CN106581020A - Pharmaceutical composition and preparation method thereof, and hemorrhoid treating medicine - Google Patents
Pharmaceutical composition and preparation method thereof, and hemorrhoid treating medicine Download PDFInfo
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- CN106581020A CN106581020A CN201510663189.7A CN201510663189A CN106581020A CN 106581020 A CN106581020 A CN 106581020A CN 201510663189 A CN201510663189 A CN 201510663189A CN 106581020 A CN106581020 A CN 106581020A
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Abstract
The present invention discloses a pharmaceutical composition and a preparation method thereof, and a hemorrhoid treating medicine. 1800 parts of the pharmaceutical composition comprises, by weight, 2.5-7.5 parts of hydrocortisone, 2.5-7.5 parts of dibucaine hydrochloride, 10-20 parts of borneol, 8-15 parts of escin, 5-10 parts of metronidazole, and the balance of a fat-soluble matrix. The hemorrhoid treating medicine comprises an effective therapeutic dose of the pharmaceutical composition. According to the present invention, through the synergistic effect of various components contained in the pharmaceutical composition and the hemorrhoid treating medicine, the pharmaceutical composition and the hemorrhoid treating medicine provide significant effects of bleeding stopping, swelling subsiding and pain stopping for hemorrhoid treatment, and have advantages of significant treatment effect, safety, no pain, rapid onset, convenient use, and the like.
Description
Technical field
The invention belongs to field of medicaments, is specifically related to a kind of pharmaceutical composition and preparation method thereof and has
The medicine of the treatment hemorrhoid of effect dosage pharmaceutical composition.
Background technology
Hemorrhoid be the venous plexuses of anal orifice and rectal intestine bottom and anal mucosa there is varicose and cause one or more are soft
A kind of chronic disease of soft venous group.Hemorrhoid are the most common anal and intestinal diseases of the mankind, and China's sickness rate is about
50～70%.The pathogenic factor of hemorrhoid is a lot of, sitting, stands long, and fatigue etc. makes human body long-time in a kind of solid
Determine position, so as to affect blood circulation, make in pelvic cavity that internal organs are congested in slow blood flow and abdomen, cause haemorrhoidal vein
Over filling, varicose, protuberance, wall of vein tension force decline and cause morbidity.Woman gestationperiod, due to pelvic cavity
Compression of vein is compeled, and hinders blood circulation that hemorrhoid can often occur, and many fat people can also suffer from hemorrhoid.If
With hemorrhoid, the wall of vein of the great distortion of anal can become very thin, therefore easily rupture during defecation.Internal hemorrhoid
It is the long hemorrhoid in anus catheter section start, it is if the vein of expansion is located at further below, almost in anal canal mouth, this
Varicosis are just external hemorrhoid.External hemorrhoid is deviate from sometimes or is burst outside anal canal mouth.
Therefore, hemorrhoid are not a kind of vascular lesion, and it is that pathologic hypertrophy, displacement occur because of anus pad in fact
Deng the local agglomerate of abnormal formation.That is, take any treatment meanss all effect a radical cure hemorrhoid,
Simply alleviate the symptom of hemorrhoid.The method for the treatment of hemorrhoid is a lot, mainly has operative treatment and No operation to treat at present
Method.
Traditional remedies mostly are operation, drug injection, ligation, laser, freezing, radio frequency etc..But operation means
Increased the distress level of patient, it can be seen that prior art needs further to improve and develop.
Symptomatic hemorrhoid more than 80% can Jing non-operative treatment eliminate symptom, non-operative treatment includes endo-medicine
And external used medicine, critically important status is accounted in treatment.Medicine for external use divides suppository, ointment, patch etc. again,
Particularly suppository.Suppository is anum administration, has certain advantage with oral medicine ratio, be also prevented from gastric acid and
Destruction of the digestive enzyme to medicine, exempts direct stimulation of the medicine to gastric mucosa, alleviates the burden of liver.
Simultaneously because directly acting on hemorrhoid position, absorptance oral medicine is faster, and effect can also obtain bigger performance.
