Tablet with antitumor effect, method for its making and method for treatment of patients with oncological pathology

FIELD: medicine, oncology, chemical-pharmaceutical technology, pharmacology, pharmacy.

SUBSTANCE: tablet eliciting the antitumor effect comprises active dose of aconite alkaloids in the amount 0.0125-0.0375 mg. Invention relates to a method for making tablet with antitumor effect. Method involves treatment suitable carrier taken in the amount corresponding to the content of alkaloids in tablet 0.0125-0.0375 mg with aconite tincture wherein amount of the total content of alkaloids is determined preliminary. Then carrier treated by such manner is dried at temperature 30-35°C, not above, granulated, granules are powdered and tableted. Also, invention relates to a method for treatment of oncological patients that involves prescription to patient 0.5-2 tablets with oncological designation being this treatment is determined individually. Invention can be used in manufacturing medicinal formulations of preparations used for treatment of patients with oncological pathology.

EFFECT: improved method for treatment and making, valuable medicinal properties of tablet.

8 cl, 2 ex

 

The invention relates to medicine, in particular to pharmacology and Oncology, and can be used in the manufacture of dosage forms of drugs Oncology appointment and in the treatment of patients with oncological pathology.

Currently there is an acute problem of finding adequate means of therapeutic intervention in the field of Oncology. Among therapeutic agents are of particular interest in natural remedies for use in traditional medicine is widespread and often justified due to the achievement of good results.

Among the means of plant origin are well known chaga, celandine, St. John's wort, Hemlock, and the juice of carrot, beet, celery, potato, and others (Danes NI Healing possible. Folk medicine against cancer. ,, "Labyrinth", 1993, s).

Although each of these plants in the form of tincture or juice has a certain biological activity, but it is not enough to achieve sustainable and high treatment outcome.

Among the treatment means Oncology destination known alcoholic tincture of Aconite Jungar, it is used in an amount of from 1 to 9 drops (Danes NI Healing possible. Folk medicine against cancer. ,, "Laurent", 1993, s). Usually when receiving medicinal infusions and the use of 10 g of dry root plants at 0.5 l of a 40%aqueous alcohol. Tincture of Aconite has a sufficiently high efficiency in the treatment of patients with oncological pathology.

However, the dosage form is a tincture of Aconite has significant disadvantages. A drop of the tincture is not defined amount of the active substance, which may be different depending on the quantity of raw materials used and the features of preparation of tinctures. These reasons cause inaccurate dosing tinctures, which in turn, does not allow to estimate and predict therapeutic outcome.

In addition, the need for accurate dosing of Aconite as an active Foundation drop is important because Aconite in doses exceeding a set threshold, is toxic and requires special care in the treatment.

The present invention is the creation of such a dosage form of Aconite, which through accurate dosing of the active component of Aconite achieved high treatment efficiency and eliminates the risk of side effects associated with overdose.

The problem is solved in that the tablet Oncology appointment, according to the invention, contains the alkaloids of Aconite acceptable carrier and a lubricating substance, and an active dose of alkaloids of Aconite is of 0.0125-0,0375 mg.

The authors of the present invention p is tveretina, what existing active substances of Aconite are alkaloids, the number of which depends on the achieved therapeutic effect. When setting the dose of the alkaloids of Aconite in the tablet, the authors were guided, on the one hand, achieving the maximum therapeutic effect when taking the pills, taking into account the complexity of the pathology of age-related characteristics of the organism and others, and on the other hand, the negative impact of a possible excess of the alkaloids of Aconite on the patient's body.

The choice of carrier for the active component of Aconite was carried out on the basis of the following conditions: he must not lose moisture, must yield to the pressing, it should have good flowability required for uniform distribution throughout the mass of the tablet. The specified properties to some extent possess the a lot of accepted in the field of media.

However, among all possible carriers of the most technologically acceptable is the milk sugar, the main advantage of which is a high adsorption, and so forth all the examples are for the media.

As for lubricants, they can also be any of the acceptable in this area substances, however the most suitable because of its lubricating properties and the most easy tabletting mass is calcium stearate, usually in Koli is este to 1% relative to the weight of the tablets.

