RU2363446C1 - Suppositories for treating gynaecological and urological diseases based on dead sea dirt (versions) - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine, more specifically to chemical and pharmaceutical industry, and production of suppositories which can be used for treating gynaecological and urological diseases. Proposed are suppositories based on natural producers, containing cacao oil, emulsifier, dirt and, additionally, wax. The dirt used is Dead Sea dirt. Proposed are suppositories based on natural producers, containing a base, emulsifier, dirt and, additionally, stearic acid. The dirt used is Dead Sea dirt and the base is polyethylene oxide 1500 and 400.

EFFECT: production of suppositories based on natural producers with high anti-inflammatory, antibacterial and regenerative activity.

2 cl, 2 ex, 3 tbl

Description

The invention relates to the pharmaceutical industry and the creation of new suppositories that can be used to treat chronic prostatitis, hemorrhoids, cervical erosion, endometritis, etc.

There are known suppositories containing, according to the first embodiment, propolis 0.1 g, sea buckthorn oil 0.2 g, homeopathic essences of chestnut 0.1 g, homeopathic essences of ginkgo biloba 0.1 g, homeopathic essences of aloe 0.1 g, yarrow 0.1 g, lanolin 0.15 g, wax 0.1 g and a base. The second option is a suppository containing sea buckthorn oil 0.2 g, propolis 0.1 g, homeopathic root essences 0.05 g, hypericum 0.05 g, symphitum 0.05 g, extract from Tambucan therapeutic mud 0.2 g, lanolin 0.15, wax 0.1 g and a base (RF patent No. 2256462, IPC A61K 35/78, 2005).

These well-known suppositories are used to treat prostatitis, hemorrhoids, cervical erosion, endometritis, have anti-inflammatory, regenerating effects and are not toxic.

Known suppositories consisting of 2.0 ml of a 1% aqueous humic acid solution (pH 7.4) of low mineralized peloids and a sufficient amount of cocoa butter to obtain a suppository weighing 2.0-2.2 g (RF patent No. 2241471, IPC A61K 35/10, 2004).

Suppositories are also known, the composition of which includes the following components, wt.%: Propolis extract - 3.0, buckwheat honey - 3.0, emulsifier T-2 - 10.0, cocoa butter, enriched with lipids of the Tambukan therapeutic mud to the content of carotenoids less than 1.0 mg%, the rest (RF patent No. 2142789, IPC AK61/02, 1999). These suppositories have anti-inflammatory and antibacterial activity and are closest to those proposed both in terms of the composition of their constituents and in the achieved result, and therefore are taken as a prototype.

The disadvantage of all these suppositories is the low level of mineralization of the therapeutic mud (up to 60 g / liter) and, accordingly, the effectiveness of the treatment, in contrast to the highly mineralized Dead Sea mud containing 242.4 g / liter of active substances.

The technical result of the present invention is the creation of suppositories with a significantly higher level of anti-inflammatory, antibacterial and regenerative activity.

The specified technical result according to the first embodiment is achieved due to the fact that in the composition of suppositories for the treatment of gynecological and urological diseases based on natural producers in the mud, Dead Sea mud is used in the following ratio of components, wt.%:

Dead Sea mud - 50-70

wax - 2-4

emulsifier - 1-4

cocoa butter - the rest.

The specified technical result according to the second embodiment is achieved due to the fact that the composition of suppositories for the treatment of gynecological and urological diseases based on natural producers uses Dead Sea mud, stearic acid as a base, polyethylene oxide 1500 or 400 as a base in the following ratio, wt .%:

Dead Sea mud - 50-70

stearic acid - 15-20

emulsifier - 1-4

polyethylene oxide 1500 or 400 - the rest.

In tables 1 (option 1), 2 (option 2) are examples of specific composition of suppositories.

Table 1 Suppository Composition Components The content of the components in the composition of suppositories one 2 3 Dead Sea Mud fifty 60 70 Wax four 3 2 Emulsifier four 2.5 one Cacao butter rest rest rest

table 2 Suppository Composition Components The content of the components in the composition of suppositories one 2 3 Dead Sea Mud fifty 60 70 Stearic acid twenty fifteen 10 Emulsifier four 2.5 one Polyethylene oxide 1500 or 400 rest rest rest

The invention is as follows.

The manufacture of a batch of suppositories includes the following steps.

Option 1

- preparation of the basis by mixing

cocoa butter, wax and emulsifier

- Introduction to the basis of the Dead Sea mud;

- the formation and packaging of suppositories.

Option 2

- preparation of the basis by mixing

stearic acid, emulsifier and polyethylene oxide 1500 or 400;

- Introduction to the basis of the Dead Sea mud;

- the formation and packaging of suppositories.

First, all the components of the base are weighed: cocoa butter, wax and emulsifier (option 1) or stearic acid, emulsifier and polyethylene oxide 1500 or 400 (option 2). They are loaded into the reactor and melted by feeding steam into the jacket of the reactor to a temperature of 60-70 ° C. After the base is completely melted, it is mixed with a mixer, then, while continuing to mix, Dead Sea mud is introduced.

As a result of mixing the components, a dark brown substance is obtained, closer to black, with a consistency corresponding to cocoa butter at 20 ° C, having a smell similar to that of cocoa butter.

From the resulting mass make suppositories. The weight of one suppository is 3.5 g. Suppositories are laid out in boxes, 10 pieces in each box.

It is recommended to store ready-made packaging with suppositories in a dry, cool, dark place.

The following is an example for the preparation of an experimental batch of suppositories.

