CN1284531C - Drop pills for treating oral disease - Google Patents
Drop pills for treating oral disease Download PDFInfo
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- CN1284531C CN1284531C CN 200410088421 CN200410088421A CN1284531C CN 1284531 C CN1284531 C CN 1284531C CN 200410088421 CN200410088421 CN 200410088421 CN 200410088421 A CN200410088421 A CN 200410088421A CN 1284531 C CN1284531 C CN 1284531C
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- polyethylene glycol
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Abstract
The present invention discloses a medicinal composition having the functions for expelling wind, removing toxin, dispersing swelling, relieving pain, clearing heat from the throat and benefiting the throat, particularly a medicinal composition oral preparation which is prepared by reforming dosage forms on the basis of the patent formula of golden-throated health-care sprays. The present invention aims to overcome the defects of the existing oral medicine preparation used for treating pharyngalgia, dry throat, red swollen throat, painful swollen gums, dental ulcer and the like caused by wind heat, and to provide a golden-throated health-care drop pill having the advantages of high biological availability, fast medicine release, rapidness for taking effect, fewer toxic or side effects, no pollution in production and low production cost. The drop pill preparation is prepared according to a drop pill technology on the basis of the technology of the golden-throated health-care sprays.
Description
Technical field
The present invention relates to a kind of detoxifcation of dispeling the wind that has, reducing swelling and alleviating pain, pharynx-clearing and throat-smoothing action, the pharmaceutical composition that is used for pharyngalgia due to the wind heat, dry pharynx, pharyngitis, gingival swelling and pain, oral ulcer disease, be particularly related to prescription, change a social system a kind of drug composition oral preparation that forms through dosage form based on JINHOUJIAN PENWUJI.
Background technology
The JINHOUJIAN PENWUJI that is prepared from according to the prescription that provides among the national drug standards WS-10293 (ZD-0293)-2022 and extraction process, being to be the pharmaceutical composition that feedstock production forms with Oleum Blumeae Balsamiferae, Fructus cinnamomi camphorae oil, Mentholum, ammonium glycyrrhizinate, is pharyngalgia due to the treatment wind heat, dry pharynx, pharyngitis, gingival swelling and pain, the highly effective medicine of oral ulcer disease.Therefore be made into spray and obtained national inventing patent because it has the obvious treatment effect, but domesticly still do not had drops at present and occur.
Owing to reasons such as being subjected to medicine and prior art limits, existing most of medicinal aerosol all can not be accomplished dosed administration, dosage is difficult to accurate control when therefore operating, and this promptly directly affects therapeutic effect, may cause waste and increase incidence rate of adverse reaction because of misoperation again simultaneously; This dosage form uses the crowd limited, and especially old man and child inconvenience is used; The manufacturing cost of this dosage form is higher, has objectively increased patient's medical burden.
Summary of the invention
Purpose of the present invention, be to replenish the existing deficiency that is used for disease oral drug preparations such as pharyngalgia due to the wind heat, dry pharynx, pharyngitis, gingival swelling and pain, oral ulcer, a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is littler, and produces pollution-free, production cost is lower, and can improve the strong drop pill of golden larynx of medication accuracy greatly.
The strong drop pill of golden larynx involved in the present invention is a raw material with Oleum Blumeae Balsamiferae, Fructus cinnamomi camphorae oil, Mentholum, the ammonium glycyrrhizinate that contains active constituents of medicine, on the basis of JINHOUJIAN PENWUJI technology, is prepared from through dropping pill technique again.Be prepared by the following technical solutions, can obtain the strong drop pill of golden larynx involved in the present invention:
[preparation method of drop pill raw material]
With g or kg is unit, ratio according to Oleum Blumeae Balsamiferae 56.1%, Fructus cinnamomi camphorae oil 14%, Mentholum 16.1%, ammonium glycyrrhizinate 13.8%, accurately take by weighing above four flavor Chinese medicines, except that ammonium glycyrrhizinate, three flavors such as all the other Chinese mugwort sodium Oleum sesami, add an amount of ethanol and make it dissolving, the sour monoamine salt of other extracting liquorice, add an amount of heating of water and make dissolving, merge with above-mentioned alcoholic solution, stir evenly, decompression cryoconcentration to density is 1.2～1.5 thick paste, or again through decompression, cold drying, be ground into dry powder promptly.
