Abstract
The use of proteolytic enzymes in the surgical treatment of adhesions has indicated a definite superiority for the vegetable enzyme, papain. 1 , 2 , 3 , 4 This report is concerned with the development of a sterile papain preparation suitable for clinical use, the standardization of the product and some descriptive aspects of its behavior in the peritoneum.
The two procedures previously described for the preparation of a sterile trypsin product 5 have been applied to papain with varying success. The simplest method, namely, the pressure filtration of a glycerine extract has been discarded as unsuitable for clinical purposes. Even though filtered glycerine extracts of trypsin lose very little activity in the course of 8 months'storage and glycerine extracts of papain show a high degree of heat stability, the storage behavior of the latter is unfavorable. About 50 assays on 12 different lots over periods up to 4 months showed that filtrates stored open in the refrigerator averaged a 50% activity-loss in 1 month and ampouled filtrates stored in the refrigerator averaged a 50% activity-loss in 4 months. The cause for this deterioration was not determined although a number of possibilities were examined such as atmospheric oxidation, contact with mercury vapor, exposure to ultra-violet light and absorption of alkali from the container.
The second method, previously described, consisted in filtration of aqueous or glycerine extracts through Berkefeld filters (N) and precipitation of the active product with alcohol and ether. This presented no unexpected difficulty when applied to papain and the powdered products have shown consistent stability on storage. The firm of Parke Davis & Co. have cooperated in producing sterile and standard preparations by this method. The activity of the standardized, sterile product corresponds closely to that of the ordinary stock product, mgm. for mgm.
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