FR2617049A1 - Colostrum extract, process for obtaining it and its uses, in particular in the treatment of acne - Google Patents

Abstract

The colostrum extract according to the invention is a reddish-brown oily liquid with an aromatic odour, which is insoluble in water, partially soluble in ethyl alcohol and soluble in ethyl ether, chloroform and petroleum ether and which possesses: - a refractive index nD<35> of 1.4423 to 1.4441, - a saponification value of 198 to 204, - an acid value of 7.21 to 7.23, - an ester value of 190 to 196, and - a concentration of Zimmermann chromogens of at least 1800 mu g/g. Application, in particular, to the local treatment of acne.

Description

Colostrum extract. orocede for its obtaining and uses. especially in the treatment of acne.

The subject of the invention is a novel extract of colostrum, in particular from bovines, a process for its production and its uses, in particular in the local treatment of acne.

It has already been proposed to use the unsaponifiable fraction of the lipid part of colostrum in human therapy, in particular in the field of systemic hormone therapy.

Patent FR 1 569 698 describes a process for extracting this fraction according to which at least most of the water contained in the colostrum is removed, the remaining part is saponified, the saponification product is extracted with a solvent of the colostrum. unsaponifiable matter and the solvent removed from the extract to collect the desired unsaponifiable matter.

This patent recommends the use of 15 d 25 kg, preferably 17 & 21 kg of potassium hydroxide for 150 kg of wrung out coagulum or 120 kg of nebulized powder, which correspond to approximately 550 kg of colostrum. It can be seen from the examples that this process provides about 250 g of unsaponifiable matter from 550 kg of colostrum.

The product thus obtained which is very poor in 17-ketosteroids as determined by the reaction of
Zimmermann, exhibits poor therapeutic properties and is ineffective in the local treatment of acne.

The research carried out by the applicant has enabled him to obtain a new extract which is very effective in hormone therapy and, what is more, and this is quite surprising and unexpected, effective in the local treatment of acne.

More precisely, according to one of its aspects, the subject of the invention is an extract of colostrum which is characterized in that it is a reddish-brown oily liquid, of aromatic odor, insoluble in water. , partially soluble in ethyl alcohol, soluble in ethyl ether, chloroform and petroleum ether and which additionally exhibits
- a refractive index, n35 from 1.4423 to 1.4441, nD
- a saponification index of 198 d 204,
- an acidity index of 7.21 to 7.23,
- an ester number of 190 to 196, and
- a concentration of Zimmermann chromogens of at least 1800 pg / g.

According to a preferred embodiment, the concentration of Zimmermann chromogens is at least 2100 pg / g; it is advantageously close to 2500 pg / g
The definition and the method of measurement of these various indices and concentrations are given in the experimental part which follows.

According to another of its aspects, the subject of the invention is a process for obtaining the colostrum extract defined above, according to which at least the major part of the water contained in the colostrum is removed, the colostrum is treated. remaining part with an alkali, the liquid phase resulting from this treatment is extracted and the extraction solvent is driven off to collect the desired extract, characterized in that the treatment with an alkali is carried out in a gentle manner, by means of 0, 02 å 0.06 mol of alkali per liter of colostrum used.

The at least partial elimination of the water can be done by any process which can be carried out under relatively mild conditions which do not degrade the active constituents of the colostrum, in particular by evaporation under reduced pressure (for example of about 4, 0.103 Pa) by heating moderately by circulating water, for example at a temperature of around 70-C, in the lining of the tank which contains the colostrum.

Advantageously, this treatment is carried out in several stages with successive introductions of colostrum into the tank, as evaporation progresses.

This evaporation leads to obtaining a consistent and granular paste.

The alkali treatment is preferably carried out in a short chain alkanol (1 to 3C), in the presence of a relatively small amount of water. Advantageously, this treatment takes place in 95% ethanol.

The alkali used is preferably potassium hydroxide or sodium hydroxide.

