| 摘要 |
Disodium cromoglycate (I) of apparent density >0.45g/ml (by BS No. 1460 (1967)) is new. Apparent density is pref. 0.5-0.7, esp. 0.53-0.66 g/ml and (I) is pref. in the form of hard granules. Pref. (I) contains 5, esp. 1 wt. % (partic. 0%) other cpds., except for water. Pref. 20 wt. % particles are of dia. >250 mu and is not >60 wt. % are 60 mu (esp. pref. are 20 wt. % at >200 mu and is not >60 wt. % at 90 mu), and 20% are 60 mu (45 mu). Granular (I) may be prepd. by passing (I) of water content 15-35 (esp. 22-24) wt. % through a sieve (4-30 holes inch), then drying to 5-8 wt. % humidity. Pref. water is added prior to sieving at 2 wt. %/min. (0.5-1.5%), pref. by spraying. Granulation is pref. at 50 degrees C and drying is at 60-100 degrees C esp. 75-85 degrees C. (I) is known for use in treating asthma and gastro-intestinal troubles associated with allergic or immunological reactions. The granular form can be encapsulated, easily without the need for flowing aids (i.e. lactose), lubricants etc. The dosage forms are useful in treating e.g. allergy to milk (at 5-250mg) or hay fever (at 1-10mg). |
