The method of preparation of drugs based on pantogematogen

 

(57) Abstract:

The invention relates to medicine, namely to the technology of medicines. The method consists in the following: powdered dried nedifferentsirovannoi the blood of the deer, the deer or spotted deer is subjected to microencapsulation, which is prepared with pre-soaking 8-10% aqueous solution of the above powder at a temperature of 30-35oC, the resulting solution is injected solution supporting material, after which the pellet fluidized bed prepared solution was applied to the microspheres of the supporting material with their simultaneous drying, then on the surface of the microgranules put the shell on the basis of auxiliary material is dried at a temperature of 38-40oWith to a moisture content of not less than 2%, and before discharge into the granulator add calcium stearate. As an auxiliary material used sugar, and/or lactose and/or glucose and/or fructose and/or sorbitol. As an additive can be used ascorbic acid, which is injected into the solution of auxiliary material used in the coating shell. The method allows to prepare drugs with increased time odnosno to technology of drugs and can be used in preventive pharmacology for the preparation of long-term storage of the blood of deer.

Known drug from the blood of the deer "pantogematogen" and its application in complex treatment of various somatic diseases and functional autonomic disorders. So, it is known psychoactive drug for the treatment of anemia and General loss of strength after infectious diseases "Pantogematogen". The tool contains defibrinating the blood of the deer, the deer or spotted deer taken during cutting antlers, 96% ethanol, sugar syrup, fruit essence, ascorbic acid, in the following ratio, wt.%: defibrinated blood of the deer, the deer or spotted deer 56-60; 96% ethanol (5,2-5,6; sugar syrup 35-37; the essence of the fruit of 0.4-0.6; ascorbic acid 0,09-0,11 (EN 2008008 C1, A 61 K 35/14, Institute of pharmacology, Tomsk scientific center, 28.02.1994) [1].

It is also known tool that has both adaptogenic and nootropic effect, containing dried nedifferentsirovannoi the blood of the deer, the deer or spotted deer, ascorbic acid, and optionally pharmaceutically acceptable filler at slna from 0.5 to 99.5 and ascorbic acid of 0.5 to 99.5. This product expands the Arsenal of tools with nootropic and adaptogenic activity of prolonged action and higher pharmacological activity (RU 2136292 C1, A 61 K 35/14, Institute of pharmacology, Siberian branch of the Russian Academy of medical Sciences, 09.10.1999) [2].

It is also known remedy, at the same time possessing neuroprotective and adaptogenic activity of prolonged action of the dried nedifferentsirovannoi deer blood, deer or spotted deer. The method of obtaining such funds is limited to drying nedifferentsirovannoi deer blood, deer or spotted deer taken during the period from June to November. Drying is carried out at a temperature of 45-50oC for 1.5-2 h to paste with subsequent final drying for 4-5 h to a moisture content of 4-5% (EN 2130314 C1, A 61 K 35/14, JSC "TPA Smirnov and To" 20.05.1999) [3] is the nearest equivalent.

However, during storage of dried nedifferencirovannaja the blood of the deer, the deer or spotted deer due to contact with the environment undergoes the process of oxidation and decomposition. Therefore, recommended certain storage conditions: temperature less than 15oC, humidity above 70%, and the retention period does not exceed 1 year. Traditional sterilization methods, including heating, viewshoney protein structure and as a result to loss of activity of the drug.

The objective of the invention is to increase the shelf life of drugs based on pantogematogen and reduced requirements to the conditions of their storage, which is the technical result.

The technical result of the invention is achieved by a method of preparation of drugs based on pantogematogen includes processing powder Foundation - dried nedifferentsirovannoi deer blood, deer or spotted deer, supplementation, subsequent filling and packaging. In the process mentioned powdery Foundation subjected to microencapsulation. To do this, prepare preliminary soaking 8-10% aqueous solution of the dried nedifferentsirovannoi deer blood, deer or spotted deer at a temperature of 30-35othen in the resulting solution is injected solution supporting material. Further, through the granulator, fluidized bed prepared solution was applied to the microspheres of the supporting material with their simultaneous drying. Then, on the surface of the microgranules put the shell on the basis of auxiliary material is dried at a temperature of 38-40oWith to a moisture content of not less than 2%, and before unloading covering the material used sugar, and/or lactose and/or glucose and/or fructose and/or sorbitol.