According to a preferred embodiment of the invention, the amount of alkali used is close to 0.04 mol per liter of colostrum used.

The treatment should take place under moderate conditions, ie with relatively dilute alkali, preferably with 0.01 to 0.10 N alkali, and avoiding exceeding the temperature of 80 ° C.

When the treatment is finished, a solid phase containing soaps and casein separates from the liquid phase, in particular hydroalcoholic. This phase is extracted, preferably several times, by means of a solvent for 17-ketosteroids such as ethyl ether, preferably petroleum ether, and in particular petroleum ether boiling at 50-70 ° C.

The solvent for extracting the hydroalcoholic phase which contains the desired extract is advantageously removed under reduced pressure of 103 to 104 Pa, for example.

According to yet another of its aspects, the subject of the invention is pharmaceutical and cosmetic compositions containing the extract according to the invention as active principle.

Indeed, the extract according to the invention can be used in various therapeutic applications in human and animal medicine.

Among its therapeutic applications in human medicine, by general route, we can mention in fen
- menstrual cycle disorders,
- mastopathies,
- menopause disorders,
- certain disorders of urinary function such as cystalgia with clear urine in shame
- benign prostate conditions,
- male climacteric,
- gynecomastia in children
- true non-tumor precocious puberty,
- early non-tumor pseudopubertes, especially in girls,
- puberty delays,
- infantile mastopathies.

In these various applications, the treatment is carried out by the general route, in particular orally.

The extract according to the invention is, as the analyzes show, practically devoid of dehy droepiandrosterone.

As it does not exhibit androgen anabolic or anti-androgen-anabolic activity, it can be used in these various applications without the risk of annoying interference.

The extract according to the invention can also be used in the local or general treatment of seborrhea and its complications.

Finally, a completely unexpected application of the extract according to the invention is its use in the local treatment of acne.

It should be noted that it can also be used in the treatment of systemic acne.

As a pharmaceutical form which can be used orally, recourse may advantageously be had to soft capsules, in particular of the type of those manufactured by the SCHERER company according to its process and containing a dose of extract according to the invention in solution in a vegetable oil.

For local application, use may advantageously be made of gels or thick creams.

A suitable gel can essentially comprise an effective amount of extract according to the invention dissolved in ethyl alcohol, in particular at 90, to which is added the just necessary amount of ethyl ether, in the presence of a preservative such as butylhydroxytoluene. and a compound forming a gel with ethyl alcohol, such as carboxypropylcellulose or a polyoxyethylene glycol (PEG), for example PEG 400.

A suitable thick cream may for example be of the water-in-oil emulsion type, with for example 30% of water and 70% of oil chosen in particular from cetylstearic alcohol and thick petrolatum oil, optionally adding a thickener such as PEG 1000.

In practice, the different batches of oily extract according to the invention are more or less concentrated in active ingredients. Several batches are therefore advantageously mixed in order to have a product that is as constant as possible, exhibiting, for example, a Zimmermann chromogen concentration in the region of 2500 pg / g.

The following description of an example of preparation of the extract according to the invention, of the methods of analysis of this extract, of its pharmacological study, of examples of preparation of gels containing this extract and of their use is intended for better explain the invention, but should in no way be construed as limiting the scope.

I. Example by DreDaratlon of the extract according to the invention
In this example, an extract of colostrum from bovines is prepared.

1. Harvesting colostrum
Relatively large quantities of fresh colostrum must be collected soon after calving and processed without delay to obtain a compliant extract.

In this regard, preliminary tests have shown that the best yields and qualities are obtained in particular by using colostrum from cows of breeds
Friesian black pie, Eastern spotted, Montbéliarde red pie.

The collection is done twice daily the day and the day after calving. The transport takes place in perfectly clean milk cans and the colostrum is stored in a refrigerated tank at + 4'C.

Colostrum must be refrigerated within six hours of harvesting and must not be diluted, fermented, or soiled, especially with blood.

