CN1634490A - Drop pills for treating throat diseases and preparation method thereof - Google Patents
Drop pills for treating throat diseases and preparation method thereof Download PDFInfo
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- CN1634490A CN1634490A CN 200410096708 CN200410096708A CN1634490A CN 1634490 A CN1634490 A CN 1634490A CN 200410096708 CN200410096708 CN 200410096708 CN 200410096708 A CN200410096708 A CN 200410096708A CN 1634490 A CN1634490 A CN 1634490A
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Abstract
The invention relates to a medicinal oral preparation for treating throat pain, furuncle and carbuncle, which has the advantages of high biological availability, quick-speed medicine release, quick-speed effect, less toxic and side effects, higher medicinal content, smaller amount of administration, accurate administration dosage, easy administering, low price, and facilitated carrying.
Description
Technical field
The present invention relates to a kind of heat-clearing and toxic substances removing that has, the effect of detumescence sore-throat relieving; Be used for the treatment of laryngopharynx swelling and pain, single bilateral tonsillitis, the scarlet fever furuncle, the pharmaceutical composition of symptoms such as carbuncle furuncle and phyma poison particularly based on Chinese traditional patent formulation six clever balls, is changed a social system a kind of drug composition oral dropping pill formulation that forms through dosage form.
Background technology
According to the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation WS
3The six clever balls that prescription that provides among-the B-3773-98 and method for making are prepared from are to have heat-clearing and toxic substances removing, detumescence sore-throat relieving; Be used for laryngopharynx swelling and pain, single bilateral tonsillitis, the scarlet fever furuncle, the treatment of carbuncle furuncle and phyma poison treatment etc. symptom micropill class preparation, through clinical verification for many years, steady quality, determined curative effect is clinical and family is used for the treatment of the common drug preparation of above disease.Also there is not other similar oral formulations at present.
Below be the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation WS
3The prescription and the method for making of the six clever balls that provide among-the B-3773-98:
Prescription: artificial Calculus Bovis 0.64g, Moschus 0.43g, Margarita (system) 0.64g, Borneolum Syntheticum 0.43g, Realgar 0.43g, Venenum Bufonis 0.43g;
Method for making: above Six-element, Margarita, Realgar water respectively fly into impalpable powder, and all the other artificial Calculus Boviss wait four flavors to be ground into fine powder respectively, filter, and except that the Venenum Bufonis fine powder, with all the other five tastes powder facing-ups, sieve mixing.Get 2/3 powder earlier with Chinese liquor general ball, to be formed after with remaining 1/3 powder and Venenum Bufonis mixing, the general ball of continuation usefulness Chinese liquor is a clothing with the Pulvis Fumi Carbonisatus, polishing is dried, and makes 1000 balls, promptly.
Annotate: the concocting method of Margarita: get Margarita and wrap, put into bean curd, boiled 3～4 hours, take out, dry with cloth.
Be explained as follows for this pill in institute's Annex VI spirit ball description:
Nomenclature of drug: six clever balls;
Main component: artificial Calculus Bovis, Moschus, Margarita (system), Borneolum Syntheticum, Realgar, Venenum Bufonis;
Character: this product is the coated micropill of black; Gas fragrance, distinguish the flavor of little suffering, fiber crops;
Function cures mainly: heat-clearing and toxic substances removing, detumescence sore-throat relieving.Be used for laryngopharynx swelling and pain, single bilateral tonsillitis, scarlet fever furuncle, carbuncle furuncle and phyma poison;
Usage and dosage: buccal, one time 5～10 ball, 1～2 time on the one.Children's is cut down according to the circumstance, or follows the doctor's advice.External melts with Chinese liquor, puts on the skin in the affected part;
Specification: the heavy 0.3g of per 100 balls.
Six clever balls belong to solid orally ingestible, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.Owing to reasons such as technologies of preparing, it is low that pellet exists medicament contg, and taking dose is big, and taking dose is inaccurate, takes inconvenient characteristics.In addition, the Chinese medicine solid oral dosage form that other are conventional is as tablet, capsule, granule etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention is to replenish existing a kind of heat-clearing and toxic substances removing, the detumescence sore-throat relieving; Be used for laryngopharynx swelling and pain, single bilateral tonsillitis, scarlet fever furuncle, the poison treatment of carbuncle furuncle and phyma etc. the deficiency of oral drug preparation of symptom, provide a kind of bioavailability height, release fast, quick produce effects, toxic and side effects is littler, and the medicament contg height, taking dose is little, and taking dose is accurate, and taking convenience is cheap, and be convenient to go out to carry, store drug composition oral preparation six drop pills easily.