[drop pill prescription]
1. raw material---the thick paste that contains active pharmaceutical ingredient or the dry powder that obtain through above technology;
2. substrate: Polyethylene Glycol
2000,4000,6000,8000,10000,20000, one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. (with g is unit to proportioning, by weight): drug extract: substrate=1: 1～1: 9.
[preparation method]
1. according to the given ratio of prescription, accurately take by weighing the thick paste (or dry powder) and the substrate that contain active pharmaceutical ingredient, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing active pharmaceutical ingredient and substrate and/or emulsion and/or suspension;
2. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～100) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
3. treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step during desired state of temperature, to contain the thick paste (or dry powder) of active pharmaceutical ingredient and the pharmaceutical composition mixed liquor of substrate and place in the water dropper storage vat of drop pill machine, splash in the condensing agent by water dropper with suitable speed.
Condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
4. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
Beneficial effect
The JINHOUJIAN PENWUJI that is prepared from according to the prescription that provides among the national drug standards WS-10293 (ZD-0293)-2022 and extraction process, being to be the pharmaceutical composition that feedstock production forms with Oleum Blumeae Balsamiferae, Fructus cinnamomi camphorae oil, Mentholum, ammonium glycyrrhizinate, is pharyngalgia due to the treatment wind heat, dry pharynx, pharyngitis, gingival swelling and pain, the highly effective medicine of oral ulcer disease.Therefore be made into spray and obtained national inventing patent because it has the obvious treatment effect, but domesticly still do not had drops at present and occur.
Owing to reasons such as being subjected to medicine and prior art limits, existing most of medicinal aerosol all can not be accomplished dosed administration, dosage is difficult to accurate control when therefore operating, and this promptly directly affects therapeutic effect, may cause waste and increase incidence rate of adverse reaction because of misoperation again simultaneously; This dosage form uses the crowd limited, and especially old man and child inconvenience is used; The manufacturing cost of this dosage form is higher, has objectively increased patient's medical burden.
The strong drop pill of golden larynx involved in the present invention is compared with existing spray, has following beneficial effect:
1. golden larynx involved in the present invention is good for drop pill; utilize surfactant to be substrate; make solid dispersion with thick paste that contains active constituents of medicine or dry powder; 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 that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
Drop pill with the solid dispersion technology preparation can adopt oral and sublingual administration, and effective ingredient is fully contacted with mucomembranous surface, absorbs by mucomembranous epithelial cell, directly enters blood circulation.Owing to directly enter blood circulation without gastrointestinal tract and liver, avoided first pass effect effectively, also avoided gastrointestinal irritation, thereby it is rapid to have an onset, bioavailability height, characteristics such as side effect is little, and medication is convenient.
2. golden larynx involved in the present invention is good for drop pill, contacts promptly with saliva and dissolves rapidly, and absorbed by oral mucosa, and is not only rapid-action, and the influence of not taken food, and promptly all can containing take after meal ante cibum.
3. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.The active constituents of medicine of drop pill is uniformly dispersed in substrate, and dosage is accurate, and the ball method of double differences is different little than tablet, and production cost is usually with about 50% of other oral formulations of kind, and the patient medical expense is lower.
4. the strong drop pill of golden larynx involved in the present invention mixes the thick paste (or dry powder) 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.
In sum, make the strong drop pill of golden larynx involved in the present invention have the advantage of triple effect (quick-acting, efficient, long-acting), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use).
The specific embodiment
Now with the test and the result thereof of several groups of specific embodiments, the preparation method of being good for drop pill with regard to golden larynx of the present invention is described further.
