CN101584764B - Medicinal dripping pill for treating chronic cystitis - Google Patents
Medicinal dripping pill for treating chronic cystitis Download PDFInfo
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- CN101584764B CN101584764B CN2008101121173A CN200810112117A CN101584764B CN 101584764 B CN101584764 B CN 101584764B CN 2008101121173 A CN2008101121173 A CN 2008101121173A CN 200810112117 A CN200810112117 A CN 200810112117A CN 101584764 B CN101584764 B CN 101584764B
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- polyethylene glycol
- dropping ball
- medicinal dropping
- weight portion
- medicinal
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Abstract
The invention discloses a medicinal dripping pill for treating chronic cystitis. Raw materials of the medicinal dripping pill consist of red yeast rice, corktree bark, red bean and polyethyleneglycol.A preparation method for the medicinal dripping pill comprises that: composition intermediates are prepared into dry extract of bulk drug extracts by the conventional process to obtain the medicinal dripping pill. The medicinal dripping pill has remarkable effect of treating the chronic cystitis and has no side effect.
Description
Technical field
The present invention relates to a kind of medicinal dropping ball, particularly relate to a kind of medicinal dropping ball for the treatment of chronic cystitis.
Background technology
Chronic cystitis is the modal disease of urinary system, sees with the women especially more.Primary disease is not as an independently disease appearance in most of cases, but the part of urinary system infection or the secondary infection of other disease of urinary system.The inflammation of bladder can be divided into acute and chronic two kinds, and both can transform mutually again, and acute chronic cystitis can not get thorough treatment and can delay into chronicly, and chronic cystitis reduces or local patholoic change factor when increasing the weight of at Abwehrkraft des Koepers, can change into acute attack again.The chronic cystitis symptom is similar to acute chronic cystitis, but degree is lighter, is characterized in morbidity " slowly ", inflammatory reaction " gently ", diseased region " deeply ".
Summary of the invention
The object of the invention is to provide a kind of medicinal dropping ball for the treatment of chronic cystitis.
Another purpose of the present invention is to provide the preparation method and the new purposes of this medicinal dropping ball.
Drop pill of the present invention is to make with the raw material of following weight portion:
Composition intermediates: Polyethylene Glycol=1: 3-6.Preferred weight part of described drop pill raw material is: composition intermediates: Polyethylene Glycol=1: 3,4.5 or 1: 5.5.Described Polyethylene Glycol can be a Polyethylene Glycol
2000-2000, comprise Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000Or Polyethylene Glycol
20000Deng, preferred Polyethylene Glycol
4000
The crude drug of the pharmaceutical composition intermediate of medicinal dropping ball of the present invention consists of:
Monas cuspurpureus Went 1-5 weight portion Cortex Phellodendri 3-8 weight portion Semen Phaseoli 1-5 weight portion
The crude drug composition of the pharmaceutical composition intermediate of medicinal dropping ball of the present invention is preferably:
Monas cuspurpureus Went 3 weight portion Cortex Phellodendris 5 weight portion Semen Phaseolis 3 weight portions
The crude drug composition of the pharmaceutical composition intermediate of medicinal dropping ball of the present invention is preferably:
Monas cuspurpureus Went 2 weight portion Cortex Phellodendris 4 weight portion Semen Phaseolis 4 weight portions
The crude drug composition of the pharmaceutical composition intermediate of medicinal dropping ball of the present invention is preferably:
Monas cuspurpureus Went 4 weight portion Cortex Phellodendris 7 weight portion Semen Phaseolis 2 weight portions
Described composition intermediates can prepare the dried cream of crude drug extract according to a conventional method respectively and mix and make; Also can according to a conventional method the crude drug co-extracted be prepared into the dried cream of extract makes again; Described conventional method includes but not limited to water extracting method, and decoction and alcohol sedimentation technique, water extract-alcohol precipitation are crossed macropore adsorption column method, CO
2Supercritical extraction etc.
Described water extraction method includes but not limited to following method:
Get arbitrary medical material in the crude drug of the present invention, decocting boils 1-2 time, adds 4-8 times of water gaging respectively, decocts 1-2 hour at every turn, merges decocting liquid, and concentrate drying must this medical material water extract.Perhaps get arbitrary medical material in the crude drug of the present invention, decocting boils 1-2 time, adds 4-8 times of water gaging respectively, decocted 1-2 hour, and merged decocting liquid, being concentrated into relative density is 1-1.1, centrifugal, supernatant is crossed macroporous resin column, and water lotion is abandoned in washing, the 30-80% ethanol elution, reclaim ethanol, concentrate drying must this medical material water extract.