Therefore suppository is applied more universal in hemorrhoid treating medicine.
The mostly Chinese medicine preparation such as Ma Yinglong Moschus ZHICHUAN SHUAN of domestic listing, Jiuhua Zhichuang Shuan, YUNNAN BAIYAO hemorrhoid
The external used medicines such as skin ulcer bolt, PuJi BenShi Fang, but its action is slow, and patient uses bad adaptability.China is special in addition
Sharp application number 2011104514725 is disclosed containing diosmin and pectolinarigenin, the treatment hemorrhoid of Borneolum Syntheticum
External used medicine, and the disclosure of China Patent No. 2006100006751 is containing two kinds of medicines of diosmin and Hesperidin
The ZHICHUAN SHUAN of thing component, the external application drug for haemorrhoid thing effect that this two patents are disclosed are also single.
The content of the invention
It is an object of the invention to overcome above-mentioned prior art defect, there is provided a kind of pharmaceutical composition and its preparation
Method and a kind of medicine for treaching hemorrhoie, it is intended to which the action for solving existing treatment external application drug for haemorrhoid thing presence is slow, suffers from
Person uses bad adaptability, the single technical problem of drug effect effect.
For achieving the above object, the technical scheme of the embodiment of the present invention is as follows：
A kind of pharmaceutical composition, is made up of the component of following weight portion：
And, a kind of preparation method of pharmaceutical composition comprises the steps：
Each raw material is weighed according to the component and content contained by pharmaceutical composition of the present invention；
By the hydrocortisone for weighing, cinchocaine hydrochloride, Borneolum Syntheticum, aescine, metronidazole raw material
Carry out pulverization process；
The described fat-soluble substrate for weighing is carried out into heat and melts process, the liposoluble of process described in Jing, will heated
Property substrate and the pulverization process described in after the hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum, seven leaf soaps
Glycosides, metronidazole raw material carry out emulsifying, then carry out cooling shaping process.
And, a kind of medicine for treaching hemorrhoie, including effective effective dose the invention described above pharmaceutical composition or
The pharmaceutical composition prepared by the invention described above pharmaceutical composition preparation method.
Pharmaceutical composition of the present invention is using hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum, aescine and wide
Spectrum anti-anaerobic agent metronidazole constitutes compound preparation together, is obtained by substantial amounts of experiment by inventor,
It is antipruritic using hydrocortisone glucocorticoid infection control antibacterial, pain relieving, arresting bleeding and healing up ulcer.It is misery using salt
The obvious pain relieving of cocaine surface local anesthetic, alleviation postoperation or hemorrhoid, the intolerable pain of anal fissure
The effect of pain；Local infection is prevented using metronidazole antibacterial；Using aescine blood vessel protective agent to affected part
Blood vessel effective protection, increases its tension force, prevents the injury such as rupture.Thing Jing clinical testing datas prove, this
Potentiation of the bright pharmaceutical composition by the above-mentioned each component contained by which, has substantially hemostasis to hemorrhoid treating,
The effect of reducing swelling and alleviating pain, which is evident in efficacy, safety it is painless, work it is rapid, easy to use the advantages of.
The preparation method of the invention described above pharmaceutical composition by hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum,
Aescine, metronidazole raw material granularity are controlled, and the fat-soluble substrate after directly being melted with heat is carried out at emulsifying
Reason aftershaping, which has been effectively ensured pharmaceutically active and stability, so as to medicine of the present invention has been effectively ensured
The drug effect of the treatment hemorrhoid of compositionss.In addition, its preparation technology is low for equipment requirements, without complicated technology,
The stability of drug effect is ensure that in technique, there is provided production efficiency, reduce production cost.
The invention described above medicine for treaching hemorrhoie due to containing the invention described above pharmaceutical composition, therefore, the present invention
Medicine for treaching hemorrhoie has substantially hemostasis, the effect of reducing swelling and alleviating pain, and which is evident in efficacy, and safety is painless, action
Rapidly, the advantages of easy to use.
Specific embodiment
To make the objects, technical solutions and advantages of the present invention become more apparent, with reference to embodiments, it is right
The present invention is described in further detail.Specific embodiment described herein only to explain the present invention, and
The present invention is not limited.
