TR201703079A2 - THE USE OF A VEGETABLE FORMULATION CONTAINING PUMPKIN SEED OIL IN THE TREATMENT OF BPH - Google Patents

Abstract

In the pharmaceutical industry; prepared with pumpkin seed oil, especially rich in essential fatty acids; It is about the use of a herbal formulation in soft capsule form with antioxidant properties in the treatment of BPH (Benign Prostate Hyperplasia / Benign prostatic enlargement). Said herbal formulation contains pumpkin seed oil, gelatin which provides the integrity of dl and capsule formation.

Description

TECHNICAL FIELD This invention is used in the chemical industry, pharmaceutical industry, pumpkin seed oil (Oleum Cucurbitae). relates to the use of an herbal formulation containing semen.

The invention is especially combined with pumpkin seed oil, which is rich in essential fatty acids. prepared; of a herbal formulation in soft capsule form with antioxidant properties. With its use in the treatment of BPH (Benign Prostatic Hyperplasia / Benign Prostatic Enlargement) KNOWN STATE OF THE TECHNIQUE essential fatty acids; removal of the organism from outside in order to continue its life What is needed are fatty acids that cannot be synthesized in the body. These essential fatty acids are obtained through food. or it should be taken into the organism with some supplements. Essential substance taken from the outside into the organism Fatty acids help treat BPH (Benign Prostatic Hyperplasia / Benign Prostatic Enlargement) are working as.

In the current technique; BPH (Benign Prostatic Hyperplasia / Benign Prostatic Enlargement) treatment Synthetic substance or chemical substance in certain proportions in products used as auxiliary are available. The use of synthetic and chemical substances has many side effects in the organism. As a result, it affects many systems of the body in a bad way.

Also, in many of the current applications, the products are available in liquid form. This situation makes controlled dosing difficult. Therefore, the required dose is complete and clear. cannot be provided.

One of the patents on the subject in the literature is the application numbered CN105981810.

The present invention; pumpkin seed extract, as well as many herbal products, water and a high percentage of milk blood pressure regulator, kidney and spleen revitalizer, constipation He mentions fermented yogurt, which helps treatment and delays aging.

Another application numbered CN102908544 in the current technique is pumpkin. By mixing many herbal materials proportionally, including the seeds, It is made from a formulation that is good for heart health and by boiling this formulation. It talks about the preparation technique.

As a result, due to the above-mentioned negativities and existing solutions Due to its inadequacy about BPH (Benign Prostatic Hyperplasia / Good It has been deemed necessary to make a development in the technical field related to benign prostatic enlargement.

OBJECTIVE OF THE INVENTION The main object of the invention is to produce a vegetable oil containing pumpkin seed oil (Oleum Cucurbitae semen). formulation for the treatment of BPH (Benign Prostatic Hyperplasia / Benign Prostatic Enlargement) its use as an aid. Pumpkin seed oil 5-0i reductase enzyme does its inhibition. In this way, the conversion of testosterone to dihydrotestosterone (DHT) It has been reported that it helps the treatment of diseases related to the prostate gland by preventing it.

Pumpkin seed oil relaxes the bladder muscles when the bladder is filled with nitric oxide. prevents incontinence. Due to these dual effects on the pelvic muscles and nitric oxide As a result, pumpkin seed oil reduces incontinence. Pumpkin seed oil, especially like cystitis It can also be used as an aid in the treatment of urinary tract infections.

Another aim of this invention is that the formulation formed does not contain any chemicals, Even in the production of pumpkin seed oil, any heat or chemical treatment not applicable. Like this; active ingredients, nutritional values, vitamins and minerals pass directly to the product without being lost.

Another aim of this invention is to protect human health thanks to the content created without chemicals. It is to ensure that the side effects that will adversely affect are minimized. completely natural and very rarely with the use of herbal products, such as nausea, vomiting, diarrhea, only gastro-intestinal side effects affecting the system are observed.

Another object of this invention is that the formulation formed is in capsule form, so that the patient It is to provide ease of use in terms of compliance and patient compliance. Moreover, in obtaining the dosing in the mentioned indications thanks to the capsule form created. advantage is provided.

DETAILED DESCRIPTION OF THE INVENTION In order to achieve the aim of this invention, it is obtained by using pumpkin seed oil. The preferred use of an herbal capsule formulation that has been for understanding and without any limiting effect is explained.

Pumpkin Seed Oil: Pumpkin seed oil has been used as a herbal medicinal product for centuries. Pumpkin seed oil The fact that the substances in its composition are very diverse and the therapeutic activities of each are different. It has many different pharmacological effects.