Described decoction and alcohol sedimentation technique includes but not limited to following method:
Get arbitrary medical material in the crude drug of the present invention, decocting boils 2-3 time, add 4-8 times of water gaging respectively, decocted 1-2 hour, merge decocting liquid, being concentrated into relative density is 1-1.1, centrifugal, supernatant added 4-8 times of weight 30-80% ethanol precipitation 24 hours, reclaimed ethanol, concentrate drying must this medical material water extract-alcohol precipitation extract.
Described water extract-alcohol precipitation is crossed macropore adsorption column method and is included but not limited to following method:
Get arbitrary medical material in the crude drug of the present invention, decocting boils 2-3 time, adds 4-8 times of water gaging respectively, decocted 1-2 hour, and merged decocting liquid, being concentrated into relative density is 1-1.1, centrifugal, supernatant added 4-8 times of weight 30-80% ethanol precipitation 24 hours, reclaimed ethanol, be concentrated into relative density and be 1-1.1, centrifugal, supernatant is crossed macroporous resin column, the 30-80% ethanol elution, reclaim ethanol, concentrate drying must be crossed macropore adsorption column extract by this medical material water extract-alcohol precipitation.
Described super zero boundary extraction includes but not limited to following method:
Get arbitrary medical material in the crude drug of the present invention, supercritical CO
2Extraction adds in the 10-40% crude drug of the present invention arbitrary medical material amount 75-95% ethanol and makes entrainer, and extracting pressure 20-40Mpa, temperature 30-60 ℃, must this medical material supercritical extract.Perhaps get arbitrary medical material in the crude drug of the present invention, behind the supercritical extraction, medicated powder is taken out, decocting boils 1-2 time, add 6-8 times of water gaging respectively, decocted 0.5-1 hour, merge decocting liquid, concentrate, add 75-95% ethanol and make and contain alcohol amount and reach 60-80%, left standstill 12-24 hour, filter, the filtrate concentrate drying must this medical material supercritical CO
2Extraction water extract-alcohol precipitation extract.
The preparation method of medicinal dropping ball of the present invention is: after the Polyethylene Glycol heat fused, add composition intermediates, mix homogeneously, 75 ± 2 ℃ of insulations; Go in the coolant with dropping-pill machine, wherein the temperature of coolant is 20 ± 2 ℃, after the molding drop pill is taken out, and removes the coolant on surface, and packing promptly.Described coolant is selected from any one in dimethicone, liquid paraffin or the vegetable oil.
Medicinal dropping ball of the present invention treatment chronic cystitis effect significantly and have no side effect.The present invention utilizes the solid dispersion technology principle to prepare drop pill, confirms through the test of groping property of repeated multiple times molding, with Polyethylene Glycol especially Polyethylene Glycol
4000(PEG
4000) be substrate, a system effect is best.PEG
4000After appropriate ratio and medicament mixed, the easiest fusion or the uniform dispersion of miscible formation, also the easiest dissolubility and the dissolution velocity of making type and can improving medicine.
Through composition intermediates and substrate Polyethylene Glycol ratio (A), fluid temperature (B), condensing agent temperature (C) 3 factors are investigated, each factor is got 3 levels, presses L
9(3)
4Orthogonal test table contrived experiment scheme.Optimum process condition is composition intermediates: PEG
4000=1: 4.5, fluid temperature should be 75 ± 2 ℃; Coolant temperature is 20 ± 2 ℃.
Experimental study shows that drop pill of the present invention compared with prior art has the bioavailability height, fast release, produce effects fast, medicament contg height, accurate measurement, taking convenience, characteristics such as cheap and pollution-free aborning.
1. drop pill rounding rate height of the present invention, the ball method of double differences are different little, can satisfy the quality standard of stipulating in the national drug standards fully about dropping pill formulation, therefore make that the accuracy of dosage greatly improves clinically, production cost reduces, and has therefore also possessed industrial applicibility.
2. drop pill of the present invention is substrate with the surfactant; make solid dispersion with the extract that contains active pharmaceutical ingredient; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases, and substrate is hydrophilic, and medicine is had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb to accelerate, thereby improved bioavailability, bring into play efficient, quick-acting effects etc.
