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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.
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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 new formula of effective components in TCM for anti-allergic rhinitis (AR),and pro-vide reference for developing TCM preparations for anti-AR. METHODS:Using pseudoephedrine hydrochloride (0-13.5 mg/kg), total alkaloid extracts of Aconitum carmichaelii (0-21.18 mg/kg),volatile oil of asari radix (0-0.0092 mL/kg) in Mahuang Fuzi Xixin decoction as formula objects,uniform design method was used for drug grouping,and multiple regression analysis was con-ducted for the behavioral scores before and after administration,contents of histamine and immunoglobulin E (IgE) in serum of AR guinea pigs to obtain the best formula. Using Xinqin granule,Loratadine tablet,Mahuang Fuzi Xixin decoction respectively as positive control,efficacy of the best formula was verified from aspects of behavioral scores before and after administration,con-tents of histamine and IgE of AR guinea pigs. And the safety of the best formula was preliminarily observed through acute toxicity test in mice. RESULTS:The best formula was as follow as pseudoephedrine hydrochloride 11.25 mg/kg,total alkaloid extracts of A. carmichaelii 21.18 mg/kg,volatile oil of asari radix 0.0045 mL/kg. Compared with each positive drug group,there were no sig-nificant differences in behavioral scores before and after administration in the best formula group(P>0.05). While compared with Xinqin granule group and Mahuang Fuzi Xixin decoction group,histamine content in serum in the best formula group was signifi-cantly reduced (P<0.05);compared with Xinqin granule and Loratadine tablet group,IgE content in serum in the best formula group was significant decreased (P<0.05). Median lethal dose of the best formula was 1822.04 mg/kg. CONCLUSIONS:The screened best formula shows better effect than Xinqin granule and Mahuang Fuzi Xixin decoction in terms of reducing histamine content in serum,better than Loratadine tablet and Xinqin granule in terms of reducing IgE content in serum,with good safety, which indicates the feasibility of TCM effective component formula to a certain degree.
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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.
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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.
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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 .
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OBJECTIVE:To determine the concentration of pseudoephedrine hydrochloride in human plasma by LC/MS. METHODS:The separation of sample was performed on Zorbax Eclipse XDB C18 with diphenhydramine used as the internal standard.The mobile phase was a mixture of methanol-water(10mmol?L-1 NH4Ac plus 0.1% acetic acid)(55∶45) with a flow rate of 0.2mL?min-1.The column temperature was set at 30℃.The atmospheric pressure chemical ionization-mass spectrometry(APCI-MS) were adopted with pseudoephedrine m/z =166.1 and diphenhydramine m/z =242.3.RESULTS:The linear concentration range for pseudoephedrine was 3.2～408.96ng?mL-1(r=0.999 0) with lowest detection limit at 3.2ng?mL-1.The average recovery was 98.21% with both the intra-day RSD and the inter-day RSD at less than 13%.The stability of pseudoephedrine was stable.CONCLUSION:The method is of high sensibility and accuracy,and it can be used for blood concentration monitoring pharmacokinetic study of pseudoephedrine.
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OBJECTIVE:To establish an HPLC method for the content determination of pseudoephedrine hydrochloride and dextromethorphan hydrobromide in pediatric pseudoephedrine dextromethorphan drops. METHODS:The separation was performed nomn .A Tghilee nftl oCw18 rcaotelu wmans wseitth a tm 0o.b6i lme Lp?hmasien -o1f amnedt hthaen oiln-j ewcatitoern- vtroieluthmynla mwainse 1(05 ?60L .∶ 4R3E0S ∶ U10L,TSp:H=Th3e. 0l)ineaat rd reatnegctei own ewrea v7e.3le4n～gt7h3 o.4f ?2g0?9 mL-1 for pseudoephedrine hydrochloride(r=0.999 9,n=5)with an average recovery of 99.1%(RSD=0.76%,n=9)and 2.55～25.5 ?g?mL-1 for dextromethorphan hydrobromide(r=0.999 9,n=5)with an average recovery of 98.0%(RSD=0.87%,n=9). CONCLUSION:The method is accurate and reproducible for quality control of pediatric pseudoephedrine dextrometharphan drops.
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0.999). The relative standard deviation (RSD) of chromatogram area was less than 1.0% for all of them after six successive injections. The detection limit was 0.05 ?g/mL for norephedrine (NE), 0.04 ?g/mL for norpseudoephedrine (NPE), 0.1 ?g/mL for E and PE, and 0.2 ?g/mL for mephedrine (ME) and mepseudoephedrine (MPE), respectively (S/N≥3). The recovery rate was more than 97.1% for six ephedrine alkaloids. Under this method system, all of the above-mentioned six samples were tested and found to contain some of the impurity at different levels. Conclusion This developed method, which is very simple, perfect precision, high sensitivity, and selectivity, can be used for the qualitative and quantitative determination of impurities of ephedrine alkaloid-type samples.
