CN1284528C - Orally administered dripping pills prepared by hive body - Google Patents
Orally administered dripping pills prepared by hive body Download PDFInfo
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- CN1284528C CN1284528C CNB200410088416XA CN200410088416A CN1284528C CN 1284528 C CN1284528 C CN 1284528C CN B200410088416X A CNB200410088416X A CN B200410088416XA CN 200410088416 A CN200410088416 A CN 200410088416A CN 1284528 C CN1284528 C CN 1284528C
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Abstract
The present invention discloses a medicine composition which has the functions of removing humid heat, opening the nasal cavity, relieving hepatic qi and nourishing the spleen and stomach and is used for the treatment of chronic rhinitis, chronic paranasal rhinitis, allergic rhinitis, brachychronic or chronic hepatitis and other diseases, particularly relates to an oral medicine composition preparation prepared from the raw material of honeycomb extract. The present invention has the purpose of complementing the deficiency of the existing oral medicine preparations used for the treatment of the diseases, and provides honeycomb dripping pills having the advantages of high bioavailability, quick medicine release, rapid effect, little toxic or side effect, no pollution during production and low production cost. The honeycomb dripping pills of the present invention are prepared by taking honeycomb (pure Chinese medicine) as raw material, preparing the honeycomb into extract through extracting techniques and preparing the extract into the honeycomb dripping pills through techniques for preparing dripping pills.
Description
Technical field
The present invention relates to a kind of clearing away damp-heat that has, clearing the nasal passage, dispersing liver-energy, the strengthening the spleen and stomach effect, be used for the treatment of chronic rhinitis, chronic paranasal rhinitis, allergic rhinitis, also can be used for the pharmaceutical composition of diseases such as acute, chronic hepatitis, is a kind of drug composition oral preparation that feedstock production forms with Nidus Vespae extractum particularly.
Background technology
Having provided a kind of among the national drug standards WS-11076 (ZD-1076)-2002 is the rhinitis Yiganning capsule that feedstock production forms with the Nidus Vespae, and its method for making is as follows: get Nidus Vespae extractum, add starch, mixing, granulate,, pulverize dry below 80 ℃, mixing incapsulates, promptly.
Nidus Vespae is the Nidus Vespae extract of Chinese Mel (Apis Cerana Fabricins).Nidus Vespae be with the Cera Flava be raw material by manually making septum earlier, put into beehive after, process in the above to build by Apis again and form.The composition of Nidus Vespae is very complicated, and contained compositions such as every Mel, Lac regis apis, pollen, propolis all may all exist at Nidus Vespae.Research and utilization to Nidus Vespae does not abroad appear in the newspapers as yet.According to domestic relevant, the total effective rate that is used for the treatment of various rhinitis (chronic, anaphylaxis, hypertrophy, simple property etc.) reaches 88%, can improve nasal obstruction, olfactory sensation, minimizing nasal mucus, alleviates headache and dizziness, that slept night is comfortable.Nidus Vespae also has better therapeutical effect to various hepatitis (delay property, chronic, acute, infectiousness etc.).
It is investigated at present directly be that the oral drug preparation of raw material has only the rhinitis Yiganning capsule preparation of listing in the national drug standards with the Nidus Vespae.Owing to reasons such as technologies of preparing, the oral formulations of most drug, 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.Simultaneously, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.
Moreover, conventional oral formulations complex process, medicament contg is little, uses dressing many, and industrial cost is higher, thereby has also improved patient's drug cost, has increased burden for the use of patient colony at one's own expense.
Summary of the invention
Purpose of the present invention, be to replenish the existing chronic rhinitis that is used for the treatment of, chronic paranasal rhinitis, allergic rhinitis, and the deficiency of the oral drug preparation of disease such as acute, chronic hepatitis, a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is littler, and produce pollution-freely, what production cost was lower is the drug composition oral dropping pill formulation (hereinafter to be referred as the Nidus Vespae drop pill) that active pharmaceutical ingredient is prepared from the Nidus Vespae.
Nidus Vespae drop pill involved in the present invention is a raw material with pure Chinese medicine Nidus Vespae, forms through specific prepared; Be prepared by the following technical solutions, can obtain Nidus Vespae drop pill involved in the present invention:
[preparation of Nidus Vespae extractum]
The Nidus Vespae of getting cleaning is an amount of, decocts with water three times, and each 1 hour, filter, collecting decoction left standstill 24 hours, got supernatant, removed upper strata Cera Flava, filtered, and filtrate is concentrated into relative density under 80 ℃ temperature conditions be thick paste 1.38 or more, receipts cream, promptly; Perhaps again with thick paste through drying under reduced pressure, be ground into dry powder promptly.
