes e uma semana após a manobra por meio da escala visual analógica EVA e do questionário dizziness handicap inventory. Resultados Cem indivíduos completaram o protocolo do estudo. A manobra de Epley demonstrou uma taxa de sucesso global de 95% (96% no grupo A; 94% no grupo B, p = 0,024). Os grupos A e B tiveram escores basais semelhantes na EVA (6,98 ± 2,133 e 6,27 ± 2,148, respectivamente, p = 0,100). Após o tratamento, o escore na EVA foi significantemente menor em ambos os grupos e foi menor no grupo A do que no grupo B (0,74 ± 0,853 vs. 1,92 ± 1,288, respectivamente, p = 0,000). A mudança no escore da EVA após o tratamento em comparação com a linha basal também foi significativamente maior no grupo A do que no grupo B (6,24 ± 2,01 vs. 4,34 ± 2,32, respectivamente, p = 0,000). Os valores basais no dizziness handicap inventory também foram semelhantes nos grupos A e B (55,60 ± 22,732 vs. 45,59 ± 17,049, respectivamente, p = 0,028). Após o tratamento, eles foram significantemente menores em ambos os grupos. A mudança no escore após o tratamento em comparação com a linha basal também foi significantemente maior no grupo A do que no grupo B (52,44 ± 21,42 vs. 35,71 ± 13,51, respectivamente, p = 0,000). Conclusão A manobra de Epley é eficaz no tratamento da vertigem posicional paroxística benigna. O tratamento complementar com betaistina na vertigem posicional paroxística benigna posterior resultou em melhoria tanto no escore da EVA quanto no do dizziness handicap inventory.

Betahistine alleviates benign paroxysmal positional vertigo (BPPV) through inducing production of multiple CTRP family members and activating the ERK1/2-AKT/PPARy pathway

BACKGROUND: Betahistine is a clinical medication for the treatment of benign paroxysmal positional vertigo (BPPV). Otolin, a secreted glycoprotein with a C-terminal globular domain homologous to the immune complement C1q, has been identified as a biomarker for BPPV. However, the role of complement C1q/TNF-related proteins (CTRPs) with a C-terminal globular domain in BPPV is unclear, so we explored the change of CTRPs in betahistine treated BPPV. METHODS: We treated BPPV patients with Betahistine (12 mg/time, 3 times/day) for 4 weeks and observed the clinical efficacy and the expression of CTRP family members in BPPV patients. Then, we constructed a vertigo mice model of vestibular dysfunction with gentamicin (150 mg/Kg) and a BPPV model of Slc26a4loop/loop mutant mice. Adenoviral vectors for CTRP expression vector and small interfering RNA were injected via the intratympanic injection into mice and detected the expression of CTRP family members, phosphorylation levels of ERK and AKT and the expression of PPARγ. In addition, we treated mice of vestibular dysfunction with Betahistine (10 mg/Kg) and/or ERK inhibitor of SCH772984 (12 mg/Kg) and/or and PPARγ antagonist GW9662 (1 mg/Kg) for 15 days, and evaluated the accuracy of air righting reflex, the time of contact righting reflex and the scores of head tilt and swimming behavior. RESULTS: After treatment with Betahistine, the residual dizziness duration and the score of the evaluation were reduced, and the expression of CTRP1, 3, 6, 9 and 12 were significantly increased in BPPV patients. We also found that Betahistine improved the accuracy of air righting reflex, reduced the time of contact righting reflex and the scores of head tilt and swimming behavior in gentamicin-treated mice and Slc26a4loop/loop mutant mice. The expression levels of CTRP1, 3, 6, 9 and 12, phosphorylation levels of ERK and AKT, and PPARγ expression were significantly increased, and the scores of head tilt and swimming behavior were decreased in vestibular dysfunction mice with overexpression of CTRPs. Silencing CTRPs has the opposite effect. SCH772984 reversed the effect of Betahistine in mice with vestibular dysfunction. CONCLUSION: Betahistine alleviates BPPV through inducing production of multiple CTRP family members and activating the ERK1/2-AKT/PPARy pathway.