The weight portion of embodiment of the present invention each component noted in the disclosure not only may refer to each component
Concrete content, it is also possible to represent the proportionate relationship according to weight portion of each component, therefore, as long as according to this
In inventive embodiments description, the content of pharmaceutical composition each component is scaled up or is reduced of the invention real
Apply within a description scope of disclosure.Specifically, the weight portion described in embodiment of the present invention description can
Being unit of weight known to the field of medicaments such as μ g, mg, g, kg, it is of course possible to regard percentage by weight as.
On the one hand, embodiments provide one kind and there is substantially hemostasis to treating hemorrhoid, reducing swelling and alleviating pain
Effect, which is evident in efficacy, and safety is painless, work rapid pharmaceutical composition.In one embodiment, the medicine
Compositions, are made up of the component of following weight portion：
Wherein, used as one of active drug active component, which is again for the hydrocortisone in aforementioned pharmaceutical compositions
Name hydrocortisone, which is natural short-acting adrenal hormone class medicine, with antiinflammatory, antiallergic and suppression immunity etc.
Multiple pharmacological effect.For treating hypoadrenocorticism, the various adrenal gland caused by severe infections increase
Raw disease and some inflammation diseases.Therefore, in the present embodiment pharmaceutical composition, with regard to hydrocortisone one-component
For, its energy effective control bacterial infection, pain relieving, arresting bleeding and healing up ulcer are antipruritic.
In one embodiment, hydrocortisone can be 3.5-6 parts in the content of pharmaceutical composition, concrete
In embodiment, hydrocortisone can be 5 parts in the content of pharmaceutical composition.
Cinchocaine hydrochloride in aforementioned pharmaceutical compositions is white crystals or crystalline powder；Odorless, taste are micro-
Hardship, subsequently paralysis sense again.It is soluble in ethanol, acetone and chloroform and is slightly soluble in benzene, ethyl acetate and hot toluene,
Insoluble in ether and oil.It is mainly used in local anaesthesia.Therefore, it is in the present embodiment pharmaceutical composition, misery with regard to salt
For cocaine one-component, its have the obvious pain relieving of surface local anesthetic, alleviate postoperation or hemorrhoid,
The effect of the intolerable pain of anal fissure.
In one embodiment, cinchocaine hydrochloride can be 5.5-6 parts in the content of pharmaceutical composition, in tool
In body embodiment, cinchocaine hydrochloride can be 5 parts in the content of pharmaceutical composition.
Borneolum Syntheticum in aforementioned pharmaceutical compositions, also known as piece brain, Borneolum Syntheticum, Mei Bing Deng Shi Borneolum Syntheticum section plant Borneolum Syntheticum
The crystallization for obtaining is extracted in fragrant resin and volatile oil processing, enters almost pure dextro Borneolum Syntheticum.Can be used to close disease
Coma, for conjunctival congestion and swelling pain, sore throat life skin ulcer, for sore swell and ache curative is not held back after bursting.
In one embodiment, Borneolum Syntheticum can be 3-17 parts in the content of pharmaceutical composition, in a particular embodiment,
Borneolum Syntheticum can be 15 parts in the content of pharmaceutical composition.
Aescine in aforementioned pharmaceutical compositions can promote body to improve ACTH and cortisone plasma concentration,
Blood vessel wall can be promoted to increase PGF2Secretion, machine interior free yl can be understood, so as to play antiinflammatory, impermeabilisation,
Intravenous tension is improved, accelerates venous blood flow, promoted lymphatic return, improve blood circulation and microcirculation, and have
Play the role of to protect blood vessel wall.Therefore, in the present embodiment pharmaceutical composition, with regard to aescine one-component
Speech, which increases its tension force to affected part blood vessel effective protection, prevents the injury such as rupture.
In one embodiment, aescine can be 10-13 parts in the content of pharmaceutical composition, concrete real
Apply in example, aescine can be 12 parts in the content of pharmaceutical composition.
