Stability of (1R,2S)-(-)-Ephedrine hydrochloride in Candida albicans-inoculated urine and blood samples.

The stability of drugs in biological evidence during collection and storage is of particular concern in forensic investigations. Microbes in the samples and other elements are an essential component of these investigations. In the current study, the HPLC method was used to examine the stability of (1R, 2S)-(-)-Ephedrine hydrochloride in plasma and urine samples inoculated with C. albicans after storage at 37 °C for 48 h and -20 °C for six months. In the stability experiment, MIC50% of (1R, 2S)-(-)-Ephedrine hydrochloride was applied according to MIC and MFC that were determined in this work. This drug had MIC and MFC of 50 and 100 ppm, respectively. In HPLC analysis, the standard (1R, 2S)-(-)-Ephedrine hydrochloride had a retention time of 1.63 and was used to identify this drug in samples that had or had not been exposed to C. albicans. The findings demonstrated that within 48 h at 37 °C, C. albicans had an impact on the drug concentration (10% and more than 15%, respectively, were lost in plasma and urine samples inoculated with C. albicans). In plasma samples, the drug content remained stable at -20 °C for three months, although it degraded in urine samples after one month. In plasma and urine samples, the concentration reduction had surpassed 70% and 50% by the sixth month, respectively. The results of this investigation show that C. albicans can change the stability of (1R, 2S)-(-)-Ephedrine hydrochloride in plasma and urine samples that contain MIC50% of Ephedrine hydrochloride.

Detection and Identification of an Unknown Impurity in Ephedrine HCl 5 mg/mL Cyclic Olefin Syringes: Formulation Development.

An unknown impurity was detected in in-house prepared ephedrine hydrochloride (HCl) 5 mg/mL prefilled sterilized syringes when applying a stability-indicating British Pharmacopoeia 2018 impurity method for ephedrine injection. Ultraviolet, chromatographic, mass spectral, and physicochemical methods were combined to identify the unknown impurity. The unknown impurity was identified as methcathinone, which is generated from ephedrine drug substance through an oxidation reaction. A formulation study, in which different process adjustments were tested, was carried out to reduce the amount of unknown impurity. Nitrogen gassing in combination with 0.05 M citrate buffer addition proved to be the most potent process adjustment in reducing methcathinone formation in ephedrine HCl 5 mg/mL prefilled sterilized syringes after 4 months of storage in the dark at room temperature (20 °C ± 5 °C). More detailed research on the long-term stability of the reformulated ephedrine HCl drug product is currently underway, with promising results for up to 9 months gathered already.

Protective effect of gui zhi (Ramulus Cinnamomi) on abnormal levels of four amino acid neurotransmitters by chronically ma huang (Herb Ephedra) intoxicated prefrontal cortex in rats treated with a ma huang-gui zhi herb pair.

ETHNOPHARMACOLOGICAL RELEVANCE: The Herb Ephedra (Ma Huang in Chinese)-Ramulus Cinnamomi (Gui Zhi in Chinese) herb pair is a classic traditional Chinese herb pair used to treat asthma, nose and lung congestion, and fever with anhidrosis. In previous study, we found that chronic administration of ma huang induced obvious neurodegeneration in rat brains, with the prefrontal cortex showing the greatest effect. Gui zhi decreased hyperactivity produced by repeated ma huang administration, and attenuated oxidative stress in rat prefrontal cortex induced by ma huang. AIM OF THE STUDY: The study was aimed to investigate the protective effect of gui zhi on ma huang-induced abnormal levels of four amino acid neurotransmitters in rat prefrontal cortex. MATERIALS AND METHODS: All ma huang and ma huang-gui zhi herb pair extracts were prepared using methods of traditional Chinese medicine and were normalized based on the ephedrine content. Two-month-old male Sprague-Dawley rats (6 rats/group) were administered ma huang or ma huang-gui zhi herb pair extracts for 1, 3, 5 or 7 days (ephedrine = 48 mg/kg). The contents of ephedrine, glutamate (Glu), aspartic acid (Asp), glycine (Gly), and gamma-aminobutyric acid (GABA) in the prefrontal cortex were determined using ultra-high-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) at 0.5, 1.0, 5.0 h after administration. RESULTS: Ma huang significantly enhanced the levels of GABA, Gly, Glu and Asp in the prefrontal cortex, while gui zhi partially abolished the effects. CONCLUSIONS: Ma huang-induced neurotoxicity may be associated with its effects on amino acid neurotransmitters. Gui zhi is a promising neuroprotective agent against for ma huang-induced neurotoxicity. The information presented in this study will help supplement the available data for future ma huang-gui zhi herb pair compatibility studies.

