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12A composition based on sodium silicate, thi-ochevine and potassium hydrophosphate has been developed to impart flame-retardant properties to cellulose materials.
The optimal conditions for the treatment of fabrics were determined, the effect of the concentration of the working solution, the temperature of impregnation and thermal fixation on the flame-retardant properties of the fabric was studied. The improvement of the flame-re-tardant properties of cellulose materials modified by the proposed composition is shown.
By the method of electron-scanning microscopy, it was found that the treatment of fabrics with flame-retardant compositions leads to a change in the morphology of the surface of the fibers. It is shown that cellulose materials modified with compositions based on sodium silicate, thiourea, and potassium hydrophosphate increase their flame-retardant properties. The proposed compositions ensure the achievement of higher fire resistance indicators. Processing can be carried out on the standard equipment of finishing enterprises without the stage of high-temperature fixing of the preparation.
Conclusion
1. Liquid glass, thiourea, and sodium dihydro-phosphate contributed to the formation of a new composition. The heat treatment time was studied in terms of the concentration of the working solution, the temperature of the heat treatment, and the fire resistance of the fabric. The fire resistance of the treated samples is increased in comparison with the new undigested material based on sodium dihydrogen phosphate.
2. Using infrared spectroscopy, the interaction of measuring compositions with cellulose fibers was studied, the cotton fabric did not lose its properties even after treatment with sodium dihydrogen phosphate.
3. Initially, the surface of the untreated fabric was not smooth, and after processing, it was observed that the surface was smooth. The method of electron scanning microscopy showed that the treatment of tissues with advanced compositions leads to a change in the morphology of the surface of the fibers.
References
1. Alongi J., Carosio F., Kiekens P. Recent developments in the development of water-based flame retardant coatings for polyester and polyester-cotton blends. Polymers. 2016. 8. pp. 357-380.
2. Shah A. U. R, Prabhakar M. N., Song J.Modern achievements in the field of fire resistance of natural fibers and composites on a biological basis-Review//In-ternational Journal of Precision Engineering and Manufacturing-Green Technologies. 2017. pp. 242-262.
3. Liu X., Zhang Q., Cheng B., Ren Y., Zhang Y., Ding C. Strong fire-resistant cellulose fibers modified with a new, light and effective finishing agent based on phytic acid/ / Cellulose, 2018, 25. P. 799-811.
4. Tausarova B. R., Abilkasova S. O. Fire-resistant modification of cellulose materials by n-and p-contain-ing composites / / Fiber Chemistry, 2017, vol. 49, no. 4. pp. 242-245.
5.Lu Y., Jia Y., Zhou Y., Zou J., Zhang G., Zhang
F. Simple one-stage solvent-free synthesis of flame retardant for cotton with excellent efficiency and durability. / / Carbohydrate polymers. 2018. 201. P. 438-445.
6. Ismail V. N. Sol-gel technology of innovative finishing of fabrics-Review / / J Sol-Gel Sci. Technol. 2016. 78P.698-707.
7. Lin D., Tseng H., Li H., Lai H. Easy production of superhydrophobic and fire-resistant coatings on cotton fabrics by layer-by-layer assembly. // Cellulose. 201825. P. 3135-3149
8. Tausarova B. R. Takei E. Sol-gel technology for giving fire-resistant properties to cellulose textile materials. Nano industry. 2018. 80. No. 1 p. 68-73.
9. Rosace G., Castellano A., Trovato V., Yakono
G., Malusell G. Thermal and fire-resistant properties of cotton fabrics treated with a new nitrogen-containing carboxyl-functionalized organophosphorus system. 2018.196. pp. 348-358.
10. Lin D., Zeng X., Li H., Lai X., Wu T. Production of superhydrophobic and flame-retardant coatings on cotton fabrics by the sol-gel reaction method / / Journal of Colloid and Interface Science. 2019.533. P. 198206.
DEVELOPMENT OF THE COMPOSITION AND STUDY OF THE ENCAPSULATED DOSAG FORM
BASED ON LEVOMYCETIN
Zainullina A.S.
Candidate of Technical Sciences (PhD), associate Professor in the specialty Chemical Technology
Begadilova A. Master's degree of Chemistry, Chemical Technology and Ecology, Almaty Technological Universitya.
Abstract
The article is devoted to the development of technology for obtaining a drug based on levomicetin in the form of capsules. Marketing analysis has shown the relevance of the development of medicinal preparations in the form of capsules in Kazakhstan. The main physical, chemical and technological properties of the substance samples were studied. The quality indicators of the initial raw material and the finished product are determined. Technological calculations were carried out.
Keywords: drug, non-steroidal anti-inflammatory drugs, levomicetin, encapsulated form of the drug.
Introduction
Today, the pharmaceutical industry produces huge names of medicines every year in the form of tablets, capsules and ampoules. It is worth noting the profitability of the production of medicines produced mainly in developed European countries, as well as in America, South Korea and Russia. The analysis of statistical data shows that the share of encapsulated forms of medicines in these countries is 5-17% of the total number of medicines produced. In Russia, this figure is just over five percent [1-3].