Metronidazole in aforementioned pharmaceutical compositions is the wide spectrum anti-anaerobic agent of nitroimidazole synthesis.Can be used for
Anaerobe in intestinal, preventing and treating postoperation or hemorrhoid, anal fissure local infection are killed, Intestinal Anaerobic Bacteria is killed
Also improve stool, promote the pharmacological action of blood coagulation.Therefore, in the present embodiment pharmaceutical composition,
For metronidazole one-component, which prevents local infection.
In one embodiment, metronidazole can be 7-9 parts in the content of pharmaceutical composition, in specific embodiment
In, metronidazole can be 8 parts in the content of pharmaceutical composition.
Therefore, based on mentioned above, embodiment of the present invention pharmaceutical composition can also be following examples formula：
In one embodiment, embodiment of the present invention pharmaceutical composition is made up of the component of following weight portion：
Hydrocortisone 3.5-6 parts, cinchocaine hydrochloride 5.5-6 parts, Borneolum Syntheticum 13-17 parts, aescine 10-13
Part, metronidazole 7-9 parts, fat-soluble substrate complement to 1800 parts.
In another embodiment, embodiment of the present invention pharmaceutical composition is made up of the component of following weight portion：
5 parts of hydrocortisone, 5 parts of cinchocaine hydrochloride, 15 parts of Borneolum Syntheticum, 12 parts of aescine, first nitre
8 parts of azoles, fat-soluble substrate complements to 1800 parts.
It is optimized by the content to foregoing embodiments pharmaceutical composition each component, can further improves medicine
Compositionss are stopped blooding, and the effect of reducing swelling and alleviating pain is evident in efficacy further to improve which, and safety is painless, it is fast to work
Speed.
In embodiments described above pharmaceutical composition, the fat-soluble substrate in pharmaceutical composition equivalent to
Adjuvant, specifically can serve as excipient.Therefore, in one embodiment, the fat-soluble substrate selects suppository
Substrate.In a particular embodiment, the suppository base for the C8-C18 fatty glycerides composition of saturation half
At least one in synthetic glyceride.Effectively can be given in each embodiment above from such fat-soluble substrate
Suppository of the pharmaceutical composition in form stable, and ensure effective release time of active constituents of medicine.
Pharmaceutical composition mentioned above be based on based on inventor's many experiments obtain, by hydrocortisone,
Cinchocaine hydrochloride, Borneolum Syntheticum, aescine, metronidazole etc. form compound preparation according to a certain percentage, specifically
Such as the compound preparation of suppository, for treating during the treatment of hemorrhoid, internal hemorrhoid, external hemorrhoid mixed hemorrhoid etc. can be treated, be had
There is substantially hemostasis, the effect of reducing swelling and alleviating pain works well.Specifically, using glucocorticoid infection control
Antibacterial, pain relieving, arresting bleeding and healing up ulcer are antipruritic；Using the obvious pain relieving of surface local anesthetic, alleviate postoperation or
The effect of hemorrhoid, the intolerable pain of anal fissure；Local infection is prevented using antibacterial；Protected using blood vessel
Shield agent increases its tension force to affected part blood vessel effective protection, prevents the injury such as rupture.This external application drug for haemorrhoid thing
Compositionss Jing clinical testing data proves, can be used to treat all kinds of hemorrhoid, with evident in efficacy, safety is painless,
The advantages of working rapid, easy to use.
Correspondingly, on the basis of based on pharmaceutical composition mentioned above, the embodiment of the present invention is additionally provided
A kind of preparation method of the pharmaceutical composition described in text.In one embodiment, the preparation method includes following step
Suddenly：
Step S01：The component contained by pharmaceutical composition and content as described above weighs each raw material；
Step S02：By the hydrocortisone for weighing, cinchocaine hydrochloride, Borneolum Syntheticum, aescine,
Metronidazole raw material carries out pulverization process；
Step S03：The described fat-soluble substrate for weighing is carried out into heat and melts process, hot melt described in Jing is being processed
Described fat-soluble substrate and the pulverization process described in after the hydrocortisone, cinchocaine hydrochloride, ice
Piece, aescine, metronidazole raw material carry out emulsifying, then carry out cooling shaping process.