In practice, colostrum from cows which have been producing milk for a year or two is preferably used because first-time heifers provide quality colostrum, but in limited quantity.

In addition, it is necessary to have relatively large quantities of colostrum, for example 250 to 300 liters, in a relatively short time, that is to say less than a week, in order to process a product free from fermentations.

In the example described here, colostrum from cows 2 to 3 years old is used,
Eastern spotted, collected in early spring.

2. Concentration
The first treatment consists in eliminating almost all of the water of constitution.

To do this, in the context of this example, a vacuum evaporator is used consisting of a stainless steel tank, with a total capacity of 300 liters, equipped with a mechanical stirring system, a double bottom and a double envelope for water circulation.

The tank being hermetically closed, a vacuum is made there using a vacuum pump with condenser, until a residual pressure of approximately 4.0.103 Pa (30 mm of mercury) is obtained.

The colostrum is introduced by suction into the refrigerated tank at + 4 ° C. To start, we introduce 120 liters of colostrum and we circulate water at 70-C in the double jacket and the double bottom
When the content of the tank is reduced by half, again introduced 60 liters of colostrum.

After approximately 8 hours of operation, a new 60 liters are added, which brings to 240 liters the total volume of colostrum introduced.

The concentration operation must be carried out without interruption until a thick pasty product is obtained.

At this stage, the tank is opened to fold back the projections which are on the walls and the cover.

The apparatus is closed, the vacuum restored, and the operation is continued with reduced heating (-r 50C) of the double bottom, until a very consistent and granular leg is obtained.

The evaporator is then stopped and the bottom is carefully scraped to loosen the dry residue.

3. Gentle treatment. in alcoholic mllieu. var la Dotasse 0.07 N.

As soon as the whole has returned to room temperature, the dry residue is mixed with 60 liters of industrial denatured 95 'ethanol, added in small quantities so as to obtain a fine dispersion of the solid particles.

480 g of potassium hydroxide are dissolved in a glass jar containing 10 l of 95% ethanol. When dissolution is complete, the contents of the jar are poured into the reactor containing the concentrated colostrum from step 2.

50 liters of 95% ethanol are added, the reactor is closed and the mechanical stirring system is started.

We ensure the establishment of the reflux system and the water circulating in the double jacket and the double bottom is gradually brought to a temperature of around 85-C.

When the alcohol comes to a boil, the temperature inside the tank reaches 78 to 80 ° C.

This temperature is kept for 3 to 4 hours, without ever exceeding 80 ° C.

As soon as the treatment is finished, the heating is stopped and the mass is allowed to cool while maintaining stirring.

After several hours of cooling and as soon as the interior temperature is close to 30-C, cold water (tap water) is circulated in the double jacket and the double bottom.

When the mixture is well cooled, the agitator is stopped and allowed to stand while maintaining the circulation of cold water.

The reactor is opened after a standing period of about 8 hours and the solid material collected at the top is separated. The liquid phase is recovered by centrifugation.

The liquid phase is placed in closed cans and stored in a cold room for 48 hours in order to precipitate in particular the remaining casein.

4. Extraction
The hydrolyzate is mixed with its volume of demineralized water in a 300-liter stainless steel tank fitted with a turbine.

After standing for a few hours and cooling, a quantity of petroleum ether of so-called "railway" grade having a boiling point of 50 - 70 ° C., equal to half the quantity of alcoholic liquid coming from the gas, is added. potassium hydroxide treatment.

The mixture is stirred for 20 to 30 minutes and left to stand overnight.

After decantation, the hydro-alcoholic phase is returned to the tank while the ethereal phase is reserved.

Twice, the extraction of the hydro-alcoholic phase is repeated with the same quantity of petroleum ether.

5. Distillation
The ethereal liquors are combined and washed twice with 10 to 15 liters of demineralized water.

They are then dried by passing over anhydrous sodium sulfate and subjected to controlled distillation under reduced pressure of approximately 5.3.103 Pa (40 mmHg) l.