Efficacy and safety of Carbamazepine in treatment of vestibular complications / 中华老年医学杂志

Objective To evaluate the efficacy and safety of Carbamazepin (CBZ)compared with Oxcarbazepine (OXC ) therapy for vestibular paroxysmia. Methods Eighty-two patients with vestibular paroxysmia were admitted during June 2013 and June 2017 in this study. According to the agents administered ,all patients were divided into the CBZ group(n＝ 31) ,CBZ+ Betahistine(BMT) group(n＝ 26)and OXC+ BMT group(n＝ 25).The clinical efficacy ,frequency ,vertigo and adverse reactions of three groups were compared after 3 months follow-up. Results In CBZ group ,14 cases were cured ,13 were improved ,and the effective rate was 87.1%.In CBZ+BMT group ,18 cases were cured ,7 were recovered ,and the effective rate was 96.2%.In OXC+BMT group ,15 cases were cured , 8 cases were recovered ,and the effective rate was 92.0% . There was no significantly difference in effective rate among the three groups(χ2＝0.783 ,P＝0.129).Meanwhile ,the CBZ+BMT group had the lowest frequency of vestibular paroxysmia and vertigo degree ,while the CBZ group was the highest ;the difference in the frequency and vertigo degree between groups was statistically significant (P＜ 0.05).Furthermore ,the incidences of side-effects were 51.6%(n＝ 16) ,30.8%(n ＝ 8)and 16.0%(n＝4)in the CBZ group ,CBZ+BMT group and OXC+BMT group ,respectively. Conclusions The effect of Carbamazepine and Oxcarbazepine for vestibular paroxysmia is similar ,and is safely and significantly improved when combined with Betahistine.

Needle-knife therapy combined with moxa stick pressure moxibustion for cervical vertigo: a randomized controlled trial / 中国针灸

OBJECTIVE@#To compare the effect difference between needle-knife therapy combined with moxa stick pressure moxibustion and western medicine for cervical vertigo.@*METHODS@#A total of 60 cervical vertigo patients were randomized into an observation group and a control group, 30 cases in each group. The patients in the observation group were treated with needle-knife therapy combined with moxa stick pressure moxibustion at Baihui (GV 20), Shenting (GV 24), Tianzhu (BL 10), Yuzhen (BL 9), Touwei (ST 8), etc. The needle-knife therapy was given once a week, 1-3 times. The pressure moxibustion was given once a day, 6 times a week. The patients in the control group were received 12 mg of betahistine mesylate, twice a day, and 75 mg of diclofenac sodium double release capsule, once daily for oral treatment. The treatment was given for 3 weeks in both groups. The symptom and functional evaluation scale of cervical vertigo were observed before and after treatment and 3 months after treatment. The long-term effect was observed 3 months after treatment.@*RESULTS@#The total effective rate in the observation group was 93.3% (28/30), which was significantly higher than 63.3% (19/30) in the control group (<0.05). Compared with those before treatment, the scores of vertigo symptom and functional evaluation scale, dizziness, neck and shoulder pain, headache, daily life, psychological and social adaptability were increased in the two groups (<0.05, <0.01). Except for a slight decrease in headache and total score at the follow-up period in the observation group, the remaining 4 individual scores were higher than those after treatment (all <0.05). At follow-up, the total score and five individual scores were lower than those after treatment in the control group (<0.05, <0.01). Compared with those in the control group, the vertigo scale scores and the five individual scores in the observation group were increased significantly after treatment and at follow-up (<0.05, <0.01).@*CONCLUSION@#Needle-knife therapy combined with moxa stick pressure moxibustion can significantly relieve dizziness, headache, neck and shoulder pain in patients with CV, and can improve the quality of life . The combination therapy are better than western medicine, and have a better long-term effect.

Uncertainty Evaluation in the Determination of Methane Sulfonic Acid in Betahistine Mesylate by Ion Chro-matography / 中国药师

Objective:To establish an ion chromatography method for the determination of methane sulfonic acid in betahistine me-sylate and evaluate the uncertainty in the measurement. Methods: An ion chromatographic column IonPac AS11-HC ( 25 mm × 4. 0 mm,5 μm) was used with 12 mmol·L-1 NaOH as the eluent and an electrical conductivity detector with the suppressor of 30 mV. Results:The results showed that methane sulfonic acid could be detected without any interference. The calibration curve was linear within the range of 10-30 μg·ml-1(r=0.999 9)and the LOQ was 0.116 μg·ml-1. The average recovery was 100.8% (RSD=1. 2%, n=9). Based on the results of experiments, the influencing factors of uncertainty in the measurement were quantitatively eval-uated. The expanded uncertainty was obtained. Conclusion:The method is simple, accurate and selective. It can be used for the de-termination of methane sulfonic acid in betahistine mesylate. Based on the evaluation of uncertainty, the analysis can help reduce the uncertainty in the measurement and improve the accuracy and reliability of the determination.