Specifically, the component and content in above-mentioned steps S01 contained by pharmaceutical composition is such as above in connection with medicine
Described in compositions, in order to save length, will not be described here.
To hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum, aescine, metronidazole in above-mentioned steps S02
It can individually carry out pulverization process to each raw material that raw material carries out pulverization process, it is also possible to close according to proportioning
After system is mixed, smashing process is carried out together.The purpose of the pulverization process, primarily to control is each
The size of raw material, so that improve can be dispersed in each component following step S03.Another effect is logical
Pulverization process is crossed, smashing process is carried out together to each component raw material such as, moreover it is possible to increased each component raw material and mixed
Close uniform.In one embodiment, after size-reduced process, raw material particle size is controlled to 100～300 mesh.
In above-mentioned steps S03, carry out fat-soluble substrate heat to melt process is in order that fat-soluble substrate is in heat
Melt in processing procedure, in order to the raw material of pulverization process in Jing above-mentioned steps S02 is added to fat-soluble base
Dispersion and emulsion process is carried out in matter.In order to ensure the drug substance stable of the raw material of pulverization process in above-mentioned steps S02
Property, in one embodiment, heat is carried out to fat-soluble substrate and melts the temperature control of process at 45～55 DEG C.
In another embodiment, the emulsifying in above-mentioned steps S03 be speed be 1500～3000 turns/
Carry out under conditions of point, certainly, for emulsifying effectiveness and pharmaceutically active stability, in one embodiment,
In emulsion process, the temperature control of mixture is kept at 45～55 DEG C.
After fully emulsified process, according to the requirement of dosage form, the emulsion can be carried out sizing cooling shaping,
In a particular embodiment, the mixed liquor Jing after emulsifying is noted in suppository production equipment, carries out cooling shaping bolt
Agent.In one embodiment, chilling temperature can control temperature near 12 DEG C or its.
Therefore, the preparation method of embodiments of the present invention pharmaceutical composition by hydrocortisone, salt is misery can
Caine, Borneolum Syntheticum, aescine, metronidazole raw material granularity are controlled, the fat-soluble base after directly melting with heat
Matter carries out emulsifying aftershaping, and which has been effectively ensured pharmaceutically active and stability, so as to be effectively ensured
The drug effect of the treatment hemorrhoid of the pharmaceutical composition.In addition, its preparation technology is low for equipment requirements, without complexity
Technique, ensure that the stability of drug effect in technique, there is provided production efficiency, reduces production cost.
Correspondingly, on the basis of pharmaceutical composition mentioned above and preparation method thereof, the embodiment of the present invention
Additionally provide a kind of medicine for treaching hemorrhoie.The medicine for treaching hemorrhoie includes the mentioned above of effective effective dose
Pharmaceutical composition prepared by the preparation method of pharmaceutical composition or pharmaceutical composition by mentioned earlier.
Specifically, effective effective dose of the pharmaceutical composition refers to therapeutically effective amount, refers to and be enough to individuality
Show the amount of the compound of the present invention of benefit or clinical meaning.It will be understood to those of skill in the art that administration
Actual amount or dosage and administration time-histories will depend on the property and seriousness of treated disease, treated
Experimenter age and general status and administering mode etc..
In one embodiment, above-mentioned medicine for treaching hemorrhoie can be according to administering mode or dosage form, selecting one
Fixed pharmaceutically acceptable adjuvant.The pharmaceutically acceptable adjuvant refers to well known by persons skilled in the art being adapted to
In any adjuvant of specific mode of administration.As in a particular embodiment, the pharmaceutically acceptable adjuvant can be with
Including can with one or more pharmaceutically acceptable carrier of embodiment of the present invention triterpenoid compound compatibility,
On solvent, excipient, buffer agent, stabilizer, adjuvant, prodrug and treatment can be benefited from hemorrhoid or strengthen
State the other therapeutic agents of pharmaceutical composition pharmaceutically active.Therefore, above-mentioned medicine for treaching hemorrhoie can be administered alone,
If can also be with other compositionss administering drug combinations of necessity.
