CN102579569A - Pharmaceutical composition for treating piles as well as preparation method and application thereof - Google Patents
Pharmaceutical composition for treating piles as well as preparation method and application thereof Download PDFInfo
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- CN102579569A CN102579569A CN2012100454471A CN201210045447A CN102579569A CN 102579569 A CN102579569 A CN 102579569A CN 2012100454471 A CN2012100454471 A CN 2012100454471A CN 201210045447 A CN201210045447 A CN 201210045447A CN 102579569 A CN102579569 A CN 102579569A
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Abstract
The invention provides a pharmaceutical composition for treating piles, which is a suppository. The invention also provides a preparation method and application of the pharmaceutical composition. The pharmaceutical composition is prepared from the following components in parts by weight: 80-120 parts of berberine hydrochloride, 7-20 parts of procaine hydrochloride, 1.5-4.2 parts of hydrocortisone, 7-18 parts of borneol, 3.5-6.5 parts of menthol and 1000 parts of fat-soluble matrix. The pharmaceutical composition can directly reach piles infected part through rectal administration, thus the side effect of enterohepatic circulation due to oral administration is reduced. The pharmaceutical composition for treating piles provided by the invention can be used for solving the defect that oral administration is slow in acting for diseases in intestine, can substitute for the traditional operative treatment, is convenient to use and does not damage organisms.
Description
Technical field
The invention belongs to field of medicaments, relate to a kind of pharmaceutical composition of treating hemorrhoid.
Background technology
Hemorrhoid are the venous plexus generation varicose of anal orifice and rectal intestine bottom and anal mucosa and a kind of chronic disease of the one or more softish vein group that forms.Usually when defecation, continue to exert oneself, cause here that intravenous pressure raises repeatedly, vein will enlargement.The women because the pelvic cavity compression of vein is compeled, hinders blood circulation regular meeting that hemorrhoid take place in trimester of pregnancy, and the people of many obesities also can suffer from hemorrhoid.If suffer from hemorrhoid, the wall of vein of anal enlargement distortion will become very thin, so very easily breaks during defecation.Internal hemorrhoid is long hemorrhoid at the anus catheter section start, if expansible vein is positioned at more below, almost is on the anal canal mouth, and the vein of this varicose just is external hemorrhoid.External hemorrhoid is deviate from sometimes or is appeared suddenly outside the anal canal mouth.But this situation only just can take place when defecation, its original position of can withdrawing again behind the defecation.No matter thrombosis all possibly take place in internal hemorrhoid or external hemorrhoid.When thrombosis takes place, the blood clotting in bulk in the hemorrhoid, thus cause pain.
The method of treatment hemorrhoid is a lot; Traditional remedies is how with operation, medicine injection, ligation, laser, radio frequency, freezing etc.; But the oral medicine onset is slow, and means such as operation have increased patient's distress level, this shows that prior art needs further improvement and develops.
Summary of the invention
For overcoming above-mentioned defective; The object of the present invention is to provide a kind of pharmaceutical composition of treating hemorrhoid, its composition by following weight portion is processed: 80～120 parts of berberine hydrochloride, 7～20 parts of procaine hydrochlorides, 1.5～4.2 parts of hydrocortisone, 7～18 parts of Borneolum Syntheticums, 3.5～6.5 parts of Mentholums, fat-soluble substrate complement to 1000 parts.
Preferably, said pharmaceutical composition is processed by the composition of following weight portion: 90～110 parts of berberine hydrochloride, 9～11 parts of procaine hydrochlorides, 1.8～2.2 parts of hydrocortisone, 9～11 parts of Borneolum Syntheticums, 4.5～5.5 parts of Mentholums, fat-soluble substrate complement to 1000 parts.
More preferably, said pharmaceutical composition is processed by the composition of following weight portion: 105 parts of berberine hydrochloride, 10 parts of procaine hydrochlorides, 2.0 parts of hydrocortisone, 10 parts of Borneolum Syntheticums, 5 parts of Mentholums, fat-soluble substrate complement to 1000 parts.
Said fat-soluble substrate is fat-soluble suppository substrate; Said fat-soluble suppository substrate is one or both in semi-synthetic fatty acid ester or the glycerin gelatine.
Said pharmaceutical composition provided by the invention is a suppository.
The present invention also provides a kind of method for preparing aforementioned pharmaceutical compositions, and this method comprises the steps:
1) the coarse powder raw medicinal material pulverize separately of berberine hydrochloride, procaine hydrochloride, Borneolum Syntheticum, Mentholum is become subsequent use behind the fine powder;
2) substrate is melted, temperature is controlled at 50～60 ℃, adds fine powder after the above-mentioned pulverizing, adds load weighted hydrocortisone in above-mentioned prescription ratio, and stirring and evenly mixing cools off.