A randomized, open-label study to evaluate the effectiveness and safety of betahistine dihydrochloride in beta-cyclodextrin versus betahistine dihydrochloride in the treatment of vertigo

OBJECTIVE: To compare the effectiveness and safety of Betahistine dihydrochloride (in beta cyclodextrin) with Betahistine dihydrochloride in treating patients with vertigo.DESIGN/METHODS: This was a randomized, open label study enrolling 68 patients, ages 18 to 65 years old, diagnosed clinically with vertigo.RESULTS: Sixty two patients completed the study. EEV scores of both groups continuously decreased to similar levels. EEV scores significantly deceased from baseline to week 4. In group A patients, EEV scores decreased from 9.81+/- 3.73 at baseline to 2.39 +/- 3.46, pGroup A patients reported 2.6 +\- 2.9 side effects while Group B patients reported 2.7 +/- 2.5 side effects (p=0.92). There were more patients who experienced vomiting, abdominal pain, nausea, vomiting and/ or diarrhea in Group B patients (8/32 in Group A vs 16/30 in Group B, p=0.022).CONCLUSION: Betahistine dihydrochloride with beta cyclodextrin and Betahistine dihydrochloride alone are both effective in reducing the symptoms of dizziness from vertiginous syndromes. Betahistine dihydrochloride with beta cyclodextrin appears to have less gastrointestinal side effects than Betahistine dihydrochloride alone.

Multicenter Randomized Study on the Efficacy of Isosorbide in Patients with Mèniére's Disease / 대한평형의학회지

OBJECTIVES: Mèniére's disease is one of the most common causes of episodic vestibular syndrome that shows symptom complexes of recurrent vertigo, hearing loss, tinnitus and ear fullness. Isosorbide (Isobide) is a osmotic diuretics which has been used for Meniere's disease to reduce the endolymphatic pressure. The purpose of this study was to evaluate the efficacy of isosorbide in the treatment of Mèniére's disease by comparing the combined therapy of isosorbide and betahistine (Meniace) to betahistine only. METHODS: Among 220 patients enrolled with Mèniére's disease from 9 centers, 187 patients completed this clinical study. Patients were randomly subjected either to betahistine alone therapy at dose of 6 mg three times a day (n=97) or to combined therapy with isosorbide (dose of 30 mL three times a day) and betahistine (n=90) for 12 weeks. Two groups were compared at 4 and 12 weeks after treatment on frequency of vertigo, hearing level (pure tone audiometry, speech audiometry), electocochleography (ECoG), tinnitus (Tinnitus Handicap Inventory, THI) and quality of life (Korean functional level scale, Korean dizziness handicap inventory). RESULTS: During first 4 weeks after treatment, the frequency of vertigo was not reduced in either betahistine alone therapy group or combined therapy group. However, between 8 and 12 weeks, the frequency of vertigo was significantly reduced in either group, and in the combined group frequency of vertigo was more significantly reduced than in the betahistine alone therapy group (p=0.041). The hearing level, ECoG, tinnitus and quality of life was not significantly different between two groups. CONCLUSION: Isosorbide and betahistine combined therapy were more effective for vertigo control than betahistine alone therapy. Isosorbide is an effective diuretic in vertigo control in definite Mèniére's disease.

Epley maneuver associated with vertigo calming for treating posterior semicircular canal benign paroxysmal positional vertigo in young / 中国综合临床

Objective To analyze the efficacy of epley maneuver associated with vertigo calming for treating posterior semicircular canal benign paroxysmal positional vertigo (PC-BPPV) in young.Methods Two hundred and fifty-eight cases(age was 18-50 years old) with PC-BPPV were randomly divided into maneuver group(86 cases),betahistine group(86 cases) and vertigo calming group(86 cases).The maneuver group was treated by epley maneuver associated with placebo,2 pills per time,3 times daily for one month and follow up one month.The betahistine group and vertigo calming group were treated by epley maneuver with betahistine(12 mg/ time,Tid) or vertigo calming(2 piles/time,Tid),the same dose,period of treatment and follow-up as maneuver group.Results After one time treatment,199 cases were cured in 258 patients,including 68 cases in maneuver group,66 cases in betahistine group,65 cases in vertigo calming group,and the difference between groups was not statistically significant(x2 =0.308,P＞0.05).After treatments and followed up for one month,72 cases were cured,3 cases were effective,11 cases were invalid in maneuver group;74 cases were cured,3 cases were effective,9 cases were invalid in betahistine group;81 cases were cured,4 cases were effective,1 cases were invalid in vertigo calming group.Efficient of betahistine group,maneuver group and vertigo calming group were 89.5％,87.2％ and 98.8％,and the difference between maneuver group and betahistine group was not statistically significant(x2=58.65,P＞0.05),the difference of vertigo calming group between with other groups was statistically significant(P＜0.05).Conclusion The effects of vertigo calming in addition to Epley maneuver is significantly better than both Epley maneuver and Epley maneuver combined with betahistine in young PC-BPPV,while the effects of Epley maneuver combined with betahistine isn't better than Epley maneuver.

