CN1634472A - Drop pills containing bear gall and tendril-leaved fritillary bulb and preparation method thereof - Google Patents
Drop pills containing bear gall and tendril-leaved fritillary bulb and preparation method thereof Download PDFInfo
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- CN1634472A CN1634472A CNA2004100960303A CN200410096030A CN1634472A CN 1634472 A CN1634472 A CN 1634472A CN A2004100960303 A CNA2004100960303 A CN A2004100960303A CN 200410096030 A CN200410096030 A CN 200410096030A CN 1634472 A CN1634472 A CN 1634472A
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Abstract
Disclosed is a bear gall and tendril-leaved fritillary bulb dripping pill, which is a pharmaceutical composition having the functions of heat-clearing and phlegm resolving and cough-relieving, 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. The medicine is prepared through the conventional drop pill preparing process.
Description
Technical field
The present invention relates to a kind of removing heat-phlegm that has, antitussive action is used for the treatment of phlegm-heat cough, expectoration is more than, the abundant expectoration tachypnea, the pharmaceutical composition of symptoms such as it is not well to cough up phlegm particularly based on Fel Ursi Bulbus Fritillariae Cirrhosae oral liquid, is changed a social system a kind of drug composition oral dropping pill formulation that forms through dosage form.
Background technology
The Fel Ursi Bulbus Fritillariae Cirrhosae oral liquid that is prepared from according to the prescription that provides among the national drug standards WS-11130 (ZD-1130)-2002 and extraction process, it is a kind of removing heat-phlegm that has, antitussive action, be used for the treatment of phlegm-heat cough, expectoration is more than, abundant expectoration tachypnea, the pure Chinese medicinal preparation of symptom such as it is not well to cough up phlegm, through clinical verification, steady quality, determined curative effect is the oral drug preparation commonly used that clinical and family is used for the treatment of above disease.
Below be prescription and the extraction process that provides among the drug standard WS-11130 (ZD-1130)-2002:
Prescription: Fel Ursi powder 1.2, Bulbus Fritillariae Cirrhosae 75, aqua armeniacae 30ml, Mel 80, Mentholum 0.3, sucrose 560, sodium benzoate 560, ethyl hydroxybenzoate 0.5, caramel 30
Method for making: the above five tastes, get Fel Ursi powder, stir to join slowly down and boil and be chilled in the water about 60 ℃, add sodium benzoate and ethyl hydroxybenzoate while hot, treat dissolving fully after, water is to 12ml, bear bile fluid is standby.Get Bulbus Fritillariae Cirrhosae, pulverize, press (appendix IO of Chinese Pharmacopoeia version in 2000) percolation under fluid extract and the extractum item, use 70% ethanol percolation, collect the liquid 75ml that filters, it is standby to get Bulbus Fritillariae Cirrhosae fluidextract.Get more and more prosperous 450ml, boil, add Mel and sucrose, stirring and dissolving, defoam and impurity, add sodium benzoate, filter, add above-mentioned bear bile fluid and aqua armeniacae, Bulbus Fritillariae Cirrhosae fluidextract, Mentholum, ethyl hydroxybenzoate stirs, dissolving, filter, add caramel, add the distilled water that newly boils to ormal weight, embedding, sterilization, promptly.
Be explained as follows for said preparation in the appended Fel Ursi Bulbus Fritillariae Cirrhosae oral liquid description:
Nomenclature of drug: Fel Ursi Bulbus Fritillariae Cirrhosae oral liquid;
Main component: Fel Ursi powder, Bulbus Fritillariae Cirrhosae, aqua armeniacae, Mentholum;
Character: this product is light yellow liquid to light yellowish brown; Feeble QI perfume (or spice), has cooling throat feel at the sweet little hardship of distinguishing the flavor of;
Function cures mainly: removing heat-phlegm, and cough-relieving is used for phlegm-heat cough, expectoration is more than, the abundant expectoration tachypnea, it is not well to cough up phlegm;
Usage and dosage: oral, a 10ml, 2～3 times on the one, the child reduces by half;
Owing to reasons such as technologies of preparing, 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.And that the syrups preparation also exists medicament contg is low, and taking dose is big, and taking dose is inaccurate, takes inconvenient characteristics, also is not easy to go out to carry wait deficiency.
In addition, 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, 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, be to replenish the deficiency of the oral drug preparation that has symptoms such as being used for the treatment of acute and chronic bronchitis and panting now, a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is littler, and the medicament contg height, and taking dose is little, taking dose is accurate, taking convenience, cheap, and be convenient to the drug composition oral preparation Fel Ursi Bulbus Fritillariae Cirrhosae drop pill of going out to carry.
