INFLAMMATION Technical Field

The invention relates to the herbal and pharmaceutical composition that intends to decrease the symptoms of chronic and infectious prostate inflammation such as pain, discomfort and pollakiuria. The invention also contains the production method of such composition. Prior Art

Prostatitis (prostate inflammation) is an inflammatory disease of prostate and, occasionally, effecting surrounding tissues. Prostate is a common inflamatory problem among men and it is usually seen in every 4 of 10 men who apply to a doctor due to genital or urinary problems. Found in every healthy man and necessary for reproduction, prostate gland can also get infected like any other organs of the body. Prostate infection medically known as prostatitis can also be seen in men who are young and are at a reproductive age. Unless treated at an early stage and property, prostatitis will become chronic in time highly inclined to get chronic. A part of prostate types can develop prostate infection even without bacteria. This is a condition that can appear at any age after puberty. Frequently encountered, chronic prostatitis can not be diagnosed since it has no distinct symptoms and mostly occur in conjunction with other urinary tract infections.

Non-bacterial chronic infection of prostate causes "chronic non-bacterial prostatitis" in men which is the infection of prostate without a cause of a particular bacteria. Prostatitis is observed in 90% of the cases.

Though seen rarely, acute prostate infection is quite a serious case. Many types of bacteria can cause such sudden infection. However, chronic bacterial prostate infection is a more frequent condition. This prostate infection which lasts three months or longer is also caused by bacteria. In contrast with acute prostatitis, symptoms develop more slowly for this type, and the symptoms are almost the same as chronic non-bacterial prostatitis. Chronic bacterial prostatitis does not show any symptoms for many patients. The most distinct symptom is the acute urinary tract infections that become chronic. The main cause of chronic bacterial prostatitis is not clear. The reason for its emergence may be the bacteria in the urinary system, bladder or blood infection.

The most complicated complications of prostatitis are infertility and prostate cancer. Prostatitis can develop also in other organs such as urethra and bladder.

Prostatitis is called infectious prostatitis if associated with pathogen. This type of prostatitis appear due to bacteria (staphylococcus, pneumococcus, streptococcus), viruses (herpes), both bacteria and viruses or a specific infection (tuberculosis, ureaplasma, microplasma).

The treatment for various forms of prostatitis is generally common. Antibiotic treatment which is applied as the first step is continued for 2 to 8 weeks. Other treatments are non antiinflammatory steroids; immunomodulators; and combined phytopreparates following alpha-1 adrenoblockers and antibiotics.

Antibiotics are the first choice for all types of prostatitis. Though it is believed that the etiologies of approximately 90% of all chronic prostatitis cases, antibiotic treatment is applied to many patients. The reason for this is that the patients with negative culture respond to antibiotics treatment and that almost half of the patients from all the categories profit by quinolon treatment. A drug must highly melt in lipid and bind to serum proteins as least as possible in order for such drug to penetrate into prostate. Many types of antibiotics are not available for the treatment of prostate infections since such antibiotics are ionized in serum and ionized agents cannot permeate through prostate epithelium. The use of herbal compositions have become widespread to overcome such issues. The Turkish Patent application no. TR201800115 titled "The herbal composition to eliminate prostate cancer and the production method for such product" explains the anticancer herbal composition and its production which helps to permanently extinguish prostate cancer, a type of cancer that is frequently seen in men. The herbal composition subject to the aforementioned invention consists of epilobium parviflorum essence, ruscus aculeatus essence and distilled water.

Furthermore, it has been observed that recognized status of the technique used in the pharmaceutical preparation called Prostatonin also have herbal contents. The pharmaceutical preparation called Prostatonin comprises urtica dioca and pygenium africanum herbs. The indications of Prostatonin are known to have alleviated the early symptoms of prostatitis. Such drug helps patients to empty bladder better, have less frequent need for urination, decrease nocturia and normalize urination rate.

Description of the Invention

The purpose of the invention is to decrease the symptoms of chronic and infectious prostate inflammation such as pain, discomfort and pollakiuria using a new herbal composition subject to this invention.

The second purpose of the invention is to overcome the aforementioned problems that occur in the recognized technique.

The composition subject to such invention is a product that comprising epilobium parviflorum, urtica dioca, arctostaphylos uva-ursi, avocado-soy and quercetin. The formulation developed is a herbal preparation used following the surgical interventions to severe and chronic bacterial prostatitis and prostate gland.

Such formulation shows high efficiency and activity on resistant strains. The efficiency of treatment has been increased and treatment period has been shortened when used with antibiotics. Epilobium parviflorum is a compound officially approved by the European Union due to its antioxidant, antibacterial and analgesic effects and is used for the elimination of lower urinary system symptoms associated with benign prostate hyperplasia. It was demonstrated with lab tests that the herb inhibits aromatase and 5-alpha reductase enzymes which effect the metabolism of hormones and contribute to hyperplasia development of prostatic stromal and epithelium cells.

Urtica dioca ensures anti-inflammatory effect and inhibits 5-alpha reductase and aromatase activities. Therefore, it suppresses testosterone and the induced increases in prostate. As a result, urtica dioca is efficient in the symptomatic treatment of lower urinary tract diseases (nocturia, polyuria, urine retention etc.).

Arctostaphylos uva-ursi essence can react against the most common pathogens (Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Mycobacterium smegmatis, Shigella sonnei, Proteus mirabilis and Pseudomonas aeruginosa).