The starting components for 1000 suppositories (g):

Option 1

- Dead Sea mud - 2500

- cocoa butter - 950

- wax - 150

- emulsifier - 100.

Option 2

- Dead Sea mud - 2500

- stearic acid - 500

- emulsifier - 100

- polyethylene oxide 1500 or 400.

The introduction of the Dead Sea mud into the composition of the claimed substance contributes to a marked increase in the anti-inflammatory and antibacterial activity of the substance in comparison with the prototype (3-4 times).

Mud of the Dead Sea refers to sulfide mud, has a black color with a brownish tint. Physico-chemical properties of dirt: specific gravity of 1.65 g / dm ³ ; shear resistance 2697.7 dyne / cm ² ; heat capacity 0.46 cal / g; particle clogging> 0.25 mm - less than 0.05%; mineralization of the mud solution 242.4 g / l.

The main therapeutic effects of silt sulfide peloids: anti-inflammatory, immunomodulating, desensitizing, biostimulating, metabolic, reparative and regenerative, defibrosing, keratolic, bactericidal. The main active factors of the peloid are thermal, mechanical and chemical: irritating the thermo-, mechano-, baro-, chemo- and osmoreceptors of the mucosa and exerting a complex reflex and humoral effect on the patient's body.

The introduction of cocoa butter, emulsifier and wax (option 1) or stearic acid, emulsifier and polyethylene oxide 1500 or 400 (option 2) in appropriate proportions allows you to ensure the melting point of the substance below 37 ° C, which is required for suppositories when used, and maintaining a solid consistency at 25 ° C, what is needed during storage.

Example 1. The use of suppositories based on Dead Sea mud for gynecological diseases.

A total of 37 patients aged 21-38 years were examined: 18 patients with true cervical erosion, 12 patients with simple cervical ectopy, 7 patients with chronic cervicitis.

The duration of the disease ranged from 3 to 18 months.

Patients in the group did not statistically significantly differ in their main characteristics.

The treatment consisted of using suppositories based on Dead Sea mud of the above composition. The course of treatment is 10 procedures.

As a result of the treatment, a statistically significant decrease in the number of pathological leucorrhoea, an improvement in the vaginal microbiocenosis, an increase in the number of lactobacilli, and a significant decrease in the cervical transformation zone were noted.

One month after the end of treatment, 90.4% of patients noted the effectiveness of treatment as “significant”, 9.6% - as “satisfactory”.

Example 2. The use of suppositories based on Dead Sea mud for urological diseases.

We examined 18 patients with chronic bacterial prostatitis aged 38 to 55 years. The course of treatment using suppositories of the above composition was 10 procedures.

To evaluate the effectiveness of treatment, the following examinations were performed on patients before and after the course of treatment: TR ultrasound of the prostate gland; analysis of the secretion of the prostate gland; PSA test uroflowmetry; I-PSS, L.

The main characteristics of the patients are shown in table 3.

Table 3 Data of an objective examination of patients before and after treatment Indicator Before treatment After treatment Age years 47.5 +/- 8.5 IPSS points 19.1 6.1 Max 23 Max 12 Min 15 Min 2 QoL, points 3.8 2.2 Max 5 Max 3 Min 3 Min 1 Qmax, ml / s 14,4 16,2 Max 16.5 Max 17.5 Min 12,1 Min 14.8 Prostate volume 21.8 19.7 cm ³ Max 22,4 Max 23.0 Min 18.3 Min 17.1 amount 45.8 in the field of sp. 10,4 white blood cells Max 70 in the field of sp. Max 15 in prostate secretion Min 30 in the field of sp. Min 8 in sight

The performance criteria in the group of examined patients were the following indicators: general condition improvement; the disappearance of pain in the perineum; disappearance or reduction of the phenomena of dysuria; lack of renal colic; decrease in diuretic phenomena; improvement of sexual function; normalization of sleep; TR ultrasound of the prostate (reduction of the size of the gland, reduction of the size of the cysts of the prostate); analysis of prostate secretion (disappearance or decrease in the number of leukocytes, mucus, epithelial cells, amyloid bodies); with rectal digital examination, a decrease in edema and soreness of the gland; PSA test; uroflowmetry (improvement of uroflowmetry indicators).

As a result of evaluating the data obtained during the study, a positive result was achieved in all patients of the group with a significant decrease in the number of leukocytes in the field of view, an improvement in urodynamic parameters, and normalization of the IPSS.

Thus, the study revealed the effectiveness of monotherapy with the use of suppositories based on Dead Sea mud in the treatment of bacterial forms of chronic prostatitis.

The claimed therapeutic agent expands the arsenal of funds for the treatment of chronic inflammatory diseases of the genital organs in women and men.

Claims (2)

1. Suppositories for the treatment of gynecological and urological diseases based on natural producers, containing cocoa butter, emulsifier and dirt, characterized in that the composition is additionally introduced with wax, Dead Sea mud is used as dirt in the following ratio, wt.%:
Dead Sea Mud 50-70 wax 2-4 emulsifier 1-4 cacao butter rest 2. Suppositories for the treatment of gynecological and urological diseases based on natural producers, containing a base, emulsifier and dirt, characterized in that stearic acid is additionally introduced into the composition, Dead Sea mud is used as dirt, polyethylene oxide 1500 and 400 are used as a base in the following ratio components, wt.%:
Dead Sea Mud 50-70 stearic acid 15-20 emulsifier 1-4 polyethylene oxide 1500 or 400 rest