Prostacor solution for making injections
SUBSTANCE: solution has extract produced from cattle prostate and a carbohydrate.
EFFECT: no toxic effects; storage stability.
2 cl, 1 tbl
The invention relates to medicine and related drug, used as a drug in the treatment of acute and chronic prostatitis.
The main active ingredient of the drug is an extract from the prostate bulls and steers, the age of sexual maturity, are exempt from androgenic and estrogenic hormones and proteins (RU, patent 2089204, C1 And 61 To 35/48, 35/55). Extract, representing a solution of the regulatory peptides, and other peptides in aqueous solutions exposed to the mechanisms of chemical and physical decomposition, so when stored under normal conditions the concentration decreases sharply.
Known liquid drug Reveron ("ROBAPHARM L.T.D." Switzerland), containing an extract from the prostate gland, which is added m-Cresol, ensuring the stability of the content of regulatory peptides in the product during storage (Medmaravis "Drugs", Vilnius, 1994, Vol.2, p.143). However, m-Cresol has toxic properties, so patients with the introduction of Everone sometimes anaphylactic shock, allergic reactions, urticaria or eczema. In such cases, the drug is contraindicated, so he currently excluded from the range of medicines permitted for medical use.
The closest in composition and the achieved result is that the drug is: "Prostatilen" ("Belmedpreparaty" Belarus, "Biopharma" Ukraine)in which to ensure the stability of the content of regulatory peptides during storage of the drug in the extract from the prostate gland adds cryoprotector (glycine), and then poured into ampoules and lyophilizer (reference Vidal. Astra Pharm Service. Meters, the - 1997-p. B-486). The product is a lyophilized powder for preparation of injection solution. Immediately before use, dissolve themselves and prepare a solution for injection.
However, the production of a lyophilized drug is a costly process. In addition, there is a need for preparation of a solution of the drug directly to the introduction, which complicates the work of medical personnel in aseptic conditions.
The objective of the invention is to provide a liquid non-toxic drug dosage form for intramuscular injection, sustainable (stable) during storage.
The problem is solved by the introduction part of the preparation of carbohydrate (e.g., mannitol, maltose etc,), which as a preservative and stabilizer provides stability (the stability of) the liquid preparation when stored.
The exception process of freeze drying eliminates the need for dissolution of the drug before the introduction, allows to simplify the production technology lekarstvennayaforma, to reduce energy and labor costs and ultimately reduce the cost of the drug. In addition, the product does not contain toxic components such as m-Cresol.
Liquid dosage form of the drug contains 1 ml of 4 to 6 mg of regulatory peptides and from 30 to 60 mg of carbohydrate.
The solution protecor for injection is prepared as follows.
To prepare 100 l of a solution for intramuscular take 100 l of an extract from the prostate gland of cattle (containing 1 ml of 4 to 6 mg of regulatory peptides) and from 3.0 to 6.0 kg of carbohydrate.
In a reactor with a capacity of 100 l 90 pour l extract of prostate cancer include a stirrer and with constant stirring download small portions weighted carbohydrate. Not disabling the mixer, open the valve on the supply of sterile nitrogen into the reactor and verbatimout for 30 minutes Then bring the volume of solution in the reactor extract up to 100 l, adjust pH, mix and verbatimout nitrogen until complete dissolution of the carbohydrate. After dissolution spend sterilizing filtration of the resulting solution, under aseptic conditions gradually poured into ampoules and sealed.
The resulting solution for intramuscular injection is a clear yellowish liquid. The drug is a sterile, apyrogenic, non-toxic, has a pH of 5.6-6,. The resulting solution for injection was stored for 3 years at room temperature.
Comparative tests for retention of liquid dosage forms of the drug and lyophilized production unitary enterprise "plant" (table) showed that the solution is stable when stored and qualitative indicators (including quantitative content of regulatory peptides, the reaction of the alkaline phosphatase, inhibited by cysteine, toxicity, progenote) is not different from lyophilized Prostatilen. Accordingly, the liquid dosage form of the drug can be stored at least 2 years.
