CN1634473A - Almond cough-relieving drop pills and preparation method thereof - Google Patents
Almond cough-relieving drop pills and preparation method thereof Download PDFInfo
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- CN1634473A CN1634473A CN 200410096031 CN200410096031A CN1634473A CN 1634473 A CN1634473 A CN 1634473A CN 200410096031 CN200410096031 CN 200410096031 CN 200410096031 A CN200410096031 A CN 200410096031A CN 1634473 A CN1634473 A CN 1634473A
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Abstract
The invention discloses an apricot kernel cough-relieving drop pills, which is a medicinal oral preparation having the functions of cough-relieving and phlegm reducing, and can be used for treating acute and chronic bronchitis, cough and expectoration. The drop pill 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 drop pill is prepared through the conventional apricot kernel cough-relieving electuary preparing processes.
Description
Technical field
The present invention relates to a kind of preventing phlegm from forming and stopping coughing effect that has, be used for the treatment of acute and chronic bronchitis, the pharmaceutical composition of symptoms such as cough ant phlegm particularly based on Chinese traditional patent formulation almond cough-relieving electuary, is changed a social system a kind of drug composition oral dropping pill formulation that forms through dosage form.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The almond cough-relieving electuary that prescription that provides among-the B-0552-91 and extraction process are prepared from, it is a kind of preventing phlegm from forming and stopping coughing effect that has, be used for the treatment of acute and chronic bronchitis, the oral syrup class pure Chinese medicinal preparation of symptoms such as cough ant phlegm, through clinical verification, steady quality, determined curative effect is clinical and common drug preparation family.
Below be drug standard WS
3Prescription that provides among-the B-0552-91 and extraction process and brief description:
Prescription: aqua armeniacae 40ml, Radix Polygalae fluid extractum 22.5ml, Pericarpium Citri Reticulatae fluidextract 15ml, Radix Platycodonis fluidextract 20ml, Radix Glycyrrhizae fluidextract 15ml, Radix Stemonae fluidextract 20ml;
Method for making: above Six-element, each fluid extract is mixed, be concentrated into the thick paste of relative density 1.30 or more, put coldly, add aqua armeniacae, mixing adds 3.5 times again and measures sucrose, and mixing is made granule, in the 40-50 cold drying, granulate, promptly.
Nomenclature of drug: almond cough-relieving electuary;
Character: this product is brown xanchromatic granule; Sweet, the little hardship, puckery of distinguishing the flavor of;
Function cures mainly: preventing phlegm from forming and stopping coughing is used for acute and chronic bronchitis, cough ant phlegm;
Usage and dosage: warm boiled water, one time one bag, 1～2 time on the one;
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.In addition, conventional peroral dosage form 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 be used for the treatment of acute and chronic bronchitis, the deficiency of the oral drug preparation of symptoms such as cough ant phlegm, a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is littler, and medicament contg height, taking dose is little, and taking dose is accurate, taking convenience, cheap, and be convenient to the drug composition oral preparation almond cough-relieving drop pills of going out to carry.
Almond cough-relieving drop pills involved in the present invention determines that through a large amount of experiment sievings based on the extraction process of Chinese traditional patent formulation almond cough-relieving electuary, 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 almond cough-relieving drop pills involved in the present invention:
[preparation method]
1. be unit with l or ml, adopt commercially available finished product, aqua armeniacae 30.2%, Radix Polygalae fluid extractum 17%, Pericarpium Citri Reticulatae fluidextract 11.3, Radix Platycodonis fluidextract 15.1%, Radix Glycyrrhizae fluidextract 11.3%, Radix Stemonae fluidextract 15.1%, above Six-element, aqua armeniacae is mixed with each fluid extract, be concentrated into the thick paste of relative density more than 1.30 promptly; Perhaps again through cold drying, pulverizing, it is standby promptly to get dry powder;
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 the thick paste of drug extract or dry powder: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing thick paste or the dry powder and the substrate of drug extract, 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. 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. 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 places 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 drug standard WS promulgated by the ministries or commissions of the Central Government
3The almond cough-relieving electuary that prescription that provides among-the B-0552-91 and extraction process are prepared from, it is a kind of preventing phlegm from forming and stopping coughing effect that has, be used for the treatment of acute and chronic bronchitis, the oral syrup class pure Chinese medicinal preparation of symptoms such as cough ant phlegm, through clinical verification, steady quality, determined curative effect is clinical and common drug preparation family.