Fel Ursi Bulbus Fritillariae Cirrhosae drop pill involved in the present invention determines that through a large amount of experiment sievings based on the extraction process of Chinese traditional patent formulation Fel Ursi Bulbus Fritillariae Cirrhosae oral liquid, process is adjusted extracting section technology, and cooperates drop pill preparation technology to be prepared from.Be prepared by the following technical solutions, can obtain Fel Ursi Bulbus Fritillariae Cirrhosae drop pill involved in the present invention:
[preparation method]
1. be unit with g or kg, according to the weight portion meter, 1 part of Mentholum, 4 parts of Fel Ursi powders, 100 parts of aqua armeniacae, 250 parts of Bulbus Fritillariae Cirrhosaes, more than four the flavor through extraction process make the drug extract thick paste or dry powder standby;
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 drug extract: substrate=1: 1～1: 9.
4. according to 3. ratios that provide, accurately take by weighing drug extract and substrate, gradation is progressively inserted in the heating container, and heating while stirring is standby until the fused solution that obtains containing drug extract 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-5 ℃～40 ℃;
6. 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 Mentholum adding is contained in the fused solution and/or emulsion and/or suspension of drug extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, insulation, 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.
[a kind of preparation method of drug extract]
With g or kg is unit, according to the weight portion meter, get 1 part of Mentholum, 4 parts of Fel Ursi powders, 100 parts of aqua armeniacae, 250 parts of Bulbus Fritillariae Cirrhosaes respectively, more than four the flavor, get Bulbus Fritillariae Cirrhosae, pulverize, according to percolation under fluid extract and the extractum item among appendix IO of Chinese Pharmacopoeia version in 2000, with 70% ethanol percolation 24 hours, the collection liquid of filtering, filter, filtrate adds aqua armeniacae, under 70 ℃～80 ℃ temperature, be evaporated to relative density and be 1.20～1.30 extractum, Fel Ursi powder is crossed 200 sieves, add above-mentioned extractum with Mentholum, promptly; Perhaps pass through low temperature, drying under reduced pressure again, pulverize, promptly get dry powder.
Given here is according to a kind of preparation method of extract comparatively commonly used, its processing step adjustment is formed again.Similarly method is a lot, is not limited to this a kind of method during actual enforcement.
Beneficial effect
The Fel Ursi Bulbus Fritillariae Cirrhosae oral liquid that is prepared from according to the prescription that provides among the national drug standards WS-11130 (ZD-1130)-2002 and extraction process, it is a kind of removing heat-phlegm that has, antitussive action, be used for the treatment of phlegm-heat cough, expectoration is more than, abundant expectoration tachypnea, the pure Chinese medicinal preparation of symptom such as it is not well to cough up phlegm, through clinical verification, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above disease.
Owing to reasons such as technologies of preparing, 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.And that the syrups preparation also exists medicament contg is low, and taking dose is big, and taking dose is inaccurate, takes inconvenient characteristics, also is not easy to go out to carry wait deficiency.
In addition, 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, 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.
Fel Ursi Bulbus Fritillariae Cirrhosae drop pill involved in the present invention is compared with Fel Ursi Bulbus Fritillariae Cirrhosae oral liquid and other Fel Ursi Bulbus Fritillariae Cirrhosae oral formulations has following beneficial effect:
1. Fel Ursi Bulbus Fritillariae Cirrhosae drop pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extractum or the dry powder that contain four flavor active ingredient of Chinese herbs such as Fel Ursi powder, Bulbus Fritillariae Cirrhosae, aqua armeniacae, Mentholum; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.Compare with the administering mode of other Fel Ursi Bulbus Fritillariae Cirrhosae oral formulations, exist essential distinction.Utilize the drop pill of solid dispersion technology preparation, can adopt oral and sublingual administration, effective ingredient is fully contacted with mucomembranous surface, absorb, directly enter blood circulation by mucomembranous epithelial cell.Because active constituents of medicine directly enters blood circulation without gastrointestinal tract and liver, avoided first pass effect effectively, also avoided gastrointestinal irritation, thereby it is rapid to make Fel Ursi Bulbus Fritillariae Cirrhosae drop pill involved in the present invention have an onset, the bioavailability height, characteristics such as side effect is little, and medication is convenient.
2. Fel Ursi Bulbus Fritillariae Cirrhosae 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. Fel Ursi Bulbus Fritillariae Cirrhosae drop pill involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
In sum, make Fel Ursi Bulbus Fritillariae Cirrhosae 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 several groups of specific embodiments, be described further with regard to the preparation method of Fel Ursi Bulbus Fritillariae Cirrhosae drop pill of the present invention.
