RU2500399C2 - Combined analgesic and anti-spasmodic drug - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutics and represents a combined analgesic and anti-spasmodic drug containing caffeine and drotaverine hydrochloride, characterised by the fact that as active substances it additionally contains ketorolac or a compound thereof, such as ketorolac tromethamine and diphenylhydramine in the amount of: ketorolac or a compound thereof, such as ketorolac tromethamine 5 - 40 mg, caffeine 50 - 100 mg, diphenylhydramine 20 - 50 mg, drotaverine hydrochloride 40 - 80 mg.

EFFECT: invention provides developing the drug possessing strong analgesic action in moderate or severe pain syndromes, various cramping pains.

2 cl, 3 ex

Description

The invention relates to medicine and can be used as an effective analgesic and antispasmodic.

Currently, there are combined analgesic and antispasmodic drugs containing non-steroidal anti-inflammatory drugs (NSAIDs), drotaverine hydrochloride, antihistamines and caffeine as active substances. The most famous of the drugs in this group are the following:

- the drug Spazmalgon company "Actavis" Switzerland, containing metamizole sodium, pitophenone and fenpiverinium;

- drug Trigan D, CADILA, India, containing paracetamol and dicycloverin;

- the drug No-Shpalgin, CHINOIN, Hungary, containing paracetamol, drotaverine hydrochloride and codeine phosphate.

The closest analogue is the drug Pentalgin, coated tablets (VIDAL, PENTALGIN Guide, manufactured by Pharmstandard-Leksredstva OJSC Russia, registration date 06/17/2010, LSR-005571/10, (www.vidal.ru/ poisk preparatov / pentalgin.htm)) containing paracetamol, naproxen, caffeine, drotaverine hydrochloride and pheniramine maleate,

All these combinations are much less effective than the developed composition of ketorolac (ketorolac tromethamine), drotaverine hydrochloride, diphenhydramine and caffeine. The novelty of the invention is represented by the use of a ketorolac or its compound (for example, tromegamine ketorolac) as an analgesic, which significantly surpasses all other representatives of the NSAID group in terms of action, as well as a combination of active components. The presented composition of active components in the composition of the finished medicinal product has not been previously used.

The use of components that enhance the action of ketorolac allows you to:

- increase the analgesic effect of the total combination;

- it becomes possible to vary the dose of the main analgesic component (ketorolac) in the direction of reduction (with a decrease in side effects) without reducing the therapeutic effect;

- The combination of ketorolac and drotaverine hydrochloride enhances the effect on spastic pain. The objective of the invention is an effective effect on pain of moderate and severe severity, as well as spastic pain of various origins.

Ketorolac belongs to the NSAIDs group, in terms of force of action significantly exceeds all other representatives of this group, it is used for moderate and severe pain, including in the postoperative period, with injuries, cancer, pain, toothache, muscle pain.

Caffeine enhances the action of NSAIDs, has a general tonic effect.

Diphenhydramine (diphenhydramine) enhances the action of NSAIDs, has an antihistamine, decongestant effect.

Drotaverinum hydrochloride is an antispasmodic myotropic action, has a strong and long-lasting effect.

The specified technical result is achieved by the fact that the claimed combined analgesic and antispasmodic agent contains, as active substances, ketorolac or its compounds (for example, ketorolac tromethamine), caffeine, diphenhydramine (diphenhydramine) and drotaverine hydrochloride in therapeutic concentrations and pharmaceutically acceptable auxiliary components for creating the dosage form for oral administration (capsules, tablets, etc.) and injections (ampoules with sterile solution).

The possibility of carrying out the invention can be confirmed by the following examples, which serve to illustrate, but do not limit the scope of the invention.

Example 1

Tablets containing components, mg:

Ketorolac 5-10 Caffeine 50-100 Diphenhydramine 20-50 Drotaverine hydrochloride 40-80

Pharmaceutically acceptable excipients for preparing a coated tablet or coated tablet.

Example 2

Capsules containing components, mg:

Ketorolac 5-10 Caffeine 50-100 Diphenhydramine 20-50 Drotaverine hydrochloride 40-80

Hard gelatin capsules No. 1 to No. 3, pharmaceutically acceptable auxiliary components, to obtain a mass for filling capsules.

Example 3

Ampoules containing components, mg:

Ketorolac 20-40 Caffeine 50-100 Diphenhydramine 20-50 Drotaverine hydrochloride 40-80

Ampoules of 1-3 ml, pharmaceutically acceptable auxiliary components, to obtain a solution for filling ampoules.

Claims (2)

1. The combined analgesic and antispasmodic agent containing caffeine and drotaverine hydrochloride, characterized in that the active substances it additionally contains ketorolac or its compound, such as ketorolac tromethamine and diphenhydramine (diphenhydramine) in the amount of:
ketorolac or its compound, such as ketorolac tromethamine 5-40 mg caffeine 50-100 mg diphenhydramine (diphenhydramine) 20-50 mg drotaverine hydrochloride 40-80 mg 2. The combined analgesic and antispasmodic agent according to claim 1, characterized in that it is in the form of a dosage form for oral administration, such as capsules, tablets or injections using pharmaceutically acceptable auxiliary components.