RU2241471C1 - Suppository for treatment of chronic prostatitis - Google Patents

Abstract

FIELD: medicine, urology, pharmacy.

SUBSTANCE: invention relates to the development of suppository consisting of 2.0 ml of 1% an aqueous solution of humic acids (pH = 7.4), low-mineralized peloids and sufficient amount of butyrum cacao for preparing suppository with mass 2.0-2.2 g. Invention provides the development of a medicinal agent comprising humic acids, low-mineralized silt sulfide dirt free of ecotoxicants of different nature and eliciting high biological activity. Invention can be used in treatment of prostatitis.

EFFECT: valuable medicinal properties of suppository.

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Description

The invention relates to medicine, namely to pharmacology, and can be used in the treatment of prostatitis. Chronic prostatitis is the most common disease in men of young and mature age. Despite the development of numerous treatments for chronic prostatitis, this problem currently remains relevant. This is due to untimely diagnosis, inadequate treatment, the predominant use of drug therapy. It is known that antibacterial, antiseptic therapy does not lead to prolonged remission of this disease. A short-term effect forces long and regular courses of antibiotic therapy, which often leads to undesirable side effects [1, 2, 3].

The positive results of the treatment of chronic prostatitis using mud therapy in the spa [4]. It should be noted here that in the difficult modern socio-economic conditions in Russia, spa treatment has become inaccessible to the general population.

The positive results of the treatment of chronic prostatitis with the help of mud applications, rectal tampons are known [5]. The anti-inflammatory effect is realized due to the chemical ingredients of the mud. However, native mud therapy has a number of contraindications. In addition, in modern environmental conditions, native peloid therapy is becoming unsafe, given the ability of therapeutic muds to accumulate ecotoxicants of various nature.

Known biogenic preparation “Raveron”, which is an extract from the prostate gland of mature animals, freed from estrogen hormones and proteins, used as an injection [6]. The latter creates difficulties with outpatient treatment. For the course of treatment requires qualified medical personnel, the use of sterile instruments and disinfectants. In addition, the use of the drug requires a long course of treatment and gives a temporary improvement, often causing an allergic reaction in the form of a skin rash.

Known tool "Vitaprost" [7] for the treatment of the prostate gland, which is a suppository containing a complex of bioregulatory peptides of the prostate gland of cattle. The disadvantages of Vitaprost include that this drug has an organotropic effect on the prostate and can cause a violation of the hormonal status of the body.

Known suppositories with components of the Tambukan therapeutic mud [8] “Medicinal substance of the suppository with natural producers” (Scherbak I.F., Tolcheev A.V., Yakubov A.A.), including propolis extract, bee honey, T-2 emulsifier, cocoa butter, enriched with lipids of the Tambukan therapeutic mud, to a content of carotenoids of at least 1 mg%. The disadvantage of this drug is the high likelihood of allergic reactions to both propolis and bee honey. In addition, a small group of biologically active components of the peloid is introduced into the suppository.

This drug is the closest to the invention in essence, achieved therapeutic effect and is selected as a prototype. The inventive treatment tool differs from the prototype in that it contains a quantitatively predominant natural healing environmentally friendly biologically active substance that has anti-inflammatory effect - humic acids.

The objective of the invention is the creation of a new drug with anti-inflammatory effect for the treatment of chronic prostatitis, containing humic acids of low mineralized silt sulfide mud, purified from ecotoxicants of various nature, with high bioavailability and anti-inflammatory activity, low cost.

Humic acids are a natural component of therapeutic mud, harmless to the body, do not cause side effects, allergic reactions. The study of the acute toxicity of humic acids was carried out on sexually mature Wistar rats weighing 180-200 g. Observation of the animals was carried out for 14 days. Administration of “per os” from 0.5 to 15 g / kg did not cause a toxic effect. Intramuscular administration of 1 to 20 mg / kg also did not cause death of animals. The introduction of a larger amount of the active substance cannot be carried out practically and is unreasonable.

Cocoa butter is a fatty oil obtained by pressing fried and peeled cocoa seeds cultivated in the tropical chocolate tree Theobroma Cacao L. sem. Sterkuliev (Sterculiaceae). Dense homogeneous mass of yellowish color, slight aromatic odor and pleasant taste, brittle at room temperature; melts at 33-34 ° C, turning into a transparent liquid (GF X, 1968).

The problem is solved in that the proposed tool contains biologically active humic acids, according to the invention is made in the form of a suppository and additionally contains a base in the following ratio of components in grams per candle 10% solution of humic acids (pH 7.4) - 0 , 2 ml, base, sufficient amount to obtain a suppository weighing 2.0-2.2 g.

In this case, cocoa butter is used as a base. Preparation of a suppository consists of the following operations: 20.0 cacao butter is weighed and placed in a mortar, 2.0 ml of a 1% aqueous humic acid solution is measured (pH 7.4), and crushed until a homogeneous mass is formed. A bar is formed from the suppository mass, which is divided into 10 equal parts and the suppositories are rolled out. The resulting dosage form is packaged and issued for vacation.

