CN101837007B - A pharmaceutical composition for treating hemorrhoid, and its preparation method - Google Patents
A pharmaceutical composition for treating hemorrhoid, and its preparation method Download PDFInfo
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- CN101837007B CN101837007B CN2010101454624A CN201010145462A CN101837007B CN 101837007 B CN101837007 B CN 101837007B CN 2010101454624 A CN2010101454624 A CN 2010101454624A CN 201010145462 A CN201010145462 A CN 201010145462A CN 101837007 B CN101837007 B CN 101837007B
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- 208000014617 hemorrhoid Diseases 0.000 title claims abstract description 30
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 28
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 229920001607 Policresulen Polymers 0.000 claims abstract description 52
- ACZKMKGNTMOPBD-UHFFFAOYSA-N policresulen Chemical compound CC1=CC(O)=C(S(O)(=O)=O)C=C1CC1=CC(S(O)(=O)=O)=C(O)C(CC=2C(=CC(O)=C(C=2)S(O)(=O)=O)C)=C1C ACZKMKGNTMOPBD-UHFFFAOYSA-N 0.000 claims abstract description 52
- 229960002954 policresulen Drugs 0.000 claims abstract description 52
- 239000000203 mixture Substances 0.000 claims abstract description 44
- IVHBBMHQKZBJEU-UHFFFAOYSA-N cinchocaine hydrochloride Chemical compound [Cl-].C1=CC=CC2=NC(OCCCC)=CC(C(=O)NCC[NH+](CC)CC)=C21 IVHBBMHQKZBJEU-UHFFFAOYSA-N 0.000 claims abstract description 35
- 239000000829 suppository Substances 0.000 claims abstract description 11
- 239000002674 ointment Substances 0.000 claims abstract description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 36
- 238000000034 method Methods 0.000 claims description 18
- 238000003756 stirring Methods 0.000 claims description 16
- 239000003814 drug Substances 0.000 claims description 13
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 12
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerol group Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 12
- 239000000843 powder Substances 0.000 claims description 12
- 238000005303 weighing Methods 0.000 claims description 11
- 125000005456 glyceride group Chemical group 0.000 claims description 9
- 239000000314 lubricant Substances 0.000 claims description 8
- 229940031955 anhydrous lanolin Drugs 0.000 claims description 7
- 239000007766 cera flava Substances 0.000 claims description 7
- 229940099259 vaseline Drugs 0.000 claims description 7
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 6
- 239000000890 drug combination Substances 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 5
- 239000002671 adjuvant Substances 0.000 claims description 5
- 238000009472 formulation Methods 0.000 claims description 5
- 230000004927 fusion Effects 0.000 claims description 5
- 239000002552 dosage form Substances 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000009413 insulation Methods 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 235000021355 Stearic acid Nutrition 0.000 claims description 3
- 150000002191 fatty alcohols Chemical class 0.000 claims description 3
- 229940075507 glyceryl monostearate Drugs 0.000 claims description 3
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 claims description 3
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 3
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 3
- 230000008520 organization Effects 0.000 claims description 3
- 239000008117 stearic acid Substances 0.000 claims description 3
- 244000141353 Prunus domestica Species 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 14
- 239000004480 active ingredient Substances 0.000 abstract description 4
- 230000036407 pain Effects 0.000 abstract description 4
- 230000017423 tissue regeneration Effects 0.000 abstract description 4
- 230000023597 hemostasis Effects 0.000 abstract description 3
- 238000002690 local anesthesia Methods 0.000 abstract description 3
- 230000008929 regeneration Effects 0.000 abstract description 3
- 238000011069 regeneration method Methods 0.000 abstract description 3
- 208000016583 Anus disease Diseases 0.000 abstract description 2
- 239000013543 active substance Substances 0.000 abstract description 2
- 150000001875 compounds Chemical class 0.000 abstract description 2
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 2
- 206010002153 Anal fissure Diseases 0.000 abstract 1
- 206010068172 Anal pruritus Diseases 0.000 abstract 1
- 208000009531 Fissure in Ano Diseases 0.000 abstract 1
- 206010020565 Hyperaemia Diseases 0.000 abstract 1
- 208000009544 Pruritus Ani Diseases 0.000 abstract 1
- 235000019606 astringent taste Nutrition 0.000 abstract 1