Simultaneous Determination of Ephedrine Hydrochloride ，Pseudoephedrine Hydrochloride ，Methamphetamine Hydrochloride and Paeoniflorin in Xiaoqinglong Granule by Micellar Capillary Electrophoresis Method / 中国药房

OBJECTIVE： To establish the method for simultaneous determination of ephedrine hydrochloride， pseudoephedrine hydrochloride， methamphetamine hydrochloride and paeoniflorin in Xiaoqinglong granule. METHODS： Micellar capillary electrophoresis （MCE） method was adopted. The optimum conditions for the separation were as follows as a fused silica capillary column as the separation channel， the buffer solution composed of 10 mmol/L borax-10 mmol/L SDS （95 ∶ 5， pH 10.5）， detection wavelength of 195 nm， separation voltage of 20 kV， capillary column temperature of 15 ℃，the sampling at a pressure for 0.5 psi×5 s. Two batches of Xiaoqinglong granules were collected from 2 manufacturers to determine the contents of ephedrine hydrochloride， pseudoephedrine hydrochloride， methamphetamine hydrochloride and paeoniflorin. The results of content determination were compared with the results determined by HPLC method stated in Chinese Pharmacopeia of 2015 edition. RESULTS： The linear range of ephedrine hydrochloride， pseudoephedrine hydrochloride， methamphetamine hydrochloride and paeoniflorin were 10-160， 10-160， 1-100， 10-500 μg/mL （r＝0.997 9-0.999 8）， respectively. RSDs of precision， reproducibility and stability tests were all ≤2.74％ （n＝5-6）. The average recoveries were 101.55％， 101.62％， 100.15％， 101.85％ （RSD≤3.94％， n＝6）， respectively. The contents of 4 components determined by micellar capillary electrophoresis were in accordance with the results of HPLC method. CONCLUSIONS： The established MCE method is simple， quick and sensitive， and can be used for simultaneous determination of 4 components mentioned above in Xiaoqinglong granule.

Ephedrine hydrochloride protects mice from staphylococcus aureus-induced peritonitis.

Staphylococcus aureus is a Gram-positive (G+) bacterium that causes a wide range of diseases in humans and livestock. Therefore, the development of innovative and effective therapies is essential for the treatment of S. aureus-induced severe infections. Ephedrine hydrochloride (EH) is a compound derived from ephedrine and is widely used for the management of cardiovascular diseases and hypotension. The results of our previous studies demonstrated that EH has anti-inflammatory activity in macrophages and protects against endotoxic shock. However, whether EH regulates the function of dendritic cells (DCs) and the immune response in S. aureus-induced infection is unknown. In this study, the anti-inflammatory and regulatory activity of EH on DCs was evaluated. EH increased the production of anti-inflammatory cytokine IL-10 and decreased the production of proinflammatory cytokines TNF-α and IL-12 in DCs stimulated with peptidoglycan (PGN), the main cell wall component in G+ bacteria. The PI3K/Akt and p38 MAPK signaling pathways controlled EH-induced IL-10 expression and EH-inhibited TNF-α expression, respectively. The PGN-induced expression of co-stimulatory molecules CD40, CD80, CD86, and MHC class II molecule Iab was down-regulated in DCs by EH. Furthermore, EH protected the liver and kidney and increased the survival rate of mice with S. aureus-induced peritonitis. In conclusion, EH helps to keep immune homeostasis and alleviate organ damage during S. aureus-induced peritonitis. Therefore, EH may be a promising drug candidate in the treatment of S. aureus-induced severe infections and other invasive G+ bacterial infections.