Therefore, embodiments of the present invention medicine for treaching hemorrhoie is due to containing the invention described above pharmaceutical composition,
Therefore so which has substantially hemostasis, the effect of reducing swelling and alleviating pain, and which is evident in efficacy, safety is painless, action
Rapidly, the advantages of easy to use.
Pharmaceutical composition and preparation method thereof etc. is further described below in conjunction with specific embodiment.
Embodiment 1
The present embodiment provides the suppository for the treatment of hemorrhoid.
1. prescription：Hydrocortisone 7.5g, cinchocaine hydrochloride 2.5g, Borneolum Syntheticum 10g, aescine 8g,
Metronidazole 10g, the semi-synthetic glyceride of the C8-C18 fatty glycerides composition of saturation complement to 1800g.
2. the suppository preparation method for treating hemorrhoid is as follows：
Above-mentioned hydrocortisone, cinchocaine hydrochloride original, Borneolum Syntheticum, aescine, metronidazole are crushed respectively
Standby into after subdivision, the fine powder crosses 100 mesh sieves, and substrate is melted at 45 DEG C, adds in prescription ratio
Fine powder after above-mentioned crushing, Jing mulsers carry out emulsifying with 1500 revs/min, note and give birth in suppository after the completion of emulsifying
In product equipment, cooled down, chilling temperature is 12 DEG C, is obtained final product.
Embodiment 2
The present embodiment provides the suppository for the treatment of hemorrhoid.
1. prescription：Hydrocortisone 7.0g, cinchocaine hydrochloride 3.0g, Borneolum Syntheticum 20g, aescine 15g,
Metronidazole 10g, the semi-synthetic glyceride of the C8-C18 fatty glycerides composition of saturation complement to 1800g.
2. the suppository preparation method for treating hemorrhoid is as follows：
By above-mentioned hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum, aescine, metronidazole raw material difference powder
Be broken into subdivision after it is standby, the fine powder crosses 150 mesh sieves, substrate is melted at 48 DEG C, is added in prescription ratio
Enter the fine powder after above-mentioned crushing, Jing mulsers carry out emulsifying with 2000 revs/min, note in suppository after the completion of emulsifying
In production equipment, cooled down, chilling temperature is 10 DEG C, is obtained final product.
Embodiment 3
The present embodiment provides the suppository for the treatment of hemorrhoid.
1. prescription：Hydrocortisone 5g, cinchocaine hydrochloride 3.0g, Borneolum Syntheticum 150g, aescine 8g,
Metronidazole 5g, the semi-synthetic glyceride of the C8-C18 fatty glycerides composition of saturation complement to 1800g.
2. the suppository preparation method for treating hemorrhoid is as follows：
By above-mentioned hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum, aescine, metronidazole, crush respectively
Standby into after subdivision, the fine powder crosses 150 mesh sieves, and substrate is melted at 50 DEG C, adds in prescription ratio
Fine powder after above-mentioned crushing, Jing mulsers carry out emulsifying with 2000 revs/min, note and give birth in suppository after the completion of emulsifying
In product equipment, cooled down, chilling temperature is 12 DEG C, is obtained final product.
Embodiment 4
The present embodiment provides the suppository for the treatment of hemorrhoid.
1. prescription：Hydrocortisone 4g, cinchocaine hydrochloride 6g, Borneolum Syntheticum 20g, aescine 10g, first
Nitre azoles 10g, the semi-synthetic glyceride of the C8-C18 fatty glycerides composition of saturation complement to 1800g.
2. the suppository preparation method for treating hemorrhoid is as follows：
By above-mentioned hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum, aescine, metronidazole, crush respectively
Standby into after subdivision, the fine powder crosses 200 mesh sieves, and substrate is melted at 55 DEG C, adds in prescription ratio
Fine powder after above-mentioned crushing, Jing mulsers carry out emulsifying with 3000 revs/min, note and give birth in suppository after the completion of emulsifying
In product equipment, cooled down, chilling temperature is 15 DEG C, is obtained final product.
