EXTRACT, AND PREPARATION CONTAINING SAID EXTRACT

• US 20160089402A1
• Filed: 04/30/2014
• Published: 03/31/2016
• Est. Priority Date: 04/30/2013
• Status: Active Grant

• Current Assignee: Nippon Zoki Pharmaceutical Co., Ltd.
• Original Assignee: Nippon Zoki Pharmaceutical Co., Ltd.
• Inventors: NAKAZAWA, Yoshitaka, SHIBAYAMA, Yoji, NAKAMURA, Ko
• Granted Patent: US 9,884,077 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 35/36 Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells islets of Langerhans A61K35/39
• CPC Class Codes: A61K 35/76 Viruses; Subviral particles; Bacteriophages
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/04 Antipruritics
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

An object of the present invention is to provide an extract from inflamed skins of rabbits inoculated with vaccinia virus where the quality of the extract is more stabilized and also to provide a preparation, etc. containing said extract as an active ingredient.

When the amount of sulfated tyrosine contained in an extract from inflamed skins of rabbits inoculated with vaccinia virus and also contained in a preparation containing said extract as an active ingredient is used as an index, the quality of the extract and the preparation among the manufacturing lots can be warranted as a more stabilized one. In the extract from inflamed skins of rabbits inoculated with vaccinia virus and the preparation containing said extract where the quality thereof is more stabilized by such a method, the efficacy and the safety thereof are now guaranteed more strictly resulting in very high usefulness.

Claims

1. A preparation comprising an extract from inflamed skins of rabbits inoculated with vaccinia virus, wherein the variations in the effect of the preparation among manufacturing lots are reduced by the amount of sulfated tyrosine contained in the preparation being measured for each manufacturing lot and the content is confirmed to be 125 ng or more per unit of the extract in the preparation.

2. A preparation as claimed in claim 1 which is an injectable preparation and the amount of sulfated tyrosine contained in the injectable preparation is measured for each manufacturing lot and the content is confirmed to be 150 ng or more per mL of the injectable preparation.

3. A preparation as claimed in claim 1 which is a tablet and the amount of sulfated tyrosine contained in the tablet is measured for each manufacturing lot and the content is confirmed to be 500 ng or more per tablet.

4. The preparation according to claim 1, wherein the effect is an analgesic effect.

11. A method for making a preparation as claimed in claim 1 comprising providing an extract from inflamed skins of rabbits inoculated with vaccinia virus having a predetermined amount of sulfated tyrosine where the variations in the content of sulfated tyrosine among the manufacturing lots are reduced, the amount of sulfated tyrosine contained in the extract being 125 ng or more per unit of the extract, and incorporating the extract into an injectable preparation or a tablet preparation.

12. A method for providing an analgesic effect comprising administering a preparation as claimed in claim 4.

5. An extract from inflamed skins of rabbits inoculated with vaccinia virus, the extract comprising sulfated tyrosine wherein the variations in the content of sulfated tyrosine among the manufacturing lots are reduced so that the amount of sulfated tyrosine contained in the extract is made 125 ng or more per unit of the extract by adding an extraction solvent to crushed inflamed tissues to obtain a mixture, allowing the mixture to stand for 3 to 7 days, and warming the mixture at 30 to 45°

C. for 3 to 4 days more.

6. A preparation comprising the extract from inflamed skins of rabbits inoculated with vaccinia virus according to claim 5, wherein the amount of sulfated tyrosine contained in the preparation is 125 ng or more per unit of the extract in the preparation.

7. The preparation according to claim 6, wherein the preparation is an analgesic agent.

8. A method for manufacturing an extract from inflamed skins of rabbits inoculated with vaccinia virus comprising adding an extraction solvent to crushed inflamed tissues to obtain a mixture, and allowing the mixture to stand for 5 to 12 days.

9. The method for manufacturing an extract from inflamed skins of rabbits inoculated with vaccinia virus according to claim 8, wherein warming at 30 to 45°

C. with or without stirring is conducted during the period where the extraction solvent is added to crushed inflamed tissues and allowed to stand for 5 to 12 days.

10. The method for manufacturing an extract from inflamed skins of rabbits inoculated with vaccinia virus according to claim 9, wherein, after an extraction solvent is added to the crushed inflamed tissues and allowed to stand for 3 to 7 days, it is warmed at 35 to 40°

C. with stirring for 3 to 4 days more.

13. A method for controlling the manufacture of a preparation containing an extract from inflamed skins of rabbits inoculated with vaccinia virus in which the variations in the effect of the preparation among manufacturing lots are reduced, comprising measuring the amount of sulfated tyrosine contained in the preparation for each manufacturing lot, and only distributing preparations having a sulfated tyrosine content which is 125 ng or more per unit of the extract in the preparation.

14. A method for controlling the manufacture of a preparation as claimed in claim 13 wherein the preparation is an injectable preparation, and only distributing the preparation when the amount of sulfated tyrosine contained in the injectable preparation is measured for each manufacturing lot and that the content is 150 ng or more per mL of the injectable preparation.

15. A method for controlling the manufacture of a preparation as claimed in claim 13 wherein the preparation is a tablet, and only distributing the tablet when the amount of sulfated tyrosine contained in the tablet is measured for each manufacturing lot and the content is 500 ng or more per tablet.

16. The method for controlling the manufacture according to claim 13, wherein the effect is an analgesic effect.

20. The method for controlling the manufacture according to claim 14 wherein the effect is an analgesic effect.

21. The method for controlling the manufacture according to claim 15 wherein the effect is an analgesic effect.

17. A method for inspection of a preparation containing an extract from inflamed skins of rabbits inoculated with vaccinia virus in which the variations of the effect of the preparation are reduced, comprising measuring the amount of sulfated tyrosine contained in the preparation for each lot, and only shipping, distributing or using preparations as an analgesic which have a sulfated tyrosine content that is 125 ng or more per unit of the extract in the preparation.

18. A method for inspection of a preparation as claimed in claim 17 wherein the preparation is an injectable preparation, and only shipping, distributing or using preparations when the amount of sulfated tyrosine contained in the injectable preparation is measured for each lot and the content is 150 ng or more per mL of the injectable preparation.

19. A method for inspection of a preparation as claimed in claim 17 wherein the preparation is a tablet, and only shipping, distributing or using the tablet when the amount of sulfated tyrosine contained in the tablet is measured for each lot and that the content is 500 ng or more per tablet.