Six drop pills involved in the present invention determine that through a large amount of experiment sievings based on the method for making of Chinese traditional patent formulation six clever balls, process is adjusted part technology, and cooperate drop pill preparation technology to be prepared from.Be prepared by the following technical solutions, can obtain six drop pills involved in the present invention:
[preparation method]
1. raw material and preparation: with g or kg is unit, according to the weight portion meter, and each 3 parts of artificial Calculus Bovis, Margaritas, respectively 2 parts of Moschus, Borneolum Syntheticum, Realgar, Venenum Bufoniss, more than 6 the flavor, get Margarita and wrap with cloth, put into bean curd, boiled 3～4 hours, take out, dry, Margarita, Realgar water respectively fly into impalpable powder, sieve; Artificial Calculus Bovis, Moschus, Borneolum Syntheticum, Venenum Bufonis etc. four flavor is ground into fine powder respectively, sieves; The facing-up mixing, it is standby to get medicine material dry powder;
2. substrate: Polyethylene Glycol
(1000,2000,4000,6000,8000,9300,10000,20000), 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. proportioning: with g is unit, by weight, and medicine dry powder: substrate=1: 1～1: 9.
4. according to the given ratio of prescription, accurately take by weighing medicine dry powder and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing medicine dry powder and substrate and/or emulsion and/or suspension;
5. 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 (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating in dropping-pill machine head and the condensation column that the condensing agent temperature is stable respectively and being in the desired state of temperature of preparation method 2, to contain the fused solution of medicine dry powder and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper;
Condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. 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
According to the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation WS
3The six clever balls that prescription that provides among-the B-3773-98 and preparation process are prepared from are a kind of heat-clearing and toxic substances removing, the detumescence sore-throat relieving; Be used for laryngopharynx swelling and pain, single bilateral tonsillitis, the scarlet fever furuncle, the pellet preparations of carbuncle furuncle and phyma poison treatment, through clinical verification for many years, steady quality, determined curative effect is clinical and family is used for the treatment of the common drug preparation of above disease.
Six clever balls belong to solid orally ingestible, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.Owing to reasons such as technologies of preparing, it is low that pellet exists medicament contg, and using dosage is big, and using dosage is inaccurate, uses inconvenient characteristics.
And tablet, capsule etc. in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of oral formulations such as tablet, capsule, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Six drop pills involved in the present invention are compared with six clever balls, have following beneficial effect:
1. six drop pills involved in the present invention, compare with six clever balls (micropill): micropill is meant all kinds of pills of diameter less than 2.5mm, and drug loading is limited, and the single taking dose is big, takes inconvenience.And the solid preparation dropping pill formulation is more suitable for carrying and conveniently take, and taking dose is accurate.
2. six drop pills involved in the present invention; utilize surfactant etc. to be substrate; make solid dispersion with the dry powder that contains active constituents of medicine; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate has wetting action to medicine, can make that medicine is rapidly molten to loose into microgranule or solution, thereby makes the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
Compare with the administering mode of traditional oral formulations, exist essential distinction.With the drop pill of solid dispersion technology preparation, oral except adopting, all right sublingual administration can make effective ingredient fully contact 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.
3. six drop pills involved in the present invention contact promptly with saliva and to dissolve rapidly, and are absorbed by oral mucosa, and are not only rapid-action, and the influence of not taken food, and promptly all can containing take after meal ante cibum, and local application's onset is faster.
4. six drop pills involved in the present invention mix the dry powder that contains active constituents of medicine mutually with molten matrix, splash in the not miscible condensed fluid and make.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 six drop pills 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 several groups of specific embodiments, be described further with regard to the preparation method of six drop pills of the present invention.
First group: the test of single-matrix
1. make earlier according to [preparation method] 1 and contain artificial Calculus Bovis, Margarita, the medicine dry powder of 6 kinds of Chinese medicines such as Moschus, Borneolum Syntheticum, Realgar, Venenum Bufonis is standby;
2. substrate: Polyethylene Glycol
(1000,2000,4000,6000,8000,9300,10000,20000), 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. proportioning---with g or kg is unit, by weight, and medicine dry powder: substrate=1: 1～1: 9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make six drop pills of various different sizes.
[result of the test]
Test 1: for observe medicine dry powder and different substrates when 1: 1 the proportioning prepared six drop pills in qualitative difference, according to 1: 1 ratio, with medicine dry powder 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 experiments that contain medicine dry powder and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe medicine dry powder and different substrates when 1: 3 the proportioning prepared six drop pills in qualitative difference, according to 1: 3 ratio, with medicine dry powder 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 experiments that contain medicine dry powder and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe medicine dry powder and different substrates when 1: 9 the proportioning prepared six drop pills in qualitative difference, according to 1: 9 ratio, with medicine dry powder 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 experiments that contain medicine dry powder and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. make earlier according to [preparation method] 1 and contain artificial Calculus Bovis, Margarita, the medicine dry powder of 6 kinds of Chinese medicines such as Moschus, Borneolum Syntheticum, Realgar, Venenum Bufonis is standby;
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,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
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 or kg 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 hybrid medicine dry powder: mixed-matrix weight and=1: 1～1: 9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make six drop pills of various different sizes.