Preparation method given here is not limited to this a kind of preparation method for a kind of method commonly used.
[drop pill prescription]
1. raw material: the thick paste that contains the Nidus Vespae effective ingredient or the dry powder that obtain through above preparation 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. proportioning: with g or kg is unit, by weight, and thick paste or dry powder: substrate=1: 1～1: 9.
[preparation method]
1. according to the given ratio of prescription, accurately take by weighing thick paste or dry powder and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing thick paste or dry powder 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, the pharmaceutical composition mixed liquor that will contain thick paste or dry powder and substrate places 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
Nidus Vespae is the Nidus Vespae extract of Chinese Mel (Apis Cerana Fabricins).Nidus Vespae be with the Cera Flava be raw material by manually making septum earlier, put into beehive after, process in the above to build by Apis again and form.The composition of Nidus Vespae is very complicated, and contained compositions such as every Mel, Lac regis apis, pollen, propolis all may all exist at Nidus Vespae.Research and utilization to Nidus Vespae does not abroad appear in the newspapers as yet.According to domestic relevant, the total effective rate that is used for the treatment of various rhinitis (chronic, anaphylaxis, hypertrophy, simple property etc.) reaches 88%, can improve nasal obstruction, olfactory sensation, minimizing nasal mucus, alleviates headache and dizziness, that slept night is comfortable.Nidus Vespae also has better therapeutical effect to various hepatitis (delay property, chronic, acute, infectiousness etc.).
It is investigated at present directly be that the oral drug preparation of raw material has only the rhinitis Yiganning capsule preparation of listing in the national drug standards with the Nidus Vespae.Owing to reasons such as technologies of preparing, the oral formulations of most drug, 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.Simultaneously, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.
Moreover, conventional oral formulations complex process, medicament contg is little, uses dressing many, and industrial cost is higher, thereby has also improved patient's drug cost, has increased burden for the use of patient colony at one's own expense.
Nidus Vespae drop pill involved in the present invention is compared with its rhinitis Yiganning capsule, has following beneficial effect:
1. Nidus Vespae drop pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with extractum 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.
Compare with the administering mode of traditional oral formulations, exist essential distinction.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. Nidus Vespae drop pill involved in the present invention contacts promptly with saliva and to dissolve rapidly, and is 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.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
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.
4. Nidus Vespae drop pill involved in the present invention mixes the thick paste (perhaps 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 Nidus Vespae drop pill 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, be described further with regard to the preparation method of Nidus Vespae drop pill of the present invention.
First group: the test of single-matrix
[prescription]
1. Nidus Vespae dry powder: the method preparation that provides through [preparation of Nidus Vespae extractum] and dry powder;
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 or kg is unit to proportioning, by weight): Rhododendron dahuricum extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] is prepared, and can obtain the Nidus Vespae drop pill of different size.
[result of the test]
Test 1: for observe the dry powder that contains active constituents of medicine and different substrates when 1: 1 the proportioning prepared Nidus Vespae drop pill in qualitative difference, 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, step according to the preparation method regulation is prepared, 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: for observe the dry powder that contains active constituents of medicine and different substrates when 1: 3 the proportioning prepared Nidus Vespae drop pill in qualitative difference, 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, step according to the preparation method regulation is prepared, 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: for observe the dry powder that contains active constituents of medicine and different substrates when 1: 9 the proportioning prepared Nidus Vespae drop pill in qualitative difference, 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, step according to the preparation method regulation is prepared, 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]
1. Nidus Vespae dry powder: the method preparation that provides through [preparation of Nidus Vespae extractum] and dry powder;
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 Rhododendron dahuricum extract: mixed-matrix weight and=1: 1～1: 9.
4. the process that provides according to [preparation method] is prepared, and can obtain the Nidus Vespae drop pill of different size.
[result of the test]
Test 4: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 1 the proportioning prepared Nidus Vespae drop pill 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, 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: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 3 the proportioning prepared Nidus Vespae drop pill 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, 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: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 9 the proportioning prepared Nidus Vespae drop pill 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, 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: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 1 the proportioning prepared Nidus Vespae drop pill 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, 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: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 3 the proportioning prepared Nidus Vespae drop pill 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, 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: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 9 the proportioning prepared Nidus Vespae drop pill 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, 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: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 1 the proportioning prepared Nidus Vespae drop pill 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, 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: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 3 the proportioning prepared Nidus Vespae drop pill 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, 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: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 9 the proportioning prepared Nidus Vespae drop pill 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, 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.