Simultaneous Determination of 5 Constituents in Xiao'er Magan Granule by HPLC-QAMS / 中国药师

Objective:To develop a method of quantitative analysis of multi-components by single marker(QAMS)for the determi-nation of five constituents(ephedrine hydrochloride,amygdalin,liquiritin, baicalin and ammonium glycyrrhizinate)in Xiao'er Magan granule. Methods:Amygdalin was used as the internal reference substance, and the relative correlation factors(RCF) of ephedrine hydrochloride,liquiritin,baicalin and ammonium glycyrrhizinate to amygdalin were calculated and evaluated. The contents of the five constituents were determined by the external standard method(ESM) and QAMS,respectively. The content results determined by the two methods were compared and the feasibility of QAMS method was verified. Results:The RCF between amygdalin and the other con-tents was 1.237,1.318,1.327 and 0.884,respectively. There were no significant differences in the results between QAMS and ESM with the relative errors less than 0.3%. Conclusion:The QAMS method is accurate and feasible for the simultaneous determination of Xiao'er Magan granule.

Simultaneous Determination of Ephedrine Hydrochloride and Amygdalin in Kangzhi Syrup by HPLC / 中国药师

Objective:To establish an HPLC method for the determination of ephedrine hydrochloride and amygdalin in Kangzhi syrup. Methods:The separation was performed on a Waters ODS2(250 mm×4.6 mm,5 μm) column. The mobile phase consisted of acetonitrile-0.2% phosphoric acid solution(containing 0.1% triethylamine) with gradient elution,the detection wavelength was at 205 nm,the flow rate was 1.0 ml·min-1,and the column temperature was 30℃. Results: Ephedrine hydrochloride and amygdalin was linear within the range of 0.169-3.380 μg(r=0.999 9)and 0.141-2.820 μg(r=0.999 7), respectively.The average recovery of e-phedrine hydrochloride and amygdalin was 98.8% and 99.1% with the RSD of 1.93% and 1.22%(n=6), respectively.Conclu-sion:The method is rapid and accurate for the simultaneous analysis of ephedrine hydrochloride and amygdalin, which can provide a reliable way for the quality control for Kangzhi syrup.

Simultaneous Determination of Six Components in Xiao'er Kechuanling Granule by HPLC / 中国药师

Objective:To establish an HPLC method to determine the contents of ephedrine hydrochloride, (R, S)-goitrin, lae-trile,chlorogenic acid,licorice glycosides and glycyrrhizic acid in Xiao'er Kechuanling granule.Methods:The chromatography condi-tions were as follows:an Agilent Eclipse XDB-C18(250 mm×4.6 mm,5 μm) column was used,and acetonitrile-0.1% phosphoric acid was applied as the mobile phase. The flow rate was 1.0 ml·min-1with gradient elution. The wavelength was 207 nm for ephed-rine hydrochloride and laetrile,237 nm for glycyrrhizic acid,licorice glycosides and chlorogenic acid and 245 nm for (R,S)-goitrin. Results:The linear range of ephedrine hydrochloride was 2.423-96.920 μg·ml-1(r =0.999 2), and the average recovery was 100.1% (RSD=0.30%,n=6). The linear range of (R, S) -goitrin was 1.920-76.798 μg·ml-1(r=0.999 9), and the average recovery was 99.86% (RSD=1.14%,n=6). The linear range of chlorogenic acid was 2.396-92.891 μg·ml-1(r=0.999 9),and the average recovery was 98.57% (RSD =0. 75%,n =6). The linear range of amygdalin was 1.982-79.279 μg·ml-1(r =0.999 8),and the average recovery was 99.67% (RSD=0.59%,n=6). The linear range of glycyrrhizin was 2.136-85.440 μg· ml-1(r=0.999 9),and the average recovery was 98.57% (RSD=0.69%,n=6). The linear range of glycyrrhizic acid was 2.432-97.260μg·ml-1(r=0.999 9),and the average recovery was 98.57% (RSD=0.11%,n=6). Conclusion: The method is accu-rate and reliable,which can be used for the quality control of Xiao'er Kechuanling granule.