Pumpkin seeds; rich in phytosterols, tocopherols and essential fatty acids content (mostly linoleic and oleic acid) and the assumed active ingredients in pumpkin seeds They are A7-sterols (avenasterol and spinasterol) and A5-sterols (sitosterol, stigmasterol). Pumpkin Seed oil inhibits 5-0i reductase enzyme. In this way, testosterone In diseases related to the prostate gland by preventing the conversion of dihydrotestosterone (DHT) It has been reported to be helpful in treatment.

To investigate the effects of pumpkin seed oil on benign prostatic hyperplasia. Many nonclinical and clinical studies have been done. Pumpkin seeds in clinical studies essential oil is clinically safe and helpful in the treatment of benign prostatic hyperplasia. shown to be applicable.

Pumpkin seed oil has long been used as an adjunct to anthelmintic (schistosomiasis, tapeworm, etc.) treatment. has been used for years. In a clinical study, primarily in Asia and Africa, Zucchini for Schistosomiasis, a serious parasitic disease spread by snails kernels have been shown to be helpful. In the studies carried out, pumpkin seeds have been reported to be helpful in the treatment of tapeworm.

Capsule formulation content In the formulation, pumpkin seed oil as active ingredient and dl oil as auxiliary substances tocopherol, di-tocopheryl acetate, glycerin, purified water and gelatin are used. dl oi-tocopherol and dI oi-tocopheryl acetate is used as a preservative. In the formulation in question; dl oi-tocopherol, dl oi-tocopheryl acetate are added at ppm level. the integrity of the content For the gelatin used to provide; bovine gelatin is used. Alternative to gelatin As an alternative, other gelatins of animal origin and vegetable origin can be used.

As stated in Table 1; pumpkin seed oil at a rate of 42,635% by weight; Table 1. Contents and weight percentages of the capsule Preferred by usable weight quantity (%) Pumpkin seed oil 42,635 320 dl oi-tocopherol 0.0030 0.024 dl oi-tocopheryl acetate 0.0213 0.160 Glycerin 10,723 80.5 water 23.312 175 Gelatin 23.312 175 Production method of the capsule: The production steps of the capsule formulation are as follows: Pumpkin, which is one of the raw materials The seed is passed through the screening process. After the sieving process, if necessary, the crushing process is carried out. Pumpkin seeds are passed through the aforementioned processes and the desired size is obtained. After being processed, it is sent to the cold press unit. With the cold press method The process of extracting oil from the raw material is carried out. In the said method, 55 0C should not be stepped on. The oil from the cold press unit is removed before the filtration process. are kept in mixing and settling tanks. Thus, possible particles, mixing and It is easier to leave with resting procedures. extracted oil; after mixing and resting tanks, indoors and at room temperature is fed to the filter unit. In the filter unit, the particles in the oil content, if any, are filtered. is being done. After the filtration step, the obtained oil; dl oi- as preservative tocopherol and dI d-tocopheryl acetate as preservative are added. Thus the content The resulting mixture is obtained.

While these transactions are being carried out, on the other hand; in the gelatin preparation unit, the capsule The gelatin used to ensure its integrity is being prepared.

After the mixture is formed and the gelatine is prepared, it is sent to the capsule production unit. capsules are prepared in the desired dosage. Said capsule, soft gelatin capsule.

After the capsule is prepared, the drying process is carried out. dried capsules is being packaged.

Capsule Usage Instructions: Therapeutic Indications The capsule is rich in essential (essential) fatty acids content. BPH (Benign Prostate It is used as an adjunct to the treatment of hyperplasia.

D_ozai and the UVqulama Method . Dosage frequency and duration of administration: Unless otherwise recommended by the doctor taken by way. 0 Method of Application: Sufficient amount of water without crushing or chewing the capsules in the mouth It should preferably be swallowed with a full stomach. Additional Information on Special Populations: o Kidney/liver failure: Adequate safety has been established in kidney and liver patients. Since there is no study, it should not be used in these patient groups. o Pediatric population: Capsule for children under 18 and adolescents should be used under control. o Geriatric population: There is no study in the elderly.

Contraindications - Those who are allergic to the active substance or any component of the capsule, - During pregnancy and lactation, - It should not be used in patients with liver and kidney failure.

Special Warnings and Precautions for Use The daily dose of the capsule should not exceed 3 g in patients using oral anticoagulant drugs. required.

Each capsule contains 0.0805 g of glycerin. However, at this dose, any glycerin-related No side effects are expected.

If your complaints get worse while using the capsule or if you have fever, spasm, blood in the urine, painful If symptoms such as urination or urinary retention are observed, tell your doctor or pharmacist. you consult.