Comparison of the safety and efficacy of caroverine and betahistine in patients of subjective tinnitus.

Background: Owing to lack of any established treatment and handicap assessment methods, subjective tinnitus can be a debilitating disorder. This study was carried out to compare the safety and efficacy of caroverine and betahistine in patients of subjective tinnitus. Methods: A total of 60 patients of subjective tinnitus were randomized into two groups and followed-up for 12 weeks using tinnitus handicap inventory (THI) questionnaire. One group received 8 mg betahistine tablet TDS for a month whereas the other group was given supervised intravenous (IV) infusion of 160 mg of caroverine dihydrochloride. Data for the safety were also recorded. Results: Both the drugs showed significant improvement in severity of symptoms at 1 week, 4 weeks and 12 weeks individually as assessed by the THI scores. The response to caroverine was significant up to 4 weeks, but it was not significant at 12 weeks; whereas the response to betahistine was significant up to 12 weeks. A total of 28 adverse drug reactions (ADRs) were reported (53.6% with caroverine, 46.4% with betahistine). 24 ADRs were mild and 4 were moderate in intensity. There was no serious adverse event. Conclusions: Both the drugs are safe and efficacious in reducing the handicap of subjective tinnitus. A single IV infusion of caroverine may suffice for 4-6 weeks, so it may be repeated after 6 weeks to maintain the relief.

Comparação da bioequivalência entre duas formulações de dicloridrato de betaistina 24 mg comprimidos em voluntários sadios após a administração de dose única / Comparison of the bioequivalence between two formulations of betahistine hydrochloride 24 mg tablets in healthy volunteers after a single dose dministration

A biodisponibilidade de uma dose única de dicloridrato de betaistina em comprimidos de 24 mg produzidos por Aché Laboratórios Farmacêuticos S.A. foi comparada com o medicamento referência (à época do estudo) dicloridrato de betaistina 24 mg (Labirin®, Apsen Farmacêutica S.A.). Um estudo de dose única, randomizado, aberto, cruzado em dois períodos foi realizado em 34 voluntários brasileiros, sadios, de ambos os gêneros. Dezenove coletas de sangue foram realizadas durante 24 horas. As amostras foram mantidas congeladas até o momento de análise. As concentrações plasmáticas de ácido 2-piridilacético, um metabólito da betaistina, foram determinadas utilizando um método de CLAE-EM/EM validado. Os intervalos com 90% de confiança para concentração plasmática máxima (Cmáx) e área sob a curva (ASC0-t) foram determinados utilizando os dados após transformação logarítmica. As formulações teste e referência foram consideradas bioequivalentes se os intervalos com 90% de confiança para a média geométrica da razão teste/referência ficassem compreendidos na faixa de 80% a 125%. Os intervalos com 90% de confiança para as razões das médias geométricas para Cmáx foi 105,18% (97,31%-113,70%) e para ASC0-t foi 99,33% (95,55%-103,26%). Em conclusão, os comprimidos de dicloridrato de betaistina 24 mg testados (Aché Laboratórios Farmacêuticos S.A.) foram bioequivalentes aos comprimidos de Labirin® 24 mg, de acordo com taxa e extensão de absorção.

Modified Epley maneuver associated with betahistine for treating posterior semicircular canal benign paroxysmal positional vertigo / 中国基层医药

Objective To analyze the efficacy of modified epley maneuver associated with betahistine for treating posterior semicircular canal benign paroxysmal positional vertigo(PC-BPPV).Methods 78 cases with unilateral PC-BPPV were divided into complexed therapy group(39 cases)and control group(39 cases)randomly.The complexed therapy group was treated by modified epley maneuver associated with betahistine 6mg per time,3 times daily for successive 1 month.the control group was treated by modified epley maneuver only.Results 78 patients after first treatment,56 cases were cured,control group(28 patients),complexed therapy group(28 cases),no statistically significant difference between the two groups.After 1 month of treatment,the control group were cured 30 cases,effective 3 cases,invalid 6 cases;the complexed therapy group were cured 37 cases,effective 1 case,invalid 1 case;complexed therapy group,the cure rate was 94.9％,significantly higher than the 76.9％ of control group(x2=4.3365,P＜0.05).Conclusion The modified epley maneuver associated with betahistine is effective to treat PCBPPV,which is worth being promoted.