First group: the test of single-matrix
[prescription]
(technology that provides according to [preparation method of drop pill raw material] is prepared, and can obtain containing the dry powder of active constituents of medicine.)
1. raw material---the dry powder that contains active pharmaceutical ingredient that is prepared from through previous methods;
2. substrate: Polyethylene Glycol
2000,4000,6000,8000,10000,20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. (with g is unit to proportioning, by weight): drug extract: substrate=1: 1～1: 9.
[result of the test]
Test 1: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and different substrates prepared golden larynx when 1: 1 the proportioning, according to 1: 1 ratio, the dry powder that will contain active constituents of medicine respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions that dry powder and different substrates constituted experiments that contain active constituents of medicine, and obtain 15 groups of different experimental results and see Table 1.
Test 2: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and different substrates prepared golden larynx when 1: 3 the proportioning, according to 1: 3 ratio, the dry powder that will contain active constituents of medicine respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions that dry powder and different substrates constituted experiments that contain active constituents of medicine, and obtain 15 groups of different experimental results and see Table 2.
Test 3: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and different substrates prepared golden larynx when 1: 9 the proportioning, according to 1: 9 ratio, the dry powder that will contain active constituents of medicine respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions that dry powder and different substrates constituted experiments that contain active constituents of medicine, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
[prescription]
(technology that provides according to [preparation method of drop pill raw material] is prepared, and can obtain containing the dry powder of active constituents of medicine.)
1. raw material---the dry powder that contains active pharmaceutical ingredient that is prepared from through previous methods;
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch is at alkali condition
Down with the sodium salt of the starch carboxymethyl ester of monoxone effect generation,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. (with g is unit to proportioning, by weight)
3.1 the ratio of composite interstitial substance---polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10,
3.2 drug extract: substrate=1: 1～1: 9.
[result of the test]
Test 4: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 1 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 4.
Test 5: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 3 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 5.
Test 6: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 9 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 6.
Test 7: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 1 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 7.
Test 8: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 3 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 8.
Test 9: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 9 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 9.
Test 10: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 1 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 10.
Test 11: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 3 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 11.
Test 12: be good for drop pill in qualitative difference in order to observe the dry powder that contains active constituents of medicine and mixed-matrix prepared golden larynx when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, the dry powder that will contain active constituents of medicine according to 1: 9 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 dry powder and single-matrix
(dry powder: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | 50.0 | 61 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 75 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 86 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 85 | ＜30 | ＜10 | ++ |
| Stearic acid | 50.0 | 53 | ＜30 | ＞10 | + |
| Sodium stearate | 50.0 | 54 | ＜30 | ＞10 | |
| Glycerin gelatine | 50.0 | 55 | ＜30 | ＞10 | |
| Polyoxyethylene stearate 40 esters | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Lac | 50.0 | 49 | ＜30 | ＞10 | |
| The polyoxyethylene monostearate | 50.0 | 71 | ＜30 | ＞10 | + |
| Polyethers | 50.0 | 72 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 71 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 69 | ＜30 | ＞10 | + |
The group practices of table 2 dry powder and single-matrix
(dry powder: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | 25.0 | 77 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 89 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 93 | ＜30 | ＜10 | ++ |
| Stearic acid | 25.0 | 72 | ＜30 | ＞10 | + |
| Sodium stearate | 25.0 | 73 | ＜30 | ＞10 | + |
| Glycerin gelatine | 25.0 | 63 | ＜30 | ＞10 | + |
| Polyoxyethylene stearate 40 esters | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Lac | 25.0 | 68 | ＜30 | ＞10 | + |
| The polyoxyethylene monostearate | 25.0 | 77 | ＜30 | ＞10 | + |
| Polyethers | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 83 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 25.0 | 76 | ＜30 | ＞10 | + |
The group practices of table 3 dry powder and different substrates
(dry powder: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | 10.0 | 86 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Stearic acid | 10.0 | 83 | ＜30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 79 | ＜30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 77 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Lac | 10.0 | 72 | ＜30 | ＞10 | ++ |