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.In addition, conventional peroral dosage form 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.
Almond cough-relieving drop pills involved in the present invention is compared with almond cough-relieving electuary or other almond cough-relieving class oral formulations has following beneficial effect:
1. almond cough-relieving drop pills 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 Herba Ephedrae, Semen Armeniacae Amarum, Gypsum Fibrosum, Radix Glycyrrhizae (processing); 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 almond cough-relieving 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 thereby it is rapid to make that almond cough-relieving drop pills involved in the present invention has an onset, the bioavailability height, characteristics such as side effect is little, and medication is convenient.
2. almond cough-relieving drop pills 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. pedestrian's cough-relieving drop pills 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 almond cough-relieving 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 almond cough-relieving drop pills of the present invention.
First group: the test of single-matrix
1. be unit with l or ml, adopt commercially available finished product, aqua armeniacae 30.2%, Radix Polygalae fluid extractum 17%, Pericarpium Citri Reticulatae fluidextract 11.3, Radix Platycodonis fluidextract 15.1%, Radix Glycyrrhizae fluidextract 11.3%, Radix Stemonae fluidextract 15.1%; Above Six-element mixes aqua armeniacae with each fluid extract, be concentrated into behind the thick paste of relative density more than 1.30 again through cold drying, pulverizing, dry powder is standby;
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 dry powder: substrate=1: 1～1: 9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the almond cough-relieving drop pills of various different sizes.
[result of the test]
Test 1: for observe drug extract dry powder and different substrates when 1: 1 the proportioning prepared almond cough-relieving drop pills 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 dry powder and different substrates when 1: 3 the proportioning prepared almond cough-relieving drop pills 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 dry powder and different substrates when 1: 9 the proportioning prepared almond cough-relieving drop pills 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. be unit with l or ml, adopt commercially available finished product, aqua armeniacae 30.2%, Radix Polygalae fluid extractum 17%, Pericarpium Citri Reticulatae fluidextract 11.3, Radix Platycodonis fluidextract 15.1%, Radix Glycyrrhizae fluidextract 11.3%, Radix Stemonae fluidextract 15.1%; Above Six-element mixes aqua armeniacae with each fluid extract, be concentrated into behind the thick paste of relative density more than 1.30 again through cold drying, pulverizing, dry powder 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 extract: mixed-matrix weight and=1: 1～1: 9,
4. be prepared according to [preparation method] again, promptly can make the almond cough-relieving drop pills of various different sizes.
[result of the test]
Test 4: for observe extract dry powder and mixed-matrix when 1: 1 the proportioning prepared almond cough-relieving 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 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 extract dry powder and mixed-matrix when 1: 3 the proportioning prepared almond cough-relieving 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 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 5.