Examples of the composition of the solution for intramuscular injection
Ingredients: Extract of the prostate gland, containing 5.2 mg/ml of regulatory peptides up to 100 l and maltose 6 kg of the resulting solution with a content of regulatory peptides 5.2 mg/ml maltose 60 mg/ml and a pH of 5.7. After 3 years the solution contained 5.1 mg/ml of regulatory peptides, 60 ml/mg of maltose and pH of 5.8.
Ingredients: Extract of the prostate containing 5.5 mg/ml of regulatory peptides up to 100 l and mannitol 3 kg of the resulting solution with a content of regulatory peptides of 5.5 mg/ml, mannitol, 30 mg/ml and pH of 5.8. After 3 years the solution contained 5.4 mg/ml of regulatory peptides, 30 ml/mg of mannitol and pH 6.0.
Composition: the Former is ract of the prostate, containing 5.4 mg/ml of regulatory peptides up to 100 l and maltose 4 kg of the resulting solution with a content of regulatory peptides of 5.4 mg/ml maltose 40 mg/ml and pH 6.0. After 3 years the solution contained 5.3 mg/ml of regulatory peptides, 40 ml/mg of maltose and a pH of 6.2.
Comparison of quality of Prostatilen lyophilized powder for preparation of injection solution 5 mg and 0.5% solution of Prostacare for injection in the preparation and after 3 years of storage.
|The quality indicators||Prostatilen lyophilized powder for preparation of injection solution 5 mg||0.5% solution of Prostacare for injection|
|When cooking||After 3 years||When cooking||After 3 years|
|1. Appearance||Dried porous mass compacted in tablet white with a yellowish sheen color||Dried porous mass compacted in tablet white with a yellowish sheen color||Transparent yellowish liquid with a weak peculiar smell||Transparent yellowish liquid with a weak peculiar smell|
|2. Transparency||Ol is dissolved transparent||When dissolved transparent||Transparent||Transparent|
|3. Color||When dissolved harder standard 5B||When dissolved harder standard 5B||Harder standard 3b||Harder standard 3b|
|8. Reactivation of alkaline phosphatase, inhibited by cistena||27%||26%||27%||26%|
|9. Total nitrogen||13,8%||13,8%||0,1%||0,1%|
|11. Heavy metals||Not more than 0.005%||Not more than 0.005%||Not more than 0.005%||Not more than 0.005%|
|12. Glycine||18 mg/ml||18 mg/ml||No||No|
|14. Maltose||No||No||40 mg/ml||40 mg/ml|
|15. Regulatory peptides||5.4 mg/ml||5.3 mg/ml||5.4 mg/ml||5.3 mg/ml|
1. Solution for injection, containing an extract from the prostate gland of cattle and stabilizer, carbohydrate in the following ratio of components 1 ml:
|The carbohydrate mg||30-60|
|Extract from the prostate gland, major|
|cattle containing from 4 to 6 mg/ml|
|regulatory peptides||To 1 ml|
2. The solution according to claim 1, characterized in that the carbohydrate it contains mannitol or maltose.
FIELD: medicine, urology.
SUBSTANCE: one should rectally introduce medicinal cocktail of the following composition: 0.5%-Novocain 5 ml, halidor 2 ml, Dimexid 5 ml, and, additionally, perorally - berlithion 300 mg twice daily. The innovation suggested provides complex impact upon pain pathogenesis at the above-mentioned diseases, removes psychoemotional tension by, thus, improving patient's quality of life.
EFFECT: higher efficiency of therapy.