Determination of Ephedrine Hydrochloride in Tongxuan Lifei Pills by Accelerated Solvent Extraction Com-bined with QuEChERS Purification / 中国药师

Objective:To study the feasibility of the determination of ephedrine hydrochloride in Tongxuan Lifei pills by acceler-ated solvent extraction ( ASE) combined with QuEChERS purification, and compare the results with those of the extraction method in Chinese Pharmacopoeia. Methods: The extraction efficiency of ephedrine hydrochloride in Tongxuan Lifei pills determined by HPLC was used as the evaluation index, and the operation parameters of ASE were optimized by orthogonal experiments. Results: The opti-mum conditions of ASE for the determination of ephedrine hydrochloride in Tongxuan Lifei pills were as follows:the samples were defat-ted by n-hexane ( the extraction temperature was 80℃, the static extraction time was 5 min for one cycle, and the flush volume was 100%. ) ,and then methanol was used as the extraction solvent for the extraction of ephedrine hydrochloride ( the extraction temperature was 80℃,the static extraction time was 8 min for three cycles) ,in the end, the impurities were purified by PSA purifying agent. Using the optimized ASE method to extract ephedrine hydrochloride in Tongxuan Lifei pills, the extraction time was reduced to 40 minutes with less interference, and compared with that of the method in Chinese Pharmacopoeia, the determination of the relative standard devi-ation was less than 5%. Conclusion:The ASE technique combined with QuEChERS purification is simple, quick and effective,and it can be used as the pretreatment method for the determination of ephedrine hydrochloride in Tongxuan Lifei pills.

Simultaneous Determination of Six Active Constituents in Jizhi Syrups by HPLC with Wavelength Switc-hing / 中国药师

Objective:To establish an HPLC method for the simultaneous determination of six active constituents ( ferulic acid, chlorogenic acid,ephedrine hydrochloride,protocatechuic acid,protocatechualdehyde and naringin) in Jizhi syrups. Methods:A Zorbax XDB-C18(4.6 mm×250 mm,5 μm)column was used. The mobile phase consisted of acetonitrile (A)-0.9% acetic acid (B) with gradient elution at the flow rate of 1. 0 ml·min-1 . The detection wavelength was changed as follows:257 nm for 0-22. 0 min, 326 nm for 22. 0-30. 0 min, 320 nm for 30. 0-52. 0 min, 210 nm for 52. 0-58. 0 min and 283 nm for 58. 0-60. 0 min. The column temperature was 30 ℃ and the injection volume was 10 μl. Results:The separation of the six active constituents was good. The linear range ( r>0. 9990) was 2. 817-112. 670, 2. 342-93. 670, 0. 710-28. 415, 0. 776-31. 035, 0. 694-27. 755 and 1. 279-51. 175 ng for ferulic acid, chlorogenic acid, ephedrine hydrochloride, protocatechuic acid, protocatechualdehyde and naringin, respectively. The average recover-ies varied from 99.3% to 99.8%(RSD varied from 0.18% to 0.28%). Conclusion: The method is rapid with high sensitivity, promising accuracy and good specificity, which can provide scientific basis for the quality control of Jizhi syrups.

