Clinical use

“Kyzyl may” herbal balsam production technology and clinical usage.

S. E. Pavelkovskaya, E.G. Perepelitsa, V.G. Perepelitsa, KazIUVMZRK, LLP “FitOleum”.

Phycisians have long been using herbs as balms and prophylactic agents for treatment of a wide range of diseases. Among them the most valuable drugs are complex balsamic solutions, made with the help of various production technologies. In this case most extractants are natural substances, including oil, fat, alcohol, water. The majour challege of herbal solution production is to maximize its properties of attracting and retaining bioactive substances as well as the BAS-like complexes with targeted pharmacological action in their original form. These issues pinpoint the Know-How of various technologies.

“Kyzyl may” herbal balsam is a polyherbal oil, belonging to the group of natural drugs with metabolic action and containing biologically active substances from 7 plant species, six of which are edible, ie constanthomeostasis regulators.The drugwas developed and introducedinto medical practice bythe Department of Pharmacology, Technology and Medicine Quality Control at the KazGIUV and by LLP”FitOleum” in association with the Ministry of Health of the Republic ofKazakhstan along with a number of research institutes and hospitals.

To prepare polyherbal oil harvest wild species, collected in ecological biocenoses at the foothills of the Tien Shan and Altai. Various plant organs are used for that purpose: flowers, leaves, fruits, roots, rhizomes of valuable plants such as wild rose, buckthorn, St. John’s wort, licorice, nettle, thyme and lemon balm. Collect those parts during periods of maximum bioactive substances accumulation within them. While collecting raw materials take into account the phase of development, biocenoses properties as well as astrobiospheric factors. All the abovementioned together with electoral extraction regimes define the pinpoint of technology, ie its Know-How. The polyherbal oil manufacturing process finishes at the Almaty Pharmaceutical Factory. The technological production process includes the following steps: infusion, adding composites, sedimentation, filtration and bottling. Chemical additives, reagents and exposure to high temperatures are not used in the production process.

The unique technology ensures that polyherbal oil has wide enough range of native bioactive substances, including both lipophilic and hydrophilic compounds in amounts close to those compatible with human physiology. The fresh plant cellular fluid serves a source of soluble structures, used in the extract.

“Kyzyl may” polyherbal oil is an oil extract of medicinal plants, approved for usage in medical practice. All 7 plant species underwent preclinical and clinical testing and were granted certificates (pharmacopoeial articles) of approval. These types of raw materials and drugs were also noted to have a wider pharmacological spectrum than the list of properties specified in the annotation to “Kyzyl may” herbal balsam.

One may find phytoncids, esters, resins, balsams, fatty oils, vitamins and pro-vitamins, trace elements, organic acids, enzymes, and small amounts of polyphenol, triterpene, anthraquinoneglycosides among the principal active ingredients of such plants as wild rose, St. John’s wort, buckthorn, nettle, licorice, lemon balm, thyme. There are no traces of potent and toxic compounds in the abovementioned plants.

An in-depth biochemical analysis has shown the following ingredients in “Kyzyl may” (mg %): carotenoids-over 2.0; flavonoids- circa0.5; tocopherol-14.1; retinol-0,001; unsaturatedfattyacids:oleic-18.5; linolenic-0.7; erucic-1;trace elements(mg %) : MnO-0,001;Mg-1.0; Co -0.01; Cu-0,03: Si-0.01; Ca-1.0; Ti-0.0001and others.There are no potentially dangerous toxic elements found (arsen, mercury, selenium, chromium, zinc), and lead content is100 time slower than the tolerance limit. Radioactivity check showed negative results.

Biologically active substances complex, inherent in polyherbal oil, provides for its anti-inflammatory and reparative properties owing to carotenoids, flavonoids and essential oils. Its antioxidant properties come from significant tocopherol, linoleic and linolenic acids content. Meanwhile, cholesterol control is carried out by means of a fatty acid complex. Flavonoid components, essential oils, herbal antibiotics and resins account for analgesic, antispasmodic and antibacterial properties of the drug while organic acids – citric, malic, succinic – are triggers or emergency regulators. In chemical and pharmacological aspects all BAS groups are compatible ingredients of herbal balsam have long served together as constituent parts of herbal medicinal products.

We must emphasize the fact that “Kyzyl may” contains amounts of bioactive compounds compatible with human physiology, thus, having a trigger pharmacological effect which sets it apart from wild rose oil and buckthorn oil.

Based on all the mentioned above we recommend clinical application “Kyzyl may” polyherbal oil as means of wound healing, as well as antiambustial, antiinflammatory, reparative, metabolic, antibiotic and analgesic solution.