In Kazakhstan, the share of the pharmaceutical market engaged in encapsulated drugs lags behind the world level. In this regard, the development of medicines in the form of capsules is an urgent task of pharmaceutical science.
The encapsulated form of the drug has a number of advantages, which leads to its high demand and production.
Soft gelatin capsules have several advantages in the recent growth rate of their popularity in the world [4]. The encapsulated form of the drug has a number of significant advantages in comparison with other dosage forms:
4) a major role in the production of a medicinal product is played by profitability, which can be increased by reducing raw material costs. The encapsulated form of the drug allows you to reduce the dose of the biologically active substance by reducing the dose, which is due to an increase in its bioavailability.
5) the problem of maintaining the stability of medicinal components that are easily oxidized is a serious problem. The presence of a soft gelatin capsule protects the contents of the capsule from the penetration of air oxygen at low relative humidity.
6) for the production of soft gelatin capsules, mainly liquid compositions or compositions in the form of a paste are used, which reduces the likelihood of dust formation, which is important;
7) the use of the encapsulated form solves the acute problem of falsification of medicinal products, as the shell of the capsule deteriorates when opened;
8) in many cases, it is known that medications have a bitter, sometimes unpleasant taste and smell. Soft gelatin shell
9) various variants of shape and size, a wide color scheme, the ability to insert the name, signs, and numbers directly into the capsule provide the possibility of identifying the drug.
Experimental part.
The form of the study: the composition for the manufacture of the drug "Levomycetin" in a capsule.
The composition prepared for the manufacture of the drug "Levomycetin" in a capsule consists of the following substances:
Chloramphenicol is the active substance of the drug. White-light gray or light yellow, thin, crystalline powders or fine crystals in the form of needles. It is distinguished by its hard, sour taste and belongs to the list of broad-spectrum antibiotics.
Sugar powder is a medicinal product that is used as a filler. It is a white crystalline powder with no white crystals or odour depending on the type, and has a faint sweet taste.
Calcium stearate-the composition of the drug has an antifractive function. Depending on the type, the powder is fine crystalline, pale, odorless.
In order to bind the mixtures contained in the starch - drug, it is necessary to use potato starch. The main reserve carbohydrate obtained from the composition of potatoes is carbohydrates. It consists of two polysaccharides formed from glucose residues, i.e. amylose and amylopectin. Their appearance is a flourlike white powder. [22]
Necessary equipment for obtaining the type of drug "Levomycetin" in a capsule: semi-automatic capsulator model ITA-014 (Fig. 8). Power 80 W
Figure 1. Semi-automatic encapsulator model ITA-014
The physico-chemical and technological characteristics of active and auxiliary substances are interrelated and can in a certain way affect the process of obtaining high-quality capsules with the necessary therapeutic effect.
The substance-acetylsalicylic acid and paracetamol and masses for encapsulation were subjected to
physico-chemical and pharmaco - technological studies. All indicators were determined in accordance with GOST.
Results and their discussion The drugs are produced in different countries of the world. Unfortunately, the main share of medicines presented in the pharmaceutical market of Kazakhstan
is made up of imported drugs: India (24%), Russia Table 1 shows the distribution of dosage forms de-
(11%), and the share of Kazakhstani manufacturers is pending on the forms produced. only 12%.
Table 1.
Total number of medicines registered in the State Register of the Republic of Kazakhstan.
№ Forms of medicinal products registered in the GF of the Republic of Kazakhstan Specific weight of the dosage form % total number of medicinal products
1 Soft gaseous drugs 1,71 137
2 Medicinal products in a mild form 5,16 413
3 Medicinal products in liquid form 28,39 2272
4 Medicinal products in solid form 64,74 5180
From Table 1, solid medicines are in the first Table 2 shows the ratio of solid-form drugs to the
place, 64.74% of the total number of registered total number of drugs produced. medicines, followed by liquid medicines - 28.39%, soft medicines - 5.16% and gaseous medicines - 1.71%.
Table 2.
Ratio of solid medicinal products
№ Types of medicines in solid form Dosage of the drug
1 Tablets 3433
2 Capsules 655
3 Powder 569
4 Suppositories 143
5 Granules 70
6 Powder 13
The analysis of the ratio of solid-form medicines to the total number of medicines showed that the maximum number of tablets (3412) is the total number of solid medicines (3412). The encapsulated form of the drug is in third place, despite a number of significant advantages (651). Powders, suppositories, granules, dragees are produced in small quantities: 568, 142, 69, 12, respectively.
Marketing analysis of medicines produced in various forms and for various purposes shows that the main share of medicines produced in solid form is accounted for by Film-coated tablets (55.03%).
The results obtained in Kazakhstan, i.e. in the future
indicates the need to expand and expand the pharmaceutical industry for the production of medicines.
