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OBJECTIVE To study the intervention effects and mechanism of Compound yu ’e nasal drops on ovalbumin induced allergic rhinitis in rats . METHODS The allergic rhinitis model of rat was induced with ovalbumin . Model rats were randomly divided into model group ，triamcinolone acetonide group （positive control ，0.026 mg/kg），Compound yu ’e nasal drops high-dose，medium-dose and low -dose groups （134.4、67.2、33.6 mg/kg），12 rats in each group . Another blank control group was set. Except for blank control group ，the corresponding drugs were given by nasal drip twice a day for 14 days. One hour after last administration，the nasal symptom scores of rats were recorded ；the levels of serum immunoglobulin E （IgE），interleukin-2（IL- 2），IL-13 and tumor necrosis factor -α（TNF-α）were measured by enzyme -linked immunosorbent assay . The changes of nasal mucosa in rat were observed by HE staining . The expressions of TNF -α，IL-2 and IL -13 in nasal mucosa were detected by Western blot. RESULTS Compared with blank control group ，nasal symptom score and the levels of serum IgE ，IL-2，IL-13，TNF-α in model group were increased significantly （P＜0.01）；obvious pathological injury was found in nasal mucosa ，and the expressions of TNF -α，IL-2 and IL -13 protein were increased significantly （P＜0.01）. Compared with model group ，Compound yu ’e nasal drops significantly reduced the nasal symptom score ，the levels of serum IgE ，IL-2，IL-13，TNF-α to different extents ，improved pathological injury of nasal mucosa and significantly inhibited the expressions of TNF -α，IL-2 and IL -13 protein（P＜0.05 or P＜ 0.01）. CONCLUSIONS Compound yu ’e nasal drops play significant effects against allergic rhinitis in rats by regulating the balance of t ype 1 helper T cells/type 2 helper T cells ，balancing and inhibiting the secretion of inflammatory cytokines .
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Siddha system of medicine, one of the ancient, traditional Indian systems of medicine has unique diagnostic methods, therapeutics and treatment procedures. It has a vast range of external modalities of treatment for health management. This external management is classified into 32 types. They include minor surgical procedures and treatment procedures. These therapies are used both as mainstream and supportive therapies � both curative and prophylactic. Most of the therapies are aimed to maintain the equilibrium of the three humours (Vatham, Pitham, Kabam). Among them Nasiyam (Nasal instillation) is one of the external therapies which is a non-invasive procedure. Nasiyam is the process by which the drug is administered through nostrils. This is the treatment procedure to balance the Thirithodam in its normal level. This paper documents the efficacy of Nasiyam, methods of application, shelf life, effect of Nasiyam in treating various diseases, the list of single drug and compound drug formulations that can be used as Nasiyam, Indications and contraindications are discussed in detail. Nasiyam therapy is used to treat the diseases of vitiated Kabam such as migraine, sinusitis, bronchial asthma, nasal polyp etc.
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Introduction: Patola is an important plant drug used in many Ayurvedic medicinal preparations. The source plant of Patola is Trichosanthes cucumerina var. cucumerina, belonging to Cucurbitaceae family, found distributed (growing wild) throughout India especially in Bengal, Gujarat, Konkan, Deccan and Kerala. It is an extensively climbing annual herb with slightly downy or pubescent slender five angular 杅urrowed stems. It is found climbing over small trees, hedges and suitable supports. The present work is taken up with an objective to standardize Patola with detailed physical and preliminary phytochemical standards. Methods: Samples of Trichosanthes cucumerina var. cucumerina (Patola) was collected from Thellakom, Kottayam district. The plant was properly identified and authenticated by Dept of Botany, University of Kerala. The sample was shade dried and stored in an air tight container. Physicochemical, phytochemical, chromatographic and heavy metal analysis was carried out as per ICMR procedures. Result: On physicochemical evaluation water soluble extractive value was 9.07+ 0.012 and alcohol soluble extractive value was 18.72+ 0.027. Heavy metals copper, cadmium, iron and lead levels were within normal limits. HPTLC was carried out with Toluene: Ethyl acetate: Formic acid as solvent system and 3 spots were obtained. Conclusion: Patola, Trichosanthes cucumerina var. cucumerina, Phytochemicals, HPTLC, AAS.