- 239000000969 carrier Substances 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 230000001338 necrotic effect Effects 0.000 abstract 1
- 230000001954 sterilising effect Effects 0.000 abstract 1
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- PASHVRUKOFIRIK-UHFFFAOYSA-L calcium sulfate dihydrate Chemical compound O.O.[Ca+2].[O-]S([O-])(=O)=O PASHVRUKOFIRIK-UHFFFAOYSA-L 0.000 description 8
- 235000011132 calcium sulphate Nutrition 0.000 description 7
- 229940079593 drug Drugs 0.000 description 4
- 210000001519 tissue Anatomy 0.000 description 4
- 201000009030 Carcinoma Diseases 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 229960001747 cinchocaine Drugs 0.000 description 3
- PUFQVTATUTYEAL-UHFFFAOYSA-N cinchocaine Chemical compound C1=CC=CC2=NC(OCCCC)=CC(C(=O)NCCN(CC)CC)=C21 PUFQVTATUTYEAL-UHFFFAOYSA-N 0.000 description 3
- 230000007850 degeneration Effects 0.000 description 3
- 230000036571 hydration Effects 0.000 description 3
- 238000006703 hydration reaction Methods 0.000 description 3
- 206010025482 malaise Diseases 0.000 description 3
- ODLIHNXQTJXBDT-UHFFFAOYSA-N 2-hydroxy-6-methylbenzenesulfonic acid Chemical compound CC1=CC=CC(O)=C1S(O)(=O)=O ODLIHNXQTJXBDT-UHFFFAOYSA-N 0.000 description 2
- 206010010774 Constipation Diseases 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 210000002919 epithelial cell Anatomy 0.000 description 2
- 210000000981 epithelium Anatomy 0.000 description 2
- 239000003589 local anesthetic agent Substances 0.000 description 2
- 230000001575 pathological effect Effects 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 206010012110 Defaecation urgency Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000015815 Rectal disease Diseases 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 238000001467 acupuncture Methods 0.000 description 1
- 230000003444 anaesthetic effect Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 210000000436 anus Anatomy 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 238000009207 exercise therapy Methods 0.000 description 1
- 210000003608 fece Anatomy 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 208000006454 hepatitis Diseases 0.000 description 1
- 231100000283 hepatitis Toxicity 0.000 description 1
- 206010020718 hyperplasia Diseases 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 208000028774 intestinal disease Diseases 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000007912 intraperitoneal administration Methods 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 150000004965 peroxy acids Chemical group 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 210000002307 prostate Anatomy 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 230000036186 satiety Effects 0.000 description 1
- 235000019627 satiety Nutrition 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 229960002372 tetracaine Drugs 0.000 description 1
- GKCBAIGFKIBETG-UHFFFAOYSA-N tetracaine Chemical compound CCCCNC1=CC=C(C(=O)OCCN(C)C)C=C1 GKCBAIGFKIBETG-UHFFFAOYSA-N 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
- -1 vaseline Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention discloses a pharmaceutical composition for treating hemorrhoids, which is a compound preparation formed by mixing policresulen and cinchocaine hydrochloride serving as active ingredients and pharmaceutically acceptable auxiliary materials serving as carriers, wherein in the pharmaceutical composition, the policresulen accounts for about 3-10% of the total weight of the composition, and the cinchocaine hydrochloride accounts for about 0.1-0.8% of the total weight of the composition. The policresulen, the main active substance, has the functions of hemostasis, astringency, epithelial regeneration and sterilization, so that necrotic tissues are coagulated and separated, and the wound surface is quickly cleaned. At the same time, a strongly reactive local hyperemia is produced and thus tissue regeneration is promoted. In order to inhibit the pain of the wound surface, the cinchocaine hydrochloride with quick effect is adopted for local anesthesia. The pharmaceutical composition is prepared into external preparations, including suppository, ointment and the like, and is suitable for treating hemorrhoids, anal fissure and rhagadia, pruritus ani and the like.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used to treat hemorrhoid; It is to be active component with policresulen, cinchocaine hydrochloride; Mix the Pharmaceutical composition that forms as carrier with acceptable accessories; And this preparation of drug combination method, this invention belongs to medical technical field.