| The polyoxyethylene monostearate | 10.0 | 82 | ＜30 | ＞10 | +++ |
| Polyethers | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 82 | ＜30 | ＞10 | +++ |
| Sodium lauryl sulphate | 10.0 | 75 | ＜30 | ＞10 | +++ |
The group practices of table 4 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 82 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 79 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 67 | ＜30 | ＞10 | + |
The group practices of table 5 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 87 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 88 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 86 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 6 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 87 | ＜30 | ＜10 | +++ |
The group practices of table 7 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 87 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 84 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 85 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 85 | ＜30 | ＞10 | ++ |
The group practices of table 8 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | ++ |
The group practices of table 9 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
The group practices of table 10 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 89 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 88 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 85 | ＜30 | ＞10 | ++ |
The group practices of table 11 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
The group practices of table 12 dry powder and mixed-matrix
(dry powder: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of the dry powder that contains active constituents of medicine and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of dry powder that contains active constituents of medicine and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of dry powder that contains active constituents of medicine and substrate is 1: 9, though the rounding rate, the ball method of double differences is different and index such as hardness has raising, and is not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. an oral administration dripping pill for the treatment of oral disease is a raw material with Oleum Blumeae Balsamiferae, Fructus cinnamomi camphorae oil, Mentholum, ammonium glycyrrhizinate, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) be unit with g or kg, ratio according to Oleum Blumeae Balsamiferae 56.1%, Fructus cinnamomi camphorae oil 14%, Mentholum 16.1%, ammonium glycyrrhizinate 13.8%, accurately take by weighing above four flavor Chinese medicines, except that ammonium glycyrrhizinate, three flavors such as all the other Chinese mugwort sodium Oleum sesami, add an amount of ethanol and make it dissolving, the sour monoamine salt of other extracting liquorice, add an amount of heating of water and make dissolving, merge with above-mentioned alcoholic solution, stir evenly, the decompression cryoconcentration is 1.2～1.5 thick paste to density, or continue to make drying, be ground into dry powder, promptly get the extract that contains pharmaceutically active ingredient in above-mentioned four flavors;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium; By weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, describedly contains that the extract of pharmaceutically active ingredient and the ratio of substrate are 1: 3 in above-mentioned four flavors;
(3) according to aforementioned proportion, accurately take by weighing described extract and the substrate that contains pharmaceutically active ingredient in above-mentioned four flavors, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described Chinese medicine extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper temperature heating of drop pill machine and remains on 50 ℃～100 ℃, and the temperature cooling of condensing agent also remains on 40 ℃～-5 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state of temperature respectively, the described medicinal liquid that contains Chinese medicine effective component extracts and substrate is placed in the water dropper storage vat of drop pill machine, splash in the condensing agent, shrink molding, promptly.
2. oral administration dripping pill as claimed in claim 1 is characterized in that: described condensing agent is any one in liquid paraffin, methyl-silicone oil, the vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410088421 CN1284531C (en) | 2004-11-02 | 2004-11-02 | Drop pills for treating oral disease |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410088421 CN1284531C (en) | 2004-11-02 | 2004-11-02 | Drop pills for treating oral disease |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1634440A CN1634440A (en) | 2005-07-06 |
| CN1284531C true CN1284531C (en) | 2006-11-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410088421 Expired - Fee Related CN1284531C (en) | 2004-11-02 | 2004-11-02 | Drop pills for treating oral disease |
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| Country | Link |
|---|---|
| CN (1) | CN1284531C (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101301355B (en) * | 2008-06-26 | 2010-06-16 | 贵州宏宇药业有限公司 | Oil composition containing 1,8-cineole and flavanones extracted from Litsea lancilimba Merr. and Blumea Balsamifera DC. And use thereof |
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2004
- 2004-11-02 CN CN 200410088421 patent/CN1284531C/en not_active Expired - Fee Related
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| Publication number | Publication date |
|---|---|
| CN1634440A (en) | 2005-07-06 |
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