The authors have provided the possibility of introducing a tablet of some inert functional additives, in particular aromatic and/or effervescent components.

The claimed tablet cancer treatment (Aconite) may be of any convenient to use a lot, such as 0.2,

To determine therapeutic action of the claimed tablets experiments were carried out, aimed at studying their impact on tumor growth.

The experiments were conducted on mice, as a model for the study of antitumor activity of the tablets was selected human epidermoid carcinoma, Lewis lung.

In the study used the tablets of Aconite. Because the weight of the mouse is on average 25 g, single dose was 0.05 mg of the alkaloids of Aconite in the tablet. Control animals were injected with distilled water in the same mode.

It was found that the introduction of the proposed drug causes a statistically significant reduction of tumor growth, starting with 21 days of its development.

In General, the drug reduced the rate of tumor growth in 3,49 times (in the control, the average is 0,464 mm/day, and the experience - 0,186 mm/day).

The biggest difference between control and experiment detected on day 36 of the experiment, however, further differences began to decrease, due to the development of necrosis in to ntalnyh animals.

More rapid development of necrotic changes in the tumors of the control animals, indicating the attainment of a new phase of development - decay of the primary tumor, even more confirmed the antitumor activity of the proposed drug.

At the opening of the control mice in some of them metastases in the lungs. At the same time experienced mice visible metastases not detected, which also indicates the pronounced effect of the claimed tablets.

The effectiveness of the treatment of people declare that the tablet will be shown when considering the treatment of cancer patients.

Tablet Aconite is a new dosage form, resistant to light, well kept.

In addition, the set of components of the inventive tablet provides her with prolonging the action.

Another objective of the present invention is to provide such a method of producing tablets Oncology destination where by a particular combination of action and modes to achieve high therapeutic efficacy of tablets when given therapeutically safe dose.

The problem is solved in that a method of manufacturing tablets Oncology appointment, according to the invention, is that the tincture of Aconite, in which pre-determine the amount of alkali is Dov, process acceptable carrier, taken in the quantity corresponding to the achievement of each tablet of 0.0125-0,0375 mg alkaloids, and then the thus treated carrier is dried at a temperature not exceeding 30-35°and granularit. Granules optivault acceptable lubricant, after which they tabletirujut.

As noted above, the main problem when creating the dosage form of Aconite is accurate dosing of alkaloids. In the present method of manufacturing tablets this is achieved, first of all, a preliminary quantification of the amounts of the alkaloids of Aconite in the tincture of Aconite.

Such action is justified, because, knowing the exact content of alkaloids in the tincture, conventional analytical techniques can bring it up to concentrations providing a dose of alkaloids in the resulting tablet in the range of 0.0125-0,0375 mg.

Using these steps, you can apply for tincture Aconite any regional origin, in particular the Carpathian, the activity of which can be adjusted provided by the authors.

It is noticed that during the drying treated with tincture of Aconite with a certain concentration of alkaloids media is quite essential not to exceed the temperature of 30-35°because otherwise are destruct the main processes resulting therapeutic activity tablets Oncology destination drops significantly.

With regard to use of media and lubricants, they choose from acceptable for this purpose substances, however, the authors point out the lactose and calcium stearate, the use of which combination has a greater impact on technology and consumer properties of the tablets.

In addition, another objective of the present invention is to provide a method for treatment of cancer patients, in which, through the selection of dosage and mode of administration of the inventive tablets Oncology appointment achieve a high efficiency of treatment and are excluded adverse reactions of the body of the patient.

The problem is solved because, according to the method of treatment of patients with oncological pathology patient is assigned a day for 0.5 to 2 tablets Oncology appointment according to claim 1, with the course of treatment is determined individually.

Proposed by the authors of this method of treatment the dose pills Aconite selected on the basis of its maximum therapeutic action and taking into account peculiarities of oncological pathologies, age characteristics of the organism and the absence of undesirable side effects.

The course of treatment is determined individually depending on tumor localization and heavy the tee illness.

This method of treatment is suitable for patients who refused for various reasons from chemotherapy, radiation therapy or surgical treatment, and for complex treatment of patients undergoing such treatment.

The invention is illustrated by examples of specific performance.

