General characteristic of placental components of series Plazan.

A multistage system of work with human placental material is formed in laboratories of OOO NPP Zhes-par-Bios. The given system is a result of more than 15-year working experience of our team in this area. We treat with great care the initial material, obtaining it from maternity homes after the virologic, microbi-ological and histological analysis of the placenta of each donor. After that each placenta passes the re-peated control for virus and microbiological cleanliness in our laboratory of the firm and the placenta is started in a production cycle. After extraction of an active component we test again on cleanliness in the laboratory, and then transfer samples for analysis into the laboratory of Ministry of Health. The party is considered fit to realization at confirmation of its cleanliness at all stages of the internal and external con-trol.
The similar multistage monitoring system completely guarantees cleanliness and quality of production of the brand Plazan according to the requirements of the World Health Organization. Then the samples of all production are transferred to analyses in the certified laboratories of the services of the State Sanitary-and-Epidemiologic supervision of the Russian Federation to receive the sanitary-and-epidemiologic expert report. At last stage the products are sent to the services of the Russian State Standard for reception of Certificate of Conformity.
For today our enterprise manufactures six active components, extracted of tissues of human placenta and navel-strings. There is high molecular Plazan (h.m.), low molecular Plazan, hyaluronic acid of navel-strings, placental glycosaminoglycans, hydrolysate of placental protein and elastin-collagenous complex.

High molecular Plazan

General characteristic
It is an extract of high-molecular-weight components of human placenta with molecular weight from above 10,000 Da. As an active component contains protein (albuminous fraction)-45 g/l, glycosaminoglycans - 10 g/l, haemoglobin-35 g/l. It is an opaque liquid of cherry color containing 50% of glycerin as the stabi-lizer. Shelf life is 12 months at room temperature in the place protected from light or 24 months in a refrig-erator at 4°С.
The form of output: a vial of 20 ml of medical glass or plastic packing of 1 l.

Properties

Anti-virus activity

Table 1

Estimation of influence of proteins of human placenta on an infectious titre of the flu viruses in a culture of chicken embryos

 According the table data, Plazan has more expressed anti-virus effect, than well-known interferons, approximately in 1,3 times. Its property can be used at treatment and prophylaxis of any dermal viral diseases (in particular herpetic ones).

Estimation of influence PLAZAN on an infectious titre of the flu viruses in culture of chicken embryos

PLAZAN

INTERFERON

Strain of a virus

Quantity of virus particles on 1 ml allantois liquids (million).

 Wound-healing effect

Wound-healing ability of high molecular Plazan was determined on the model of burn thermal wounds of underbred rats of mass of 180-200 g. Burn was made on an area of 32-40 мм² on depilated lateral side of the skin by means of boiled water. Then the burn was treated by Plazan and methyluracil ointment was used for comparison. A plane geometry of wounds was fulfilled in 7, 11, 14 and 21 day. The wounds which were not treated served as control. Results of experiment are listed in Table 2.

Table 2

Dynamics of regeneration progress of experimental dermal wounds at rats after a thermal combustion (plane geometry)

According to the table date, Plazan accelerated healing of burn wounds. The healing period of the wounds was shorter by 5-6 days in comparison with methyluracil and by 15-16 in comparison with the control group. Besides visual observation of the regeneration process of the wound surface showed, that in a case with application of Plazan the healing of wounds went without formation of cicatrical tissue (keloid formation) and pyosis which is so typical for burn wounds was not observed. Thus, high molecular Plazan has the expressed wound-healing effect.

Stimulating activity on the skin cells

Seedling cells of the epidermis basal layer have ability for duplication by mitotic division due to that the epidermis is renewed during 10-30 days (physiological regeneration). This group of cells is very important during rejuvenation and restoration of the skin. We determined transcription activity of DNA in nucleus as an integrated index of activity of the cells (alpha coefficient) during regeneration. Results of the analyses are listed in Table 3.

As it is seen, high molecular Plazan will activate synthetic processes in basal epidermocytes in 1,8 times at the first stages of regeneration.

Table 3

Transcription activity (alpha coefficient) if DNA of nucleus of basal epidermocytes

The same parameters were studied and for fibroblasts of the dermis. The given group of cells is the fundamental unit in creation of collagenous structures of the skin. Results of the researches are given in Table 4.

Table 4

Transcription activity (alpha coefficient) of DNA of nucleus of fibroblasts of the dermis

As it is seen in this group of cells Plazan stimulates synthetic processes in 2 times more strongly, rather than in the control group. But especially clearly this law (Table 5) was showed on perivascular cells of the dermis which responsible for growth of capillaries in the skin, so, for nutrition of all groups of cells.

Table 5

Transcription activity (alpha coefficient) of DNA of nucleus of perivascular cells of the dermis

The stimulation of fibroblasts of the human dermis was shown in the culture of cells in the system in vitro. In this experiment we utilized as the additional control a placenta extract. As it is seen from the data of experiment, high molecular Plazan practically in 2 times strengthens processes of synthesis in fibroblasts (Table 6).

Table 6

Action of h.m. Plazan on fibroblasts in the culture of cells

Thus, action of Plazan was studied in clinic on models of trophic ulcers, a pyosis of posttraumatic wounds, purulent diseases of the skin and of hypodermic fat. In treatment there were 80 patients under observation.

Figure 2

Dynamics of monocultures

In 24 hours of Plazan      The control of Plazan the Control

Golden staphylococcus

The wonderful mud puppy

Epidermal staphylococcus

Intestinal rod

Diplococcus

Figure 3

Dynamics of associations

In one week In two weeks

In 24 hours of Plazan      The control of Plazan the Control

0,34%

The wonderful mud puppy + epidermal staphylococcus

Epidermal staphylococcus

The wonderful mud puppy + pyocyanic rod

Golden staphylococcus + intestinal rod

Golden staphylococcus + pyocyanic rod

Dynamics of monocultures during treatment testifies, that in one week of treatment of Plazan the contents of golden staphylococcus dropped from 41 up to 17% in the wound and the given pathogen was not found out in the wound by second week of treatment (Fig. 2).

Dynamics of changes of microbial associations also confirmed antimicrobial properties of high molecular Plazan. So, in 7 days of Plazan treatment the association of golden staphylococcus and pyocyanic rod decreased from 41 up to 10% and was not determined at all in 14 days (Fig. 3).

Thus, Plazan confirmed in clinic the antimicrobial properties and ability to stimulate processes of regeneration.

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