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Objective To optimize extraction process of Qinhao Nasal Drops by multi-index comprehensive evaluation Method. Methods With L9(34) orthogonal design, the content of rupestonic acid, chlorogenic acid, pseudoephedrine hydrochloride, total flavonoids and extract yield were set as indexes, and extraction technology of Qinhao Nasal Drops was optimized.Results Optimum extraction technology was:12 times amount of 60% ethanol, extracted three times. Conclusion The optimized extraction technology is simple, practical, and adapt to the production needs, which can be used as the basis for reasonable development of the preparation.
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OBJECTIVE:To study the effect of HP-β-CD on solubility of 1,8-oxido-p-menthane in volatile oil of magnoliae flos,and optimize the extraction technology of Xinzhi nasal drops. METHODS:Steam distillation method was adopted to extract the volatile oil in magnoliae flos. Using the content of 1,8-oxido-p-menthane in volatile oil of magnoliae flos as index,HPLC was adopted to determine the effects of HP-β-CD with different concentration on solubility of 1,8-oxido-p-menthane in volatile oil of magnoliae flos. Using the comprehensive scores of imperatorin and extract yield as indexes,orthogonal test was used to optimize the amount of ethanol,volume fraction and extraction time in extraction technology of Xinzhi nasal drops. Verification test was car-ried out. RESULTS:50% HP-β-CD aqueous solution can improve the solubility of 1,8-oxido-p-menthane to 7.6 times. The optimal extraction technology of Xinzhi nasal drops was as follow as 10-fold 80% ethanol,extracting twice,1 h every time. In verification test,the average content of imperatorin was 0.078%(RSD=2.01%,n=3),and extract yield was 10.80%(RSD=1.85%,n=3). CONCLUSIONS:HP-β-CD shows good solubilization effect on the 1,8-oxido-p-menthane in volatile oil of magnoliae flos,and the optimized extration technology for Xinzhi nasal drops is feasible.
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OBJECTIVE:To optimize Azelastine hydrochloride (AH) thermosensitive in-situ gel nasal drops formulation. METHODS:Using poloxamer 407(P407)and poloxamer 188(P188)as excipients,AH thermosensitive in-situ gel was prepared by cold solution method. The formulation was optimized by central composite design-response surface methodology using the amount of P407 and P188(g/100 ml)as factors and phase-transition temperature as index. Binomial expression was fitted,and pre-dicted and measured values were compared. RESULTS:The correlation coefficient R2 fitted by binomial expression was equal to 0.986 5. The optimal formulation was as follows as P407 for 20.414 4%,P188 for 5.035 4%,measured value of(30.81±0.02)℃, predicted values of 31 ℃,deviation of 0.61%. CONCLUSIONS:AH thermosensitive in-situ gel nasal drops formulation is opti-mized by central composite design-response surface methodology.
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En el presente trabajo se realizó el estudio de estabilidad de las gotas nasales de efedrina. Primero se evaluó la influencia de los agentes preservantes demostrándose la incompatibilidad del clorhidrato de efedrina y el clorobutanol, por lo que fue seleccionada la combinación de cloruro de benzalconio y edetato disódico con excelentes resultados en la efectividad de preservos. Se elaboraron tres lotes pilotos de la formulación y se les realizó los estudios de estabilidad por el método acelerado y de vida de estante, respectivamente. Durante los seis meses (estabilidad acelerada) y hasta los 24 meses (vida útil) las características organolépticas cumplieron con las especificaciones establecidas. El pH del medio se comportó de manera estable cumpliendo con los límites establecidos. El principio activo no alcanzó una degradación mayor al 5%, mostrando buena estabilidad. La concentración de los preservos cumplió con los parámetros, así como el conteo microbiano del producto terminado. La formulación envasada en frascos de vidrio ámbar de calidad hidrolítica III, de capacidad nominal 15 mL con tapa de polipropileno de 18 mm y gotero interior de polietileno de alta densidad, mostró adecuada estabilidad física, química y microbiológica durante 24 meses.