The method can be characterized also by the fact that when used as an additive ascorbic acid latter is introduced into the solution of auxiliary material used in drawing the shell.

The method can be characterized also by the fact that when using sugar as microgranules downloads in the granulator is carried out in the form of powder and/or sand particle size of 100 to 300 micrometers.

The method can be characterized, moreover, by the fact that when using sugar as an auxiliary material prepared solution to granulate lead up to a concentration of 50 - 65%.

The analysis of the sources of information showed that the principle known microencapsulation technology (see, for example, Chueshov Century. And. and other Industrial technology of drugs, in 2 volumes, dir. by Professor C. I. Chueshov, Kharkov, Ukraine, in Ukrainian.FA "Basis, 2000) and, in particular, in the manufacture of nitroglycerin prolonged action (EN 2082395 C1, A 61 K 9/26, 27.06.97). However, the sources of information should not be known causal link "distinctive features - technical result in relation to the production method of pantogematogen, enabling the s conduct at the facility fluidized bed (EN 2143313 C1, CSDB, B 01 J 2/16, 27.12.1999), in principle not different from the known, but having a tangential input components and finished product, which is quite convenient in maintenance and provides uniform distribution of the binder on the particles of the material.

An example implementation. Prepare preliminary soaking for 2 hours at a temperature of 30-35oWith an aqueous solution of the dried nedifferentsirovannoi blood red (63 g pantogematogen 1500 ml of distilled water). Filter the solution through a nylon cloth and the precipitate was washed with 500 ml of water. Then, the obtained solution is injected 800 g of sugar. Then in the granulator fluidized bed and the tangential input of the prepared solution was applied to the pre-loaded microspheres sugar (powder and/or sand particle size of 100-300 μm), with simultaneous drying. Then, on the surface of the microgranules put the shell on the basis of sugar (pure sugar syrup and mix it with ascorbic acid fed to the granulator), dried at a temperature of 38-40oto a moisture content of not less than 2%, and before unloading in microencapsulated pantogematogen add calcium stearate.

The above example does not implement a glucose, and/or fructose and/or sorbitol.

The invention improves the retention of the drug up to 3 years under normal conditions. The obtained patent-pending method microencapsulated pantogematogen can be used in various pharmaceutical forms: pills, capsules, suppositories, pressed tablets. When using the drug as aqueous solutions (see, for example, guidelines 2000/79 "vegetal stabilizing effects of balneotherapy with pantogematogen treatment asteno vegetative disorders, Institute of pharmacology RAMS Siberian branch, Tomsk 2000) further improves the dissolution rate when creating a matrix of solutions.

1. The method of preparation of drugs based on pantogematogen, involving the processing of powder Foundation - dried nedifferentsirovannoi deer blood, deer or spotted deer, supplementation, subsequent filling and packaging, characterized in that the processing mentioned powdery Foundation subjected to microencapsulation, which is prepared with pre-soaking 8-10% aqueous solution of the dried nedifferentsirovannoi deer blood, deer or spotted deer at a temperature of 30-35oS, then p is eat the prepared solution was applied to the microspheres of the supporting material with their simultaneous drying, then, on the surface of the microgranules put the shell on the basis of auxiliary material is dried at a temperature of 38-40oWith to a moisture content of not less than 2%, and before discharge into the granulator add calcium stearate.

2. The method according to p. 1, characterized in that the supporting material use sugar, and/or lactose and/or glucose and/or fructose and/or sorbitol.

3. The method according to p. 1 or 2, characterized in that when used as an additive ascorbic acid, the latter is introduced into the solution of auxiliary material used in drawing the shell.

4. The method according to p. 1 or 2, characterized in that when using sugar as microgranules downloads in the granulator is carried out in the form of powder and/or sand particle size of 100-300 μm.

5. The method according to p. 1 or 2, characterized in that when using sugar as an auxiliary material, the prepared solution for pellet was adjusted to a concentration of 50-65%.

 

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FIELD: medicine, surgery.

SUBSTANCE: at the background of basic therapy in complex therapy of acute pancreatitis one should introduce ceruloplasmin to be applied at the dosage of 600-1000 mg/d for 5 d. If necessary, the course of ceruloplasmin introduction should be repeated. This method provides pancreatic tissues viability in case of pancreonecrosis by increasing efficiency of correction the endogenous intoxication and decreasing the number of complications in the course of therapy conducted.

EFFECT: higher efficiency of pharmacological correction.

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