3. drop pill of the present invention contacts promptly with saliva and dissolves rapidly, and is absorbed by oral mucosa, and is not only rapid-action, and the influence of not taken food, be all can containing to take after meal ante cibum, also can not produce any residual harmful substance, thereby make that patient's medication is safer at gastric; Also have medication convenience, characteristic of accurate simultaneously.
4. the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
5. the production technology of drop pill of the present invention, equipment are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height; Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
Experiment and embodiment are used to further specify but are not limited to the present invention below.
Experimental example 1 medicinal dropping ball of the present invention reaches more than 95% through clinical treatment 40 routine chronic cystitis patient's total effective rates, and chronic cystitis case diagnosis standard and criterion of therapeutical effect are pressed the Ministry of Public Health standard and confirmed, 35 routine produce effects wherein, 3 examples effectively, 2 examples are invalid.
| Criterion of therapeutical effect | Produce effects (routine number) | Effectively (routine number) | Invalid (routine number) |
| 40 examples | 35 examples | 3 examples | 2 examples |
| Effective percentage | 88％ | 7％ | 5％ |
Experimental example 2 airpillow-dry condition researchs
Composition intermediates is 40-60 ℃, 60-80 ℃, 80-100 ℃ by temperature of charge, hydrojet speed 20-25 liter/hour, the 25-35 liter/hour, 35-40 liter/hour screen the result: when temperature of charge was 40-60 ℃, temperature of charge was low excessively, powder is difficult for dry, easily caking.Hydrojet speed be the 20-25 liter/hour, hydrojet speed is low, flow is little, influences efficient.Hydrojet speed be the 35-40 liter/hour, hydrojet speed is fast, powder is difficult for fully dry, easily caking.When temperature of charge was 80-100 ℃, temperature of charge was too high, may cause the decomposition of effective ingredient in the composition intermediates.So select temperature of charge be 60-80 ℃, hydrojet speed 25-35 liter/hour condition carry out airpillow-dry as the airpillow-dry condition.
Experimental example 3 drop pill adjuvant screening experiment of the present invention
To The selection result, be that index is estimated with hardness, roundness, dissolve scattered time limit, yield, stability on the 7th, simultaneously test drop pill adjuvant is screened.The results are shown in following table.
Table 1 drop pill development mesostroma and coolant The selection result table
The result shows, uses PEG respectively separately
4000, PEG
6000, PEG
10000And S-40 is when doing substrate, no matter composition intermediates: adjuvant=1: 3.0, still be at 1: 4.5 1: 5.5, what molding effect was best is to use PEG separately
4000Do substrate, medicine and substrate composition be at 1: 4.5 o'clock, integration the highest (22).
Experimental example 4 optimum process condition screening experiment
Respectively the medicine in the drop pill development of the present invention is investigated with ratio (A), fluid temperature (B), coolant temperature three kinds of factors such as (C) of substrate with orthogonal experiment, every factor is got three levels; With hardness, roundness, dissolve scattered time limit, yield evaluation index as this product key property, set standards of grading and test and assess, and do statistical analysis, find out optimum process condition.The set A of orthogonal test, B, three kinds of factors of C all have certain influence to droplet ball Forming Quality of the present invention.Wherein A factor extreme difference maximum (5.667) proves that the A factor is the main factor of influence test; Next is B factor (extreme difference is 1.667); Be C factor (extreme difference is 2.500) once more; That is: A＞B＞C.A in the A factor
3(be A
K3) value maximum (18.667), prove A
3Be the auxilliary proportioning of best medicine; B in the B factor
2(be B
K2) value maximum (16.667), prove B
2Be the suitableeest fluid temperature; C in the C factor
2And C
3(be C
K2And C
K3) be worth big (16.000), prove C
2Or C
3Be the suitableeest condensing agent temperature.The main factor that the A factor is really tested for influence, and tool significant difference P＜0.05=, the B factor also has clearly influence to test, and the C factor also has certain influence to result of the test.The result shows that the optimum condition of proportioning raw materials and technical study is A
3B
2C
3Be that the drop pill raw material is composition intermediates: PEG
4000=1: 4.5, fluid temperature should be 75 ± 2 ℃; Coolant temperature is 20 ± 2 ℃.
Following embodiment all can realize the effect of above-mentioned experimental example.