The distillation residue is freed from traces of solvent by the action of vacuum (4.0.103 Pa) for 15 minutes at room temperature.

At the end of this last manipulation, one obtains approximately 500 g of a reddish-brown oily liquid, with a very characteristic aromatic odor, insoluble in water, incompletely soluble in ethyl alcohol, but entirely soluble in ethyl ether. , chloroform and petroleum ether.

This product constitutes the extract according to the invention and can be characterized as follows.

He. Analysis of the extract according to the invention
The analytical identification of this product is based on index determinations, thin layer chromatography and Zimmermann chromogen assay.

A. Indices
1. Refractive index
The determination of the refractive index at 35 ° C., n35D, is carried out using an ABBE type refractometer (Zeiss-Iéna) thermostated at +0.02 μl.

2. SaDonlflcatlon index
The technique used is that described in
French Pharmacopoeia, 9th edition, 1974, tome II, pages 279 and 280, with test sockets p1 close to 1 g and 20 μl of 0.5 N ethanolic potassium hydroxide solution.

3. Acidity index
The technique used is that described in
French Pharmacopoeia, 9th edition, 1974, tome II, pages 276 and 277, with p2 test samples close to 1 g, dissolved in 20 ml of absolute ethanol, neutralized by potassium hydroxide in alcoholic solution. The titration is carried out with an alcoholic solution of potassium hydroxide 0.4 or 0.5 N, in the presence of phenolphthalein.

4. Ester index
It is defined in the French Pharmacopoeia, 9th edition, volume II, page 279, as the difference
Ester index = Saponification index - Acidity index.

5. Iodine number
The technique used is that described in
French Pharmacopoeia, 9th edition, volume II, pages 277 to 279 with p3 test sockets close to 0.60 g and a contact of 1 hour in the dark. To facilitate the observation of the end of the titration, it is preferable to add 10 ml of CC14 before starting the addition of Na2S203.

B. Thin layer chromatography (TLC)
The TLC are carried out on analytical plates of 20 cm X 20 cm of silica gel 60 (thickness 0.20 mm) without fluorescent indicator (product Merck 5721).

Two solvent systems are used in parallel
System I: n-hexane / ethyl acetate: 65/35 (vol / vol).

System II: chloroform.

In each case, the plates receive 4 tracks of 10 μl using the “Cordis” application combs marketed by the company ROUCAIRE, France.

Track n-1: dehydroepi-androsterone (DHeA), 7.5 pg
Track n'2: pure extract according to the invention
Lane n-3: extract according to the invention diluted 1/3 in THF (tetrahydrofuran).

Lane # 4: cholesterol, 8.33 pg.

After migration, the plates are dried and are sprayed with the reagent & picric acid according to Wreberlen [J. Clin. Endocrinol. (1965), 25, 288]: 0.1 g of picric acid is dissolved in a mixture of 36 ml of crystallizable acetic acid and 6 ml of 70% perchloric acid.

The plates are then examined after staying in an oven at 80 ° C., after 6 minutes and 15 minutes.

The results obtained are summarized in Tables I and II which summarize the Rf values of the characteristic spots obtained in the two solvent systems.

TABLE I Svstèmel f Description Rf Description
(6 minutes) (15 minutes)
r 0.97 purplish spot
= 0.95 to 0.87 wide spot
light brown
t 0.65 to 0.59 brown streaks
light to 0.62 2 large spots i 0.50 light gray *
t 0.58 to 0.55 stain
violet **
(cholesterol) * - no other spots visible
- the cholesterol (Rf s 0.57) and DHeA (Rf
0.27) do not appear yet ** - DHeA (Rf> 0.27) is not visible, even with a
pure extract deposit
TABLE II
System II
Read after 15 minutes
Rf Description
Rf Description "0.97 purplish stain r 0.92 å 0.85 broad light brown stain r 0.50 å 0.43 striped light brown area # 0.28 purple stain (cholesterol) # 0.21 to 0.14 area light brown streaked with
has 0.17 faint pink spot
violet * (DHeA) * this spot at 0.17 no longer appears after dilution at
1/3 Dosaae of Zimmermann's chromoaenes (classic reaction characterizing 17-ketosteroids).