Background technology
Hemorrhoid are common anorectal diseases, and its sickness rate accounts for 87.25% of all anal and intestinal diseases, and the men and women all can get this disease, and women's sickness rate is 67%, and male's sickness rate is 53.9%; Any age all can fall ill, and wherein the people in 20-40 year comparatively more sees, and increases the weight of with advancing age and gradually, so saying of " ten people, nine hemorrhoid " arranged.Its pathogenic factor is a lot of, and the people is standing or during seat, anal orifice and rectal intestine is positioned at the bottom, because the compressing of gravity and internal organs influences the blood backflow, vein is expanded flexing easily, so often stand or the people of seat suffers from hemorrhoid easily.Hypomotility, enterokinesia reduces, and feces is descending slow, also can the constipation of forming the habit property.Podex is caught a cold, is heated, constipation, diarrhoea, excessive consumption of alcohol and eat maror more, all can stimulate anus and rectum.Because of all can making intra-abdominal pressure increase, hepatitis interstitialis chronica, hepatohemia and cardiac function incompensation etc. and diseases such as intraperitoneal tumor, prostate hyperplasia form hemorrhoid.Also have some living habit problems in addition, such as the diet satiety, often eat meticulous food or suppress just, Asiatic water closet pan is crossed and is waited so long, and all is the reason that forms hemorrhoid.Though hemorrhoid generally can not produce big harm, but still can produce inconvenient influence to daily life.At present, the method for treatment hemorrhoid has operative treatment, acupuncture and moxibustion therapy, and methods such as exercise therapy and Drug therapy, various Therapeutic Method account for very consequence in treatment, but being difficult to effect a radical cure still and having caused very big puzzlement and misery to people of hemorrhoid.
Policresulen has hemostasis, convergence, epithelium regeneration and germ-resistant effect, makes slough condense and separates the wound surface rapid cleaning.Simultaneously, produce the contrafluxion of kickback property and also therefore impel tissue regeneration.
Cinchocaine hydrochloride is onset local anesthesia effect rapidly, can suppress the pain of wound surface, and the anesthetic action persistent period is more of a specified duration.
Summary of the invention
The object of the present invention is to provide pharmaceutical composition of a kind of effective treatment hemorrhoid and preparation method thereof, for hemorrhoid patients provides a kind of new medicine.
The present invention is achieved in that
A kind of pharmaceutical composition of treating hemorrhoid is the active constituents of medicine that form with policresulen, cinchocaine hydrochloride, mixes the Pharmaceutical composition that forms as carrier with acceptable accessories.
Scheme further is: described pharmaceutical composition Chinese medicine absorption of active ingredient is: policresulen accounts for 3 to 10% of composition total weight, and cinchocaine hydrochloride accounts for 0.1 to 0.8% of composition total weight, and all the other are adjuvant.
The scheme of more optimizing is: described pharmaceutical composition Chinese medicine absorption of active ingredient is: policresulen accounts for 4 to 6% of composition total weight, and cinchocaine hydrochloride accounts for 0.1 to 0.5% of composition total weight, and all the other are adjuvant.