EXAMPLE 1

Crushed roots of Aconite Junggar pour a 40-degree alcohol based obtain 3% tincture. Insist in a dark place for 14 days.

The resulting infusion analyze known method, such as potentiometric titration of 0.01 N hydrochloric acid. The quantitative analysis suggests that 3% tincture is 0.03% alkaloids, a determinant of activity in the treatment of oncological pathologies, in 1 l of tincture is 0.3 g (300 mg) alkaloids of Aconite.

A simple calculation shows that to obtain tablets weighing 0.2 g containing alkaloids 0,0124 mg should 4.8 kg, for example, tablet mass to handle 1 l tinctures with content 0.3 g of alkaloids.

The obtained wet mass is dried at a temperature of 30-35°dried mass is passed through a sieve with holes of 2 mm, as a result of this processing gain granulate, which is subjected to dusting with calcium stearate.

Then the resulting mass tabletirujut on a rotary press and get the tablets weighing 0.2 g, for this example, the composition tablets next, mg:

The alkaloids of Aconite of 0.0125

Milk sugar 197,9875

Calcium stearate 2,0000

EXAMPLE 2

Patient L., 1973 birth in March 2000, he suffered a viral infection, in may there was a sudden pain in the chest, weakness, shortness of breath. Conducted radiography of the chest, signs of a lesion (hydrophilic tumor) varnishing mediastinum. The dimensions of education of 3.5×3,5 see the Patient refused diagnostic puncture, radiation therapy, chemotherapy, and surgery. Tumor growth continued, so I decided to spend treatment tablets Aconite. The patient took 2 tablets (dose of 0.0125 mg alkaloids per tablet) 3 times a day for 20-30 minutes before eating. The treatment lasted 3 months, after 2-3 weeks of being sick has improved significantly decreased weakness, virtually disappeared shortness of breath.

When radiography is conducted after three months of treatment, found no signs of a lesion.

We offer drug treated 7 patients with stage 3-4 of ecoprocess who refused chemo treatment, including 3 patients with lung cancer, 4 with prostate cancer.

The first group of patients, life expectancy ranged from 1.5 to 3.5 years, in the second group of patients - from 3 to 5 years.

In addition, a survey was conducted and the treatment of 40 patients with malignant tumors of different localization (mainly squamous cell carcinoma)who received radiation therapy.

Treatment was performed with tablets, the dose of alkaloids which treatment was chosen depending on the condition of the patient.

Studies have shown that the total radiation reactions (headaches, nausea, changes in blood) in patients who took the pill, was missing.

Thus, the claimed tablets Oncology appointment showed high treatment efficiency. The method of manufacture of such tablets is quite simple and provides accurate dose of the active component of Aconite - the amount of alkaloids, which is very essential to achieve reliable therapeutic effect.

The ability to control the precise therapeutic dose in tablet allows the use of raw materials (monkshood), growing in every region, including in the Carpathians.

Studies on patients with oncological pathology showed promising treatment by the claimed method.

1. Tablet antitumor activity, characterized in that it contains the alkaloids of Aconite acceptable carriers and grease, and an active dose of alkaloids of Aconite is of 0.0125-0,0375 mg.

2. The tablet according to claim 1, great is the rpm die, that as the carrier contains milk sugar.

3. The tablet according to claim 1 or 2, characterized in that the lubricant contains calcium stearate.

4. The tablet according to claim 1 or 2, or 3, characterized in that it further comprises aromatic and/or effervescent components.

5. Method of preparation tablets antitumor activity, characterized in that the tincture of Aconite, in which pre-determine the amount of alkaloids, process acceptable carrier, taken in the quantity corresponding to the achievement of each tablet of 0.0125-0,0375 mg alkaloids, and then the thus treated carrier is dried at a temperature no higher than 30-35°and granularit, granules optivault acceptable lubricant, after which they tabletirujut.

6. The method according to claim 1, characterized in that as an acceptable media use milk sugar.

7. The method according to claim 1 or 2, characterized in that the lubricant used calcium stearate.

8. The method of treatment of patients with oncological pathology, characterized in that the patient is prescribed 3 times a day at 0.5 to 2 tablets antitumor activity according to claim 1, with the course of treatment is determined individually.



 

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