1. PrinclDe
The chromogens are determined by colorimetry according to the modified Zimmermann reaction, after saponification with alcoholic potassium hydroxide and extraction with ethyl ether.

2. Reagents
- 0.5% solution of potash in 95% alcohol.

- methanol of analytical purity
- Codex ethyl ether
- Aqueous solution of 5 8 hyamine: di-isobutylphenoxy-ethoxyethyl-dimethyl-benzylammonium chloride, 1 H20 (product Merck 12058)
- Saturated solution of metadinitrobenzene in aqueous hyamine at 5%
- 8 N aqueous solution of potassium hydroxide
- DHeA standard solution (dehydro-epi-androsterone; product Merck 3681), 250 pg / ml in methanol
- Aqueous solution of 1N NaOH
3. Technology
A test portion p4, exactly weighed, close to 0.50 g, is boiled under reflux in a water bath for two hours, with 100 μl of alcoholic potassium hydroxide at 0.5 8.

Allowed to cool, evaporated in vacuo, taken up in 50 ml of water and extracted 4 times with 50 ml of ether.

During extraction, an emulsion often appears which produces three layers in the decanter.

The upper (ethereal) and lower (aqueous) layers are separated and reserved. The central layer (enulsion) is dispersed in a separatory funnel with 30 to 40 ml of water and extracted with ethyl ether (20 to 30 ml).

After standing, three layers still appear, the central layer (emulsion) has diminished considerably, the same process is repeated until the emulsion has completely disappeared; in general 3 or 4 of these operations are sufficient. The ethereal phases are united.

The initial aqueous phase is extracted 3 times with 50 ml of ethyl ether. The whole of all the ethereal phases is washed twice with 30 ml of substantially normal sodium hydroxide.

After decantation, it is possible to dry the combined ethereal phases over the minimum of anhydrous sodium sulfate for 2 hours with stirring.

Filtered, the sodium sulfate washed with anhydrous ether, all of the filtrate and the washing ether fractions evaporated.

The residue is taken up in 50 ml of methanol. This gives the stock solution which is filtered if necessary.

1 ml, 2 ml and 3 ml of stock solution are respectively introduced into tubes A, B, C and then the methanol is evaporated off in a water bath. The tubes are then completed as indicated in the table which follows.

Tubes 1, 2, 3 and 4 which serve as references and tube T (blank Z test - control) contain only the products mentioned in the table, without evaporation residue of the stock solution of the extract to be assayed.

DHeA which is practically absent from the extract according to the invention serves as a reference because, like all 17-ketosteroids, it gives a color in the Zimmermann reaction.

4. Dosaae
TABLE III
Tube: ABC 1 2 3 4 T 1: ml ethanol 0.4 0.4 0.4 0.3 0.2 0.1 0 0.4 heel DHeA OO 0 0.1 0.2 0.3 0.4 0 initrobenzene 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2
Potash 8 N 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4
All the tubes are shaken identically. The color is allowed to develop at room temperature for 20 to 25 minutes and 4 ml of hyamine solution are added to each tube. It is read with a photometer, at 480 nm, against the T tube.

Tube A, B or C, the coloration of which corresponds to a concentration lying in the mean values of the range (25 å 70 pg / ml), is used for the calculation of the titer.

It should be noted that it is best to perform the entire dosage in the same day.

In the particular case of the extract obtained under
I above, the Zimmermann chromogen assay gives a value of 2100 pg / g.

5. Results
a) Indices
The examination of samples of various batches of extract according to the invention allows the establishment of average values for these indices.