Scheme further is: described adjuvant is one or more mixture in 36 type mixed fatty glycerides, anhydrous lanolin, calcium sulphate dihydrate, 20% weight fraction sodium hydroxide solution, vaseline, Cera Flava, stearic acid, high fatty alcohol, the glyceryl monostearate.
Scheme further is: described pharmaceutical composition is suppository or ointment.
The present invention also provides the preparation of drug combination method of treating hemorrhoid as previously mentioned, comprises following step:
Step 1, by the said medicine absorption of active ingredient, take by weighing 36% policresulen solution, using 20% sodium hydroxide solution adjust pH is 2.5 to 3.6; Concentrating under reduced pressure under 45 to 55 ℃ of conditions then, the concentration that makes policresulen is 55 to 62%, adds calcium sulfate; Stir, it is gone in the drip pan, drying under reduced pressure under in 45 to 55 ℃ of conditions; Pulverize then, cross 80 mesh sieves, get the policresulen fine powder; Said solution concentration is mass concentration;
Step 2, cinchocaine hydrochloride is pulverized the back cross 80 to 100 mesh sieves;
Step 3, with policresulen fine powder and the cinchocaine hydrochloride that sieves with the equivalent method mix homogeneously that progressively increases;
Step 4, in order to make the pharmaceutical composition of suppository formulation, should: take by weighing mixed fatty glycerides and lanoline, mix post-heating to 55 ℃; Make its fusion complete; Temperature is reduced to 38 to 45 ℃ then, and the policresulen and the cinchocaine hydrochloride of insulation and adding mix homogeneously stir;
Step 5, mixture slowly are cooled to 35 to 38 ℃ and pour in the mould, and mould is coated with one deck lubricant earlier, and lubricant is glycerol and 75 to 95% alcohol mixeding liquids; Ratio is 1g: 5/mL, slowly is cooled to 18 to 22 ℃, prunes with cutter and overflows part; Opening mold; Suppository is released, packed, promptly make the pharmaceutical composition of the treatment hemorrhoid of suppository formulation.
In order to make the pharmaceutical composition of ointment dosage form; Can also take by weighing vaseline, Cera Flava, lanoline and be heated to 75 to 85 ℃, make it complete fusion, when temperature is reduced to 50 to 55 ℃; A small amount of repeatedly the policresulen and the cinchocaine hydrochloride of mix homogeneously joined in the fused solution, stir.When being cooled to 40 to 45 ℃, stop to stir, naturally cool to room temperature, be distributed into ointment, promptly make the pharmaceutical composition of the treatment hemorrhoid of ointment dosage form.
Chinese medicine compositions of the present invention is a main component with cinchocaine hydrochloride and policresulen.M-cresol sulfonic acid in the policresulen molecule is borrowed methylene bridges, can have 20 M-cresol sulfonic acids to link together at most.Therefore, it is a peracid body, and molecular surface has very strong negative charge.Necrosis or pathological tissues are had optionally effect, pathological tissues is condensed and be easy to get rid of, but normal squamous epithelial cancer is then unaffected.Policresulen has broad-spectrum antibacterial action, can suppress to comprise common gram positive bacteria, gram negative bacteria, mycete and virus, has the tissue selectivity effect simultaneously.Normal cell has complete cell membrane, and its surface is electronegative, and policresulen repels each other with it, so it is not had influence.After cell sustained damage, surface polarity changed, and policresulen can combine with it, makes it degeneration.It is alkaline-resisting not acidproof to be positioned at cervical canal and ectopic columnar epithelial cell, and policresulen can act on it and make its degeneration.
Therefore, even normal squamous epithelial cancer can not be affected in the policresulen of high concentration yet.Impaired squamous epithelial cancer and the degeneration under the effect of policresulen of ectopic columnar epithelial cell, come off, be excreted, help tissue repair.