2 ex, 1 tbl
SUBSTANCE: method involves carrying out excretion cystometry with total action potential of motor units of perineal muscles and muscles of external anal sphincter being recorded using skin electrodes. Obstructive urination diagnosis being confirmed with excretion cystometry data and total action potential of motor units increment being greater than 500 mcV, myorelaxant agent central action mechanism like tizanidine is administered at a dose of 24 mg per day taken in three portions (8 mg three times a day).
EFFECT: enhanced effectiveness in eliminating sphincter dysfunction; prevented disease recurrence.
< / BR>and their pharmaceutically acceptable salts, esters, where Y is O; Q is CH; X, Z and Z' each independently represent CH or N; m=0-1; n=0-4; R1and R2independently selected from H, F, Cl, Br, OCH3OC2H5, OCH2CF3CH3WITH2H5, CF3isopropylate; R3represents H; R4and R5represent H or phenyl, except that R1represents H, R2represents H, Cl or CF3, R3, R4and R5=N, Y=0, and Q=CH, if m=0 and n=1; and also except that R1represents H, R2is OCH3, R3, R4and R5=H, Y=0, Q=CH, if m=0 and n=2
FIELD: pharmaceutical industry, in particular phospholipid-based pharmaceutical composition hawing hepatoprotective and metabolism normalizing activity in form of tablets, pellets, capsules, injection solutions, etc.
SUBSTANCE: claimed composition contains both plant and animal origin phospholipid, essential amino acid such as methionine and threonine, and filler at total phospholipid and amino acid content of 15-80 % in mass ratio of 2:1.
EFFECT: effective pharmaceutical composition having excellent hepatoprotective and lipid, protein, and carbohydrate metabolism normalizing activity.
12 cl, 26 tbl, 98 ex
SUBSTANCE: method involves acidifying and/or alkalinized by buffering and/or controlling pH to provide nicotine tmax in arterial subject blood in short time after introduction. Aerosol atomizing is preferentially done into oral cavity for following distribution in lungs. Method for preparing the composition, system for achieving smoking desire reduction and/or satisfaction feeling without smoking is also suggested.
EFFECT: enhanced effectiveness in introducing nicotine via lungs; avoided harmful actions caused by smoking.
FIELD: medicine; medical engineering.
SUBSTANCE: preparation comprises carrier treated with electromagnetic field. The carrier is a substance selected from a group composed of pharmaceutically permissible powder or pill substrate having crystalline substance in the amount of at least 23% by mass, physiologic fluid or liquid crystals. The carrier is treated with electromagnetic field using frequencies of 0.01-9.0 kHz, 10.0-100.0 kHz or 0.5-10.0 MHz during 0.5-60 min. Method involves producing a preparation comprising carrier being a substance selected from a group composed of pharmaceutically permissible powder or pill substrate having crystalline substance in the amount of at least 23% by mass, physiologic fluid or liquid crystals. The carrier is treated with electromagnetic field of abovementioned frequency during 0.5-60 min. Optimum treatment time is selected depending on carrier nature.
EFFECT: stable properties during one year; enhanced effectiveness in agricultural production processes; encouraging future application in medicine.
13 cl, 2 tbl
FIELD: medicine, oncology, pharmacy.
SUBSTANCE: invention relates to agents used in treatment of tumors and can be used in treatment of different tumor neoplasms. The proposed agent possessing an antitumor activity comprises methylene glycol as an active component and a saline solution as an inert solvent in the following ratio of components, wt.-%: calcium chloride (CaCl2), 0.018-0.021; potassium chloride (KCl), 0.018-0.021; methylene glycol, 0.1-1.0, and water, the balance. The optimal curative daily dose is 20-40 mcl/1 kg of body weight. Invention provides achievement of the stable clinical effect, reducing treatment time and decreasing the toxic effect.
EFFECT: valuable medicinal property of agent.
2 cl, 5 ex
FIELD: medicine, pharmacy.