Embodiment 5
The present embodiment provides the suppository for the treatment of hemorrhoid.
1. prescription：Hydrocortisone 5g, cinchocaine hydrochloride 5g, Borneolum Syntheticum 15g, aescine 12g, first
Nitre azoles 8g, the semi-synthetic glyceride of the C8-C18 fatty glycerides composition of saturation complement to 1800g.
2. the suppository preparation method for treating hemorrhoid is as follows：
By above-mentioned hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum, aescine, metronidazole raw material difference powder
Be broken into subdivision after it is standby, the fine powder crosses 200 mesh sieves, substrate is melted at 50 DEG C, is added in prescription ratio
Enter the fine powder after above-mentioned crushing, Jing breast mulsers carry out emulsifying with 2500 revs/min, note in bolt after the completion of emulsifying
In agent production equipment, cooled down, chilling temperature is 10 DEG C, is obtained final product.
Comparative example 1
The suppository for the treatment of hemorrhoid：
1. prescription：Hydrocortisone 5g, cinchocaine hydrochloride 5g, the C8-C18 fatty glycerides of saturation
The semi-synthetic glyceride of composition complements to 1800g.
2. the suppository preparation method of hemorrhoid is treated
Above-mentioned hydrocortisone and cinchocaine hydrochloride raw material are respectively crushed into into standby, the fine powder after subdivision
200 mesh sieves being crossed, substrate being melted at 50 DEG C, the fine powder after above-mentioned crushing is added in prescription ratio, Jing is newborn
Change machine carries out emulsifying with 2500 revs/min, notes in suppository production equipment, cooled down after the completion of emulsifying, cold
But temperature is 10 DEG C, is obtained final product.
Clinical trial
1. clinical data：
180 cases of screening, are randomly divided into 2 groups, treatment group and matched group.
Treatment group：The suppository obtained by the prescription and preparation method in embodiment 5
Matched group：The suppository obtained by the prescription and preparation method in comparative example 1
Treatment group is 105, and matched group is 75.
Include case standard：
A. the age is between 18-65 one full year of life；
B. Clear consciousness, the patient that can accurately express service condition；
C. patient knows the inside story and agrees to.
Excluded cases standard：
A. suffer from serious skin disease；
B. the bowel disease of compressibility malignant tumor
C. can't take care of oneself, slurred speech patient
The standard of curative effect evaluation：
Efficacy evaluation is pressed《Newest hospital clinical medical diagnosis on disease foundation and healing improvement manual of standards》Be defined execution.
1) significantly：Patient's proctalgia disappears, edema extinction, and blood stasis disappear or bounce back, hemostasis, promotion wound
Heal in face；
2) effectively：Patient's proctalgia mitigates, and edema mitigates, and blood stasis slightly diminish, and bleeding mitigates；
3) it is invalid：After treatment, above-mentioned symptom is without improvement；
2. experimental technique：
1) treatment group：The suppository that method according to embodiment 5 is prepared, is touched daily into anal [1-2cm
Place, 1 times a day, one a time, is used in conjunction 7-14 days；
2) matched group：The suppository that method according to comparative example 1 is prepared, is touched daily into anal 1-2cm
Place, 1 times a day, one a time, is used in conjunction 7-14 days.
3. experimental result：
Treatment group is shown in Table 1, table 2, table 3 with matched group Comparison of therapeutic：
1 treatment group's experimental data of table
2 matched group experimental result of table
3 two groups of comparitive study results of table
| Group | Effectively (n) | Invalid (n) | Total effective rate (%) | Amount to (n) |
| Treatment group | 103 | 2 | 98.1% | 105 |
| Matched group | 56 | 19 | 74.7% | 75 |
3. experiment conclusion：As shown in table 1, table 2, table 3, treatment group is with matched group in treatment hemorrhoid edema
Have notable difference on blood stasis with reducing, from clinical observation, treatment group in hemostasis, promote wound healing, antiallergic,
Detumescence, and in patient's comfort, all it is substantially better than matched group.Therefore, medicine provided in an embodiment of the present invention
Potentiation of the compositions by the above-mentioned each component contained by which, has substantially hemostasis, disappears to hemorrhoid treating
The effect of swollen pain relieving, which is evident in efficacy, safety it is painless, work it is rapid, easy to use the advantages of.