Said step 2) carrying out refrigerative temperature behind the stirring and evenly mixing in is 10～15 ℃.
Said step 2) the fine powder fineness in is 40～400 orders.
The present invention also provides the application of said pharmaceutical composition in the medicine of preparation treatment hemorrhoid.
Weight portion of the present invention can be the known unit of weights of field of medicaments such as μ g, mg, g, kg.
Berberine hydrochloride is claimed berberine again, is present in many plants of 4 sections, 10 genus such as Berberidaceae.Be a kind of isoquinoline alkaloid, its molecular formula is C
20H
18NO
4, it has inhibitory action to dysentery bacterium, escherichia coli, Diplococcus pneumoniae, golden Portugal bacterium, streptococcus, Bacillus typhi and ameba.Clinical intestinal infection and the bacillary dysentery etc. of being mainly used in.Recently find also that these article have the antiarrhythmic effect.
Procaine hydrochloride is white crystals or crystalline powder; Odorless, mildly bitter flavor has the paralysis sense subsequently.These article are prone to dissolve in water, dissolve in the ethanol part omitted, and slightly soluble in chloroform, almost insoluble in ether, be mainly used in local anaesthesia.
Hydrocortisone has another name called hydrocortisone, and it is natural fugitive Aeroseb-Dex.Antiinflammatory action and immunosuppressant, antitoxin, Antishock function are arranged, be used to treat various adrenal hyperplasia disease and some inflammation disease due to shock that adrenocortical insufficiency, severe infections, autoimmune disease, anaphylactic disease, a variety of causes cause, disease in the blood system, the hormone dyssynthesis.
Borneolum Syntheticum has another name called sheet brain, Fructus Citri tangerinae sheet, Borneolum Syntheticum, MEIHUA BINGPIAN, Dipterocarpus pilosus, Flos Mume brain, Borneolum Syntheticum brain, Mei Bing etc., is that the resin and the volatile oil processed goods of Dipterocarpaceae plant Borneolum Syntheticum extracts the crystallization that obtains, and is near pure dextro Borneolum Syntheticum.Also useful chemical method is synthetic.It can be used for being used for the excess syndrome of stroke coma, is used for conjunctival congestion and swelling pain, the sore throat aphtha, is used for skin infection and swells and ache, and does not hold back after bursting etc.
Mentholum system by in the leaf of Herba Menthae and the stem extract white crystal, molecular formula C
10H
20O is the main component in Herba Menthae and the lavender quintessence oil.In the world, China and Brazil are main natural Herba Menthae manufacturing country, and the annual production of Oleum menthae all reaches 2000-3000t.Mentholum and racementhol all can be used as toothpaste; Perfume; The odorant of beverage and confection etc.As excitants, act on skin or mucosa pharmaceutically, refrigerant itching-relieving action is arranged; Take orally and can be used as carminative, be used for headache and nose; Pharynx; Laryngitis etc.
The inventor is through a large amount of discovering; When berberine hydrochloride, procaine hydrochloride, hydrocortisone, Borneolum Syntheticum, Mentholum are processed suppository and are applied to treatment of hemorrhoid according to certain proportioning combination; Effect with obvious hemostasis, reducing swelling and alleviating pain, loosening bowel to relieve constipation; Demonstrated unforeseeable effect, brought into play the synergism between them greatly, effective percentage has reached 100%.
The pharmaceutical composition of treatment hemorrhoid provided by the invention is a suppository, can treat internal hemorrhoid, external hemorrhoid, mixed hemorrhoid etc.The pharmaceutical composition of said treatment hemorrhoid is the bonded compound preparation of Chinese medicine and western medicine compatibility.Be to obtain through a large amount of experiments by the inventor; It reduces the side effect that the circulation of oral administration liver sausage absorbs through the rectally hemorrhoid affected part of can going directly, and has solved the slow defective of the general oral medicine onset of enteral illness; Alternative traditional operation therapy, and easy to use, do not decrease body.
And have antiinflammatory, detumescence, pain relieving, heat clearing away, antianaphylactic effect.Be used to treat all kinds of hemorrhoid, have advantages such as evident in efficacy, easy to use, that onset rapid, safety is painless.Effective percentage reaches 100%.
The said preparation of drug combination method of preparation provided by the invention has raw material and obtains simple operation and other advantages easily.
The specific embodiment
Following examples are used to explain the present invention, but are not used for limiting scope of the present invention.