The subject of this paper is a stability study of ephedrine nasal drops. We started by assessing the influence of preservative agents in the stability of the formulation. Ephedrine hydrochloride was proven to be incompatible with chlorobutanol. This led the researchers to choose a combination of benzalkonium chloride and edetate disodium, which yielded excellent results in terms of effectiveness. Three pilot batches of the formulation were prepared, and stability studies were carried out under the accelerated and shelf-life methods. For the six-month period of the accelerated stability study and the 24-month period of the shelf-life study, organoleptic characteristics were within established acceptable limits. The pH of the medium also remained stable, within acceptable limits. The degradation of the active ingredient was not greater than 5%, which indicates good stability. The concentration of preservative agents and microbial count in the finished product were also within established parameters. The formulation was packaged in amber glass bottles of hydrolytic quality III and 15 mL nominal capacity, with an 18 mm polypropylene cap and an HDPE internal dropper, and it showed adequate physical, chemical and microbiological stability during the 24 months of the shelf life stability study.
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Objective:To establish a method for the simultaneous determination of chlorphenamine maleate and ephedrine hydro-chloride in chlorphenamine maleate and ephedrine nasal drops by HPLC. Methods:An HPLC method was performed on a column of Purospher STAR RP18(150 mm × 4. 6 mm,5 μm)with the mobile phase of acetonitrile -potassium dihydrogen phosphate buffer(pH 3. 0 ± 0. 1)(18:82 v/v)at the detection wavelength of 210 nm(adjusting the flow rate and column temperature to 1. 0 ml·min-1 and 35℃,respectively). The injection volume was 20 μl. Results:A good linear relationship was established between the peak response and the concentration of ephedrine hydrochloride and chlorphenamine maleate over the range of 19. 81-118. 85μg·ml-1(r=0. 999 6) and 6. 21-37. 25 μg·ml-1(r=0. 999 8),respectively. The mean recovery of ephedrine hydrochloride and chlorphenamine maleate was 100. 39%(RSD=0. 69%,n=9)and 100. 11%(RSD=0. 60%,n=9),respectively. Conclusion:The proposed method shows high repeatability,good durability and promising accuracy. It can be employed for the determination of two components in chlorphena-mine maleate and ephedrine nasal drops.
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Objective To assess the efficacy of topical application of Ephedrine and furacilin nasal drops combined with tetracaine in reducing complications of pack removal after nasal surgery.Methods 81caseshaving un-dergone nasal septum surgery were randomly divided into the experimental group and control group: the former were treated with Ephedrine and furacilin nasal drops combined with tetracaine and the blank control group.The occur-rence of complications at removing nasal fillers after nasal surgery was assessed.Results The hemorrhage and pain in the experimental group were significantly less than those in the blank control group (p <0.05).Conclusion top-ical application of Ephedrine and furacilin nasal drops combined with tetracaineis an effective method for reducing the pains of pack removal after nasal surgery.
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OBJECTIVE: To prepare compound lincomycin nasal drops for children and establish a quality control method for this preparation. METHODS: Compound lincomycin nasal drops for children were prepared using lincomycin hydrochloride as main component with its content determined by polarimetry. The content and stability of the preparation within 12mon under room temperature were investigated. Meanwhile irritating test of rabbits' nasal mucosa was conducted. RESULTS: The prepared eye drops were limpid colorless liquid and it met the related standards stated in China Pharmacopeia(2005 edition) in identification as well as tests etc. Lincomycin hydrochloride showed a good linear relation in the range of 3.2～20.0mg?mL-1(r=0.999 9), with average recovery at 100.6%(RSD=0.69%). This preparation showed a little irritation on nasal mucosa, and it was stable within 12mon under room temperature. CONCLUSIONS: This preparation is simple and feasible in preparation technology and controllable in quality.
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OBJECTIVE:To optimize the ratio of glycerol in Chloramphenicol and Ephedrine Nasal Drops included in China's Hospitals Agents Norms.METHODS:By formula optimization and observation on clinical trials,the ratio of glycerol in Chloramphenicol and Ephedrine Nasal Drops was reduced from 300mL to 50mL.RESULTS & CONCLUSION:The Chloramphenicol and Ephedrine Nose Drops prepared in an optimized ratio of glycerol is of much less irritability,good transparency,good compliance in patients,more reliable efficacy,thus deserving to be popularized.