[result of the test]
Test 4: for observe medicine dry powder and mixed-matrix when 1: 1 the proportioning prepared six drop pills in qualitative difference, 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, according to 1: 1 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe medicine dry powder and mixed-matrix when 1: 3 the proportioning prepared six drop pills in qualitative difference, 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, according to 1: 3 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: for observe medicine dry powder and mixed-matrix when 1: 9 the proportioning prepared six drop pills in qualitative difference, 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, according to 1: 9 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe medicine dry powder and mixed-matrix when 1: 1 the proportioning prepared six drop pills in qualitative difference, 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, according to 1: 1 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe medicine dry powder and mixed-matrix when 1: 3 the proportioning prepared six drop pills in qualitative difference, 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, according to 1: 3 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe medicine dry powder and mixed-matrix when 1: 9 the proportioning prepared six drop pills in qualitative difference, 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, according to 1: 9 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: in order to observe six drop pills that medicine dry powder and mixed-matrix make when 1: 1 the proportioning in qualitative difference, 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, according to 1: 1 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: in order to observe six drop pills that medicine dry powder and mixed-matrix make when 1: 3 the proportioning in qualitative difference, 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, according to 1: 3 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: in order to observe six drop pills that medicine dry powder and mixed-matrix make when 1: 9 the proportioning in qualitative difference, 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, according to 1: 9 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 medicine dry powder and single-matrix
(medicine 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 | ????77 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????50.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????50.0 | ????85 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 9300 | ????50.0 | ????86 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ????50.0 | ????80 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin | ????50.0 | ????72 | ????＜30 | ????＜10 | + |
| Poloxamer | ????50.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium | ????50.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Sodium lauryl sulphate | ????50.0 | ????68 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ????50.0 | ????55 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????50.0 | ????54 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????50.0 | ????55 | ????＞30 | ????＞10 | ++ |
| Lac | ????50.0 | ????52 | ????＞30 | ????＞10 | ++ |
The group practices of table 2 medicine dry powder and single-matrix
(medicine 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 | ????81 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????87 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????90 | ????＜30 | ????＞10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????95 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 9300 | ????25.0 | ????87 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ????25.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????78 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????81 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????85 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????80 | ????＜30 | ????＞10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
The group practices of table 3 medicine dry powder and single-matrix
(medicine 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 | ????82 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 9300 | ????10.0 | ????85 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 10000 | ????10.0 | ????78 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 20000 | ????10.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????93 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????10.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????92 | ????＜30 | ????＜10 | ++ |
| Carboxymethyl starch sodium | ????10.0 | ????86 | ????＞30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????83 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????77 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????75 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????70 | ????＞30 | ????＞10 | +++ |
The group practices of table 4 medicine dry powder and mixed-matrix
(medicine 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 | ????93 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????80 | ????＜30 | ????＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????78 | ????＜30 | ????＞10 | + |
The group practices of table 5 medicine dry powder and mixed-matrix
(medicine 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 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????87 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????83 | ????＜30 | ????＞10 | ++ |
The group practices of table 6 medicine dry powder and mixed-matrix
(medicine 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 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????94 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????88 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 medicine dry powder and mixed-matrix
(medicine 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 | ????95 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????88 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????82 | ????＜30 | ????＞10 | ++ |
The group practices of table 8 medicine dry powder and mixed-matrix
(medicine 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 | ????95 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????25 | ????86 | ????＜30 | ????＜10 | ++ |
The group practices of table 9 medicine dry powder and mixed-matrix
