Rectal suppositories with solid licorice extract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmacy, namely technology of preparation of rectal suppositories. The suppositories with solid licorice extract consist of solid licorice extract 0.75 g on a hydrophilic base, polyethylene glycol 6000 1.25 g and polyethylene glycol polystear 0.25 g.

EFFECT: making the preparations exhibiting anti-inflammatory action, and also a positive effect on the hormonal status and the copulative function.

7 tbl

 

The invention relates to a pharmacy, namely the production of rectal suppositories.

Known suppositories "Supersol" thick licorice root extract (HEX), using the weight of the part: GEX - 0,75; polyethylene glycol-4000 - 1,25; PEG-monostearate- 0,25 [1, 2, 3].

However, due to the high content GEX (33%) suppositories specified structure had insufficient hardness (26,3 N, determination of hardness suppozitornyj masses was carried out on the device SBT firm "Erweka"), were plastic and deformed in the introduction, therefore before you apply them, you had to stand in a refrigerator at a temperature of 2-3°C for at least 1 hour.

The task of improvement of technological parameters, to increase the biological availability, implementation of anti-inflammatory action, normalization of level of sex hormones and copulative functions.

This object is achieved by using the proposed composition of PEG-6000, and as a solubilizer officinal drug - PEG-stearate.

For studies used different bases: lipophilic - cocoa butter with the addition of emulsifier PEG-stearate and hydrophilic PEG (because licorice is a water - soluble substance) with different molecular weight. As preservative used nipagin (methyl paraben) in the amount of 0.3% of the total mass is s. Composed of 9 model formulations specified in table No. 1.

To obtain suppositories for formulations 1 and 4; 2 and 3 melted down, respectively, PEG 4000 and PEG 6000 at a temperature of from 60°C.-70°C. in Addition, rectal suppositories No. 3 was present PEG-stearate, and No. 4 - PEG-monostearate. Recipe No. 5 as the basis used witepsol N 15 and PEG-stearate, and No. 9 - witepsol N 15, emulsifier T2 and Aerosil A380. To obtain suppositories No. 6 and 7 cocoa butter melted at a temperature of 35°C-50°C With an emulsifier T2. In addition, candles, recipe No. 6 to increase the melting temperature included beeswax, and the No. 8 - And Aerosil 380. All the components of different compositions are mixed with the heated thick licorice root extract, pour into molds and placed in a refrigerator at a temperature of 3-5°C.

The prepared suppositories average weight 2.25 g have been evaluated for physico-chemical and technological parameters according to the requirements of the State Pharmacopoeia XI and XII: uniformity on the cut, the full deformation, raspadaemost (table№2) [4, 5].

As can be seen from tables 1 and 2, the preferred indicators have suppositories by recipe No. 3, 4 and 8. In addition, using UV spectrophotometry (258 nm) was studied dialysis glycyrrhizic acid (GA) from rectal suppositories these two formulations 3, 4 and No. 8. In the floor the received data output General Ledger within 1 hour (g), respectively: 0,156±0,003, 0,123±0,007 and 0.046±0,006 (P<0,001), which is a convincing evidence of the correctness of the choice of the hydrophilic base and the preference of PEG-6000. The use of PEG-6000 with PEG-stearate in the inventive composition compared with PEG-4000 with PEG-monostearate can improve raspadaemost suppositories and consequently the bioavailability of the pharmacologically active components, including glycyrrhizic acid (table 2).

Along with the specified use of the claimed composition has improved the hardness to 34.5 N, the time and temperature of storage to 25°C, to improve the quality of suppositories (homogeneity) and the comfort of introduction.

Table 1
Composition of model formulations of suppositories with a thick extract of licorice root
Name ingredientsQuantitative composition (g)
123456789
Licorice thick 0,750,750,750,750,750,750,750,750,75
Polyethylene glycol 40001,5--1,25-----
Polyethylene glycol 6000-1,51,25------
The polyethylene-glycol monostearate0,250,3
The polyethylene glycol stearate,25
Cocoa butter1,101,201,15
Emulsifier T20,20,30,30,25
Aerosil A3800,050,05
Witepsol N 151,2 1,2
Beeswax0,2
Total2,252,252,252,252,252,252,252,252,25

Table 2
Technological and physico-chemical characteristics of suppositories with a thick extract of licorice root
Name of indicatorThe number of
123456789
The homogeneity of the medium is e Not ACC.Not ACC.Not ACC.Not ACC.Not ACC.
The full deformation (min)----1221611,515,5
Raspadaemost (min)46522228-----

To assess the severity of dialysis pharmacological components thick licorice root extract was determined by the concentration of glycyrrhizic acid in the juice of the prostate in patients with HIP using UV spectrophotometry (258 nm).

