個人用PPD製品の力価について

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Social needs for a single dose preparation of purified protein derivative (PPD) have been increasing year by year in the fields of surveillance for tuberculosis and of cancer immunotherapy. For the purpose of meeting these requests, the authors examined a new type of PPD preparation that was developed recently by the Japan BCG Laboratory and named “PPD Disposable (one dose)”. Potency test was carried out in sensitized guinea pigs and human subjects according to the method described in the Minimum Requirement of Biological Products published by the Ministry of Health and Welfare, Japanese Government in 1973. As shown in Tables 1 and 2 in the text, difference in the potency between the test PPD and the standard PPD was statistically insignificant (p=0.01) in both animal and human subjects. The potencies of 10 lots of the PPD preparations were examined in sensitized guinea pigs comparing with the standard PPD. As shown in Table 3, the difference among them was not significant from each other with p=0.01. Quantitative analysis on the amount of lactose distributed into the each preparation and lyophilized and on the moisture content of the final products were performed. No significant difference among the values obtained was found. At 30 and 60 minutes after dissolving the test PPD, potency test was carried out by using sensitized guinea pigs. The results obtained are shown in Table 4, indicating that the decline of the potency was not significant even 60 minutes after the dissolving. When the procedures of sucking up the buffer solution to dissolve the test PPD were incorrectly or carelessly carried out, the skin reaction sizes reduced than those elicited by the standard PPD. The aluminum foils sealed hermetically the single dose PPD preparations were intension ally broken and the PPD preparations that became wet within 2 days by absorbing atomospheric moisture were picked up, and potency test of these preparations were carried out by using guinea pigs, and no significant decline of the potency was demonstrated. The single dose PPD preparation can be used con veniently and effectively in the daily practice, provided that the directions for use are kept correctly.
日本結核病学会の論文

個人用PPD製品の力価について

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