First group: the test of single-matrix
1. it is standby to save the extract dry powder that makes 4 kinds of pure active ingredient of Chinese herbs such as containing Fel Ursi powder, Bulbus Fritillariae Cirrhosae, aqua armeniacae, Mentholum earlier according to [a kind of preparation method of drug extract];
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. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. be prepared according to [preparation method] again, promptly can make the Fel Ursi Bulbus Fritillariae Cirrhosae drop pill of various different sizes.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae drop pill in qualitative difference, according to 1: 1 ratio, with drug extract 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 drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae drop pill in qualitative difference, according to 1: 3 ratio, with drug extract 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 drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae drop pill in qualitative difference, according to 1: 9 ratio, with drug extract 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 drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. it is standby to save the extract dry powder that makes 4 kinds of pure active ingredient of Chinese herbs such as containing Fel Ursi powder, Bulbus Fritillariae Cirrhosae, aqua armeniacae, Mentholum earlier according to [a kind of preparation method of drug extract];
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 extract: mixed-matrix weight and=1: 1～1: 9,
4. be prepared according to [preparation method] again, promptly can make the Fel Ursi Bulbus Fritillariae Cirrhosae drop pill of various different sizes.
[result of the test]
Test 4: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 1 ratio drug extract 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 experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 3 ratio drug extract 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 drug extracts and mixed-matrix constituted and obtain 4 groups of different experimental results seeing Table 5.
Test 6: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 9 ratio drug extract 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 experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 1 ratio drug extract 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 experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 3 ratio drug extract 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 experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 9 ratio drug extract 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 experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 1 ratio drug extract 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 experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 3 ratio drug extract 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 experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared Fel Ursi Bulbus Fritillariae Cirrhosae 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, according to 1: 9 ratio drug extract 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 experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: 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 | ????78 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 6000 | ????50.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 8000 | ????50.0 | ????78 | ??????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ????50.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????81 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin | ????50.0 | ????66 | ????＜30 | ????＞10 | + |
| Poloxamer | ????50.0 | ????73 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium | ????50.0 | ????71 | ????＜30 | ????＞10 | + |
| Sodium lauryl sulphate | ????50.0 | ????66 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ????50.0 | ????53 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????50.0 | ????54 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????50.0 | ????54 | ????＞30 | ????＞10 | +++ |
| Lac | ????50.0 | ????50 | ????＞30 | ????＞10 | +++ |
The group practices of table 2 drug extract and single-matrix
(drug extract: 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 | ????85 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????91 | ????＜30 | ????＜10 | ++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????93 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????81 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????82 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????25.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????70 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????69 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????68 | ????＞30 | ????＞10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: 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 | ????89 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????10.0 | ????87 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????82 | ????＜30 | ????＞10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????82 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????78 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????80 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????76 | ????＞30 | ????＞10 | +++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: 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 | ????82 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????78 | ????＜30 | ????＞10 | ++ |
| His bad dextrin doubly: Polyethylene Glycol=1: 1 | ????50 | ????73 | ????＜30 | ????＞10 | + |
The group practices of table 5 drug extract and mixed-matrix
(drug extract: 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 | ????89 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????86 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????82 | ????＜30 | ????＞10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug 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: 1 | ????10 | ????88 | ????＜30 | ????＜10 | ?+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????85 | ????＜30 | ????＜10 | ?+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????82 | ????＜30 | ????＞10 | ?+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????80 | ????＜30 | ????＞10 | ?+++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: 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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????86 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????82 | ????＜30 | ????＞10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: 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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????25 | ????86 | ????＜30 | ????＜10 | ++ |
The group practices of table 9 drug extract and mixed-matrix
(drug 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 | ????95 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????88 | ????＜30 | ????＜10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: 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 | ????92 | ????＜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 | ????84 | ????＜30 | ????＞10 | +++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: 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 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????25 | ????87 | ????＜30 | ????＜10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug 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: 10 | ????10 | ????91 | ????＜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 drug extract 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 drug extract 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 drug extract 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 (7)
- One kind be used for the treatment of phlegm-heat cough, expectoration is more than, the abundant expectoration tachypnea, the pharmaceutical composition Fel Ursi Bulbus Fritillariae Cirrhosae drop pill of symptoms such as it is not well to cough up phlegm, with Bulbus Fritillariae Cirrhosae, Fel Ursi powder, aqua armeniacae, Mentholum is raw material of Chinese medicine, after extraction obtains containing the drug extract of these four kinds of active ingredient of Chinese herbs, be prepared from a certain proportion of pharmaceutically suitable carrier again, wherein:1.1. with g or kg is unit, according to the weight portion meter, 1 part of Mentholum, 4 parts of Fel Ursi powders, 100 parts of aqua armeniacae, 250 parts of Bulbus Fritillariae Cirrhosaes, more than four the flavor make drug extract thick paste or dry powder through extraction process;1.2. 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;1.3. proportioning---with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
- 2. Fel Ursi Bulbus Fritillariae Cirrhosae drop pill 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 Fel Ursi Bulbus Fritillariae Cirrhosae drop pill as claimed in claim 1 or 2, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
- 4. Fel Ursi Bulbus Fritillariae Cirrhosae drop pill as claimed in claim 1, it is characterized in that described drug extract thick paste or dry powder obtain by the following method: with g or kg is unit, according to the weight portion meter, get 1 part of Mentholum respectively, 4 parts of Fel Ursi powders, 100 parts of aqua armeniacae, 250 parts of Bulbus Fritillariae Cirrhosaes, more than four flavors, get Bulbus Fritillariae Cirrhosae, pulverize, according to percolation under fluid extract and the extractum item among appendix IO of Chinese Pharmacopoeia version in 2000, with 70% ethanol percolation 24 hours, collect the liquid of filtering, filter, filtrate adds aqua armeniacae, under 70 ℃～80 ℃ temperature, be evaporated to relative density and be 1.20～1.30 extractum, Fel Ursi powder is crossed 200 sieves, add above-mentioned extractum with Mentholum, promptly; Perhaps pass through low temperature, drying under reduced pressure again, pulverize, promptly get dry powder.