The specific embodiment
Embodiment 1:
Monas cuspurpureus Went 3kg Cortex Phellodendri 5kg Semen Phaseoli 3kg
Said medicine prepares the dried cream of crude drug extract according to a conventional method respectively and mixes, and gets composition intermediates; According to weight ratio is composition intermediates: PEG
4000=1: 4.5 ratio adds PEG
4000, the preparation method of drop pill is: after the Polyethylene Glycol heat fused, add composition intermediates, mix homogeneously, 75 ± 2 ℃ of insulations; Go in the coolant with dropping-pill machine, wherein the temperature of coolant is 20 ± 2 ℃, after the molding drop pill is taken out, and removes the coolant on surface, and packing promptly.
Embodiment 2:
Monas cuspurpureus Went 2kg Cortex Phellodendri 4kg Semen Phaseoli 4kg
Said medicine prepares the dried cream of crude drug extract according to a conventional method respectively and mixes, and gets composition intermediates; According to weight ratio is composition intermediates: PEG
4000=1: 5.5 ratio adds PEG
4000, the preparation method of drop pill is: after the Polyethylene Glycol heat fused, add composition intermediates, mix homogeneously, 75 ± 2 ℃ of insulations; Go in the coolant with dropping-pill machine, wherein the temperature of coolant is 20 ± 2 ℃, after the molding drop pill is taken out, and removes the coolant on surface, and packing promptly.
Embodiment 3:
Monas cuspurpureus Went 4kg Cortex Phellodendri 7kg Semen Phaseoli 2kg
Said medicine is the co-extracted crude drug according to a conventional method, makes water extract-alcohol precipitation and crosses the dried cream of macroporous resin adsorption column extract, gets composition intermediates; According to weight ratio is composition intermediates: PEG
4000=1: 3.0 ratio adds PEG
4000, the preparation method of drop pill is: after the Polyethylene Glycol heat fused, add composition intermediates, mix homogeneously, 75 ± 2 ℃ of insulations; Go in the coolant with dropping-pill machine, wherein the temperature of coolant is 20 ± 2 ℃, after the molding drop pill is taken out, and removes the coolant on surface, and packing promptly.
Embodiment 4:
Monas cuspurpureus Went 2kg Cortex Phellodendri 7kg Semen Phaseoli 4kg
Said medicine is the co-extracted crude drug according to a conventional method, makes water extract-alcohol precipitation and crosses the dried cream of macroporous resin adsorption column extract, gets composition intermediates; According to weight ratio is composition intermediates: PEG
6000=1: 4.5 ratio adds PEG
6000, the preparation method of drop pill is: after the Polyethylene Glycol heat fused, add composition intermediates, mix homogeneously, 75 ± 2 ℃ of insulations; Go in the coolant with dropping-pill machine, wherein the temperature of coolant is 20 ± 2 ℃, after the molding drop pill is taken out, and removes the coolant on surface, and packing promptly.
Embodiment 5:
Monas cuspurpureus Went 4kg Cortex Phellodendri 8kg Semen Phaseoli 2kg
Said medicine is the co-extracted crude drug according to a conventional method, makes CO
2The dried cream of super zero boundary extract gets composition intermediates; According to weight ratio is composition intermediates: PEG
6000=1: 5.5 ratio adds PEG
6000, the preparation method of drop pill is: after the Polyethylene Glycol heat fused, add composition intermediates, mix homogeneously, 75 ± 2 ℃ of insulations; Go in the coolant with dropping-pill machine, wherein the temperature of coolant is 20 ± 2 ℃, after the molding drop pill is taken out, and removes the coolant on surface, and packing promptly.
Claims (13)
1. medicinal dropping ball for the treatment of chronic cystitis, it is characterized in that this medicinal dropping ball is to make with the raw material of following weight portion: composition intermediates: Polyethylene Glycol=1: 3～6, the crude drug of making composition intermediates consists of: Monas cuspurpureus Went 1-5 weight portion Cortex Phellodendri 3-8 weight portion Semen Phaseoli 1-5 weight portion.
2. medicinal dropping ball as claimed in claim 1 is characterized in that this medicinal dropping ball is to make with the raw material of following weight portion: composition intermediates: Polyethylene Glycol=1: 3.
3. medicinal dropping ball as claimed in claim 1 is characterized in that this medicinal dropping ball is to make with the raw material of following weight portion: composition intermediates: Polyethylene Glycol=1: 4.5.
