Encapsulated form of acyzol

FIELD: chemical and pharmacological industry.

SUBSTANCE: invention relates to encapsulated form of Acyzol containing Acyzol and pharmaceutically acceptable fillers in specific component ratio.

EFFECT: encapsulated mass with high technological characteristics, high biological availability and effectiveness of Acyzol component.

5 tbl, 3 dwg

 

The present invention relates to a new pharmaceutical form of Alzola (bis(1-vinylimidazole)zinc diacetate), used as an antidote.

Currently known only dosage form of this drug is 6%solution in 0.5%aqueous solution of procaine hydrochloride for intramuscular injection (Patent RF №2038079).

The disadvantage of this known dosage form is its invasive route of administration, as well as its limitations due to the inability of the patients allergic to novocaine.

The objective of the invention is the creation of oral dosage forms, devoid of the disadvantages of the known dosage forms Alzola.

The problem is solved capsulated form of composition, wt.%:

Azizolthe 31.8-35,97
Lactose63,60-59,95
Talc2,54-2,16
Aerosil1,11-0,96
Calcium stearate0,95-0,96

It should be noted that the attempt to fill the capsule substance in the absence of auxiliary substances is not possible, because the powder is hygroscopic, crumpled and not filled.

The addition of lactose in these quantities leads to loose weight, lower amounts of lactose shown below is about impairs the flowability, increasing the lactose content above this limit does not improve the flowability of the mixture.

The presence of other components allow to obtain high technological characteristics of the capsule mass (moisture resistance, flowability while maintaining uniformity of dosing, dilution, etc.

The applicant notes that this ratio was found as a result a great deal of experimental work, which is undoubtedly due to the unique structure of arizola.

Held at the Institute of toxicology health Ministry studies have shown high efficiency of the dosage form of alzola in the form of capsules in the treatment of poisoning by carbon monoxide and other products of thermal destruction.

1. The effectiveness of alzola poisoning carbon monoxide (CO)

Initially, in a special series of experiments were installed toxicometric parameters for mice and rats with static priming with exposure time of 30 minutes This exposure time was chosen based on the actual conditions of exposure to toxic chemicals on humans when performing emergency measures emergency response and rescue.

The values of experimentally determined toxicometric indicators of carbon monoxide for white rats and mice are presented in table 1.

After testing the technique of priming expertise is mental animals and determine toxicometric parameters investigated the effect of intragastric administration of Alzola in the range of doses from 60 to 160 mg/kg (for this purpose from the contents of the capsules alzola were prepared in 0.01% aqueous solution) with an interval of 20 mg/kg on the survival of mice with acute 30 minute seeds WITH a concentration of 8.5 g/m3. Such conditions seed provided the effect of carbon monoxide on the level LC84-LC100. The aggregated results of these experiments are shown in table 2.

Studies show that after intragastric administration of Alzola mice its threshold dose in relation to carbon monoxide is 80 mg/kg Area of the protective action of Alzola is in the range of doses from 100 to 160 mg/kg Maximum efficacy is observed at a dose of 120 mg/kg figure 1 shows the curve "dose of Alzola effect (survival rate, %)".

Similar experiments were carried out on white rats under static 30 minute seeds WITH concentration to 9.70 g/m3that also corresponds to the level LC84-LC100for this species. Graphical representation of dependence "dose of Alzola effect (survival rate, %)for white rats are presented in figure 2.

The results of these studies evaluating the efficacy of prophylactic use of increasing doses of Alzola presented in table 2.

When this threshold dose of Alzola in for this species is 30 mg/kg, the area of the protective action of the drug is in the dose range of 50-80 mg/kg, and the maximum protective effect nabludaetsa.pri dose of 60 mg/kg

The results of experiments conducted on two species of laboratory animals suggests that in conditions of acute inhalation exposure to carbon monoxide at concentrations close to the LC100with an exposure time of 30 minutes, the values of the dose required to achieve the maximum protective effect after intragastric administration of Alzola, is 120 mg/kg for white mice and 60 mg/kg for white rats. Thus, according to the criterion of survival of an effective protective dose of Alzola intragastric application of twice the effective protective dose prescribed for parenteral administration of the drug.

The experimental results indicate a relatively greater efficiency of Alzola when its internal use in smaller concentrations, but relatively long duration of action (up to 3.5 hours)than at high concentrations, but less exposure. This fact is important, since the use of Alzola in the dosage form for oral administration (capsules) are more focused on the protection of rescuers and people for quite a long time in conditions of high, but not lethal concentrations of carbon monoxide.

