CS254008B1 - Intravenous preparation based on pyrogen-free albumin - Google Patents

Abstract

The subject of the solution is an intravenous preparation based on animal apyrogenic albumin, which consists of 5 to 20 weight percent apyrogenic animal albumin, 1 to 10 weight percent lysine or methionine and 1 to 15 weight percent glucose or maltose. It is intended for the treatment of calves with disorders of protein-nitrogen and energy metabolism.

Description

The invention relates to an intravenous infusion solution based on animal albumin, intended for the treatment of sick calves with disorders of protein-nitrogen and energy metabolism. The product contains, in addition to albumin, glucose and essential amino acids such as lysine or methionine.

Albumin acts as a primary regulator of osmotic pressure. The corresponding mass amount of albumin possesses more osmotically active particles than the same amount of globulin. In human medicine, for therapeutic purposes, albumin is applied as a preparation intravenously (list of Czech pharmaceutical preparations 1986—87, page 736], application of albumin by other means results in hypersensitivity reactions of the macroorganism as well as decomposition of its molecule.

Albumin, due to its osmotic effect, tends to retain water in the blood capillaries and thus maintain plasma volume (HEYL J. T., GIBSON J. G., JANEWAY C. A., J. Clin. Invest. 22, 763, 1943). The movement of water inside the organism is much greater than the exchange of water between the organism and the external environment. The rate of circulation of albumin is 7% per day (DEICHMILLER M. P., DIXON F. J., MAURER P. H., Fedration Proc., 12, 386, 1953), which indicates the relative stability of albumin in the process of exchange and catabolism (HUGHES Jr., Intersitial Proteins: The Proteins of Blood Plasma and Lymph 1954, vol. II., part B, pp. 663—754).

The therapeutic importance of amino acids (especially lysine and methionine) cannot be assessed separately from their basic functions as essential and especially limiting amino acids. In addition to these functions, we find out their specific effects on the organism, which we can use therapeutically. It is known that a lack of lysine leads to a disorder of protein synthesis in the liver, which can result in its fatty degeneration (MAGIC D., Habilitation thesis, 1977). The protective effect of methionine, which is the largest supplier of methyl groups for the organism, is more pronounced (SCHiiLER D., Arch. Tiernahrung, 22, 1972, pp. 631—635). Lysine, with its buffering capacity, although to a lesser extent, regulates the acid-base state of the organism, has a beneficial effect on metabolic disorders in calves associated with hypocalcemia and hypomagnesemia, and similarly has a beneficial effect on mineral metabolism (DUDLEY W. A., J. Anim. Sci. 21, 1963, pp. 639—642). In diarrheal diseases, the absorption of amino acids worsens. In calves, it causes a state of protein malnutrition (MOJŽÍŠ, HASTUNEAK, Information Bulletin for Veterinary and Agricultural Practice 4, 1984).

So far, there is no commercially produced infusion solution based on animal albumin intended for veterinary intravenous use with an admixture of suitable sugars and essential amino acids available in the CSSR. Albumin-based preparations are produced, but due to the high content of pyrogenic substances, they are applied intramuscularly or intracutaneously, which makes the therapeutic effect minimal.

The same applies to amino acid-based preparations that are produced for veterinary use, the therapeutic effect of which is significantly limited.

The essence of the intravenous preparation based on animal albumin is that it is composed of 5-20% by weight of apyrogenic animal albumin, stabilized with 0.01 M Acetyl DL-tryptophan and 0.01 M Na caprylate. It also contains 1-10% by weight of lysine or methionine and 1-15% by weight of glucose, maltose. The pH of the preparation is adjusted to a value of 6.0 to 7.0 and it is adjusted to a sterile state by filtration through suitable bacteriological filters.

The product prepared in this way was verified in the treatment of sick calves, where it brought about an adjustment of the health status to the level of physiological values (see Table 1).

Based on the results shown in Table No. 1, where the preparation was administered intravenously to sick patients, it is clear that not only did they survive, but their health condition also improved.

Example 1

To 100 ml of animal albumin intended for intravenous use at a concentration of 10% by weight stabilized with 0.01 M Acetyl-DL-tryptophan and 0.01 M Na caprylate, 5% by weight glucose and 5% by weight lysine are added. The mixture, after adjusting the pH to 6.0, is stirred for 2 hours and filtered through bacteriological filters and diluted.

Example 2

To 100 ml of animal albumin intended for intravenous use at a concentration of 20% by weight stabilized with 0.01 Acetyl-DL-tryptophan and 0.01 M Na caprylate, 5% by weight glucose and 2.5% by weight lysine are added. The mixture, after adjusting the pH to 7.0, is stirred for 2 hours and filtered through bacteriological filters and filled.

Example 3

To 100 ml of animal albumin intended for intravenous use at a concentration of 5% by weight stabilized with 0.01 M Acetyl-DL-tryptophan and 0.01 M Na caprylate, 15% by weight glucose and 10% by weight methionine are added. The mixture, after adjusting the pH to 6.5, is stirred for 2 hours and filtered through bacteriological and bulking.

Table 1

Biochemical examination of albumin levels* (g/1) in the blood serum of calves before and after i. v. application of the products — the products were intravenously applied to calves on colostrum nutrition for disorders of the protein-nitrogen and energy profile.

Ordinal Application number (2X20 ml) calves

Pre-treatment albumin levels

Albulysin Albumin 20%

Albumin level values on the 3rd day after application of 40 ml of the preparation Albulysin Albumin %

Clinical condition

1 2 >' about 35.00 30.55 3 About CM 38.55 4 those and 35.55 5 N \r—« a 37.75 6 s jQ £3 37.75 7 < 36.10 8 37.20 9 36.10 10 35.55 2,235 X 36,060 11 Physiological 35.10 12 solution 34.65 13 36.25 Sn 0.898 X 35.13

37.70 40.75 39.50 3 37.80 35.50 42.10 39.45 43.35 42.70 £ about ·»—1 «4-1 O f | 36.15 40.10 40.15 with .a and 37.10 37.50 41.70 a w E> Ž o cd 3 36.20 45.35 40.70 φ p-í (Λ F—1 a cd S SQ 35.45 42.80 40.10 CDs n 44 CJ 38.65 41.85 39.30 thi ω β ⁴⁼³ CD and > about •ι—1 4—» 0) 30.55 42.10 41.10 >Q 0) With 44 Si-·1 00 35.00 2.137 42.75 2.040 40.10 1.277 !>» > > s cd o, tí o CO 3 Xí CD th Φ 36.01 41,475 40.87

death death

Legend:

Albumin — albulysin = 1 ml of albulysin contains 20% by weight of albumin, 10% glucose and 10% lysine and _n = standard deviation;

x = arithmetic mean i

Albumin 20% = 1 ml of albumin i. v. contains 20 percent albumin by weight

Claims (1)

An intravenous formulation based on animal pyrogen-free albumin, characterized in that it is comprised of 5 to 20% by weight of pyrogen-free animal ALUMINUM bumin, 1 to 10% by weight of lysine or metlonine and 1 to 15% by weight of glucose or maltose.