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AIM: To establish the methods for determining ephedrina hydrochloridum,pseudoephedrine hydrochloride,puerarin,baicalin in Ganmao Soft Capsule (Herba Ephedrae,Radix Puerariae lobatae,Radix Scutellariae,Ramulus Cinnamomi,Radix Angelicae sinensis,Radix Angelicae dahuricae,etc.) METHODS: Part 1(determination of ephedrina hydrochloridum and pseudoephedrine hydrochloride):The HPLC was carried out on kromasilTMC18 column(4.6 mm ? 250 mm,5 ?m) with acetonitrile-0.02 mol/L phosphoric acid solution(pH2.7)-triethylamine(2 ∶ 98 ∶ 0.1)as mobile phase,gradient elution.The detection wavelength was set at 207 nm.Part 2(determination of pueranin and baicalin):The HPLC was carried out on kromasilTMC18 column(4.6 mm ? 150 mm,5 ?m)with acetonitrile-water(11 ∶ 89)as mobile phase,gradient elution.The detection wavelength was set at 250 nm.RESULTS: The average recoveries were 99.96% with RSD 1.25% ,98.41% with RSD 1.46% ,98.67% with RSD 0.91% ,99.30% with RSD 0.88% ,respectively.CONCLUSION: The assay results demonstrate that the methods are simple,accurate and reproducible for quantification of four active components in Ganmao Soft Capsule.
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AIM: To establish the method for determining ephedrine hydrochloride and pseudoephedrine hydrochloride in Jieduwanling Pills (Rhizoma atractylodis,Herba ephedrae,Herba dendrobii,etc.)by RP-HPLC. METHODS : The Agilent Extend C_ 18 column with acetonitrile-0.1%H_3PO_4(5∶95)as the mobile phase was used. The flow rate was at 1.0 mL?min -1 and the detective wavelength was at 206 nm. RESULTS : The calibration curve was linear at a range of 0.02028 ～1.014?g for the ephedrine hydrochloride( r =0.9999). the average recovery was 97.69% and RSD was 0.9%( n =6). The calibration curve was linear at a range of 0.02254 ～ 1.127 ?g for the pseudoephedrine hydrochloride( r =0.9998). The average recovery was 98.40% and RSD was 2.3%( n =6). CONCLUSION : The method is accurate with a good reproducibility and can be used as a quantitative analysis for this preparation.
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AIM: To establish the quality standard for Fenghan Ganmao Granules. METHODS: TLC was used to identify Radix Puerariae, Pericarpium Citri Reticulatae and Radix Glycyrrhizae. The contents of ephedrine hydrochloride and pesudoephedrine hdrochloride were determined by HPLC. RESULTS: The linear range of ephedrine hydrochloride was 0.16 - 8.07 ?g, r= 0.999 9 . The average recovery was 97.00% . The linear range of pesudoephedrine hydrochloride was 0.06 - 2.86 ?g, r= 0.999 9 . The average recovery was 98.32% . CONCLUSION: The methods are simple. The result is accurate and the reproducibility is good. There mothods can be used as the quality control of Fenghanganmao Granules.
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AIM: To establish a determination for ephedrine hydrochloride and pseudoephedrine hydrochloride in Suxing Capsules(Herba Ephedrae, Semen Armeniacae Amarum, Fructus Perillal, etc.). METHODS:HPLC with Agilent ZORBAX Extend C_(18) (250 mm?4.6 mm, 5 ?m) column was used. Acetonitrile-0.2% H_3PO_4(5∶95) was used as a mobile phase. The flow rate was 1.0 mL?min~(-1). The detection wawelength was at 210 nm. RESULTS:The methodological evaluation showed that this method had a good repeatability and reproducibility; The average recovery of ephedrine hydrochloride was 99.65% and RSD was 1.6%. The average recovery of (pseudoephedr)ine hydrochloride was 98.90% and RSD was 2.3%. CONCLUSION: This method is simple, quick, accurate and with good reproducibility and can be used for the quality control of Suxing Capsules.
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OBJECTIVE:To evaluate the cough-relieving and sputum-eliminating efficacy and safety of Guaifenesin Pseudoephedrine Hydrochloride-Codeine Phosphate Oral Solution.METHODS:By a randomized control study,a total of 60 patients characterized by nonproductive cough andlittle sputum were randomly assigned to receive Guaifenesin Pseudoephedrine Hydrochloride-Codeine Phosphate Oral Solution(Trial Group)or Ambroxol Hydrochloride Oral Solution(Control Group)l0 mL tid for 5～7 d.RESULTS:Both groups had a significant improvement in symptoms including cough and expectoration after treatment(P0.05).CONCLUSION:Guaifenesin Pseudoephedrine Hydrochloride-Codeine Phosphate Oral Solution is more effective in relieving cough than Ambroxol Oral Solution,and it has certain effect in eliminating phlegm.In addition,it is safe and has little adverse reaction.
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OBJECTIVE:To evaluate the clinical efficacy and safety of guaifenesin,pseudoephedrine hydrochloride- codeine phosphate oral solution in relieving cough,eliminating phlegm,relieving nasal stuffiness and other cold symptoms. METHODS:A total of 240 patients with cold symptoms(120 cases in trial group and another 120 cases in control group) were enrolled in our multicenter,randomized,double-blinded and parallel controlled study and treated with guaifenesin-pseudoephedrine hydrochloride-codeine phosphate oral solutionI or compound codeine phosphate liquor 10mL tid for(5?2)d.RESULTS:227(112 in trial group and 115 in control group) were the valid cases with completed trial.Compared with pre-treatment,both of the 2 groups had a significant improvement in symptoms including cough,expectoration and nasal stuffiness after treatment(P