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OBJECTIVE:To establish a HPLC method for a simultaneous determination of moxifloxacin hydrochloride and ephedrine hydrochloride in compound moxifloxacin nasal drops.METHODS:The separation was performed on VP-ODS chromatographic column with column temperature at 30℃. The mobile phase consisted of phosphate buffer solution (which contained 0.02mol?L-1 sodium dihydrogen phosphate and 0.3% triethylamine, adjust pH to 3.0 by phosphoric acid) - methanol(60∶40) with flow rate at 1.0mL?min-1, detection wavelength at 214nm and sample size at 20?L. RESULTS: The linear ranges of moxifloxacin hydrochloride and ephedrine hydrochloride were 0.1～0.8(r=0.999 7,n=5) and 0.125～1.000?g (r=0.999 9, n=5), respectively,and their average recoveries were 98.94% (RSD=0.89%) and 99.67%(RSD=1.26%),respectively.CONCLUSION: The technique is simple, rapid, accurate, and reproducible, and it can be used as the quantity control of compound moxifloxacin nasal drops.
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OBJECTIVE:A RP-HPLC method to determine the contents of furacilin and ephedrine hydrochloride in compound furacilin nasal drops was established METHODS:Chromatographic detection was performed with a mixture of methanol-water-triethylamine-acetic acid(12∶88∶0 2∶1) as mobile phase and Kromasil C18(4 6mm?250mm,5?m) as separate column Chloramphenicol was selected as internal standard and the detection wavelength was 254nm RESULTS:The ingredients of compound furacilin nasal drops and internal standard were well separated within 18min Good linearities and recoveries for furacilin and ephedrine hydrochloride were obtained in their assay ranges CONCLUSION:The RP-HPLC method was found to be simple,accurate and suitable for the quality control of compound furacilin nasal drops
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OBJECTIVE: To prepare Biyanling nasal drops and establish a method for its quality control.METHODS: Biyanling nasal drops was prepared with ephedrine hydrochloride and chlorpheniramine maleate etc,and an HPLC method was established for the determination of chlorpheniramine maleate and ephedrine hydrochloride in Biyanling nasal drops.RESULTS: The Biyanling nasal drops were yellow emulsion and in line with the related standard specified in Chinese Pharmacopeia(2005 Edition) in identification and tests.The linear ranges of ephedrine hydrochloride and chlorpheniramine maleate were 0.210～2.096(r=0.999 8)?g?mL-1 and 79.6～796.0(r=0.999 9)?g?mL-1,respectively,and the average recoveries of ephedrine hydrochloride and chlorpheniramine maleate were 98.83%(RSD=1.45%) and 99.19%(RSD=1.37%),respectively.CONCLUSION: The preparation of nasal drops is feasible in technique,stable and controllable in quality.
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Objective: To establish the quality control standards of two intermediate products of Xingshen Nasal Drops:musk aromatic water and volatile oil of Acorus tatarinowii Schott so that the content of main components and composition of the different batches of ultimate products remained stable.Methods: The content limit of muskone of musk aromatic water was ascertained by GC-MS. And the characteristic finger print of volatile oil of Acorus tatarinowii Schott was established. Results: The content of muskone of musk aromatic water should be controlled at the range of 0.166～0.202mg/mL. RSD of muskone content of 3 batches of ultimate products was 4.49%, not larger than 10%. The characteristic finger point of volatile oil of Acorus tatarinowii Schott was composed of 6 main component peaks: Methyleugenol, cis-Methylisoeugenol, trans-Methylisoeugenol, Elemicin, ?-Asarone and ?-Asarone. This characteristiz finger print could be repeated when the ultimate product was determined. Conclusion: The establishment of quality control standard of intermediate product can raise the product quality of compound preparations. And GC-MS is one of effective determination methods.
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OBJECTIVE:To establish a HPLC method for content determination of ribavirin and diphenhydramine hy-drochloride in flu nasal drops.METHODS:The chromato bar was ZORBAX SB-CN,the mobile phase was acetonitrile-wa-ter-phosphoric acid(38∶62∶0.1),with the flow rate of1.0ml/min and the detection wave at224nm,the sample size was20?l.RESULTS:A good linear relationship were obtained between the peak areas and the concentrations of ribavirin and diph_ enhydramine hydrochloride respectively in the range from0.1～1.0mg/ml(r=0.9990)and0.02～0.2mg/ml(r=0.9930),the average recoveries were100.3%(RSD=0.62%,n=9)and100.8%(RSD=0.54%,n=9),respectively.CONCLUSI_ ON:This method is convenient,rapid,accurate,and brings about good recovery,it can be used for quality control of flu nasal drops.