Development of technology for obtaining "ecustim" capsule

Topicality: the development of effective diuretic medicines based on local plant raw materials is a topical problem in the pharmaceutical science. On the basis of dry extracts of herbs of amber false, wool grass, horsetail, crooks creeping, yarrow flowers, cucumber seeds, stalks with corn stigmas and the roots of licorice naked a new diuretic drug was developed [1,2], which is conditionally at first named "Urostim" after"Ecustim." The purpose of this research is to develop a technology for the preparation of a capsular dosage form "Ecustim".

Key words: dry extract, substance, technology.

Materials and methods: analysis of dry extracts mixture showed that it contained about 6% moisture, i.e. dry extract of the drug "Ecustim" is a hygroscopic substance. Considering these factors, various auxiliary substances were used in the preparation of "Ecustim" capsules, listed in Table 1.

Table 1 - Composition of "Ecustim" capsules components (in mg)

Composition

1

2

3

4

5

6

Ecustim dry extract

350,0

350,0

350,0

350,0

350,0

350,0

Aerosil 200

-

5,0

2,0

-

2,0

5,0

MCC

80,0

70,0

74,0

95,0

50,0

-

Crospovidone

-

2,0

1,0

-

1,0

2,0

Lactose anhydride

-

-

-

-

44,0

 

Calcium stearate

-

3,0

3,0

5,0

3,0

3,0

Potato starch

20,0

20,0

20,0

-

-

90,0

Total weight

450,0

450,0

450,0

450,0

450,0

450,0

In the future, each series was individually moistened with 96% ethyl alcohol, 2,5% starch paste, 2,3% gels of MC, Na-CMC and sugar syrup until the optimum moisture content was formed.

The mass we pressed in the form of granules prepared using a starch paste, gels MC and Na-CMC of different concentrations and sugar syrup, did not give positive results.

The obtained results: as a result of experimental studies it was found that the use of 96% ethyl alcohol as a binder for the preparation of compressible masses for the preparation of granules is optimal. The analysis of physico-chemical properties of the capsules showed that of the six compositions studied, the most satisfactory results were obtained for compositions 4 and 6. However, taking into consideration the production of auxiliary substances in the Republic of Uzbekistan, we selected composition 4 as the most acceptable in the future for the organization of capsule production. The results of studying the technological properties of the encapsulated mass prepared according to composition 4 are given in Table 2.

Table 2 - Technological characteristics of encapsulated mass "Ecustim"

Studied indicators

Unit measure

Obtained results

1

Fractional composition +1500

-1500 +1000

-1000 +630

-630 +500

-500 +400

-400 +315

-315 +63

-63 +50

-50

mcm,%

0,06 95,98 0,214 0,255

0,712 1,036 1,809 0,006

2

Friability

kg/c10-3

6,60

3

Bulk density

kg/m3

407

4

Residual humidity

1000С, %

1,70

Based on the results presented in Table 2, it can be seen that the technological characteristics of the encapsulated mass prepared in composition 4 have improved markedly in comparison with the substance. To obtain 100 capsules of Ecustim by 0.350 g, 9.5 g of MCC, 0.5 g of calcium stearate are added to 35.0 g of crushed dried extract Ecustim and 0.5 g of calcium stearate are added and the resulting mass is mixed in a porcelain mortar until uniform. Further, the resulting mass is moistened with 96% ethyl alcohol and passed through a sieve with a hole size of 0.63 mm. The resulting granules are dried at a temperature of 45 ± 50 °C for 30-45 minutes. The dried granules are filled into gelatine empty capsules in the size "0" to 0.45 grams on a capsule filling machine from PharmaChemIndustris (India).

Prospects for further research: the technology for the preparation of Ecustim capsules by 0.35 g was developed (with a total weight of 0.45 g). The obtained data were used in the development of laboratory technological regulations for the production of Ecustim capsules.

 

References

  1. 1. Азизов У.М., Хаджиева У.А., Маджитова Д.У. и др. / Технология получения субстанции “Уростим” // Актуальные вопросы образования, науки и производства в фармации - 17-18 ноября, 2016 г. - С.213-214.
  2. 2. Азизов У.М., Хаджиева У.А., Маджитова Д.У., Худойбердиев О.И. / Стандартизация сухого экстракта “Уростим” // Фармацевтический журнал.- Ташкент, 2017. - № 2. - С.51-54.
Year: 2017
City: Shymkent
Category: Medicine