Determination of Betahistine in Human Plasma by RP-HPLC / 中国药房

OBJECTIVE:To establish RP-HPLC method for the determination of betahistine in human plasma.METHODS:The separation of betahistine was performed on C18 column with a detection wavelength of 261nm.the mobile phase was composed of 0.05mol/L ammonium acetate-acetonitrile-0.3mol/L sodium lauryl sulphate (60∶40∶1.5)with a flow rate of 0.5ml/min.RESULTS:The linear range of betahistine was 24～480ng/ml,the recovery rate was 81.75%～87.99%with the intra-day RSD at 0.60%～4.82%and inter-day RSD at 4.78%～12.15%.CONCLUSION:This method developed in the present study is simple,fast,accurate and reproducible,which can be used as the pharmacokinetic study for betahistine in human body.

Effects of betahistine on guinea pig model of ischemic inner ear / 第三军医大学学报

Objective To investigate the improving effect of betahistine hydrochloride (BH) on the cochlear blood supply in guinea pig and the potential use in cochlear ischemia. Methods The guinea pig model of ischemic inner ear was established by ferromagnetic embolization of the target microvessels of the cochlea. A total of 10 model guinea pigs were divided into BH group and control group ( n =5 in each group). Guinea pigs in BH group were treated with 0.1% BH through gastric canal, and those in the control group with the identical volume of saline. At 24 h after treatment, the cochlear blood flow (CBF), auditory brainstem responses (ABR), ferromagnetic emboli in the microvessels of cochlear lateral wall, and the hair cell succinic dehydrogenase (SDH) activity were detected. Results CBF in 10 ears in the control group was (50?7)%, and the elevated ABR threshold was found in 7 ears (70%). Ferromagnetic emboli confirmed by carbonyl iron spheres were extensively distributed in the microvessels in the cochlear lateral wall. Spot like lesion of the outer hair cells was found in SDH stained basic membrane. However, in BH group, CBF was (81?11)%. Elevated threshold of ABR was found in only 3 ears, and the ferromagnetic emboli in the microvessles in the cochlear lateral wall were less than those in the control group. Scattered lesions of the outer hair cells were found in SDH stained basic membrane. There was significant difference in the number of deleted hair cells between the BH group and the control group. Conclusion The preliminary results indicated that BH may increase CBF and attenuate the cochlear lesion due to ischemia, resulting in partial protection of hearing.

Study on Stability of Four Kinds of Cardiovascular Ready-prepared Chinese Medicine in Betahistine Hydrochloride Sodium Chloride Injection / 中成药

Objective: To study the stability of four kinds of cardiovascular ready-prepared Chinese medicine (Injections of Ciwujia, Shenmai, Dengzhanhuasu and Gegensu) in Betahistine Hydrochlorizel Sodium Chloride Injection. Methods: Four kinds of drugs were added into Betahistine Hydrochloride Sodium Chloride, respectively, and mixed, then observed for 6 hours at 23?C. Results: The appearance, pH value and concentration of four drugs above mentioned were stable in Betahistine Hydrochloride sodium chloride sodium chloride at room temperature (23?C) and in 6 hours. Conclusion: Injections of Ciwujia, Shenmai, Dengzhaihuasu and Gegensu are stable in Betahistine Hydrochlonile Sodium Chloride.

Quantitative Determination of Main Component and the Related Substances in Betahistine Hydrochloride for Injection by HPLC / 中国药房

OBJECTIVE:To determine the contents of betahistine hydrochloride and the related substances by HPLC.METHODS:The chromatographic separation was performed on Eclipse XDB-C18 column with column temperature at 25 ℃.The mobile phase consisted of water(sodium heptanesulfonate+10 mL triethylamine+810 mL water,with the pH adjusted to 3.0 with phosphoric acid) and methanol(82:18) at a flow rate of 0.8 mL?min-1.The detection wavelength was 261 nm and the sample size was 50 ?L.RESULTS:The linear range of betahistine hydrochloride was 10～80 ?g?mL-1(r=0.999 3).The lowest detection limit was 2.84 ?g?mL-1 and the lowest quantitative limit was 3.01 ?g?mL-1.The average recovery was 99.8%(RSD=0.3%).The average content for the related substances in 3 batches of samples was 0.13%.CONCLUSION:The method is simple,rapid,accurate and reliable,and suitable for the quality control of betahistine hydrochloride.