- 5. the preparation method of a Fel Ursi Bulbus Fritillariae Cirrhosae drop pill is characterized in that being made of following process:5.1. with g or kg is unit, according to the weight portion meter, 1 part of Mentholum, 4 parts of Fel Ursi powders, 100 parts of aqua armeniacae, 250 parts of Bulbus Fritillariae Cirrhosaes, more than four the flavor through extraction process make the drug extract thick paste or dry powder standby;5.2. 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;5.3. proportioning---with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.5.4., accurately take by weighing drug extract 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 drug extract and substrate and/or emulsion and/or suspension;5.5. 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 ℃;5.6. 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 fused solution of drug extract and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, and splash into to shrink in the condensing agent by water dropper and be shaped promptly.
- 6. as the preparation method of Fel Ursi Bulbus Fritillariae Cirrhosae drop pill as described in the claim 5, it is characterized in that method 5.1 described drug extract thick pastes or dry powder obtain by the following method: with g or kg is unit, according to the weight portion meter, get 1 part of Mentholum respectively, 4 parts of Fel Ursi powders, 100 parts of aqua armeniacae, 250 parts of Bulbus Fritillariae Cirrhosaes, more than four the flavor, get Bulbus Fritillariae Cirrhosae, pulverize, according to percolation under fluid extract and the extractum item among appendix IO of Chinese Pharmacopoeia version in 2000, with 70% ethanol percolation 24 hours, collect the liquid of filtering, filter, filtrate adds aqua armeniacae, under 70 ℃～80 ℃ temperature, be evaporated to relative density and be 1.20～1.30 extractum, Fel Ursi powder is crossed 200 sieves, add above-mentioned extractum with Mentholum, promptly; Perhaps pass through low temperature, drying under reduced pressure again, pulverize, get dry powder.
- 7. as the preparation method of Fel Ursi Bulbus Fritillariae Cirrhosae drop pill as described in the claim 5, it is characterized in that: method 5.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
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| CNB2004100960303A CN1297254C (en) | 2004-11-26 | 2004-11-26 | Drop pills containing bear gall and tendril-leaved fritillary bulb and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100960303A CN1297254C (en) | 2004-11-26 | 2004-11-26 | Drop pills containing bear gall and tendril-leaved fritillary bulb and preparation method thereof |
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| CN1297254C CN1297254C (en) | 2007-01-31 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100382789C (en) * | 2005-08-11 | 2008-04-23 | 北京正大绿洲医药科技有限公司 | Orally administered dripping pills with diuresis inducing function and preparation process thereof |
| CN109528989A (en) * | 2017-09-21 | 2019-03-29 | 范文昆 | A kind of moistening lung to arrest cough cream |
| CN110051777A (en) * | 2019-05-29 | 2019-07-26 | 河南城建学院 | A kind of compound rabbit gallbladder pectoral syrup and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1256940C (en) * | 2002-02-07 | 2006-05-24 | 黄海波 | Compound Chinese medicine notoginseng dripping pills and its prepn process |
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2004
- 2004-11-26 CN CNB2004100960303A patent/CN1297254C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100382789C (en) * | 2005-08-11 | 2008-04-23 | 北京正大绿洲医药科技有限公司 | Orally administered dripping pills with diuresis inducing function and preparation process thereof |
| CN109528989A (en) * | 2017-09-21 | 2019-03-29 | 范文昆 | A kind of moistening lung to arrest cough cream |
| CN110051777A (en) * | 2019-05-29 | 2019-07-26 | 河南城建学院 | A kind of compound rabbit gallbladder pectoral syrup and preparation method thereof |
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