For the study observed 24 patients with HIP, which were divided into four groups of 6 people each. The observed 1-Oh group during the 10 days was introduced microclysters with 2.5% aqueous solution GEX 60 ml of 1 times a day, 2nd group - candles No. 8 recipe: HEX 0.75 g, cocoa butter 1,15 g, emulsifier T2 0.3 g Aerosil A380 0.05 g 2 times a day for 10 days, the 3rd group - suppositories consisting of: HEX 0.75 g, PEG-4000 1,25 g and PEG-monostearate 0.25 g, and 4-Oh groups, respectively: HEX 0.75 g, PEG-6000 1,25 g and PEG-stearate 0.25 g 2 times a day for 10 days. Then collected the juice of a prostate and 4 groups of samples were determined by GC. In the first group the number of GC was 0,013±0,0011%, the second - 0,045±0,0033%, the third of 0.066±0,0035% and the fourth 0,1±0,0022%.

In the statistical analysis of data from the four groups was found that the highest concentration of ha in the juice of the prostate is achieved using formulations used in 3 and 4 groups. Moreover, the indicators of dialysis concentration of glycyrrhizic acid was significantly higher when using PEG-6000 with PEG-stearate (0,1±0,0022%) compared with PEG-4000 and PEG-monostearate (of 0.066±0,0035%); P<0,001.

A clinical trial of rectal suppositories was conducted in 30 patients with chronic infectious prostatitis, who were prescribed solely rectal candles with HEX composition No. 3 and 4, 2 times a day for 10 days. The results of treatment are presented in tables No. 3-7.

Table 3
The dynamics of the painful feeling which deposits on the anatomical areas in the treatment of patients with chronic infectious prostatitis (3 and 4 groups)
Anatomical regiongroup 3group 4
before the treatmentafter the treatmentbefore the treatmentafter the treatment
M±m (%)M±m (%),PM±m (%)M±m (%), P
Crotch98,0±923,0±2, P<0,001100,0±1030,0±11, P<0,001
The scrotal organs42,0±43,0±1; P<0,00135,0±115,0±5, P<0,02
Pubis96,0±724,0±3, P<0,00190,0±750,0±12, P<0,01
Waist0±00±00±00±0

Table 4
The dynamics of the results of palpation studies of the prostate in the treatment of patients with chronic infectious prostatitis (3 and 4 groups)
Indicatorsgroup 3group 4
before the treatmentafter the treatmentbefore the treatmentafter the treatment
M±m (%)M±m (%), PM±m (%)M±t (%), P
Asymmetry96,0±858±10; P<0,01100,0±1070±11; P<0,02
Contour sharpness12,0±461,0±7; P<0,0010±050,0±5; P<0,001
Smoothness groovesa 99.0±129,0±3; P<0,001100,0±105,0±5; P<0,001
The presence of condensed foci0±00±00±0 0±0
Pain97,0±98,0±2; P<0,00190,0±75,0±5; P<0,001

As can be seen from tables 3 and 4, in both groups there was a positive dynamics of indicators characterizing the intensity of the inflammatory process in the prostate gland. However, information such as the irradiation of pain in the scrotum and pubis, which to a certain extent indicate the intensity of inflammation in the affected organ, respectively: 42,0±4 and 3.0±1; P<0,001; 96,0±7 and 24.0±3; P<0,001 (group 3); 35,0±11 and 5.0±5, P<0,02; 90,0±7 and 50.0±12; P<0,01 (group 4), we can conclude that more significant anti-inflammatory effect have candles, consisting of HEX hydrophilic on the basis of PEG 6000 with PEG-stearate.

Table 5
The dynamics of the main types of sexual disorders in the treatment of patients with chronic infectious prostatitis (3 and 4 groups)
NameBefore the treatmentAfter the treatmentPBefore the treatment After the treatmentP
M±m (%); group # 3M±m (%); group # 4
Rapid ejaculation71,0±1024,0±9P<0,00175,0±1020,0±9P<0,001
Erectile dysfunction90,0±752,0±10P<0,0195,0±555,0±11P<0,01
Decreased libido34,0±710±3P<0,0130,0±1115±8P>0,2
Violation of the two components of the copulative cycle48±916±8P<0,0550,0±1215±8P<0,02
Violation of the three components of the copulative cycle38,0±8 4±1P<0,00130,0±110±0P<0,02

From the data presented in table No. 5, it follows that less were recorded in both groups such violations of sexual function, as the accelerated ejaculation - 24,0±9 (P<0,001) and 20.0±9% (P<0.001) in patients and erectile dysfunction - 52,0±10 (P<0,01) and 55.0±11% (P<0,01). Violation of the two components of the copulative cycle remained only 16±8 (P<0.05) and 15±8% (P<0,02), and three components of the copulative cycle, respectively: 4±1 (P<0.001) and 0±0 (P<0,02). However, when comparing all values between 3 and 4 groups significant difference established by indicators such as decreased libido and impaired the three components of the copulative cycle. Moreover, the preferred data identified in the group, which was appointed candles, consisting of HEX hydrophilic on the basis of PEG 6000 with PEG-stearate (P<0,05).