Cinchocaine hydrochloride is the amide-type local anesthetic, because its hydrochlorate stabilized aqueous solution, but disinfection with high pressure steam and storage for a long time, so mostly its listing medicine is the hydrochlorate preparation.The evidence cinchocaine hydrochloride is identical with the main pharmacodynamics of cinchocaine.Cinchocaine is a long-acting local anesthetic, with the temporary transient combination rate of nervous tissue greater than tetracaine.Effect beginning is slow, does not wait in action effective 2-6 hour 15-20 minute incubation period, difference is very big between individuality, have to be shorter than 2-3 hour, has to reach 5-6 hour.Cinchocaine has good penetration property, to the local organization nonirritant.
This pharmaceutical composition is the compound preparation of policresulen and cinchocaine hydrochloride, and its main active substance is a policresulen, has hemostasis, convergence, epithelium regeneration and germ-resistant effect, makes slough condense and separates the wound surface rapid cleaning.Simultaneously, produce the contrafluxion of kickback property and also therefore impel tissue regeneration.For suppressing initial stage pain, adopted cinchocaine hydrochloride to carry out local anesthesia.Therefore has curative effect preferably.
Through pharmaceutical composition with method preparation of the present invention, 98 hemorrhoid sufferers are treated, use said preparation to have 50 patients to cure after 3 weeks, and 38 examples have been observed the obvious treatment effect; The therapeutic effect that subjective 79.6% sufferer is estimated preparation is very good or good.Aspect side effect, mainly showing as the defecation urgency sense increases; Slight twinge and slight constriction and pain, and the appearance of side effect is ofer short duration and slight, so patient can continue to use said preparation; And, can obtain good effect to great majority.
The specific embodiment
Embodiment one
Medicine embodiment consumption of the present invention is (weight ratio) as follows:
36% policresulen solution 11.17%, cinchocaine hydrochloride 0.10%, 20% sodium hydroxide solution 4.44%, mixed fatty glycerides 60.80%, lanoline 14.15%, calcium sulfate (two hydrations) 9.34%.
A kind of drug group of treating hemorrhoid does not have the method for preparing of hydrate, comprises following step:
Step 1, by above-mentioned prescription, take by weighing 36% policresulen solution, using 20% sodium hydroxide solution adjust pH is 2.7 to 3.3; Concentrating under reduced pressure under 50 ℃ of conditions then, the concentration that makes policresulen is 60%, adds calcium sulfate; Stir, it is gone in the drip pan, drying under reduced pressure under 50 ℃ of conditions; Pulverize then, cross 80 mesh sieves, get the policresulen fine powder;
Step 2, cinchocaine hydrochloride is pulverized the back cross 100 mesh sieves;
Step 3, with policresulen fine powder and the cinchocaine hydrochloride that sieves with the equivalent method mix homogeneously that progressively increases;
Step 4, take by weighing mixed fatty glycerides and anhydrous lanolin, mix post-heating to 55 ℃, melted fully in about 1 hour, temperature is reduced to 40 ℃ then, and insulation also adds the policresulen and the cinchocaine hydrochloride of mix homogeneously, stirs.
Step 5, the mixture that makes slowly are cooled to 36 ℃ and pour in the mould, and mould is coated with one deck lubricant earlier, and lubricant is glycerol and 95% alcohol mixeding liquid; Ratio is 1g: 5/mL; Slow cool to room temperature is pruned with cutter and to be overflowed part, opening mold; Suppository is released, promptly made the pharmaceutical composition of the treatment hemorrhoid of suppository formulation.
Embodiment two
Medicine embodiment consumption of the present invention is (weight ratio) as follows:
36% policresulen solution 14%, cinchocaine hydrochloride 0.13%, 20% sodium hydroxide solution 4.39%, mixed fatty glycerides 61.39%, anhydrous lanolin 13.15%, calcium sulfate (two hydrations) 8.77%.