(reference material is as follows: Chen Xiaomin, Chen Ling thanks flat. Nidus Vespae extract and toxicity thereof and bacteriostatic test. Jiangxi Medical College's journal 1994 (1) is P.32-36.)
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 | 74 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 80 | ＜30 | ＞10 | +++ |
| Polyethylene Glycol 8000 | 50.0 | 82 | ＜30 | ＞10 | +++ |
| Polyethylene Glycol 10000 | 50.0 | 82 | ＜30 | ＞10 | +++ |
| Polyethylene Glycol 20000 | 50.0 | 80 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 71 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 63 | ＞30 | ＞10 | + |
| Poloxamer | 50.0 | 72 | ＜30 | ＞10 | +++ |
| Carboxymethyl starch sodium | 50.0 | 70 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 69 | ＜30 | ＞10 | + |
| Stearic acid | 50.0 | 53 | ＞30 | ＞10 | + |
| Sodium stearate | 50.0 | 53 | ＞30 | ＞10 | + |
| Glycerin gelatine | 50.0 | 48 | ＞30 | ＞10 | + |
| Lac | 50.0 | 43 | ＞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 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Betacyclodextrin | 25.0 | 84 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 78 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 25.0 | 69 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 63 | ＜30 | ＞10 | ++ |
| Sodium stearate | 25.0 | 64 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 25.0 | 61 | ＞30 | ＞10 | ++ |
| Lac | 25.0 | 58 | ＞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 | 88 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 93 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 87 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Stearic acid | 10.0 | 74 | ＜30 | ＞10 | ++ |
| Sodium stearate | 10.0 | 77 | ＜30 | ＞10 | ++ |
| Glycerin gelatine | 10.0 | 72 | ＞30 | ＞10 | ++ |
| Lac | 10.0 | 76 | ＞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 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 80 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 78 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 62 | ＜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 | 88 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 84 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 81 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 86 | ＜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 | 86 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 87 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 83 | ＜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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 86 | ＜30 | ＜10 | ++ |
The group practices of table 9 Rhododendron dahuricum extract and mixed-matrix
(Rhododendron dahuricum extract: 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 | 93 | ＜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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 89 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 87 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 84 | ＜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 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 90 | ＜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 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of the Rhododendron dahuricum extract 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 Rhododendron dahuricum extract 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 Rhododendron dahuricum extract 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 drop pills for the treatment of chronic rhinitis is a raw material with Nidus Vespae extractum, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) it is an amount of to get the Nidus Vespae of cleaning, decoct with water three times, each 1 hour, filter, collecting decoction, left standstill 24 hours, and got supernatant, remove upper strata Cera Flava, filter, filtrate is concentrated into relative density under 80 ℃ of temperature conditions be thick paste more than 1.38, or again with the thick paste drying, be ground into dry powder, promptly get and contain Nidus Vespae extraction of active ingredients thing;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, and by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10; The extract of described Nidus Vespae and the ratio of substrate are 1: 3;
(3) accurately take by weighing described Nidus Vespae extract and substrate according to aforementioned proportion, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing Nidus Vespae 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 ℃;
(5) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively when reaching described state of temperature, the medicinal liquid that will contain Nidus Vespae extract and substrate places in the water dropper storage vat of drop pill machine, splashes into and shrinks molding in the condensing agent, takes out, remove the surface condensation agent, be drying to obtain.
2. Nidus Vespae drop 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 |
|---|---|---|---|
| CNB200410088416XA CN1284528C (en) | 2004-11-02 | 2004-11-02 | Orally administered dripping pills prepared by hive body |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200410088416XA CN1284528C (en) | 2004-11-02 | 2004-11-02 | Orally administered dripping pills prepared by hive body |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1634154A CN1634154A (en) | 2005-07-06 |
| CN1284528C true CN1284528C (en) | 2006-11-15 |
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ID=34847494
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB200410088416XA Expired - Fee Related CN1284528C (en) | 2004-11-02 | 2004-11-02 | Orally administered dripping pills prepared by hive body |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1284528C (en) |
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2004
- 2004-11-02 CN CNB200410088416XA patent/CN1284528C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1634154A (en) | 2005-07-06 |
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