Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences最新文献

The raw material of cyanocobalamin was tested for preparation of the "Cyanocobalamin Reference Standard (Control 951)". Analytical data obtained are as follows: loss on drying, 1.8%; infrared spectrum, the same as that of the JP Cyanocobalamin Reference Standard (Control 936); thin-layer chromatography, three impurities were detected; high-performance liquid chromatography (HPLC), eight to nine kinds of impurities were detected and the total amount of impurities was estimated to be 1.6 +/- 0.13% (n = 4); assay, 99.7% by spectrophotometry specified in the JP XII and 100.4% by HPLC, respectively. Based on the above results, the raw material was authorized as the JP Cyanocobalamin Reference Standard (Control 951).

The "Lysozyme Reference Standard (Control 951)" of the National Institute of Health Sciences was prepared. The lysozyme potency of the standard material was assayed against the Lysozyme Reference Standard (Control 915) by two turbidimetric methods using the drycells of Micrococcus luteus as the substrate. The potency of the standard material was in satisfactory agreement with that of Lysozyme Reference Standard (Control 915) and was defined as 1 mg [potency] per mg.

Number of transgenic and knock-out mice increased rapidly during the last decade. This review article describes a potential usefulness of transgenic and knock-out mice for biological safety research with respect to each toxicological category for safety evaluations, such as studies for carcinogenicity, general toxicology, genotoxicologic testing, and immuno-toxicological evaluations. In the carcinogenicity, a possible model required for a short-term study in carcinogenicity was discussed. Further, a couple of future subjects were focused specifically on the biotechnology-derived pharmaceuticals and the biotechnical recombinant-mice as a second generation, i.e. experimental mice with double or multiple gene-recombination. Those usefulnesses were also introduced briefly. Establishing the biotechnical recombinant-mice for each safety testing contributes not only to simplify and qualify the on-going evaluation system, but also to the traditional animal studies to be re-evaluated, so that the solutions may lead them to a future in vitro-alternative system much smoothly. For general references, historical reviews on the biotechnical recombination in experimental animals were also briefly introduced to elucidate a new broad area in developmental biology.

The development of information and computing infrastructure at NIHS (NICI), enabled us to provide a good environment for storing information that can be accessed by the Internet. Information can be stored either on WWW servers or on databases. All databases were developed on PC using database management systems such as 4th Dimension or Access, and were transferred to a UNIX machine with the database management system Sybase. A tool for accessing databases via the WWW (Web) was developed. This interface program used a freeware called Genera. Tools were also implemented for handling the so called VRML worlds.

The "Sennosides Reference Standard (Control 951)" was prepared, which is intended to be used for the fluorophotometric assay of sennosides content in the preparation of "Sennosides". In this assay hydroxylated mono- and dianthraquinone glucosides are chelated with boric acid, and the fluorescence intensity of the chelate is determined against that of the Reference Standard (RS). In the establishment of this RS, sennosides content in the candidate material must be determined accurately by fluorophotometry. The Sennoside AB for assay, prepared as an equimolar mixture of the purified sennoside A and Sennoside B, was used as the RS for the fluorophotometry. Based on the above concept, sennosides content in the candidate was determined as calcium salts to be 60.1 +/- 1.6% by the fluorophotometry. Thus the sennosides content of this Sennosides RS was certified to be 60%. Separately, contents of Sennoside A (SA) and Sennoside B (SB) in this candidate were determined by using HPLC. As a result, the sum of SA and SB was estimated to be 38% as free acids. Thus it was suggested that about 20% of dianthraquinone glucosides other than SA and SB and anthraquinone glucosides may be included in this Sennoside RS as free acids. Analytical results on the USP Sennosides RS were also shown and discussed, compared with the present Sennosides RS.

The raw material of digitoxin was tested for preparation of the "Digitoxin Reference Standard (Control 951)". Analytical data obtained were as follows: loss on drying, 0.0%; infrared spectrum, the same as that of the JP Digitoxin Reference Standard (Control 845); thin-layer chromatography, no impurity was detected; high-performance liquid chromatography (HPLC), two kinds of impurities were detected and the total amount was estimated to be 0.16 +/- 0.01% (n = 3); assay, 99.0% by HPLC. Based on the above results, the raw material was authorized as the JP Digitoxin Reference Standard (Control 951).

The determination of crude drugs by high performance liquid chromatograph (HPLC) method was introduced to the Japanese Pharmacopoeia (JP) 12 for the first time. At JP 13, another HPLC methods were established for eight kinds of crude drugs and relative medicines. Special conception is used in the determination of crude drugs, different from chemical medicines. Determinations were classified to two methods: "assay" and "component determination" according to standards. "The Japanese Reference Standard" or "Reagent for assay" is used in assay, and "Reagent for component determination". is used in component determination. In addition, the analysis and the dryness of crude drug were discussed because they were important to evaluate the result of analysis exactly.

The number of official inspection of coal-tar dyes and their lakes from April in 1995 till March in 1996 were 580 in total. The quantity which passed inspection amounted to 166.4 ton in Japan. The production of color in each month was summarised in Table 1, and by each producing company in Table 2. The food coal-tar dye produced in the largest quantity was Food Yellow No.4, occupying 43.9% in this period.

Raw human menopausal gonadotrophin (HMG) material was examined for preparation of the "Human Menopausal Gonadotrophin Reference Standard (Control 961)". The candidate material was assayed its follicle stimulating hormone (FSH) activity and luteinizing hormone (LH) activity against the 3rd International Standard for FSH and LH, urinary (71/264) by the augmented ovarian weight gain assay and the seminal vesicle weight gain test, respectively. The potency of the new standard was defined as 56 international units of FSH activity per mg and 61 international units of LH activity per mg as the result of 13 and 5 assays, respectively, in four collaborative laboratories.

Thermal analysis method can be applied to the quality evaluation tests of drugs. Recent advances in the technology and the data-processing system on the apparatus have accelerated the utilization of this analytical techniques in the field of drug quality control. In this report, various application techniques of the thermal analysis such as DSC, DTA, TG and the impurity analysis by DSC, were reported and discussed from the viewpoints of a general test in the Japanese Pharmacopoeia. Further the present situations of this analytical method in the US Pharmacopoeia 23 and the British Pharmacopoeia 1993 are also explained.