Test 6: for observe extract dry powder and mixed-matrix when 1: 9 the proportioning prepared almond cough-relieving 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 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 extract dry powder and mixed-matrix when 1: 1 the proportioning prepared almond cough-relieving 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 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 extract dry powder and mixed-matrix when 1: 3 the proportioning prepared almond cough-relieving 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 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 extract dry powder and mixed-matrix when 1: 9 the proportioning prepared almond cough-relieving 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 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 extract dry powder and mixed-matrix when 1: 1 the proportioning prepared almond cough-relieving 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: 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 extract dry powder and mixed-matrix when 1: 3 the proportioning prepared almond cough-relieving 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: 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 extract dry powder and mixed-matrix when 1: 9 the proportioning prepared almond cough-relieving 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: 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 | ++ |
| Betacyclodextrin: 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 (5)
1. one kind is used for the treatment of acute and chronic bronchitis, the pharmaceutical composition almond cough-relieving drop pills of symptoms such as cough ant phlegm, with aqua armeniacae, Radix Polygalae fluid extractum, Pericarpium Citri Reticulatae fluidextract, Radix Platycodonis fluidextract, Radix Glycyrrhizae fluidextract, Radix Stemonae fluidextract is raw material, be prepared from a certain proportion of pharmaceutically suitable carrier, wherein:
1.1 with 1 or ml be unit, adopt commercially available finished product, aqua armeniacae 30.2%, Radix Polygalae fluid extractum 17%, Pericarpium Citri Reticulatae fluidextract 11.3, Radix Platycodonis fluidextract 15.1%, Radix Glycyrrhizae fluidextract 11.3%, Radix Stemonae fluidextract 15.1%, above Six-element, aqua armeniacae is mixed with each fluid extract, be concentrated into the thick paste of relative density more than 1.30 promptly; Perhaps, get dry powder again through cold drying, pulverizing;
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 the thick paste of drug extract or dry powder: substrate=1: 1～1: 9;
2. almond cough-relieving 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 almond cough-relieving drop pills as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
4. the preparation method of an almond cough-relieving drop pills is characterized in that being made of following six steps:
4.1 with 1 or ml be unit, adopt commercially available finished product, aqua armeniacae 30.2%, Radix Polygalae fluid extractum 17%, Pericarpium Citri Reticulatae fluidextract 11.3, Radix Platycodonis fluidextract 15.1%, Radix Glycyrrhizae fluidextract 11.3%, Radix Stemonae fluidextract 15.1%, above Six-element, aqua armeniacae is mixed with each fluid extract, be concentrated into the thick paste of relative density more than 1.30 promptly; Or again through cold drying, pulverizing, it is standby to get dry powder;
4.2 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;
4.3 proportioning: with g or kg is unit, by weight, and the thick paste of drug extract or dry powder: substrate=1: 1～1: 9;
4.4, accurately take by weighing thick paste or the dry powder and the substrate of drug extract in 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;
4.5 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) ℃;
4.6 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, will 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.
5. as the preparation method of Chinese ephedra and almond containing cough stopping dripping 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 200410096031 CN1287771C (en) | 2004-11-26 | 2004-11-26 | Almond cough-relieving drop pills and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410096031 CN1287771C (en) | 2004-11-26 | 2004-11-26 | Almond cough-relieving drop pills and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1634473A true CN1634473A (en) | 2005-07-06 |
| CN1287771C CN1287771C (en) | 2006-12-06 |
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ID=34847827
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410096031 Expired - Fee Related CN1287771C (en) | 2004-11-26 | 2004-11-26 | Almond cough-relieving drop pills and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105267340A (en) * | 2015-10-14 | 2016-01-27 | 天津现代职业技术学院 | Preparation method for refined ephedra decoction dropping pill |
| CN105770806A (en) * | 2016-03-23 | 2016-07-20 | 福建中合医药股份有限公司 | Almond antitussive oral liquid and preparation method thereof |
-
2004
- 2004-11-26 CN CN 200410096031 patent/CN1287771C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105267340A (en) * | 2015-10-14 | 2016-01-27 | 天津现代职业技术学院 | Preparation method for refined ephedra decoction dropping pill |
| CN105267340B (en) * | 2015-10-14 | 2019-08-09 | 天津现代职业技术学院 | A kind of preparation method refining Mahuang Tang dripping pill |
| CN105770806A (en) * | 2016-03-23 | 2016-07-20 | 福建中合医药股份有限公司 | Almond antitussive oral liquid and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN1287771C (en) | 2006-12-06 |
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