Embodiment 1: the suppository of treatment hemorrhoid
1, prescription: berberine hydrochloride 105g, procaine hydrochloride 10g, hydrocortisone 2.0g, Borneolum Syntheticum 10g, Mentholum 5g, glycerin gelatine complement to 1000g.
2, method for preparing
The coarse powder raw medicinal material pulverize separately of the berberine hydrochloride of above-mentioned recipe quantity, procaine hydrochloride, Borneolum Syntheticum, Mentholum is become subsequent use behind the fine powder; Said fine powder is crossed 300 mesh sieves, and substrate is melted down at 55 ℃, adds fine powder after the above-mentioned pulverizing, adds load weighted hydrocortisone in the prescription ratio; Stirring and evenly mixing is annotated in suppository production equipment bucket; Cool off, chilling temperature is controlled to be 12 ℃, promptly gets.
Embodiment 2: the suppository of treatment hemorrhoid
1, prescription: berberine hydrochloride berberine hydrochloride 80g, procaine hydrochloride 6g, hydrocortisone 1.5g, Borneolum Syntheticum 7g, Mentholum 3.5g, semi-synthetic fatty acid ester complements to 1000g.
2, method for preparing
The coarse powder raw medicinal material pulverize separately of the berberine hydrochloride of above-mentioned recipe quantity, procaine hydrochloride, Borneolum Syntheticum, Mentholum is become subsequent use behind the fine powder; Said fine powder is crossed 40 mesh sieves, and substrate is melted down at 50 ℃, adds fine powder after the above-mentioned pulverizing, adds load weighted hydrocortisone in the prescription ratio; Stirring and evenly mixing is annotated in suppository production equipment bucket; Cool off, chilling temperature is controlled to be 10 ℃, promptly gets.
Embodiment 3: the suppository of treatment hemorrhoid
1, prescription: berberine hydrochloride berberine hydrochloride 120g, procaine hydrochloride 20g, hydrocortisone 4.2g, Borneolum Syntheticum 18g, Mentholum 6.5g, semi-synthetic fatty acid ester complements to 1000g.。
2, method for preparing
The coarse powder raw medicinal material pulverize separately of the berberine hydrochloride of above-mentioned recipe quantity, procaine hydrochloride, Borneolum Syntheticum, Mentholum is become subsequent use behind the fine powder; Said fine powder is crossed 400 mesh sieves, and substrate is melted down at 60 ℃, adds fine powder after the above-mentioned pulverizing, adds load weighted hydrocortisone in the prescription ratio; Stirring and evenly mixing is annotated in suppository production equipment bucket; Cool off, chilling temperature is controlled to be 15 ℃, promptly gets.
Embodiment 4: the suppository of treatment hemorrhoid
1, prescription: berberine hydrochloride berberine hydrochloride 90g, procaine hydrochloride 9g, hydrocortisone 108g, Borneolum Syntheticum 9g, Mentholum 4.5g, semi-synthetic fatty acid ester 300g, glycerin gelatine complements to 1000g.
2, method for preparing
The coarse powder raw medicinal material pulverize separately of the berberine hydrochloride of above-mentioned recipe quantity, procaine hydrochloride, Borneolum Syntheticum, Mentholum is become subsequent use behind the fine powder; Said fine powder is crossed 100 mesh sieves, and substrate is melted down at 60 ℃, adds fine powder after the above-mentioned pulverizing, adds load weighted hydrocortisone in the prescription ratio; Stirring and evenly mixing is annotated in suppository production equipment bucket; Cool off, chilling temperature is controlled to be 13 ℃, promptly gets.
Embodiment 5: the suppository of treatment hemorrhoid
1, prescription: berberine hydrochloride berberine hydrochloride 110, procaine hydrochloride 11g, hydrocortisone 2.2g, Borneolum Syntheticum 11g, Mentholum 5.5g, glycerin gelatine complements to 1000g.
2, method for preparing
The coarse powder raw medicinal material pulverize separately of the berberine hydrochloride of above-mentioned recipe quantity, procaine hydrochloride, Borneolum Syntheticum, Mentholum is become subsequent use behind the fine powder; Said fine powder is crossed 200 mesh sieves, and substrate is melted down at 60 ℃, adds fine powder after the above-mentioned pulverizing, adds load weighted hydrocortisone in the prescription ratio; Stirring and evenly mixing is annotated in suppository production equipment bucket; Cool off, chilling temperature is controlled to be 13 ℃, promptly gets.
