Suppositories for the treatment of chronic prostatitis

 

(57) Abstract:

The invention relates to the field of pharmaceutics and can be used in the treatment of prostatitis. The invention is to create a suppository consisting of 2.0 ml of 1% aqueous solution of humic acid (pH 7.4) low-mineralized peloids and enough cocoa butter to get the suppository mass of 2.0-2.2, the Invention provides for the creation of a medicinal product containing humic acid low mineralized silt sulfide mud, cleaned of pollutants of different nature, with high biological availability.

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 young and Mature age. Despite the development of numerous methods of treatment of chronic prostatitis, this problem is still relevant. This is due to late diagnosis, inadequate treatment, the predominant use of drug therapy. It is known that the antibacterial, antiseptic therapy does not lead to long rematerialises therapy, that often leads to unwanted side effects[1, 2, 3].

Positive results of treatment of chronic prostatitis with the use of mud in the resort [4]. Here it should be noted that in today's complex socio-economic conditions in Russia sanatorium treatment was not available to the General population.

Known positive results of treatment of chronic prostatitis with mud applications, rectal swabs [5]. Anti-inflammatory effect is realized due to the chemical ingredients of the mud. However, native mud has some contraindications. In addition, in modern environmental conditions of native pelotherapy becomes unsafe, given the ability of therapeutic muds accumulate pollutants of different nature.

Known biogenic drug “Reveron”, which is an extract from the prostate gland of adult animals, are exempt from estrogenic hormones and proteins used in injection [6]. The latter makes it difficult for outpatient treatment. For a course of treatment requires skilled medical personnel, the use of sterile and gives temporary relief, often causing an allergic reaction in the form of skin rashes.

You know the mean of “Vitaprost” [7] for the treatment of prostate cancer, representing suppositories containing complex bioregulatory peptides of the prostate gland of cattle. The disadvantages of “Vitaprost” should be considered that this drug has an organotropic action on the prostate and can cause hormonal status of the organism.

Known suppositories with components of Tambukan mud [8] “the Medicinal substance suppositories with natural producers” (Shcherbak, I. F., Tolcheev A. C., Yakubov, A. A.), including propolis extract, honey, emulsifier T-2, cocoa butter, enriched with lipids Tambukan mud, to the content of carotinoids not less than 1 mg %. The disadvantage of this drug is the most likely manifestations of allergic reactions as propolis and bee honey. In addition, the suppository is inserted a small group of biologically active components peloid.

This drug is closest to the invention in essence, the achieved therapeutic effect and selected as a prototype. the x mud natural ecologically pure biologically active substance, it has anti-inflammatory action of humic acid.

Object of the invention is the creation of new drugs having anti-inflammatory for the treatment of chronic prostatitis containing humic acid low mineralized silt sulfide mud, cleaned of pollutants of different nature, having high bioavailability and anti-inflammatory activity, low cost.

Humic acids are a natural component of curative mud, harmless to the body, do not cause side effects or allergic reactions. Study of acute toxicity of humic acids was performed on adult Wistar rats weighing 180-200 g observation of the animals was carried out for 14 days. Introduction “per os” from 0.5 to 15 g/kg did not cause toxic effects. Intramuscular injection of 1 to 20 mg/kg did not cause death. The introduction of a larger quantity of the active substance cannot perform practically and is unreasonable.

Cocoa butter is a fatty oil obtained by pressing roasted and exempt from the seed husk of the cocoa cultivated tropical chocolatero smell and pleasant taste, brittle at room temperature; melts at 33-34°C, turning into a clear liquid (GF X, 1968).

The problem is solved in that the proposed product contains biologically active humic acid, according to the invention is made in the form of a suppository and additionally provides the basis of the following ratio of components in grams per candle of 1.0% solution of humic acid (pH 7.4) and 0.2 ml basis, a sufficient amount of to obtain suppository mass of 2.0-2.2,

When this is used as a base of cocoa butter. Preparation of suppositories consists of the following operations: weighed and placed in a mortar 20,0 cocoa butter, measure 2.0 ml of 1% aqueous solution of humic acid (pH 7.4), tramped down until a homogeneous mass. From suppozitornoj mass form a block that is divided into 10 equal parts and roll out suppositories. Received dosage form pack and prepare to leave.