The analysis of the pharmaceutical market of solid dosage forms of pharmaceutical drugs in Kazakhstan shows that among the anti-inflammatory drugs found on the market, drugs based on levomycetin are affordable and effective drugs.
According to the State Register of the Republic of Kazakhstan, 93.2% of medicines in capsule form belong to foreign manufacturers, and only 6.8% - to domestic manufacturers. 17 types of medicines based on levomycetin in tablet form have been registered, of which 41.2% are produced by foreign companies, and 52.8% - by domestic manufacturers. The dosage form in the form of capsules based on levomycetin is not produced by domestic manufacturers.
Table 3 shows the qualitative definition of the active substance levomycetin.
Table 3.
Specificity of levomycetin raw materials
№ Specific indicators Technical requirements Indicators
1. Appearance White crystalline powder White powder
2. Free salicylic acid "I'm sorry," she said.S (0.2%) 0.14%
3. Presence of sulfates The substance should not exceed 0.02%. 0.15%
4. Composition of chlorides The substance should not exceed 0.004%. 0.002%
5. Sulphate ash content The content of sulfate ash in 1 g of the substance should not exceed 0.1%. 0, 09 %
6. Heavy metal composition The content of heavy metals in the substance is 0.002 %. it should not exceed. 0,0014 %
7. Reducing the mass during drying Weight loss should not exceed 0.5%. 0,40%
8. Conclusion Levomycetin meets the requirements for product quality .
In the course of the study, levomycetin was char- meets the requirements of the state pharmacopoeia of acterized by the main indicators of specificity. The data the Republic of Kazakhstan (GF) in all its main charac-presented in Table 3 indicate that the levomycetin used teristics.
Table 4.
Composition of the levomycetin model capsule
№ Ingredient: Assignment function Number
G %
1. Chloramphenicol Active substance 0,200 40
2. Microcrystalline cellulose Filler 0,100 20
3. Silicon dioxide (Aerosil) Binding agent 0,040 8
4. Hydroxypropyl cellulose Aerator 0,005 1
5. The glycerol palmitostearate Lubricant 0,005 1
Total 0,500 100
Depending on the size of the shell, the calculated volume according to the average capacity corresponds to the size of the shell of the solid gelatin capsule No. 1 (200 to 600 mg of powder).
Thus, The conducted studies have proven that the drug meets the requirements of the state pharmacopoeia
of the Republic of Kazakhstan in all indicators (table. 5). The breakdown of capsules occurs within normal limits, on the basis of which it is possible to predict the high bioavailability of the developed drug.
Table 5.
Physico-chemical and technological parameters of capsules
Indicators Value
Description Solid gelatin capsules No. 1 with a green opaque body and a white opaque lid filled with white powder.
Average weight of internal capsules 0,500 ± 0,004
Mass uniformity No more than 20 capsules deviate from the average mass of the contents of no more than ± 6.5% and no more than ± 14
Decomposition ( not more than 15 min) 9,5± 1,0
Solubility (not less than 75 %) 89,6 ± 3,0
Output of dry mass or amount of water,% 2,1 ± 0.09
In the course of the work, a feasibility study was developed, taking into account the results of the material and energy balance for one series of the drug in capsules. For this purpose, the cost of production was determined from the cost of basic raw materials, auxiliary substances and other production costs.
The addition of administrative and commercial costs to this amount determined the cost of production. Then calculate the minimum estimated price of 10,000 packages (1 Series), adding a return to this amount, which is 75% of this amount. Dividing the amount by 10,000 ultimately determined the price per unit of product.
Thus, the calculations of the feasibility study for the production of capsules" levomycetin " showed that the price of one unit of production is 377.64 tenge.
Conclusions
1.the main physical and chemical characteristics of Livomycetin were determined and their compliance with the requirements of the state standard of the Republic of Kazakhstan was demonstrated.
2.solid gelatin capsules of the drug were obtained on the basis of Livomycetin. The composition of the main and auxiliary components was selected.
4.the main indicators of product quality are determined: organoleptic properties, average mass, mass uniformity, mass consumption during drying, solubility.
6.as a result of the feasibility study, the economic feasibility of industrial production of a drug based on
levomycetin was proved. The cost of products amounted to 377.64 tenge.
References
1. Mashkovsky, M. D. Medicinal products / M. D. Mashkovsky. - M.: 2000. - T. 2. - 312-319, 427-436 p.
2. Begadilova A. B., Jarylgapova D. S. Analysis of the pharmaceutical market of solid dosage forms. Materials of the MNC of students and young scientists "Farabi ALEMI", Almaty, Kazakhstan, 6-9 April 2020-p. 19.
3. Begadilova A. B., Jarylgapova D. S. Advantages of the encapsulated form of medicinal products. Materials of the MNC of students and young scientists "Farabi ALEMI", Almaty, Kazakhstan, 6-9 April 2020-p. 12.