Comparative example 1: the suppository of treatment hemorrhoid
1, prescription: berberine hydrochloride berberine hydrochloride 105g, procaine hydrochloride 10g, glycerin gelatine complement to 1000g.
2, method for preparing
The coarse powder raw medicinal material pulverize separately of the berberine hydrochloride of above-mentioned recipe quantity, procaine hydrochloride, Borneolum Syntheticum, Mentholum is become subsequent use behind the fine powder; Said fine powder is crossed 200 mesh sieves, and substrate is melted down at 60 ℃, adds fine powder after the above-mentioned pulverizing, adds load weighted hydrocortisone in the prescription ratio; Stirring and evenly mixing is annotated in suppository production equipment bucket; Cool off, chilling temperature is controlled to be 11 ℃, promptly gets.
Clinical experiment
1, clinical data:
Filter out 180 routine cases, be divided into two groups at random, treatment group and matched group.
Treatment group: the suppository that makes by prescription among the embodiment 1 and method for preparing.
Matched group: the suppository that makes by prescription in the comparative example 1 and method for preparing.
The treatment group is 105 examples, and matched group is 75 examples.
Include the case standard in:
A. realize clear, the patient that can clearly express operating position;
B. the age is at 18-65 between year;
C. the patient knows the inside story and agrees.
Get rid of the case standard:
A. the enteropathy patient who merges malignant tumor;
B. suffers from serious skin disease patient;
C. can't take care of oneself, the slurred speech patient.
The therapeutic evaluation standard:
(version in 2006) efficacy evaluation is as the criterion execution by " up-to-date hospital clinical medical diagnosis on disease foundation and healing improvement manual of standards ".
1. produce effects: patient's proctalgia disappears, edema extinction, and blood stasis disappears or retraction, hemostasis, promotes wound healing.
2. effective: patient's proctalgia alleviates, and edema alleviates, and blood stasis slightly diminishes, and bleeding alleviates.
3. invalid: treatment back above-mentioned symptom does not have improvement.
2, test method
1. treatment group: the suppository according to the method for embodiment 1 prepares, touch place every day into anal 1-2cm, 1 time on the one, 1 1-2 grain, logotype 7-14 days.
2. matched group: the suppository according to the method for examination comparative example 1 prepares, touch place every day into anal 1-2cm, 1 time on the one, 1 1-2 grain, logotype 7-14 days.
3, result of the test
Treatment group and matched group Comparison of therapeutic are seen table 1, table 2, table 3.
Table 1 treatment group experimental result
| The hemorrhoid symptom | Example number (n) | Obvious effective rate % | Example number (n) | Effective percentage % | Example number (n) | Inefficiency % | Example number (n) | Total effective rate % |
| All kinds of pain due to hemorrhoids | ?35 | 85.7％ | ?30 | 14.3％ | ?5 | 0 | ?0 | 100％ |
| All kinds of bleeding hemorrhoidss | ?25 | 76％ | ?19 | 24％ | ?6 | 0 | ?0 | 100％ |
| All kinds of hemorrhoid edema | ?20 | 85％ | ?17 | 15％ | ?3 | 0 | ?0 | 100％ |
| Blood stasis disappears | ?25 | 72％ | ?18 | 28％ | ?7 | 0 | ?0 | 100％ |
Table 2 matched group experimental result
| The hemorrhoid symptom | Example number (n) | Obvious effective rate % | Example number (n) | Effective percentage % | Example number (n) | Inefficiency % | Example number (n) | Total effective rate % |
| All kinds of pain due to hemorrhoids | ?20 | 50％ | ?10 | 50％ | ?10 | 0 | ?0 | 100％ |
| All kinds of bleeding hemorrhoidss | ?15 | 46.7％ | ?7 | 53.3％ | ?8 | 0 | ?0 | 100％ |
| All kinds of hemorrhoid edema | ?18 | 27.8％ | ?5 | 27.8％ | ?5 | 16.7％ | ?3 | 55.6％％ |
| Blood stasis disappears | ?22 | 22.7％ | ?5 | 4.5％ | ?1 | 72.7％ | ?16 | 27.3％ |
Table 3 liang group curative effect comparative result
| Group | Effectively (n) | Invalid (n) | Total effective rate (%) | Amount to (n) |
| The treatment group | 105 | 0 | 100％ | 105 |
| Matched group | 56 | 19 | 74.7％ | 75 |
Conclusion: shown in table 1, table 2, table 3; Treatment group and matched group have notable difference in treatment hemorrhoid edema with on reducing in the total effective rate on the blood stasis, and from clinical observation, the treatment group is at hemostasis, short wound healing; Antiallergic, detumescence, and all obviously be superior to matched group on patient's comfort.