A kind of preparation of drug combination method of treating hemorrhoid comprises following step:
Step 1, by above-mentioned prescription, take by weighing 36% policresulen solution, using 20% sodium hydroxide solution adjust pH is 2.7 to 3.3; Concentrating under reduced pressure under 45 ℃ of conditions then, the concentration that makes policresulen are 60% to add calcium sulfate, stir; It is gone in the drip pan, and drying under reduced pressure under 45 ℃ of conditions is pulverized then; Cross 90 mesh sieves, get the policresulen fine powder;
Step 2, cinchocaine hydrochloride is pulverized the back cross 100 mesh sieves;
Step 3, with policresulen fine powder and the cinchocaine hydrochloride that sieves with the equivalent method mix homogeneously that progressively increases;
Step 4, take by weighing mixed fatty glycerides and anhydrous lanolin, mix post-heating to 50 ℃, melted fully in about 1 hour, temperature is reduced to 40 ℃ then, and insulation also adds the policresulen and the cinchocaine hydrochloride of mix homogeneously, stirs.
Step 5, the mixture that makes slowly are cooled to 36 ℃ and pour in the mould, and mould is coated with one deck lubricant earlier, and lubricant is glycerol and 95% alcohol mixeding liquid; Ratio is 1g: 5/mL; Slow cool to room temperature is pruned with cutter and to be overflowed part, opening mold; Suppository is released, promptly made the pharmaceutical composition of the treatment hemorrhoid of suppository formulation.
Embodiment three
Medicine embodiment consumption of the present invention is (weight fraction ratio) as follows:
36% policresulen solution 13.8%, cinchocaine hydrochloride 0.5%, 20% sodium hydroxide solution 4.12%, vaseline 59.94%, Cera Flava 2.30%, anhydrous lanolin 11.56%, calcium sulfate (two hydrations) 9.12%.
A kind of preparation of drug combination method of treating hemorrhoid comprises following step:
Step 1, by above-mentioned prescription, take by weighing 36% policresulen solution, using 20% sodium hydroxide solution adjust pH is 2.7 to 3.3; Concentrating under reduced pressure under 50 ℃ of conditions then, the concentration that makes policresulen is 60%, adds calcium sulfate; Stir, it is gone in the drip pan, drying under reduced pressure under 50 ℃ of conditions; Pulverize then, cross 80 mesh sieves, get the policresulen fine powder;
Step 2, cinchocaine hydrochloride is pulverized the back cross 100 mesh sieves;
Step 3, with policresulen fine powder and the cinchocaine hydrochloride that sieves with the equivalent method mix homogeneously that progressively increases;
Step 4, take by weighing vaseline, Cera Flava, lanoline and be heated to 80 ℃, make it complete fusion, repeatedly above mixture is joined in the fused solution on a small quantity, stir.When being cooled to 40 ℃, stop to stir, naturally cool to room temperature, be distributed into ointment, promptly make the pharmaceutical composition of the treatment hemorrhoid of ointment dosage form.