When evaluating the effectiveness of Alzola indicators of the dynamics of excretion with exhaled air used is whether the experimental model of intraperitoneal administration WITH white rats. Method intraperitoneal injection WITH white rats allows precise metering of the quantity of gas introduced into the body of the animal, and to adequately simulate the conditions of short duration (up to 20 minutes) non-fatal seed. Intraperitoneal administration WITH white rats produced on the assumption of 2.5 ml of gas per 100 g of body weight. 90 minutes before the injection of gas animals intragastrically injected drug Arizol. Exhaled air from animals collected in special samplers individually for each animal. The concentration of CO in expired air was determined using a gas analyzer PGA-VPM using indicator tubes production "Hemamali". The air sampling and investigation of concentrations was carried out during the first hour with an interval of 15 minutes and thereafter every 60 minutes for 3.5 hours. The results of the experiment are presented in table 3.

Our data indicate that acute intoxication WITH causes in the body unprotected animals the development of decompensated metabolic acidosis, as evidenced by a sharp decrease in pH, plasma bicarbonate and a shortage of buffer bases. The introduction of Alzola reduces the severity of metabolic acidosis reduces the severity of intoxication and can accelerate recovery from poisoned zhivotnyh table 4 presents data on the elimination of carbon monoxide. Figure 3 graphically depicts the dynamics of the concentration of carbon monoxide in exhaled air.

The data obtained indicate a more intensive process of elimination of carbon monoxide from the body poisoned by carbon monoxide animals for prophylactic use of Arizola.

Thus, experimental studies have shown that Azizol when used inside an effective protective tool that allows you to provide the necessary level of resistance of the organism to the toxic effects of CO in a wide range of concentrations and time of action of the poison. Identified protective dose intragastric application of Alzola in experiments 2 species. In experiments on white rats start time, end time, and duration of the protective effect of Alzola when it intragastric introduction of the criterion of survival of animals subjected to acute effects. It is shown that a single oral administration of Alzola in effective dose allows to increase the protective action of the antidote in 2-2 .5 times compared to parenteral administration of the drug.

Research of parameters of acid-base balance in the blood of white rats have shown that prophylactic oral administration of Alzola not only provides less manifestation of intoxicate the indicators of the severity of metabolic acidosis, but can accelerate recovery from poisoned animals. In addition, the positive effect of Arizola on the dynamics of the parameters characterizing blood gases (pO2, SAT), and its impact on the acceleration of processes of elimination FROM blood and tissue depot, which is probably largely related to the mechanism of the protective effect of Alzola in respect of carbon monoxide.

2. Study the protective efficacy of Alzola under the action of combustion products

Experiments to study the protective efficacy of Alzola the combined action of CO and other products of thermo-oxidative degradation, the most typical fires, performed on a special installation with radiant panel and a closed circuit gases according to the method developed by the St. Petersburg branch of the research Institute FOR the Ministry of internal Affairs of the Russian Federation.

Installation with running a tubular furnace with a certain amount of combustible material was subjected to thermal decomposition, and the resulting toxic products was applied in the seed chamber type B. Kurland volume of 0.45 m3equipped with radiation panel to create the conditions for uniform homogenization of aerosol environment, with there animals. Drug tests were conducted on adult outbred white rats-males weighing 180-220 g function Of the CSOs capsules alzola were prepared in 0.01% aqueous solution. Experimental animals the drug was administered intragastrically once 45 minutes before priming dose of 60 mg/kg in aqueous solution in a volume of 1.0 ml per 100 g body weight. The control group was administered intragastrically saline in the same volume. For burning used pine wood and polymer material based on phenol-formaldehyde resin foam stamps "Vilares-5".

Synthetic materials, such "Vilares-5", widely used as finishing and insulating materials. When combustion and thermo-oxidative degradation in addition to the oxide and carbon dioxide, are formed of a high concentration of hydrogen chloride, hydrogen cyanide, acetone and other toxic substances. Pine wood was selected as the reference source two-component mixture of volatile products of thermal destruction, as by burning it emits mainly WITH carbon dioxide and a small amount of tar.

Evaluation of the protective efficacy of the drug Arizol for products thermo-oxidative degradation of combustible materials produced by calculating the protection factor (KS):

where HL50the mass of the sample material, the combustion of which 1 m3confined space eye-catching products cause the death of 50% of the animals./p>

Generalized data on the estimates of the toxicity of combustion products of the tested materials protected Etizolam and unprotected white rats and the values of the coefficients protection are presented in table 5.

Thus, preventive intragastric administration of white rats Alzola at a dose of 60 mg/kg exerts a protective effect not only isolated effects of carbon monoxide, but also the combined effect of CO and other toxic combustion products formed during thermo-oxidative degradation of wood and synthetic non-metallic materials like "Vilares-5", used as a finishing and insulating materials.

The clinical study capsules alzola at the St. Petersburg medical Academy of postgraduate education (GOU DPO SPb. Maps of the RF Ministry of health) also showed high efficiency of the drug Arizol in the pharmaceutical form Capsules 120 mg. The drug is recommended to use as antidote and remedy for poisoning by carbon monoxide and other products of thermal destruction.

Thus, the results of preclinical and clinical trials have shown that the pharmacological activity of alzola when kapsulirovanie saved. Capsulated form Alzola has good tolerability.