Simultaneous determination of four constituents in Kesuting Capsules by HPLC / 中成药

AIM To establish an HPLC method for the simultaneous content determination of four constituents in Kesuting Capsules (a fast cough suppressant,containing Ephedrae Herba,Papaveris Pericarpium,Platycodonis Radix,etc.).METHODS The analysis of trichloromethane-strong ammonia extract of Kesuting Capsules was performed on a 35 ℃ thermostatic Welch Ultimate(◎) XB-C18 column (4.6 mm ×250 mm,5 μm),with the mobile phase comprising of acetonitrile-0.01 mol/L potassium dihydrogen phosphate buffer flowing at 1.0 mL/min in an isocratic elution manner,and the detection wavelength was set at 210 nm.RESULTS Morphine,ephedrine hydrochloride,pseudoephedrine hydrochloride and codeine phosphate showed good linear relationships within the ranges of 8.054-67.12 μg/mL (r =0.999 5),22.31-185.9 μg/mL (r =0.999 9),21.26-177.2 μg/mL (r =0.999 7) and 1.212-10.09 μg/mL (r =0.999 7),whose average recoveries (n =9) were 100.9％ (RSD =2.0％),101.4％ (RSD =3.6％),105.3％ (RSD =1.2％) and 106.2％ (RSD =1.2％),respectively.CONCLUSION This simple method can be used for the rapid quality control of Kesuting Capsules.

Simultaneous Determination of 3 Components in Compound Diphenhydramine Nasal Drop by RP-HPLC / 中国药房

OBJECTIVE:To establish a method for simultaneous determination of ephedrine hydrochloride,nitrofural and di-phenhydramine hydrochloride in Compound diphenhydramine nasal drop. METHODS:RP-HPLC method was adopted. The determi-nation was performed on Inertsil ODS-3 C18 column with mobile phase consisted of 0.05 mol/L potassium dihydrogen phosphate buf-fer(pH 7.0)-acetonitrile(gradient elution)with flow rate of 1.0 mL/min. The detection wavelength was set at 256 nm,and the col-umn temperature was 35 ℃. The sample size was 20 μL. RESULTS:The concentrations of phedrine hydrochloride,nitrofural and diphenhydramine hydrochloride ranged 122.1-366.3 μg/mL(r=0.9999),5.2-15.5 μg/mL(r=0.9998)and 31.5-94.5 μg/mL(r=0.9994),respectively. The limits of quantitation were 2.442,0.010,2.520 μg/mL,and the limits of detection were 0.810,0.003, 0.830 μg/mL,respectively. RSDs of precision,stability and reproducibility tests were lower than 1.0%. The recoveries of them were 99.2%-101.7%(RSD=0.9%,n=9),96.4%-102.0%%(RSD=1.7%,n=9),100.2%-101.9%(RSD=0.4%,n=9),respec-tively. CONCLUSIONS:The method is simple,accurate and reproducible,and can be used for simultaneous determination of ephedrine hydrochloride,nitrofural and diphenhydramine hydrochloride in Compound diphenhydramine nasal drop.

[Optimization of ultrasonic extraction process for Xiaoqinglong granules by Box-Behnken in condition of medium scale].

This paper is to investigate the optimization conditions of ultrasonic technique for extraction process of Xiaoqinglong granules in medium scale. First of all, single factor experiment was used to determine the overall impact tendency and range of each factor； secondly, Box-Behnken method was used for optimization and detecting the content of paeoniflorin, ephedrine hydrochloride, glycyrrhizic acid of the liquid medicine. Their respective extraction rate was calculated and the comprehensive evaluation was carried out. The results were used as the evaluation basis for the efficacy of Xiaoqinglong granules ultrasonic extraction. The test results showed that the optimum extraction process of Xiaoqinglong granules by ultrasonic extraction was under the following conditions: ultrasonic power 600 W, liquid-solid ratio 10∶1, extraction for 31 min. Under this condition, the predicted value of extraction rate for Xiaoqinglong granules was 85.90%, and the test value was 85.87%. The mathematical model(P<0.01) established in this paper was significant, and can be used for the analysis and prediction of the ultrasonic extraction process of Xiaoqinglong granules.