Avocado-soy is a natural herbal essence made from avocado and soy bean oil. As a supplement, it achieved to decrease the pain and the amount of non-steroidal antiinflammatory drugs (NSAID) for the patients with inflammatory diseases.

Quercetin is a bioflavonoid that is commonly comprised in polyphenolic herbs. The antioxidant and anti-inflammatory characteristics of it are certified, and the agent is known to inhibit inflammatory cytokines that play a role in prostatitis pathogenesis. Finally, quercetin also bears antifungal characteristics that can react against weak antibacterial activity and prostatitis.

Detailed Description of the Invention

The herbal composition subject to the invention which is developed for use against chronic and infectious prostate inflammation comprising epilobium parviflorum, urtica dioca, arctostaphylos uva-ursi, avocado-soy and quercetin.

Another feature of the herbal composition which has been developed for use against chronic and infectious prostate inflammation is that it comprising 4-30% by weight epilobium parviflorum, 4-60% by weight urtica dioca, 2-55% by weight arctostaphylos uva-ursi, 2-49% by weight avocado-soy and 0,1-42% by weight quercetin.

Another feature of the herbal composition which has been developed for use against chronic and infectious prostate inflammation is that it comprising at least one excipient.

The aforementioned formulation comprises viscosifying as excipient. Besides, the formulation of the developed herbal composition comprising 0.01-1% by weight viscosifier. The viscosifier is preferably xanthan gum.

The aforementioned formulation comprises solubilizer as excipient. Besides, the formulation of the developed herbal composition comprises 0.01-5% by weight solubilizer. The invention preferably comprises polyethylene glycol (PEG) as solubilizer.

Another feature of the developed formulation is that it comprises preservative as excipient. Besides, the formulation of the developed herbal composition comprises 0.01- 2% by weight preservative. The invention preferably comprises sodium benzoate and/or potassium sorbate as preservative.

Another feature of the developed formulation is that it comprises acid regulator as excipient. Besides, the formulation of the developed herbal composition comprises 0.01- 1% by weight acid regulator. The invention preferably comprises citric acid as regulator.

Another feature of the developed formulation is that it comprises sweetener as excipient. Besides, the formulation of the developed herbal composition comprises 0.01-2% by weight sweetener. The invention contains sucralose and/or liqueur as sweetener.

Another feature of the developed formulation is that it comprises a herb chosen among Arecaceae, Zingiberaceae or Cucurbitaceae family.

Another feature of the developed herbal formulation is that it comprises a 20-45% herb by weight from Arecaceae family. Saw palmetto extract from Arecaceae family was used in an application of the invention. Saw palmetto extract is obtained from the fruits of a tree called by the same name. This extract is successfully used for the treatment of prostate gland enlargement and urinary tract infection. Saw palmetto comprises oil acids that decreases the amount of di hydrotestosterone in prostate. These oil acids also diminish the movements of inflammatory agents and prevents prostate enlargement to a great extent.

Another feature of the developed herbal formulation is that it comprises a 10-65% herb by weight from Zingiberaceae family. An application of the invention availed of Curcuma longa from Zingiberaceae family which is also known as turmeric. It is known to prevent intestinal polyp formation and esophageal, colon, liver, lung and prostate cancers.

Another feature of the developed herbal formulation is that it comprises a 10-45% herb by weight from Cucurbitaceae family. Cucurbita pepo was used in an application of the invention. Cucurbita pepo is a type of summer squash. Among the recognized benefits of summer squash are increased digestion, low cholesterol levels, improved heart health and prevention of cancer.

Another feature of the developed herbal formulation is that it improves the treatment efficiency and shortens treatment period when used with antibiotics.

The effect of the product helps to improve the efficiency of antibacterial treatment by breaking the resistance of activator against antibiotics and eliminating the microbial biofilm on the mucous membrane of uric system. This helps to diminish the course of antibiotic treatment and to decrease the unfavorable reactions of antibiotics. Therefore, it is indicated that antibiotics and herbal drugs affect pathology differently. Antibiotics affect bacteria directly (their membranes and the size of their reproduction etc.) while herbal compositions indirectly decrease the the activity of contagious process (anti inflammatory activity, activation of immunoprotective mechanisms and diuretic effect etc.).

The formulation in this invention is an efficient composition in consideration of the anti inflammatory and antibacterial effects that are obtained when using the drug after a prostate surgery. The drug is used in combination with antibiotics considering that generally antibiotics are prescribed for such purpose after operations. A production method for the herbal composition, comprising;

Epilobium parviflorum and urtica dioica are distilled by ensuring the weight proportions specified and are transferred to fluid tanks.

They are distributed over xanthan gum.

Polyethylene glycol is added and the composition is stirred.

Arctostaphylos uva-ursi, avocado-soy and quercetin are added and stirred.

Sodium benzoate, potassium sorbate, citric acid, sucralose and, as aroma, liqueur excipients are added.

The composition is bottled according to dosage forms and are stored.

The product in this invention can preferably be in liquid forms such as oral solution, syrup, suspension. The dosage form of the product in this invention should not be limited with such examples and should also comprise all the forms that can be applied with the technique. An exemplary formulation of the herbal composition of this invention is provided in Table 1. The product has been produced in suspension form by performing the aforementioned production method with the specified proportions.

Table 1: Exemplary formulation