The following examples which shows how to obtain a capsulated form of alzola according to the invention.

Example 1. In the mixer, gradually introducing the components, mix 120 g alzola, 214 g of milk sugar, 8,91 g of talc and 3.59 g of Aerosil and 3.5 g of calcium stearate to obtain a homogeneous granular mass. The resulting mixture was Packed in capsules. Get 1000 capsules with a mass of capsules 0,35 gaderene active substance in one capsule of 120 mg

Sources of information

1. Report on the study of specific pharmacological activity of the dosage form (capsules) drug "AZIZA", Institute of toxicology, Russian Federation Ministry of health, 2004, Saint-Petersburg.

2. Manual on experimental (preclinical) study of new pharmacological substances. - M.: the Ministry of health of the Russian Federation, "Remedium", pp.33-38.

3. Manual on experimental (preclinical) study of new pharmacological substances. - M.: the Ministry of health of the Russian Federation, "Remedium", s.257-263.

4. Report on experimental pre-clinical study safety dosage form (capsules) drug "AZIZA", Institute of Toxicology MH RF, Saint-Petersburg, 2003

5. Report on the clinical study. Evaluation of the pharmacokinetics, safety of use and impact on physical and mental health of a healthy person of the drug arizol in the pharmaceutical form capsules, 120 mg, is presented as the antidote and remedy for poisoning by carbon monoxide and other products of termed the year. GOU St. Petersburg medical Academy of postgraduate education of the Ministry of health of the Russian Federation, 2004, Saint-Petersburg.

Table 1

Toxicometric parameters for mice and rats with static seed
AnimalThe number of animalsDurationConcentate CO, g/m3
LC16LC50LC84
White rat36305.526.85±0.328.76
White mouse40305.807.10±0.258.30

Table 2

The influence of Arizola on the survival of mice following acute inhalation exposure WITH

tr>
Dose Alzola mg/kgThe number of animals in the groupIncludingSurvival, %
SurvivedDied
0 (control)242228
601221017
80113827
1001861233*
1201871139**
140124833*
160124833*
* - the difference significantly compared with control at p<0.05
** - the difference significantly compared with control at p<0.025

40 min
Table 3

Indicators of acid-base balance in the blood of white rats at different times after acute intoxication WITH at a concentration of 5.0 g/m3with an exposure time of 30 minutes
IndicatorsThe measurement time after the seedGroups of animals (n=6)
Control (unprotected)Experience (protection Etizolam)Intact animals
12345
pH2-5 min7.170±0.0107.230±0.008*7.350±0.017
7.210±0.0307.295±0.045*
1 hour7.230±0.0087.333±0.017*
3 hours7.357±0.0257.356±0.004
p CO2, mm Hg0 min33.15±0.6931.95±0.4648.23±1.98
40 min46.05±0.8346.55±0.65
1 hour48.62±0.2147.80±0.62
3 hours49.37±1.4250.25±1.50
PO2, mm Hg2-5 min32.72±2.46At 42.25±0.24*75.76±1.67
40 min43.10±2.2951.85±0.87*
1 hour49.77±0.5467.80±1.25*
3 hoursAt 74.77±1.8878.77±1.8878.77±1.88
The HCO3, mol/l2-5 min7.35±0.228.70±0.22*24.83±1.06
40 min17.25±0.2918.45±0.56 /td>
1 hourAt 23.84±0.4623.65±0.91
3 hours27.63±0.7327.83±0.62
T CO2, mol/l2-5 min8.65±0.159.70±0.22At 26.17±1.22
40 min18.50±0.2618.85±0.46
1 hour25.31±1.4724.95±0.96
3 hours28.47±0.4828.47±0.48
ABE, mol/l2-5 min-22.00±1.29-20.45±0.20-1.03±0.61
40 min-9.90±0.58-8.50±0.44
1 hour-2.63±0.43-1.65±0.73
3 hours0.73±0.320.73±0.32
SAT %2-5 min53.37±1.9558.05±0.51*89.93±1.22
40 min64.25±0.4677.10±2.93*
1 hour66.58±2.3686.05±0.42*
3 hours91.13±0.9292.63±0.49
Note: * - the difference significantly relative to the control (p<0,05)

Table 5

Toxicity of the products of thermo-oxidative degradation of the material "Vilares-5" and pine for protected Etizolam (experience) and unprotected (control) white rats
Material typeThe group of animalsThe number of animals in the groupHCL50, g/m3The protection factor
"Vilares-5"experience1820.6±1.0*1.20
control1817.1+1.1-
Pine woodexperience1873.2±3.9*1.22
control1859.8±3.4-
* - the difference significantly compared with control at p<0.05

Capsulated form Alzola, characterized in that it contains, wt%:

Azizolthe 31.8-35,97
Lactose59,95-63,60
Talc2,16-2,54
Aerosil0,96-1,11
Calcium stearate0,95-0,96



 

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