Table 6
Dynamics of semen in the treatment of patients with chronic infectious prostatitis (3 and 4 groups)
NameBefore the treatmentP the following treatment PBefore the treatmentAfter the treatmentP
M±m (%); group # 3M±m (%); group # 4
Volume (ml)2,4±0,172,6±0,18P>0,52,54±0,132,7±0,12P>0,3
The liquefaction time (min)56±1,949±2,0P<0,0557±1,639±2,0P<0,001
The number of cells10,8±0,585,5±0,42P<0,00110,5±0,665,7±0,44P<0,001
Active reaction (PH)6,3±0,047,7±0,12P<0,0016,55±0,067,52±0,14P<0,001
The number of spermato is oidov in 1 ml 129±11,0132,9±12,1P>0,5122±14,0134,9±13,4P>0,5
The number of sperm in the ejaculate344±28,0352,1±25,4P>0,5316±44,0349,3±32,3P>0,5
Spermagglyutinatsiya (%)3,0±1,02±1,0P>0,53,0±2,01±1,0P>0,2
Actinopodidae sperm (%)47±2,058±2,0P<0,00150±2,059±2,0P<0,01
Fixed spermatozoa (%)53±2,042±1,0P<0,00150±2,041±2,0P<0,001
Abnormal sperm (%)25±1,0/td> 17,0±1,0P<0,00124±1,018,0±1,0P<0,001

P>0,5
Table 7
Evolution of results of hormonal research in the treatment of patients with chronic infectious prostatitis (3 and 4 groups)
NameBefore the treatmentAfter the treatmentPBefore the treatmentAfter the treatmentP
M±m (%); group # 3M±m (%); group # 4
Testosterone (the rate for men aged 14-50 years 5,76-30,43 nmol/l; older than 50 years, 5,41-19,54 nmol/l)4,5±0,57,6±0,7P<0,0014,9±0,26,6±0,4P<0,001
Follicle-stimulating hormone (norm - 1,0-of 13.58 mIU/ml)4,1±1,24,7±0,74,6±1,34,9±0,9P>0,8
Prolactin (normal - 53-360 honey/l)72,4±8,8109,5±21,8P>0,869,7±8,8111,5±24,9P>0,6
Luteinizing hormone (normal range of 0.8-8,4 mIU/ml)1,2±0,32,3±0,5P>0,051,5±0,52,6±0,4P>0,05

Analysis of the results presented in tables 6 and 7, showing the positive changes that indicate a marked effect of the proposed suppositories in division No. 3 and 4 in patients with chronic infectious prostatitis. So, significantly decreased the time dilution of sperm to 49±2,0 (P<0.05) and 39±2,0% min (P<0.001)and decreased the number of leukocytes to 5.5±0,42 (P<0,001) and 5.7±0,44% (P<0,001), normalized active pH of 7.7±0,12 (P<0.001) and 7,52±0,14% (P<0.001)and increased to normal values number activepageindex sperm - 58±2,0 (R<0.001) and 59±2,0% (P<0.01), and decreased the number of fixed and pathological spermatozoa respectively: 42±1,0 (P<0,001); 17,0±1,0 (P<0.001) and 41±2,0% P<,001) 18,0±1,0 (P< 0,001). Along with this, the recovered concentration of testosterone in the blood, reaching a level of 7.6±0,7 (P<0,001) and 6.6±0.4 nmol/l (P<0,001). Moreover, when comparing results between groups no significant difference was registered only in assessing the dynamics of the concentration of testosterone in those patients who were injected candles, consisting of HEX hydrophilic on the basis of PEG 6000 with PEG-stearate (P<0,05).

Thus, the developed copy rectal suppositories with thick licorice root extract hydrophilic on the basis of polyethylene glycol 6000 and polietilenglikolsuktsinata delivers the necessary technological properties, complies with the requirements as XI, and XII of the State Pharmacopoeia of the Russian Federation (homogeneity on the cut, the full deformation, raspadaemost) and has a significantly pronounced anti-inflammatory effect and a positive effect on the hormonal status and the copulative function.

Rectal suppositories containing 0.75 g of thick extract of licorice root and a base, characterized in that as the basis enabled polyethylene glycol 6000 1,25 g and 0.25 was polietilenglikolmonostearat



 

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