4. medicinal dropping ball as claimed in claim 1 is characterized in that this medicinal dropping ball is to make with the raw material of following weight portion: composition intermediates: Polyethylene Glycol=1: 5.5.
5. as the described medicinal dropping ball of one of claim 1-4, it is characterized in that described Polyethylene Glycol is a Polyethylene Glycol
2000～20000, comprise Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000Or Polyethylene Glycol
20000
6. as the described medicinal dropping ball of one of claim 1-4, it is characterized in that the preferred Polyethylene Glycol of described Polyethylene Glycol
4000
7. as the described medicinal dropping ball of one of claim 1-4, the crude drug that it is characterized in that making the pharmaceutical composition intermediate of this medicinal dropping ball consists of:
Monas cuspurpureus Went 3 weight portion Cortex Phellodendris 5 weight portion Semen Phaseolis 3 weight portions.
8. as the described medicinal dropping ball of one of claim 1-4, the crude drug that it is characterized in that making the pharmaceutical composition intermediate of this medicinal dropping ball consists of:
Monas cuspurpureus Went 2 weight portion Cortex Phellodendris 4 weight portion Semen Phaseolis 4 weight portions.
9. as the described medicinal dropping ball of one of claim 1-4, the crude drug that it is characterized in that making the pharmaceutical composition intermediate of this medicinal dropping ball consists of:
Monas cuspurpureus Went 4 weight portion Cortex Phellodendris 7 weight portion Semen Phaseolis 2 weight portions.
10. as the described medicinal dropping ball of one of claim 1-4, it is characterized in that described composition intermediates prepares the dried cream of each extracts of bulk drugs according to a conventional method respectively and mixes and make.
11., it is characterized in that described composition intermediates is prepared into the dried cream of extracts of bulk drugs with each crude drug co-extracted according to a conventional method and makes as the described medicinal dropping ball of one of claim 1-4.
12., it is characterized in that this method is: after the Polyethylene Glycol heat fused, add composition intermediates, mix homogeneously, 75 ± 2 ℃ of insulations as the preparation method of one of claim 1-4 described medicinal dropping ball; Go in the coolant with dropping-pill machine, wherein the temperature of coolant is 20 ± 2 ℃, after the molding drop pill is taken out, and removes the coolant on surface, and packing promptly; Described coolant is selected from any one in dimethicone, liquid paraffin or the vegetable oil.
13. as the application of the described medicinal dropping ball of one of claim 1-4 in the medicine of preparation treatment chronic cystitis.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101121173A CN101584764B (en) | 2008-05-21 | 2008-05-21 | Medicinal dripping pill for treating chronic cystitis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101121173A CN101584764B (en) | 2008-05-21 | 2008-05-21 | Medicinal dripping pill for treating chronic cystitis |
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| Publication Number | Publication Date |
|---|---|
| CN101584764A CN101584764A (en) | 2009-11-25 |
| CN101584764B true CN101584764B (en) | 2011-10-26 |
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ID=41369333
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2008101121173A Active CN101584764B (en) | 2008-05-21 | 2008-05-21 | Medicinal dripping pill for treating chronic cystitis |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1541684A (en) * | 2003-11-07 | 2004-11-03 | 曹斌豫 | Oral Chinese traditional medicine preparation for treating cystitis |
| CN101032586A (en) * | 2007-04-04 | 2007-09-12 | 侯雪云 | Chinese traditional medicine composition to be taken orally for curing acute cystitis |
-
2008
- 2008-05-21 CN CN2008101121173A patent/CN101584764B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1541684A (en) * | 2003-11-07 | 2004-11-03 | 曹斌豫 | Oral Chinese traditional medicine preparation for treating cystitis |
| CN101032586A (en) * | 2007-04-04 | 2007-09-12 | 侯雪云 | Chinese traditional medicine composition to be taken orally for curing acute cystitis |
Non-Patent Citations (3)
| Title |
|---|
| 刘先夺等.硫酸妥布霉素膀胱灌注治疗女性慢性膀胱炎132例.《中国药业》.2001,第10卷(第8期),34. * |
| 方兆凤.综合疗法治疗慢性膀胱炎48例.《新中医》.2003,第35卷(第6期),59-60. * |
| 王丽君等.环丙沙星治疗慢性膀胱炎的疗效观察.《北京军区医药》.1994,第6卷(第1期),7. * |
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