(medicine 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 | ????88 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????94 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????85 | ????＜30 | ????＜10 | +++ |
The group practices of table 10 medicine dry powder and mixed-matrix
(medicine 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 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????87 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????80 | ????＜30 | ????＞10 | +++ |
The group practices of table 11 medicine dry powder and mixed-matrix
(medicine 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 | ????95 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????25 | ????92 | ????＜30 | ????＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????88 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????25 | ????84 | ????＜30 | ????＜10 | +++ |
The group practices of table 12 medicine dry powder and mixed-matrix
(medicine 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 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????88 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
1. can be seen by the result in the table: when the ratio of medicine dry powder 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 medicine dry powder 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 medicine dry powder 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 (5)
1. one kind has heat-clearing and toxic substances removing, the effect of detumescence sore-throat relieving; Be used for the treatment of laryngopharynx swelling and pain, single bilateral tonsillitis, scarlet fever furuncle; pharmaceutical composition six drop pills of symptoms such as carbuncle furuncle and phyma poison; with artificial Calculus Bovis, Moschus, Margarita, Borneolum Syntheticum, Realgar, Venenum Bufonis is raw material of Chinese medicine, be prepared from a certain proportion of pharmaceutically suitable carrier, wherein:
1.1. raw material and preparation: with g or kg is unit, according to the weight portion meter, and each 3 parts of artificial Calculus Bovis, Margaritas, respectively 2 parts of Moschus, Borneolum Syntheticum, Realgar, Venenum Bufoniss, more than 6 the flavor, get Margarita and wrap with cloth, put into bean curd, boiled 3～4 hours, take out, dry, Margarita, Realgar water respectively fly into impalpable powder, sieve; Artificial Calculus Bovis, Moschus, Borneolum Syntheticum, Venenum Bufonis etc. four flavor is ground into fine powder respectively, sieves; The facing-up mixing gets medicine material dry powder;
1.2. substrate---Polyethylene Glycol
(2000,4000,6000,8000,9300,10000,20000), 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;
1.3. proportioning---with g or kg is unit, by weight, and medicine dry powder: substrate=1: 1～1: 9.
2. six drop pills as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is 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. any six drop pills as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described medicine dry powder and substrate is 1: 1～1: 5.
4. the preparation method of a drop pills is characterized in that being made of following process:
4.1. raw material and preparation: with g or kg is unit, according to the weight portion meter, and each 3 parts of artificial Calculus Bovis, Margaritas, respectively 2 parts of Moschus, Borneolum Syntheticum, Realgar, Venenum Bufoniss, more than 6 the flavor, get Margarita and wrap with cloth, put into bean curd, boiled 3～4 hours, take out, dry, Margarita, Realgar water respectively fly into impalpable powder, sieve; Artificial Calculus Bovis, Moschus, Borneolum Syntheticum, Venenum Bufonis etc. four flavor is ground into fine powder respectively, sieves; The facing-up mixing, it is standby to get medicine material dry powder;
4.2. substrate---Polyethylene Glycol
(1000,2000,4000,6000,8000,9300,10000,20000), 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;
4.3. proportioning---with g or kg is unit, by weight, and medicine dry powder: substrate=1: 1～1: 9.
4.4., accurately take by weighing medicine dry powder and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing medicine dry powder and substrate and/or emulsion and/or suspension;
4.5. adopt homemade or general drop pill machine, and adjust the temperature control system of drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also remains on-5 ℃～40 ℃;
4.6. when treating in dropping-pill machine head and the condensation column that the condensing agent temperature is stable respectively and being in the desired state of temperature of preparation method 2, to contain the fused solution of medicine dry powder and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper.
5. as the preparation method of six drop pills as described in the claim 4, it is characterized in that: method 4.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410096708 CN1634490A (en) | 2004-12-02 | 2004-12-02 | Drop pills for treating throat diseases and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410096708 CN1634490A (en) | 2004-12-02 | 2004-12-02 | Drop pills for treating throat diseases and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1634490A true CN1634490A (en) | 2005-07-06 |
Family
ID=34847881
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410096708 Pending CN1634490A (en) | 2004-12-02 | 2004-12-02 | Drop pills for treating throat diseases and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1634490A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101953851B (en) * | 2005-05-12 | 2012-03-14 | 北京亚东生物制药有限公司 | Pills for treating pharyngitis, furuncle and carbuncle and ulcers and preparation method thereof |
| CN103610775A (en) * | 2013-11-29 | 2014-03-05 | 成都九芝堂金鼎药业有限公司 | Preparation method of traditional Chinese medicine pills for treating acute tonsillitises and acute ulcers |
-
2004
- 2004-12-02 CN CN 200410096708 patent/CN1634490A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101953851B (en) * | 2005-05-12 | 2012-03-14 | 北京亚东生物制药有限公司 | Pills for treating pharyngitis, furuncle and carbuncle and ulcers and preparation method thereof |
| CN103610775A (en) * | 2013-11-29 | 2014-03-05 | 成都九芝堂金鼎药业有限公司 | Preparation method of traditional Chinese medicine pills for treating acute tonsillitises and acute ulcers |
| CN103610775B (en) * | 2013-11-29 | 2015-12-02 | 成都九芝堂金鼎药业有限公司 | A kind of medicine pill preparation method for the treatment of acute tonsillitis, acute pyogenic infection of skin |
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