Extractive and preparation containing same

一种提取物、制剂的技术，应用在痘苗病毒接种兔炎症皮肤提取物领域，能够解决没有启示、没有记载等问题，达到稳定确保、有效性和安全性恒定的效果

Active Publication Date: 2013-10-23
NIPPON ZOKI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in these Patent Documents 1 to 4, there is no description about how much of a specific substance such as N-acetylneuraminic acid contained in this extract or this preparation
Furthermore, in these documents, there is neither description nor suggestion about using the N-acetylneuraminic acid content in this extract or this preparation as an indicator for more stable quality control of this extract or this preparation.

Method used

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  • Extractive and preparation containing same
  • Extractive and preparation containing same
  • Extractive and preparation containing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Example 1 (manufacture of this extract)

[0062] The skin of healthy mature rabbits was inoculated intradermally with vaccinia virus, and the pimple-prone skin was excised and harvested. After the collected skin is cleaned and disinfected with phenol solution, excess phenol solution is removed, crushed, mixed with phenol solution, left for 3-7 days, and heated at 35-40°C while stirring for 3-4 days. Then, the extract liquid obtained by solid-liquid separation was adjusted to pH 4.5-5.2 with hydrochloric acid, heat-treated at 90-100°C for 30 minutes, and then filtered to remove protein. Then adjust the filtrate to pH 9.0-9.5 with sodium hydroxide, heat treatment at 90-100° C. for 15 minutes, and then carry out solid-liquid separation.

[0063] The obtained protein-removing solution was adjusted to pH 4.0-4.3 with hydrochloric acid, and 2% of the mass of the protein-removing solution was added with activated carbon, stirred for 2 hours, and then solid-liquid separation w...

Embodiment 2

[0064] Embodiment 2 (assay method of N-acetylneuraminic acid content)

[0065] The N-acetylneuraminic acid content of this extract and this preparation was determined by high performance liquid chromatography mass spectrometry (LC-MS) as follows.

[0066] The extract (1.2 units / mL) prepared in Example 1 was diluted 10 times with water, and injected into LC-MS.

[0067] The formulation (NTP injection) produced using the extract produced in Example 1 was also diluted 10 times with water, and injected into LC-MS.

[0068] Using this preparation (NTP tablet) produced by using the extract produced in Example 1, wash 3 tablets with 3 mL of methanol / chloroform (1:1) 3 times, remove the film coating layer, dry, and add 12 mL Suspended in water (1 unit / mL), after centrifugation, the supernatant was diluted 10 times with water, and injected into LC-MS.

[0069] For N-acetylneuraminic acid, prepare a standard solution in aqueous solution to make a calibration curve.

[0070] For LC-MS...

Embodiment 3

[0089] Example 3 (Measuring results of the N-acetylneuraminic acid content of the extract)

[0090] Table 2 shows the results of measuring the N-acetylneuraminic acid content in the present extract by the method described in Example 2 above. The active ingredient content in this extract is 1.2 units / mL. The content of N-acetylneuraminic acid in this extract is represented by both per 1 unit (" / unit") of this extract and per 1 mL (" / mL") of this extract. In addition, the symbols A to C in the lot number indicate the difference in the applicant's manufacturing location (facility). In addition, the measured values ​​are unified to 3 significant figures (hereinafter, the same for all measured values).

[0091] [Table 2]

[0092]

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PUM

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Abstract

An objective of the invention is to provide a vaccinia virus inoculation rabbit inflammation skin extractive which is more stable in quality, and a preparation which contains the extractive as an effective constituent, etc. Amount of N-acetyl neuraminic acid which is contained in the vaccinia virus inoculation rabbit inflammation skin extractive and the preparation containing the extractive is used as an index, so that quality of each preparing batch of the extractive and the preparation is more stable. Effectiveness and security of the vaccinia virus inoculation rabbit inflammation skin extractive and the preparation containing the extractive which are made in the method and have more stable quality are ensured strictly, and the extractive and the preparation have very good usefulness.

Description

technical field [0001] The present invention relates to a vaccinia virus-inoculated rabbit inflammatory skin extract confirmed to contain a predetermined amount of N-acetylneuraminic acid through tests or inspections and has more stable quality, and a preparation containing the extract as an active ingredient. Background technique [0002] Pharmaceuticals are commodities that can only be licensed for manufacture and sale if their quality is ensured. In Japan, this is regulated in Article 14 of the Pharmaceutical Affairs Law. In other countries, such treatment is basically the same in terms of the nature of pharmaceuticals. Thus quality assurance in pharmaceuticals is considered important because quality ensures the effectiveness and safety of pharmaceuticals. Conversely, medicines whose quality has not been guaranteed cannot guarantee their effectiveness and safety, and thus lack the qualifications to be used as medicines. [0003] In Japan, substances that are raw materi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/285A61K35/36A61K9/08A61K9/20A61P29/00A61P25/02A61P25/04
CPCA61K35/36A61K31/7012A61K9/0019A61K9/08A61K9/2004A61P17/00A61P19/02A61P25/00A61P25/02A61P25/04A61P27/00A61P29/00
Inventor 中泽良隆芝山洋二中村耕
Owner NIPPON ZOKI PHARM CO LTD
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