Presently preferred embodiments of the present invention is the foregoing is only, it is not to limit the present invention, all the present invention's
Any modification, equivalent and improvement made within spirit and principle etc., should be included in the guarantor of the present invention
Within the scope of shield.
Claims (10)
1. a kind of pharmaceutical composition, is made up of the component of following weight portion：
2. pharmaceutical composition according to claim 1, it is characterised in that：The hydrocortisone 3.5-6
Part, cinchocaine hydrochloride 5.5-6 parts, Borneolum Syntheticum 13-17 parts, aescine 10-13 parts, metronidazole 7-9 parts.
3. pharmaceutical composition according to claim 1, it is characterised in that：5 parts of the hydrocortisone,
5 parts of cinchocaine hydrochloride, 15 parts of Borneolum Syntheticum, 12 parts of aescine, 8 parts of metronidazole.
4. according to the arbitrary described pharmaceutical composition of claim 1-3, it is characterised in that：The fat-soluble base
Matter is suppository base.
5. pharmaceutical composition according to claim 4, it is characterised in that：The suppository base is saturation
C8-C18 fatty glycerides composition semi-synthetic glyceride at least one.
6. according to claim 1-3,5 arbitrary described pharmaceutical compositions, it is characterised in that：The medicine
Compositionss are suppository.
7. a kind of preparation method of pharmaceutical composition, comprises the steps：
Each raw material is weighed according to the component and content contained by the arbitrary described pharmaceutical composition of claim 1-6；
By the hydrocortisone for weighing, cinchocaine hydrochloride, Borneolum Syntheticum, aescine, metronidazole raw material
Carry out pulverization process；
The described fat-soluble substrate for weighing is carried out into heat and melts process, the liposoluble of process described in Jing, will heated
Property substrate and the pulverization process described in after the hydrocortisone, cinchocaine hydrochloride, Borneolum Syntheticum, seven leaf soaps
Glycosides, metronidazole raw material carry out emulsifying, then carry out cooling shaping process.
8. the preparation method of pharmaceutical composition according to claim 7, it is characterised in that：The crushing
Raw material particle size after process is 100～300 mesh；And/or
The speed of the emulsifying is 1500～3000 revs/min；And/or
The chilling temperature that the cooling shaping is processed is 8～15 DEG C.
9. a kind of arbitrary described medicine of claim 1-6 of medicine for treaching hemorrhoie, including effective effective dose
Compositionss or the drug regimen prepared by the preparation method of the arbitrary described pharmaceutical composition of claim 7-8
Thing.
10. medicine for treaching hemorrhoie according to claim 9, it is characterised in that：Can also connect including medicine
The adjuvant received.
Priority Applications (1)
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| CN201510663189.7A CN106581020A (en) | 2015-10-14 | 2015-10-14 | Pharmaceutical composition and preparation method thereof, and hemorrhoid treating medicine |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101269082A (en) * | 2008-02-25 | 2008-09-24 | 北京阜康仁生物制药科技有限公司 | Pharmaceutical combination treating hemorrhoid |
| CN102579569A (en) * | 2012-02-24 | 2012-07-18 | 北京市肛肠医院 | Pharmaceutical composition for treating piles as well as preparation method and application thereof |
| CN102641299A (en) * | 2012-05-15 | 2012-08-22 | 段亚东 | Externally-applied medicament composite for treating hemorrhoids |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101269082A (en) * | 2008-02-25 | 2008-09-24 | 北京阜康仁生物制药科技有限公司 | Pharmaceutical combination treating hemorrhoid |
| CN102579569A (en) * | 2012-02-24 | 2012-07-18 | 北京市肛肠医院 | Pharmaceutical composition for treating piles as well as preparation method and application thereof |
| CN102641299A (en) * | 2012-05-15 | 2012-08-22 | 段亚东 | Externally-applied medicament composite for treating hemorrhoids |
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