Since 1991 the drug was tested repeatedly for composition stability, the storage stability and microbiological purity. Analyses were carried out at the laboratories of the Institute of Nutrition Academy of Sciences of the Republic of Kazakhstan, Almaty Pharmaceutic and KAnL “Pharmacy”and they confirmed the composition stability, survivability for more than 2 years along with absence of pathogenic organisms.

The drug preliminary preclinical evaluation was conducted by the Department of Pharmacology of the Aktobe Medical Institute (Professor R. K. Kuzdembaeva) and Central Research Laboratory KazGIUV (Associate Professor L. V. Krivdina). There no toxic, irritant, allergic properties found in “Kyzyl may” herbal balsam.

Since 1991 polyphite oil underwent regular clinical testing at the Kaz Tuberculosis Research Institute, at the Ministry for Health of the Republic of Kazakhstan Institute of Oncology and Radiology, in Almaty City Consultative and Diagnostic Ambulatory-Care Clinic, at the Departments of Urology (Associate Professor Sh. I. Iskakbaev), Therapy (V. A. Polosuhina), Dermatovenerology (Associate Professor K. H. Akhmetova), Obstetrics and Gynecology (Associate Professor A. A. Hoffman), Children’s ENT Diseases (Associate Professor Ye. R. Goncharova) and the State Scientific Research Institute of Oncology and Radiology as well as a number of other scientific and practical medical institutions. Results proved omnidirectionally sufficiently encouraging. The formulation has a long lasting effect on acute and chronic diseases, even in small doses – 1 – 5 ml 2 – 3 times a day orally or topically in the form of irrigation, tampons, bandages, or microdouchebag application.

“Kyzyl may” boasts of much stronger reparatory, anti-inflammatory, antibacterial, antiviral properties than those of buckthorn oil.
In obstetric practice polyherbal oil was noted to normalize vaginal flora and also produces anifying and restorative effects on the wound surface.

Positive results were achieved in treatment of respiratory diseases(bronchitis, tracheitis) as well as treatment of the gastrointestinal diseases(gastritis,duodenitis, cholecystitis, colitis, proctitis, hemorrhoids).

The Department of Children’s ENT Diseases used polyherbal oil in the form of oily dressings, turundas, lubrications for 5-7 days. All patients with acute diseases saw a speeding up of recovery process. Polyherbal oil showed sufficient effectiveness as a preventive and therapeutic solution against ARVI in children and adults. It was applied intranasally 2-3 drops 3-5 times a day and proved able either to completely cure the disease or reduce its symptoms to a milder form.
The drug demonstrated a fairly great efficiency in treatment of pyelitis, prostatitis, cystitis, outcomes of previous operation experiences, including purulent complications (Associate Professor S. I. Iskakbaev). All patients experienced a decrease in inflammation and pain as well as a significant manifestation of the antibacterial and wound healing properties, thus, speeding up the process of recovery for 5 – 6 days.

We placed a particular focus on the drug use complementary to radiation therapy. “Kyzyl may” was used for the prevention and relief of radiation damage in 81 patients with the following diseases: throat cancer, esophageal cancer, nasopharyngeal carcinoma, tongue cancer, tonsil cancer, cervical cancer, vaginal cancer at the premises of KazNIIOR at the Department of Clinical Radiology (Head of Department professor S.S. Sadykov) and the State Oncology Center in Moscow. Polyphite oil was prescribed per os one teaspoonfull 2-3 times a day. At the same time accessible areas of the mucosa were lubricated 2-3 times a day using the oil. The results of the experiments were compared with those of the control group in which patients underwent treatment with buckthorn oil. This comparison showed a clear superiority of the “Kyzyl may” solution.

It is well-known that subjecting patients with aforementioned localized cancers to radiation therapy may lead the former to develop topical radioreactions in various epithelitis, if therapy is applied without necessary antiinflammatory solutions or even with them.
Preventive prescriptions of polyherbal oil allowed this category of patients to avoid radiation epithelitis and in case of their appearance helps to stop the latter in 3-4 days. At the same time patients noted partial or complete disappearance of pain, burning, itching and inflammation. All the patients were satisfied with the oil application, no side effects were observed in all cases of polyherbal oil usage for 4 months or more.

In surgicaland traumatological practice polyherbal oil gained reputationas a highly effectiveanti-bacterial, reparative andanti-inflammatory solution in the treatment ofburns, bedsores, slowly healingulcers, wounds and skin and mucousinfections (Associate Professor K. Kh.Akhmetova).

The obtained data enabledus to further expand the range of indications for use “Kyzyl may” polyherbal oil application in various clinical areas.

To sum up, we must repeat it again that in clinical practice there has not yet been a case recorded when patients suffered serious adverse effects following its application, including allergies.
Thus, polyherbal oil isa perfectly harmless, highly effective and promising the rapeutic drug.