The calculation of the standard deviation on the mean, provides the limits of validity.

n D35: 1.4432 + 0.0009
Saponification index: 201 + 3
Acidity index: 7.22 + 0.01
Ester index: 193 + 3
Iodine number: 36.7 + 0.8
b) Thin layer chromatographies
Examination of the plaques under the aforementioned conditions allows the detection of cholesterol as well as of pigments on the solvent front.

Various bands surround the cholesterol The comparison with the control track of dehydroepiandrosterone makes it possible to ensure the almost total absence of this product in the extracts according to the invention.

c) Determination of Zimmermann chromogens
The values observed for different lots are as follows
n1: 2090 pg / g
n-2: 1850 pg / g
n-3: 2802 pg / g
n * 4: 2981 pg / g
n-5: 2400 pg / g
n6: 2388 pg / g
n * 7: 3170 pg / g
The concentration of Zimmermann chromogens varies from one extract sample to another. Indeed, from one test to another, the extract is more or less concentrated in 17-ketosteroids and as a general rule, for extracts obtained from colostrum samples collected under identical conditions (same period of l year, donor cows of the same type, etc.), it can be seen that the product of the concentration times the volume of the extract is substantially constant.

However, this product may present variations, particularly seasonal.

III. Toxico - Dharmacoloale
A. Toxicolocia
Various tests were carried out for the pharmacological study on a large number of laboratory animals.

In particular for the Pincus test [Y.

Chambon et al., CR Soc. Biol. (1965), 159, 2479 and (1966), liQ, 2411l and the HCG test (human chorionic gonadotropin, 80 rabbits received daily for periods of 5 to 10 days parenteral injections of extract according to the invention ; the doses of product, related to the chromogen concentration of
Zimmermann, ranging from 80 pg to 800 pg. In particular 10 rabbits received a daily injection of 800 µg of chromogens for 5 to 10 consecutive days, 15 other rabbits received the nth dose for 10 days.

In another test 30 rats received a series of 10 daily injections of 400 µg of chromogens.

No mortality was observed among the animals which underwent these tests, nor any sign of morbidity.

The doses used, 400 pg and 800 mg, corresponding substantially to 0.15 g and 0.30 g respectively of the extract used in these tests, it can be concluded that the product is perfectly tolerated and that the product is not toxic.

B. Pharmacological
There are no animal tests to experiment with anti-acne activity.

The demonstration of this activity is described in the "Clinical Trials which follow.

On the other hand, another interesting activity and applicable in human medicine is the antiovarian activity demonstrated by the test with the HCG.

In fact, injections of the extract according to the invention halve the ovarian reactivity of rabbits receiving chorionic gonatotropin, without however causing blockage, even at high doses.

In addition, to ensure the absence of any androgen-anabolic or antiandrogen-anabolic activity, tests were performed on about thirty rats, at high doses and for 10 days.

These tests did not provide any significant response, so this kind of interference is not to be feared in therapy.

IV Examples of pharmaceutical preparations: als for the treatment of acne 1. Gel n 1
Extract containing: 20 ml 2500 pg / g of chromogens Butylhydroxytoluene: 0.15 g
Carboxypropylcellulose: 3.00 g
Ethyl ether: 30 ml
Ethanol 90-: qs 300 ml 2. Gel n 2
Extract containing: 10 mi 2500 g / g of chromogens
Butylhydroxytoluene: 0.15 g
Carboxypropylcellulose: 3.00 g
Ethyl ether: 15 ml
Ethanol 90-: qs 300 ml 3.Gel n * 3
Extract containing: 6 ml 2500 g / g of chromogens Butylhydroxytoiuene: 0.15 g
Carboxypropylcellulose: 3.00 g
Ethyl ether: 10 ml
Ethanol 90-: qs 300 ml 4. Gel n94
Extract containing: 4 ml 2500 g / g of chromogens
Butylhydroxytoluene> 0.15 g
Carboxypropylcellulose: 3.00 g
Ethyl ether: 10 ml
Ethanol at 90 *: qs 300 ml
These different gels are packaged in 15 ml bottles.