Continuing the use of the capsule for more than 2 months in consultation with the doctor recommended.

Pregnancy and Lactation 0 General Advice: Women of childbearing potential/Contraception It should not be used as there is no related study. 0 Pregnancy: Clinical data on pregnancies exposure to pumpkin seed oil not available. Studies on animals have been associated with pregnancy and/or on embryonal/fetal development and/or birth and/or postnatal development insufficient in terms of effects. The potential risk for humans is unknown. Oral There is not enough information about its use with contraceptive drugs. in pregnancy The capsule is not recommended for use during pregnancy as its safety has not been demonstrated. o Lactation period: Since its safety has not been demonstrated in lactation, the capsule should not be used in lactation. use is not recommended.

. Gastrointestinal Disorders: Common nausea, vomiting, diarrhea. Apart from these to date No undesirable effects have been reported so far.

Overdose No overdose has been reported for pumpkin seed oil to date. orally Pumpkin seed oil used can be well tolerated, no effects due to overdose are expected.

However, if any signs occur after an overdose, treatment should be symptomatic and should be supportive. There is no specific antidote and no method to increase its elimination.

Storage Conditions The shelf life of the product is determined as 2 years.

The capsule, the content and production method of which is mentioned above, is a product of the Republic of Turkey Health It has been licensed as a "Traditional Herbal Medicinal Product" by the Ministry of Health. Promise It is referred to as CUCURMIN as 320 mg soft capsules. listed above Republic of Turkey according to indications and Traditional Herbal Medicinal Product Regulation It is a Traditional Herbal Medicinal Product LICENSED by the Ministry of Health.

Product containing many synthetic chemicals, licensed for indications specified in the market has. However, those who have such an indication licensed by the health authorities in this field There are no traditional herbal medicinal products.

In most of the existing applications; when production is under poor hygienic conditions, formulation; The GMP (Good Manufacturing) required by the Ministry of Health from a pharmaceutical factory It produces in accordance with the Practises) norms.

As it is known, standardization in herbal products is a very difficult process. Relating to formulation; o In his seed; analysis of pesticides, aflatoxins, heavy metals and active substances, microbiological checks have been made.

. In cold pressed oil; method development, validation and analysis for the analysis of active substances. microbiological controls were made. 0 In design; which product?, which indication?, which dose?, which dosage form? will be calculated. . In pre-formulation; analysis of which active substance/which excipient? , which microbiological controls?, which quality control parameters, which stability studies It was thought to be done and a system was developed accordingly.

. In stability studies; to the specifications determined during the anticipated shelf life. stability studies proving its suitability have been proven; At 25°C±2, 60% ±5 humidity 24 months of operation and 6 months of operation at 40°C ± 2, 75% ± 5% humidity. analytical testing validations and data on methods and packaging specifications, interactions, analysis and control methods have been determined. o Content determination (oil component analysis) in the preparation of capsule base and internal materials, some viscosity and optical appearance control etc. tests have been done. 0 In the production procedure; in-process such as qualitative and quantitative content determination, optical control quality control such as controls and content determinations, microbiological analysis, optical control procedures have been applied. In addition, HPLC analyzes of active ingredient and product sample and fatty acid compositions were calculated. In addition, the calibration of the active substance tables are removed.

The operations described above; very important for the standardization of herbal products are details and have been made in detail in this product. This product is approved by the Ministry of Health. By licensing the pharmacodynamic properties of a Traditional Herbal Medicinal product by the authority, has been approved. This product is approved by a health authority such as the Ministry of Health for Traditional Herbal Medicine. SPC (Short Product Information-Placebook) and KT (Instruction for Use) of a product licensed and approved. This product is approved by a health authority such as the Ministry of Health. The way of use and dosage of a herbal medicinal product is standardized and licensed, and approval is obtained. has received. In this sense, the clinical practice of a traditional herbal medicinal product licensed by the Ministry of Health. Dosing in accordance with the studies is written and approved by the health authorities. It was made official and presented to the service of world medicine.

Claims (4)

REQUESTS 1. It is the use of an herbal formulation containing pumpkin seed oil in the manufacture of a drug used in the treatment of BPH. 2. It is a use as in Claim 1 and its feature is; said herbal formulation contains pumpkin seed oil, dl d-tocopherol, dl d-tocopheryl acetate, glycerine, pure water and gelatin, which ensures the integrity of the content and the formation of capsules. 3. It is a use in accordance with claim 2 and its feature is; It is used in adults at a dose of 960- 2880 mg/day. 4. It is a use according to claim 2 and its feature is; oral administration.