Fingerprint and multi-components quantitative determination for Jizhi Syrup by HPLC / 中草药

Objective: To establish an HPLC fingerprint method of Jizhi Syrup and determine the contents of its main components. Methods: The Waters XTerra RP-18 (250 mm × 4.6 mm, 5 μm) column was used with a mobile phase of 0.8% acetic acid (containning 0.2% triethylamine) and acetonitrile gradient elution, the flow rate was 1.0 mL/min, the column temperature was 35℃, and the detection wavelength was 280 nm. The Similarity Evaluation System for Chromatographic Fingerprint of TCM (2012 edition) was used to establish the fingerprint spectra and analyze the similarity degree. The common peaks were identified by reference compounds and negative controls, and the content was detected. Results: The fingerprint chromatography included 17 mutual peaks. Peak 2 and peak 8 were from Houttuyniae Herba, peak 4 and peak 10 were from Fagopyri Dibotryis Rhizoma, peaks 7, 12, and 15 were from Ilicis Chinensis Folium, peaks 1 and 13 were from Ephedrae Herba, peaks 16 and 17 were from Aurantii Fructus, and peaks 3 and 6 were from Houttuyniae Herba, Fagopyri Dibotryis Rhizoma, and Ilicis Chinensis Folium. The similarity among the batches was more than 0.98. Based on the retention time of master compounds, six components [protocatechuic acid (peak 3), protocatechualdehyde (peak 6), ferulic acid (peak 7), chlorogenic acid (peak 10), ephedrine hydrochloride (peak 13), and naringin (peak 16)] were identified and quantified. The contents of protocatechuic acid, protocatechualdehyde, ferulic acid, chlorogenic acid, ephedrine hydrochloride, and naringin in 10 batches of Jizhi Syrup were 3.122 1-3.270 0, 5.108 6-5.224 9, 8.893 2-9.120 8, 6.792 1-6.931 0, 2.154 4-2.236 2, and 4.125 8-4.183 3 mg/mL, respectively. Conclusion: The established method has high sensitivity, fast, precise and specificity, and can be used for the quality control of Jizhi Syrup.

Optimal separation and purification of extract in Sanao Sustained-release Tablets with macroporous resins by multi index comprehensive score / 中草药

Objective: To explore the optimal separation and purification of extract in Sanao Sustained-release Tablets. Methods: Taking the adsorption ratio and desorption ratio of ephedrine hydrochloride, pseudoephedrine hydrochloride, amygdalin, and glycyrrhizinate as evaluation indexes to optimize the purification process of Sanao Sustained-release Tablets by multi index comprehensive score. Results: Macroporous resin HPD 300 had the best adsorption and desorption properties. In the course of adsorption, the optimum concentration of the sample liquid was 1.67 g crude drugs of per milliliter, the resin column size ratio was 1: 7, the concentration of sample solution was 0.6 g/mL crude drug, the sample flow rate was 4.0 BV/h. In the course of elution, 2 BV deionized water was used and the resin column chromatography was eluted with 5 BV of 70% EtOH by flow rate of 3 BV/h. Conclusion: Macroporous resin HPD 300 is suitable to separate and purify the extract from Sanao Sustained-release Tablets.

Preparation and Quality Control of Thermosensitive Nasal Gel of Ephedrine Hydrochloride and Diphen-hydramine Hydrochloride / 中国药师

Objective:To prepare the thermosensitive nasal gel of ephedrine hydrochloride and diphenhydramine hydrochloride and establish its quality control method. Methods:The amounts of P407, P188 and PEG 6000 were optimized by an orthogonal test with the gelling temperature as the index. An HPLC method was established to determine the contents of ephedrine hydrochloride and di-phenhydramine hydrochloride. Results:The optimum amount of P407, P188 and PEG 6 000 was 19%, 2% and 1%, respectively. The linear range of ephedrine hydrochloride was 1.600 0-2.400 0 mg·ml-1(r=0.999 6), and the average recovery was 99.76%with RSD of 1. 02%(n=9). The linear range of diphenhydramine hydrochloride was 0. 160 0-0. 240 0 mg·ml-1(r=0. 999 7), and the average recovery was 101. 27% with RSD of 1. 10%(n=9). Conclusion:The formula design and preparation technology of the gel are feasible. The HPLC method is suitable for the quality control of the preparation.

