Prozeß-Standardisierung: Grundlage einer sachgemäßen Qualitätssicherung von Mistelpräparaten

Abstract: Remedies prepared from mistletoe extracts are multicomponent-systems like all other phytopharmaceuticals. These contain several substances which determine the effectiveness of the preparation. The contribution of each individual substance will depend on the mutual effect of the remaining components. Therefore pharmaceutical quality of mistletoe preparations can be guaranteed only by process-standardization, which includes the fixing of the times of harvest, the formula of ingredients, the 'stage of manufacture, and validated testing methods. ABNOBAviscumTM is prepared under conditions developed in view of an optimal colloidal state of the preparation. lt was demonstrated that process-standardization leads to good homogeneity from one batch to the next. Homogeneous lectin contents were obtained, for example lectin contents around 1000ng/ml ABNOBAviscumTM Mali-preparation of dilution stage 3 (containing 1.5mg of plant extract from 2.Omg of fresh mistletoe in 1ml). The amount of the lectin content depends on the host tree of the mistletoe. Extracts prepared from mistletoe grown on an oak tree contain about fifty times more lectin than extracts from mistletoe grown on a pine tree. But the amount of lectins detected in the mistletoe preparation does not correlate with the in-vitro-effects of human tumor xeonografts. The mean endotoxin value found in ABNOBAviscumTM-preparations in the highest concentration available (dilution stage 2 which contain 15mg of plant extract from 2Omg of fresh mistletoe in 1ml) comes to 67 endotoxin units (EU) per ml, corresponding to about one fifth of the commonly accepted limit value of 350 EU/ml, the human pyrogenic dose. Depending on their dilution level, lower concentrated preparations lead also to lower endotoxin test results. lt was proven that mistletoe lectins cause false positive endotoxin test results.

Keyword(s): Mistelpräparate

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