Verse Th, Sikora C, Rudolph P, Klöcker N
Universitäts-Hals-Nasen-Ohrenklinik Mannheim.
Laryngorhinootologie. 2003 Nov;82(11):782-9. doi: 10.1055/s-2003-44548.
Recent technical developments allow preservative-free nasal drug application in multi-dose systems. New pharmaceutical formulations for better tolerable nasal sprays are now possible and consequently reformulations introduced to the market. Therefore, a representative and systematic overview on comparable products is mandatory.
Marketed nasal products in the indication groups: decongestants, antiallergics, care and wound-healing, hormones and saline solutions were tested for their cytotoxic properties according to DIN EN 30 993 - 5, pH, and osmolality.
In all indication groups reformulation to preservative-free application resulted in significant increase of cell growth and reduction of cytotoxicity. Physico-chemical galenic properties are of considerable importance too. With decongestants tolerability is dependant on the concentration of the active compound.
Our data lead to the conclusion that preserved nasal sprays are obsolete, when preservative-free alternatives are available. Attention should be paid to galenic properties and dosage of the active.
最近的技术发展使得在多剂量系统中能够无防腐剂应用鼻腔药物。现在有可能开发出耐受性更好的新型鼻腔喷雾剂药物制剂，相应地也有重新配方的产品投放市场。因此，对同类产品进行具有代表性和系统性的概述是必要的。
根据DIN EN 30 993 - 5对以下适应证组的市售鼻腔产品进行细胞毒性特性、pH值和渗透压测试：减充血剂、抗过敏药、护理和伤口愈合药物、激素和盐溶液。
在所有适应证组中，重新配方为无防腐剂应用导致细胞生长显著增加，细胞毒性降低。物理化学药剂学性质也相当重要。对于减充血剂，耐受性取决于活性化合物的浓度。
我们的数据得出结论，当有不含防腐剂的替代品时，含防腐剂的鼻腔喷雾剂已过时。应注意药剂学性质和活性成分的剂量。