Claims (2)
1. preparation of drug combination method of treating hemorrhoid; The optimum organization consumption that it is characterized in that described pharmaceutical composition Chinese medicine active component is: policresulen accounts for 4 to 6% of composition total weight, and cinchocaine hydrochloride accounts for 0.1 to 0.5% of composition total weight; Adjuvant is one or more the mixture in 36 type mixed fatty glycerides, anhydrous lanolin, calcium sulfate dihydrate, 20% weight fraction sodium hydroxide solution, vaseline, Cera Flava, stearic acid, high fatty alcohol, the glyceryl monostearate in the pharmaceutical composition; This method comprises following step:
Step 1 is got 36% policresulen solution, and using 20% sodium hydroxide solution adjust pH is 2.5 to 3.6, then concentrating under reduced pressure under 45 to 55 ℃ of conditions; The concentration that makes policresulen is 55 to 62%, adds the calcium sulfate dihydrate that accounts for composition total weight 8 to 12%, stirs; It is gone in the drip pan, and drying under reduced pressure under in 45 to 55 ℃ of conditions is pulverized then; Cross 80 mesh sieves, get the policresulen fine powder;
Step 2 was pulverized 80 to 100 mesh sieves with cinchocaine hydrochloride;
Step 3 with policresulen fine powder and the cinchocaine hydrochloride that sieves with the equivalent method mix homogeneously that progressively increases;
Step 4 takes by weighing the mixed fatty glycerides that accounts for composition total weight 65 to 72% and 12 to 18% lanoline; Mix post-heating to 55 ℃; Make its fusion complete; Temperature is reduced to 38 to 45 ℃ then, and the policresulen and the cinchocaine hydrochloride of insulation and adding mix homogeneously stir and make its mix homogeneously;
Step 5 mould is coated with one deck lubricant earlier, and lubricant is glycerol and 75 to 95% alcohol mixeding liquids, and ratio is 1g: 5mL; The mixture that makes slowly cools to 35 to 38 ℃ and pours in the mould, slowly is cooled to 18 to 22 ℃, prunes with cutter and overflows part; Opening mold; Suppository is released, packed, promptly make the pharmaceutical composition of the treatment hemorrhoid of suppository formulation.
2. preparation of drug combination method of treating hemorrhoid; The optimum organization consumption that it is characterized in that described pharmaceutical composition Chinese medicine active component is: policresulen accounts for 4 to 6% of composition total weight, and cinchocaine hydrochloride accounts for 0.1 to 0.5% of composition total weight; Adjuvant is one or more the mixture in 36 type mixed fatty glycerides, anhydrous lanolin, calcium sulfate dihydrate, 20% weight fraction sodium hydroxide solution, vaseline, Cera Flava, stearic acid, high fatty alcohol, the glyceryl monostearate in the pharmaceutical composition; This method comprises following step:
Step 1 is got 36% policresulen solution, and using 20% sodium hydroxide solution adjust pH is 2.5 to 3.6, then concentrating under reduced pressure under 45 to 55 ℃ of conditions; The concentration that makes policresulen is 55 to 62%, adds calcium sulfate, stirs; It is gone in the drip pan, and drying under reduced pressure under in 45 to 55 ℃ of conditions is pulverized then; Cross 80 mesh sieves, get the policresulen fine powder;
Step 2 is pulverized the back with cinchocaine hydrochloride and is crossed 80 to 100 mesh sieves;
Step 3 with policresulen fine powder and the cinchocaine hydrochloride that sieves with the equivalent method mix homogeneously that progressively increases;
Step 4 takes by weighing vaseline, Cera Flava, lanoline and is heated to 75 to 85 ℃, makes it complete fusion, when temperature is reduced to 45 to 50 ℃, repeatedly above medicinal mixture is joined in the fused solution on a small quantity, stirs;
When step 5 is cooled to 40 to 45 ℃, stop to stir, naturally cool to room temperature, be distributed into ointment, promptly make the pharmaceutical composition of the treatment hemorrhoid of ointment dosage form.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101454624A CN101837007B (en) | 2010-04-13 | 2010-04-13 | A pharmaceutical composition for treating hemorrhoid, and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101454624A CN101837007B (en) | 2010-04-13 | 2010-04-13 | A pharmaceutical composition for treating hemorrhoid, and its preparation method |
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| Publication Number | Publication Date |
|---|---|
| CN101837007A CN101837007A (en) | 2010-09-22 |
| CN101837007B true CN101837007B (en) | 2012-05-30 |
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Address after: 641000 No. 456, Anji street, Neijiang economic and Technological Development Zone, Sichuan Patentee after: Sichuan zitonggong pharmaceutical Limited by Share Ltd Address before: 641006 Neijiang City, Sichuan Province in central music town Vitex dam Patentee before: Sichuan Zitonggong Pharmaceutical Co., Ltd. |