Quality control of hospital preparations: Establishment of a simple and rapid method for quantifying ulinastatin in vaginal suppositories.

Ulinastatin vaginal suppositories, used to prevent threatened premature delivery, are frequently used in hospitals. However, there is no established method for quantifying ulinastatin contained in suppositories. Therefore, we investigated a simple and efficient method for quantifying ulinastatin contained in suppositories. Our analytical method involved removal of the base; optimising the enzyme inhibition reaction time and enzyme reaction time; and measuring the absorbance. The modified method was reproducible, operation time was significantly shortened, and cost was reduced to approximately 1/17 of that of the previously reported method. This simple and rapid quantitative method could contribute to the improvement of quality control of ulinastatin vaginal suppositories as an extemporaneous hospital preparation.

Preparation and properties of an alpha-1-protease inhibitor concentrate with high specific activity.

BACKGROUND AND OBJECTIVES: Because the current demand for alpha-1-protease inhibitor (A1PI) exceeds the available supply, we aimed to develop a process for purification of A1PI from plasma which would achieve the highest possible degree of purity, specific activity and yield. MATERIALS AND METHODS: A1PI was purified from Cohn fraction IV-1,4 using ethanol precipitation and Q-Sepharose chromatography. Ceramic hydroxyapatite chromatography was used as a final purification step. Two independent virus-inactivation procedures (chemical and vapour heating) were applied. RESULTS: The resulting A1PI had an unprecedented high specific activity. In addition, the process led to the discovery of a new isoform of A1PI in isoelectric focusing gels. CONCLUSION: The high specific activity of the A1PI preparation achieved with this process should allow a reduction of the A1PI total protein load necessary to achieve clinically relevant effects.

[Ulinastatin Reference Standard (Control 971) of the National Institute of Health Sciences].

The "Ulinastatin Reference Standard (control 971)" of National Institute of Health Sciences was prepared. The standard material was evaluated in collaboration with one domestic laboratory, and the potency of trypsin inhibiting activity was determined to be 3, 100 units/vial by relative assay method against the Ulinastatin Reference Standard (control 942). Other analytical data obtained were as follows: UV maximum absorption was observed at 277 nm, and the molecular weight was estimated to be about 66,300 by gel filtration method. Maximum variance of material contents in 10 vials was 2.29%. Based on the above results, this standard material was authorized to be the "Ulinastatin Reference Standard (control 971)" of the National Institute of Health Sciences.

[Ulinastatin reference standard (Control 941) of the National Insutitute of Health Sciences].

The raw material of ulinastatin was examined for preparation of the "Ulinastatin Reference standard". The candidate material was evaluated in collaboration with one domestic laboratory, and the potency of trypsin inhibiting activity was determined to be 3500 unit/vial. Other analytical data obtained were as follows: UV maximum absorption was observed at 276 nm, the molecular weight was estimated to be about 66000 +/- 5000 by gel filtration method. Maximum variance of material contents in 10 vials was 6.52% by means of the weight variation test in JP XII. Based on the above results, this raw material was authorized to be the first "Ulinastatin Reference Standard" of the National Institute of Health Sciences.