V. Clinical trials
Two tests were carried out
Test n 1: t lot of gel n "1
1 lot of gel n 2
Test n2:: 1 lot of gel n 3
1 lot of gel n 4
A. Protocol
The tests were performed by Doctors
Dermatologists.

Inclusion criteria
- Patients aged over 14 and suffering from acne.

- Ability to comply with protocol.

Exclusion criteria
- Known allergic history.

- No anti-acne treatment in the previous week.

The treatment was applied each evening after washing.

The results were recorded according to the evolution Improvement: significant moderate nil
Aggravation: yes i no
Local tolerance: good / bad
B Results
1. First try
18 subjects with intractable acne were selected to enter a double-blind trial with each of the tested lots. The methodology used is that of a parallel double blind. 9 subjects received a topical treatment for 15 days with the extract according to the invention and 9 subjects received a placebo having the same appearance as the active product and containing all the constituents of the gel, with the exception of the extract.

a- Effectiveness
The effect obtained with the extract according to the invention (gels nos. 1 and 2) is significant both on the duration of the treatment (p <0.01) and on the decrease in functional signs (p <0.05). In addition, the patient's self-assessment as to the overall score that he attributes to the treatment with the extract is significant (p <0.05) compared to the placebo.

b- Tolerance
It is locally good, without induction of reactive dermatosis, nevertheless there is a sensation of local heat, or even pruritus at the place of application. This local effect is identical in the two groups (p * 0.30)
c- Conclusions
Good efficacy is noted by patients who were previously accustomed to ineffective treatments. The local tolerance reaction appears to be due to a component of the galenic form (ether) which is not essential for the stability of the active principle.

2. Second try
Its main purpose was to determine the minimum dosage of active principle. Reduced dosages even to the fifth allowed to record statistically significant results, quite comparable to those of the first experiment.

Claims (11)

1. Colostrum extract, characterized in that it is a reddish-brown oily liquid, with an aromatic odor, insoluble in water, partially soluble in ethyl alcohol, soluble in ethyl ether, chloroform and petroleum ether and which further exhibits - a refractive index, n35 from 1.4423 to 1.4441, - a saponification index of 198 to 204, - an acidity index of 7.21 to 7.23, - an ester number of 190 to 196, and - a concentration of Zimmermann chromogens of at least 1800 pg / g 2. Colostrum extract according to claim 1, characterized in that the concentration of Zimmermann chromogens is at least 2100 pg / g, and is preferably close to 2500 pg / g. 3. A method for obtaining the colostrum extract according to claim 1 or 2, according to which at least most of the water contained in the colostrum is removed, the remaining part is treated with an alkali, the water is extracted. liquid phase resulting from this treatment and the extraction solvent is driven off to collect the desired extract, characterized in that the treatment with an alkali is carried out in a controlled manner, by means of 0.02 & 0.06 mol of alkali per liter of colostrum used. 4. Method according to claim 3, characterized in that the amount of alkali used is close to 0.04 mol per liter of colostrum used. 5. Method according to claim 3 or 4, characterized in that the alkali treatment takes place in 95 'ethanol. 6. Method according to one of claims 3 to 5, characterized in that the alkali is potash or soda. 7. Method according to one of claims 3 to 6, characterized in that the alkali is 0.01 to 0.10 N. 8. Method according to one of claims 3 & 7, characterized in that the liquid phase is extracted using ethyl ether or petroleum ether, preferably using petroleum ether boiling at 50-70 * vs. 9. Pharmaceutical composition comprising the colostrum extract according to claim 1 or 2 as active principle. 10. Cosmetic composition comprising the colostrum extract according to claim 1 or 2 as active principle. 11. Gel for the treatment of acne comprising essentially an effective amount of colostrum extract according to claim 1 or 2, dissolved in ethyl alcohol and the just necessary amount of ethyl ether, a preservative and a forming compound. a gel with ethyl alcohol.