The proposed ratio of therapeutic substance and cocoa butter is the best and provided quality suppositories and therapeutic effect of the medicinal product. The dosage of the substance is established experimentally. Content complicates the manufacturing process of making suppozitornoj mass.

The effectiveness of suppositories made on the mentioned formulation has been investigated in the clinic of urology of the Samara state medical University outpatient 30 volunteers, patients with chronic prostatitis. They are appointed on 1 suppository for the night for 12 days. The results showed that the use of suppositories to improve the condition of the 19 people since 2 days, 6 persons condition has improved slightly to 7-day, 4-person status has not changed and they were converted to conventional treatment methods. One patient from increased comorbidity stopped the use of suppositories on the 4th day. In the patients treated with suppositories containing 0.002 g of humic acids on the 2nd day disappeared burning in the urethra, for 3-4 days gone dull pain in the crotch area, above the fold, on 5-6 days increased the diameter of the jet and the speed of urination, 7-10 days marked improvement in the erectile function, sexual libido. Recovery occurred on 11-12 days. During the follow up period (within 3 months) acute exacerbation of chronic prostatitis was not observed, side effects of suppository is not revealed.

During the rectal examination: prostate is slightly enlarged, mjagkoellasticheskih consistency, moderately painful, with a clear, smooth boundary. Magdalena furrow slightly flattened.

Transurethral ultrasound: the prostate of 3.8 to 3.2-3.4 cm (slightly increased), contours precise, equal, in the left lobe and along the urethra - a few small calcium. Observed congestion.

A urethral swab test: leukocyte - 30-40 - in the field of view, lecithin grains are absent, mucus - a large number of bacteria are absent.

Assigned suppositories with humic acids at a dose of 0.002 1 g once a day at night. On the 2nd day from the onset of the disease the patient has no pain and burning during urination, on the 4th day jet was satisfactory, ceased discharge of mucous character from the urethra. To 7-8 m day improved the General condition of the patient and on the 10-11th day said a full recovery. Normalize the grain in large quantities, mucus is absent. The patient additional treatment is not needed.

Thus, it is found that the suppositories have a positive therapeutic effect in the treatment of chronic prostatitis, consisting of anti-inflammatory action, the removal of edema, the disappearance of burning, discharge, normalization of the urine stream, eliminating dysuric phenomena, as confirmed by positive dynamics of laboratory and instrumental studies. The efficiency of the suppository is placed in a physiological interval recovery of the prostate. There are no side effects.

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

Sources of information

1. Goryunov Century. And., Zibarev B. I., Evdokimov centuries Causes and signs of male infertility. Ryazan, 1993.

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

3. Titova, T. M., Karpukhin, I. C., Lee, A. A., Semenov E. C. Comprehensive use of antibiotics, and the 1, S. 45-47.

4. Karpukhin I. C. Questions resort, fizioter., and physical therapy, 1991, No. 2, S. 73-75.

5. Karpukhin, I. C., Lee, A. A. pious Century.. And Sanatorium-resort therapy in andrology. Questions resort, fizioter., and physical therapy, 2000, No. 2, S. 45-47.

6. Mashkovsky M. D. Medicines. - M.: Medicine, so 2, 1994, S. 190.

7. For the treatment of diseases of the prostate “Vitaprost” C/I 96123874/14. Bull. No. 16 from 10.06.98,

8. Shcherbak of the Imperial family, Tolcheev A. C., Yakubov, A. A. Medicinal substance suppositories with natural producers. (Patent No. 2142789).

Suppositories for the treatment of chronic prostatitis, which contains cocoa butter as the base and the medicinal substance, characterized in that, as a medicinal substance they contain 1% aqueous solution of humic acid low mineralized silt sulfide mud (pH 7.4) in the following ratio of components: a 1.0% solution of humic acid (pH 7.4) and 0.2 ml; cocoa butter - enough to get the suppository mass of 2.0-2.2,



 

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