The proposed ratio of medicinal substance and cocoa butter is optimal and provides high-quality suppositories and therapeutic effect of the drug. The dose of the drug is established experimentally. The content of the therapeutic substance less than 0.002 g per candle does not provide the required therapeutic effect, and more than 0.2 ml complicates the process of preparing the suppository mass.

The effectiveness of suppositories made according to the specified recipe was investigated in the urology clinic of the Samara State Medical University on an outpatient basis on 30 volunteers with chronic prostatitis. They are assigned 1 candle per night for 12 days. The results of the study showed that the use of suppositories significantly improved the condition in 19 people starting from the 2nd day, in 6 people the condition improved slightly by the 7th day, in 4 people the condition did not change and they were transferred to treatment using generally accepted methods. One patient, due to aggravated concomitant pathology, stopped using suppositories on the 4th day. In patients treated with suppositories containing 0.002 g of humic acids, burning in the urethra disappeared on the 2nd day, dull pain in the perineum disappeared on the 3-4th day, over the bosom on the bosom, and the jet diameter increased on the 5-6th day and urination rate, on the 7-10th day, an improvement in erectile function, sexual libido was noted. Recovery occurred on the 11-12th day. During the observation (within 3 months) exacerbations of chronic prostatitis were not observed, side effects of the suppository were not identified.

Example:

Patient Belov A.V., 45 years old, has been suffering from chronic prostatitis for 10 years, undergoes outpatient treatment for this disease twice a year. Upon admission, he complained of dull pain in the perineum, radiating to the anus, frequent urination, burning and mucous discharge at the end of the urination act, lethargy, irritability, fatigue.

When examined rectally: the prostate is slightly enlarged, soft-elastic consistency, moderately painful, with clear, even contours. The interlobar sulcus is slightly flattened.

Transurethral ultrasound examination: the prostate is 3.8-3.2-3.4 cm (slightly enlarged), the contour is clear, even, in the left lobe and along the urethra - single small calcifications. Stagnation is observed.

Smear from the urethra: white blood cells - 30-40 - in the field of view, lecithin grains are absent, mucus is a large number, bacteria are absent.

Prescribed suppositories with humic acids in a dose of 0.002 g once a day at night. On the 2nd day from the onset of the disease, the patient disappeared pain and burning during urination, on the 4th day the stream became satisfactory, the discharge of the mucous character from the urethra stopped. By the 7-8th day, the general condition of the patient improved and on the 10-11th day he noted a complete recovery. The size of the prostate was normalized by TRUS (performed on the 14th day). Smear from the urethra: white blood cells - 8-10 in the field of view, lecithin grains in large quantities, mucus is absent. The patient does not need additional treatment.

Thus, it was found that the proposed suppositories have a positive therapeutic effect in the treatment of chronic prostatitis, which consists in anti-inflammatory action, relieving edema, the disappearance of burning, secretions, normalizing the urine stream, eliminating dysuric phenomena, which is also confirmed by the positive dynamics of laboratory and instrumental studies. The effectiveness of the suppository fits into the physiological interval of "recovery" of the prostate. There are no side effects.

The claimed therapeutic agent expands the arsenal of funds for the treatment of prostatitis. Compared with well-known suppositories, it has a lower cost, which has socio-economic importance. In addition, the feedstock is not currently limited.

Sources of information

1. Goryunov V.I., Zhiborev B.I., Evdokimov V.V. Causes and signs of male infertility. Ryazan, 1993.

2. Laurent O. B., Shepelev P. A., Nesterov S. N. Urology and Neforol, 1998, No. 3, pp. 39-46.

3. Titova TM, Karpukhin I.V., Li A.A., Semenova E.V. The complex use of antibiotics, immunomodulators and physiotherapy for urogenital infections in men. Issues resort, fizioter., And exercise therapy, 1999, No. 1, p. 45-47.

4. Karpukhin I.V. Issues resort, fizioter., And exercise therapy, 1991, No. 2, pp. 73-75.

5. Karpukhin I.V., Li A.A. Bogomolny V.A .. Spa treatment in andrology. Questions resort, fizioter., And exercise therapy, 2000, No. 2, p. 45-47.

6. Mashkovsky M.D. Medicines - M .: Medicine, vol. 2, 1994, p. 190.

7. The drug for the treatment of diseases of the prostate gland “Vitaprost” for s / I 96123874/14. Bull. No.16 of 06/10/98

8. Scherbak I.F., Tolcheev A.V., Yakubov A.A. Medicinal substance of a suppository with natural producers. (Patent No. 2142789).

Claims (1)

Suppositories for the treatment of chronic prostatitis, containing cocoa butter as a base and a medicinal substance, characterized in that as a medicinal substance they contain a 1% aqueous solution of humic acids of low mineralized silt sulfide mud (pH 7.4) in the following ratio of components: 1 , 0% solution of humic acids (pH 7.4) 0.2 ml; cocoa butter - a sufficient amount to obtain a suppository weighing 2.0-2.2 g