Though, used general explanation, the specific embodiment and test in the preceding text, the present invention has been done detailed description, on basis of the present invention, can make some modifications or improvement to it, this will be apparent to those skilled in the art.Therefore, these modifications or the improvement on the basis of not departing from spirit of the present invention, made all belong to the scope that requirement of the present invention is protected.
Claims (9)
1. pharmaceutical composition of treating hemorrhoid; It is characterized in that its composition by following weight portion is processed: 80～120 parts of berberine hydrochloride, 7～20 parts of procaine hydrochlorides, 1.5～4.2 parts of hydrocortisone, 7～18 parts of Borneolum Syntheticums, 3.5～6.5 parts of Mentholums, fat-soluble substrate complement to 1000 parts.
2. the compositions of treatment hemorrhoid according to claim 1; It is characterized in that its composition by following weight portion is processed: 90～110 parts of berberine hydrochloride, 9～11 parts of procaine hydrochlorides, 1.8～2.2 parts of hydrocortisone, 9～11 parts of Borneolum Syntheticums, 4.5～5.5 parts of Mentholums, fat-soluble substrate complement to 1000 parts.
3. pharmaceutical composition according to claim 1; It is characterized in that its composition by following weight portion is processed: 105 parts of berberine hydrochloride, 10 parts of procaine hydrochlorides, 2.0 parts of hydrocortisone, 10 parts of Borneolum Syntheticums, 5 parts of Mentholums, fat-soluble substrate complement to 1000 parts.
4. pharmaceutical composition according to claim 3 is characterized in that, said fat-soluble substrate is fat-soluble suppository substrate; Said fat-soluble suppository substrate is one or both in semi-synthetic fatty acid ester or the glycerin gelatine.
5. according to each described pharmaceutical composition among the claim 1-4, it is characterized in that this pharmaceutical composition is a suppository.
6. method for preparing each said pharmaceutical composition among the claim 1-5, this method comprises the steps:
1) the coarse powder raw medicinal material pulverize separately of berberine hydrochloride, procaine hydrochloride, Borneolum Syntheticum, Mentholum is become subsequent use behind the fine powder;
2) substrate is melted, temperature is controlled at 50～60 ℃, adds fine powder after the above-mentioned pulverizing, adds load weighted hydrocortisone in above-mentioned prescription ratio, and stirring and evenly mixing cools off.
7. method according to claim 6 is characterized in that, the fineness of said fine powder is 40～400 orders.
8. method according to claim 6 is characterized in that, said step 2) in to carry out refrigerative temperature behind the stirring and evenly mixing be 10～15 ℃.
9. the application of each described compositions in the medicine of preparation treatment hemorrhoid among the claim 1-5.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 201210045447 CN102579569B (en) | 2012-02-24 | 2012-02-24 | Pharmaceutical composition for treating piles as well as preparation method and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 201210045447 CN102579569B (en) | 2012-02-24 | 2012-02-24 | Pharmaceutical composition for treating piles as well as preparation method and application thereof |
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| CN102579569B CN102579569B (en) | 2013-10-30 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106581020A (en) * | 2015-10-14 | 2017-04-26 | 深圳澳美制药技术开发有限公司 | Pharmaceutical composition and preparation method thereof, and hemorrhoid treating medicine |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1579499A (en) * | 2004-05-20 | 2005-02-16 | 瞿伟 | Medicine for treating piles |
| CN101138592A (en) * | 2006-09-08 | 2008-03-12 | 海南优方科技有限公司 | Preparation method for treating internal hemorrhoid and Chinese medicine suppository thereof |
| CN101628045A (en) * | 2009-04-30 | 2010-01-20 | 北京荣昌药物研究院有限公司 | Medicine for treating hemorrhoids and preparation method thereof |
-
2012
- 2012-02-24 CN CN 201210045447 patent/CN102579569B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1579499A (en) * | 2004-05-20 | 2005-02-16 | 瞿伟 | Medicine for treating piles |
| CN101138592A (en) * | 2006-09-08 | 2008-03-12 | 海南优方科技有限公司 | Preparation method for treating internal hemorrhoid and Chinese medicine suppository thereof |
| CN101628045A (en) * | 2009-04-30 | 2010-01-20 | 北京荣昌药物研究院有限公司 | Medicine for treating hemorrhoids and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106581020A (en) * | 2015-10-14 | 2017-04-26 | 深圳澳美制药技术开发有限公司 | Pharmaceutical composition and preparation method thereof, and hemorrhoid treating medicine |
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