CN1660316A - Drop pills preparation in use for treating bronchitis and preparation method - Google Patents
Drop pills preparation in use for treating bronchitis and preparation method Download PDFInfo
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- CN1660316A CN1660316A CN 200410103551 CN200410103551A CN1660316A CN 1660316 A CN1660316 A CN 1660316A CN 200410103551 CN200410103551 CN 200410103551 CN 200410103551 A CN200410103551 A CN 200410103551A CN 1660316 A CN1660316 A CN 1660316A
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Abstract
A medicine in the form of dripping pill for treating cough, asthma, and bronchitis is prepared from littleleaf banyan extract, chorphenamine maleate, and medicinal carrier.
Description
Technical field
The present invention relates to a kind of antitussive that has, eliminate the phlegm, relieving asthma, antiinflammation, be used for the treatment of the pharmaceutical composition of diseases such as cough with asthma and chronic bronchitis, particularly the basic components with the ketelin tablet is reference, changes 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 Ketelin Tablet that prescription that provides among-the B-2742-97 and extraction process are prepared from, be a kind of antitussive that has, eliminate the phlegm, relieving asthma, antiinflammation is used for the treatment of the oral tablet of diseases such as cough with asthma and chronic bronchitis, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
Below be drug standard WS
3Prescription that provides among-the B-2742-97 and technology and brief description:
Prescription: Foliole banyan dry extract 180, chlorphenamine maleate 0.7;
Method for making: above two flavors, get Foliole banyan dry extract, be ground into fine powder, add chlorphenamine maleate and appropriate amount of auxiliary materials, mixing is made granule, is pressed into 1000, the bag film-coat, promptly;
Function cures mainly: antitussive, eliminate the phlegm, and relieving asthma antiinflammatory.Be used for cough with asthma and chronic bronchitis.
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.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 production technology of drop pill is simple, and production cost is lower, common according to measuring and calculating at about 50% of other oral formulations, patient's drug cost is reduced greatly, help improving the ability of seeking medical advice of extensive patients, also help improving the general health level of society.
Summary of the invention
Purpose of the present invention is to replenish the existing deficiency that is used for the treatment of the oral drug preparation of diseases such as cough with asthma and chronic bronchitis, and a kind of bioavailability height is provided, release fast, produce effects is pollution-free in the production fast, and cheap drug composition oral preparation ketelin drop pill.
Ketelin drop pill involved in the present invention is an active pharmaceutical ingredient with Foliole banyan dry extract and chlorphenamine maleate, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain ketelin drop pill involved in the present invention:
[preparation method]
1. medicine material: Foliole banyan dry extract, chlorphenamine maleate;
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
3.1. medicine material ratio: Foliole banyan dry extract: chlorphenamine maleate=257: 1
3.2. medicine material: substrate=1: 1～1: 9
4. according to the given ratio of prescription, accurately take by weighing medicine material and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing medicine material 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, fused solution and/or the emulsion and/or the suspension that will contain medicine material and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, under the state of 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.
Attached: the Foliole banyan extract making method
This product is the dried leaves extract of moraceae plants spire banyan Ficus microcarpa L.F..Get Folium fici microcarpae, decoct with water secondary, collecting decoction filters, and filtrate is concentrated in right amount, add ethanol and fully stir, and make and contain alcohol amount and make a call to 80～90%, leave standstill filtration, filtrate recycling ethanol, be condensed into thick paste, or, be ground into dry powder again through 60 ℃～80 ℃ dryings,, promptly.
This product is the thick or hard paste of brownish black; The mastic exquisiteness, puckery, little hardship.
Beneficial effect
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The Ketelin Tablet that prescription that provides among-the B-2742-97 and extraction process are prepared from, be a kind of antitussive that has, eliminate the phlegm, relieving asthma, antiinflammation is used for the treatment of the oral tablet of diseases such as cough with asthma and chronic bronchitis, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
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.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 production technology of drop pill is simple, and production cost is lower, common according to measuring and calculating at about 50% of other oral formulations, patient's drug cost is reduced greatly, help improving the ability of seeking medical advice of extensive patients, also help improving the general health level of society.
Ketelin drop pill involved in the present invention is compared with the ketelin tablet has following beneficial effect:
1. ketelin drop pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with Flos Daturae total alkaloids, clenbuterol hydrochloride, make medicine be molecule, colloid or microcrystalline state and be scattered in the substrate, the total surface area of medicine increases; and substrate is hydrophilic; 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.
2. ketelin drop pill involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. ketelin 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.
4. 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.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of ketelin drop pill of the present invention.
First group: the test of single-matrix
1. raw material: according to [Foliole banyan extract making method] control Foliole banyan dry extract, chlorphenamine maleate;
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
3.1. medicine material ratio: Foliole banyan dry extract: chlorphenamine maleate=257: 1
3.2. medicine material: substrate=1: 1～1: 9
4. be prepared according to [preparation method] 4～7 again, promptly can make the ZHICHUANGLING drop pill of various different sizes.