Optimization of ultrasonic extraction process for Xiaoqinglong granules by Box-Behnken in condition of medium scale / 中国中药杂志

This paper is to investigate the optimization conditions of ultrasonic technique for extraction process of Xiaoqinglong granules in medium scale. First of all, single factor experiment was used to determine the overall impact tendency and range of each factor； secondly, Box-Behnken method was used for optimization and detecting the content of paeoniflorin, ephedrine hydrochloride, glycyrrhizic acid of the liquid medicine. Their respective extraction rate was calculated and the comprehensive evaluation was carried out. The results were used as the evaluation basis for the efficacy of Xiaoqinglong granules ultrasonic extraction. The test results showed that the optimum extraction process of Xiaoqinglong granules by ultrasonic extraction was under the following conditions: ultrasonic power 600 W, liquid-solid ratio 10∶1, extraction for 31 min. Under this condition, the predicted value of extraction rate for Xiaoqinglong granules was 85.90%, and the test value was 85.87%. The mathematical model(P<0.01) established in this paper was significant, and can be used for the analysis and prediction of the ultrasonic extraction process of Xiaoqinglong granules.

Estabilidad de gotas nasales de efedrina / Stability of ephedrine nasal drops

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.

Simultaneous determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Maxing oral solution by HPLC / 药学实践杂志

Objective To establish an HPLC method for determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Maxing oral solution .Methods Phenomenex Hydro-RP (250 mm × 4 .6 mm ,4 μm) was adopted .Acetonit-nile (A) and 0 .1% phosphonic acid solution (0 .1% triethanolamine solution)(B) was used as gradient mobile phase(0-20 min , 3% →10% A)at flow rate was 1 .0 ml/min and the program of UV gradient absorbance detection was 210 nm .The sample vol-ume was 20 μl .Results A good linearity was obtained over the concentration range of 0 .99-39 .6 μg/ml for ephedrine hydro-chloride (r=0 .999 9) and 1 .09-43 .6 μg/ml for pseudoephedrine hydrochloride (r=0 .999 9) .The average recovery of ephed-rine hydrochloride was 101 .5% with RSD of 1 .77% (n=6) ,and the average recovery of pseudoephedrine hydrochloride was 100 .8% with RSD of 1 .96% (n=6) .Conclusion This method was simple ,accurate and quick ,which could be used for deter-mination and quality control of Maxing oral solution with good selectivity and repeatability .

Content Determination of Ephedrine Hydrochloride in Luofu Mountain Rheumatism Plaster by HPLC / 中国药房

OBJECTIVE:To establish a method for the content determination of ephedrine hydrochloride in Luofu mountain rheumatism plaster. METHODS:HPLC was performed on the column of Eclipse XDB-C18 with the mobile phase of acetoni-trile-0.1%phosphoric acid(9∶91,V/V),at the flow rate of 1.0 ml/min. The detection wavelength was 207 nm,the column tempera-ture was 40 ℃,and the volume was 5 μl. RESULTS:The linear range of ephedrine hydrochloride was 81.6-408 ng(r=0.999 7);RSDs of precision,stability and repeatability tests were lower than 2%;and the average recovery rate was 96.73%(RSD=1.9%, n=6). CONCLUSIONS:The method is fast and accurate,and can be used for the content determination of ephedrine hydrochlo-ride in Luofu mountain rheumatism plaster.