SUBSTANCE: invention relates to agents used in treatment of joint diseases in the form of injection solutions. The proposed agent comprises the following components, wt.-%: saccharide - chondroitin sulfate, 0.5-20.0; preserving agent, 0.1-2.0; non-ionogenic surfactant, in particular, monoester of oleic acid and polyoxyethylated sorbinate, 1.0-5.0, and water, the balance. Invention provides the high bioavailability and the diffusion rate of active substance into the joint zone.
EFFECT: valuable medicinal properties of agent.
2 cl, 3 tbl, 6 ex
FIELD: medicine, pharmacy.
SUBSTANCE: invention relates to a liquid pharmaceutical composition comprising pegilated erythropoietin as a conjugate in pharmaceutically acceptable buffer at pH from 5.5 to 7.0 and optionally one or some pharmaceutically acceptable excipients. Proposed composition is used in treatment and prophylaxis of diseases associated with erythropoiesis injury. The advantage of invention involves enhancing stability of the preparation.
EFFECT: improved and valuable property of preparation.
59 cl, 4 tbl, 11 dwg, 13 ex
FIELD: medicine, pharmacy.
SUBSTANCE: invention relates to a cycloferon-containing medicinal agent used in prophylaxis and treatment of influenza and acute respiratory diseases, herpetic infection, chronic viral hepatitis B and C and prophylaxis of oncological diseases. Agent comprises a physiological solution in the following ratio of components: 10-29 - 10-2 mg of cycloferon in 1 ml of physiological solution. Also, invention relates to a method for preparing this medicinal agent. Proposed medicinal agent enhances antiviral and antitumor activity of natural killers by 1.8-fold, not less.
EFFECT: improved preparing and using method, valuable medicinal properties of agent.
7 cl, 1 dwg, 19 ex
FIELD: medicine, pharmacy.
SUBSTANCE: invention relates to new medicinal agents for parenteral using based on an antidepressant agent pirlindole salts. Agent comprises 2,3,3a,4,5,6-hexahydro-8-methyl-1H-pyrazino[3,2,1-j,k]carbazole (pirlindole) sulfonate salts as an active substance, such as methane sulfonate or benzene sulfonate. The composition for intravenous or intramuscular injection comprises additionally citric acid and water taken in the definite ratios. Invention provides preparing an agent possessing good tolerance, low toxicity and resistance in storage.
EFFECT: improved and valuable medicinal and pharmaceutical properties of agent.
2 cl, 1 tbl, 4 ex
SUBSTANCE: invention proposes a liquid pharmaceutical composition containing nicotine in any form for administration into the mouth cavity and alkalinized with a buffer and/or by regulation of pH value. Administration is carried out preferably by spraying and the most preferably by sublingual spraying. Also, invention relates to a method for preparing the indicated composition. Use of indicated composition in therapy, such as therapy for treatment of addiction to tobacco.
EFFECT: valuable pharmaceutical properties of composition.
51 cl, 11 ex
SUBSTANCE: invention relates to microemulsion preconcentrate comprising active ingredient, oil, surfactant and hydrophilic solvent selected from group containing propylene glycol diacetate, propylene glycol acetate and salts thereof. Microemulsion preconcentrate optionally contains as active ingredient not only hydrophobic compounds but also hydrophilic compounds and proteins.
EFFECT: microemulsion preconcentrate of improved quality.
6 cl, 6 tbl, 3 dwg, 14 ex
FIELD: medicine, pharmacy.
SUBSTANCE: invention proposes a hydrophilic pharmaceutical composition with hypoglycemic effect comprising nateglinide crystals of B-type as an active component. The composition has edge angle to water surface 111 degrees or less. This edge angle is created by addition at least one hydrophilic substance to the composition chosen from groups comprising of hydrophilic polymers, surfactants, sugars and sugar-alcohols. Invention provides easy method for preparing the composition, its high solubility and rather rapid release of nateglinide.
EFFECT: improved and valuable properties of pharmaceutical composition.
13 cl, 8 dwg, 4 tbl, 6 ex