复方福尔可定口服溶液佐治儿童支气管哮喘并呼吸道感染疗效观察

目的观察复方福尔可定口服溶液（噢特斯）辅助治疗婴幼儿或儿童支气管哮喘（哮喘）并呼吸道感染的疗效。方法儿童哮喘合并呼吸道感染患儿125例,治疗组57例,对照组68例,两组患儿均采用积极的抗感染、解痉、布地奈德雾化混悬液泵雾化吸入,疗程2~3d。治疗组给予口服澳特斯,对照组给予口服盐酸氨溴索糖浆口服,疗程均为5d。按咳、痰、喘症状评价疗效。结果治疗组与对照组的总有效率分别为89.5%及73.5%,差异有显著性意义（χ^2=4.23,P〈0.05）。结论澳特斯具有祛痰、消除刺激性咳嗽、消除呼吸道黏膜充血、缓解过敏症状的作用,且没有第一代抗组胺药的不良反应。澳特斯为草莓味的深红色口服溶液适用于儿童,口味好,容易为儿童接受,服药依从性好,不良事件发生率低。澳特斯更适用于大部分具有特应性体质的婴幼儿或儿童哮喘患儿。     

Pholcodine exposure raises serum IgE in patients with previous anaphylaxis to neuromuscular blocking agents

BACKGROUND: Neuromuscular blocking agents (NMBAs) can cause anaphylaxis through immunoglobulin E (IgE) antibodies that bind quaternary ammonium ion epitopes. These epitopes are present in numerous common chemicals and drugs, exposure to which, theoretically, could be of importance in the development and maintenance of the IgE sensitization promoting allergic reactions. Pholcodine is one such drug, which in a recent pilot study was shown to induce a remarkable increase in serum IgE levels in two IgE-sensitized individuals. The present study explores the effect of pholcodine exposure on IgE in a population with previously diagnosed IgE-mediated anaphylaxis towards NMBAs. METHODS: Seventeen patients were randomized to 1 week's exposure with cough syrup containing either pholcodine or guaifenesin. The primary variables serum IgE and IgE antibodies towards pholcodine, morphine and suxamethonium were measured before and 4 and 8 weeks after start of exposure. RESULTS: Patients exposed to pholcodine had a sharp rise in levels of IgE antibodies towards pholcodine, morphine and suxamethonium, the median proportional increases 4 weeks after exposure reaching 39.0, 38.6 and 93.0 times that of the base levels respectively. Median proportional increase of IgE was 19.0. No changes were observed in the guaifenesin group. CONCLUSION: Serum levels of IgE antibodies associated with allergy towards NMBAs increase significantly in sensitized patients after exposure to cough syrup containing pholcodine. Availability of pholcodine should be restricted by medical authorities because of the potential risk of future allergic reactions to muscle relaxants.     

Prevalence of IgE antibodies to morphine. Relation to the high and low incidences of NMBA anaphylaxis in Norway and Sweden, respectively

BACKGROUND: Anaphylactic reactions to a neuromuscular blocking agent (NMBA) is more than six times as common in Norway as in Sweden, probably due to differences in preoperative sensitization. The prevalence of IgE-sensitization to morphine (MOR) and suxamethonium (SUX) in comparable populations in Bergen, Norway, and Stockholm, Sweden, was studied and related to possible sensitizing agents. METHODS: Three hundred sera of 'allergics' and 500 blood donors in Bergen and Stockholm were tested for IgE antibodies to MOR and SUX using Pharmacia Diagnostics ImmunoCAP(Uppsala, Sweden) assay and the results compared to those of 65 patients from Bergen with documented anaphylaxis to NMBA. In addition, 84 different household chemicals were tested, by IgE antibody inhibition, for SUX and MOR. RESULTS: In Norway 0.4% of blood donors, 3.7% of allergics and 38.5% of anaphylactics were IgE-sensitized to SUX, and 5.0, 10.0 and 66.7%, respectively, to MOR. No serum from Sweden was positive. The majority of those sensitized (69%) were women. Several household chemicals contained SUX and/or MOR activity, but the only difference between Norway and Sweden was cough mixtures containing pholcodine (PHO). IgE antibodies to PHO were present in 6.0% of blood donors from Norway and in no serum from Sweden. Of the anaphylactics, 65-68% were sensitized to MOR or PHO but only 39% to SUX. CONCLUSIONS: IgE-sensitization to SUX, MOR and PHO was detected in Norway but not in Sweden. One possible explanation is the unrestricted use of cough mixtures containing MOR derivatives in Norway.     

复方福尔可定口服液的HPLC和TLC测定

建立了HPLC法和TLC法分别测定复方福尔可定口服液的含量和有关物质。HPLC采用AlltimaC18色普柱，流动相对为甲醇－1．0％十二烷基硫酸钠溶液－冰醋酸25：55：35：0．3），检测波长为265nm，3个主成分的平均回收率分别为99．5％（RSD0．71％）、100．0％（RSD0．305）和100．0％（RSD0．85％）。线性相关系数均大于0．9992，日内、日间精密度均小于0．60％。TLC以硅胶G薄层层析板，展开剂为乙醇－甲苯－丙酮－浓氨溶液（70：70：65：5）。     

非水滴定与电位滴定法测定福尔可定含量的比较

目的对非水滴定和非水电位滴定法测定福尔可定的含量进行比较。方法均以冰醋酸为溶剂,非水滴定法采用结晶紫作为指示剂指示滴定终点,电位滴定法测定以第二个滴定突跃为滴定终点,两法均对滴定结果进行空白校正。结果电位滴定法滴定突跃明显,测定出的3批实际样品含量高于非水滴定的结果。结论因非水电位滴定法操作简单、滴定突跃明显,相较于非水滴定法能更好地控制福尔可定的质量。     

澳特斯小儿止咳露中4种主成分的含量测定

目的:建立同时检测复方制剂中福尔可定、盐酸伪麻黄碱、愈创木酚甘油醚和盐酸曲普利啶含量的高效液相色谱法。方法:采用C18柱,以25 mmol·L-1磷酸二氢钾水溶液(含2.5 mmol·L-1庚烷磺酸钠)-甲醇-三乙胺-磷酸(110:90:0.2:0.3)为流动相,流速为1 mL·min-1,检测波长为255 nm。结果:福尔可定、盐酸伪麻黄碱、愈创木酚甘油醚和盐酸曲普利啶4种成分的回收率分别为102.6％,100.3％,97.36％,96.82％;RSD分别为0.7％,1.1％,0.9％,1.2％(n=7)。结论:本方法操作简便,结果准确可靠。