[result of the test]
Test 1: for observe medicine material and different substrates when 1: 1 the proportioning prepared ketelin drop pill in qualitative difference, according to 1: 1 ratio, with medicine material respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain medicine material and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe medicine material and different substrates when 1: 3 the proportioning prepared ketelin drop pill in qualitative difference, according to 1: 3 ratio, with medicine material respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain medicine material and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe medicine material and different substrates when 1: 9 the proportioning prepared ketelin drop pill in qualitative difference, according to 1: 9 ratio, with medicine material respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain medicine material and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. raw material: according to [Foliole banyan extract making method] control Foliole banyan dry extract, chlorphenamine maleate;
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. proportioning: with g or kg is unit, by weight
3.1. medicine material ratio: Foliole banyan dry extract: chlorphenamine maleate=257: 1
3.2. medicine material: substrate=1: 1～1: 9
4. be prepared according to [preparation method] 4～7 again, promptly can make the ZHICHUANGLING drop pill of various different sizes.
[result of the test]
Test 4: for observe medicine material and mixed-matrix when 1: 1 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe medicine material and mixed-matrix when 1: 3 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: for observe medicine material and mixed-matrix when 1: 9 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe medicine material and mixed-matrix when 1: 1 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe medicine material and mixed-matrix when 1: 3 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe medicine material and mixed-matrix when 1: 9 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: for observe medicine material and mixed-matrix when 1: 1 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: for observe medicine material and mixed-matrix when 1: 3 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: for observe medicine material and mixed-matrix when 1: 9 the proportioning prepared ketelin 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 medicine material and single-matrix
(medicine material: 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 medicine material and single-matrix
(medicine material: 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 medicine material and single-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and mixed-matrix
(medicine material: 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 medicine material and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of medicine material and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of medicine material and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves 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. a pharmaceutical composition ketelin drop pill that is used for the treatment of diseases such as cough with asthma and chronic bronchitis is an active pharmaceutical ingredient with Foliole banyan dry extract and chlorphenamine maleate, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1. medicine material: Foliole banyan dry extract, chlorphenamine maleate;
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
Medicine material ratio: Foliole banyan dry extract: chlorphenamine maleate=257: 1,
Medicine material: substrate=1: 1～1: 9.
2. ketelin 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 ketelin drop pill as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described medicine material and substrate is 1: 1～1: 5.
4. the preparation method of a ketelin drop pill is characterized in that being made up of following step:
4.1. medicine material: Foliole banyan dry extract, chlorphenamine maleate;
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
Medicine material ratio: Foliole banyan dry extract: chlorphenamine maleate=257: 1
Medicine material: substrate=1: 1～1: 9;
4.4., accurately take by weighing medicine material and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing medicine material 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, fused solution and/or the emulsion and/or the suspension that will contain medicine material and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper, shrink molding, promptly.
5. as the preparation method of ketelin drop pill 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.
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| CNB2004101035517A CN100364506C (en) | 2004-12-30 | 2004-12-30 | Drop pills preparation in use for treating bronchitis and preparation method |
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|---|---|---|---|
| CNB2004101035517A CN100364506C (en) | 2004-12-30 | 2004-12-30 | Drop pills preparation in use for treating bronchitis and preparation method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100386071C (en) * | 2005-06-22 | 2008-05-07 | 叶耀良 | Medicine for treating cough and chronic bronchitis |
| CN101007062B (en) * | 2005-12-31 | 2011-07-06 | 朱志宏 | Traditional Chinese medicine composition capable of resisting infection |
| CN102949456A (en) * | 2011-08-30 | 2013-03-06 | 江守训 | Preparation method of ficus microcarpa extract and medicine or wound dressing for promoting wound healing |
| CN107823263A (en) * | 2017-12-08 | 2018-03-23 | 湖南康寿制药有限公司 | A kind of preventing phlegm from forming and stopping coughing Chinese medicine composition and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1247241C (en) * | 2003-11-12 | 2006-03-29 | 北京正大绿洲医药科技有限公司 | Liuwei Dihuang dripping pills and its preparation |
-
2004
- 2004-12-30 CN CNB2004101035517A patent/CN100364506C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100386071C (en) * | 2005-06-22 | 2008-05-07 | 叶耀良 | Medicine for treating cough and chronic bronchitis |
| CN101007062B (en) * | 2005-12-31 | 2011-07-06 | 朱志宏 | Traditional Chinese medicine composition capable of resisting infection |
| CN102949456A (en) * | 2011-08-30 | 2013-03-06 | 江守训 | Preparation method of ficus microcarpa extract and medicine or wound dressing for promoting wound healing |
| CN102949456B (en) * | 2011-08-30 | 2015-01-21 | 江守训 | Preparation method of Ficus microphylla extract and medicine or wound dressing for promoting wound healing |
| CN107823263A (en) * | 2017-12-08 | 2018-03-23 | 湖南康寿制药有限公司 | A kind of preventing phlegm from forming and stopping coughing Chinese medicine composition and preparation method thereof |
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| Publication number | Publication date |
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| CN100364506C (en) | 2008-01-30 |
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