CN100367937C - Throat dripping pill for clearing away heat and toxic material and its preparing method - Google Patents
Throat dripping pill for clearing away heat and toxic material and its preparing method Download PDFInfo
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- CN100367937C CN100367937C CNB2005100086198A CN200510008619A CN100367937C CN 100367937 C CN100367937 C CN 100367937C CN B2005100086198 A CNB2005100086198 A CN B2005100086198A CN 200510008619 A CN200510008619 A CN 200510008619A CN 100367937 C CN100367937 C CN 100367937C
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Abstract
The present invention relates to a medical composition for treating symptoms of swelling and pain in throat, throat itch, throat dry cough, etc., particularly a medical composition oral preparation which is prepared from traditional Chinese medicines of emblic leafflower fruit, paris root, menthol, borneol, etc. serving as raw materials. The present invention aims to replenish the insufficiency of the existing oral drug preparations for treating the disease symptoms, and provides a throat comforting drop pill of the medical composition oral preparation, and the throat comforting drop pill has the advantages of high biologic utilization degree, quick medicine release, quick curative effect, little poisonous side effect, high medicament content, cheap price and no pollution in the production. The throat comforting drop pill referred by the present invention is prepared from the traditional Chinese medicines of the emblic leafflower fruit powder, the paris root, the menthol, the borneol, etc. serving as raw materials and medicinal carriers serving as substrates.
Description
Technical field
The present invention relates to a kind of heat-clearing and toxic substances removing that has, the moistening lung and nourishing throat effect is used for laryngopharynx swelling and pain, itching throat, dry pharynx such as coughs at the pharmaceutical composition of symptom treatment, is a kind of drug composition oral preparation that feedstock production forms with 4 flavor Chinese medicines such as Fructus Phyllanthi, Rhizoma Paridis, Mentholum, Borneolum Syntheticum particularly.
Background technology
According to national drug standards WS
3The larynx that prescription that provides among-the B-4012-98 and extraction process the are prepared from buccal tablet that relaxes, it is a kind of heat-clearing and toxic substances removing that has, the moistening lung and nourishing throat effect, be used for laryngopharynx swelling and pain, itching throat, dry pharynx such as cough at the buccal tablet of symptom treatment, through clinical verification for many years, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above disease.
Below be drug standard WS
3The prescription and the extraction process of the easypro buccal tablet of the larynx that provides among-the B-4012-98:
Prescription: Fructus Phyllanthi powder 200g, Rhizoma Paridis 70g, Mentholum 0.4g, Borneolum Syntheticum 0.3g.
Method for making: above four flavors, fresh Fructus Phyllanthi is got by Fructus Phyllanthi powder system, and enucleation is squeezed the juice, and filters, and filtrate is concentrated in right amount, spraying drying powder-forming; Rhizoma Paridis is ground into fine powder, sieves.Add Fructus Phyllanthi powder and cane sugar powder 706g, sodium chloride 7.7g, dextrin 15.6g, mixing is used 80% alcohol granulation, drying; An amount of dissolve with ethanol of Mentholum, Borneolum Syntheticum with above-mentioned granule mixing, is pressed into 1000, promptly.
Be explained as follows for this tablet in the easypro buccal tablet description of appended larynx:
Nomenclature of drug: the larynx buccal tablet that relaxes;
Main component: Fructus Phyllanthi powder, Rhizoma Paridis, Mentholum, Borneolum Syntheticum;
Character: for yellow-white to brown sheet; Gas perfume (or spice) is little sour-sweet, little puckery.
Function cures mainly: heat-clearing and toxic substances removing, moistening lung and nourishing throat; Be used for laryngopharynx swelling and pain, itching throat, dry pharynx such as cough at disease;
Usage and dosage: buccal, one time 1～2, one day 10.
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 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 existing laryngopharynx swelling and pain that is used for, itching throat, dry pharynx such as cough at the deficiency of the oral drug preparation of symptom treatment, and a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is little, the medicament contg height, cheap, and free of contamination aborning drug composition oral preparation larynx drop pills.
Larynx drop pills involved in the present invention is a raw material with 4 flavor Chinese medicines such as Fructus Phyllanthi powder, Rhizoma Paridis, Mentholum, Borneolum Syntheticum, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain larynx drop pills involved in the present invention.
[preparation method]
1. the preparation of Chinese crude drug---fresh Fructus Phyllanthi is got by Fructus Phyllanthi powder system, and enucleation is squeezed the juice, and filters, and filtrate is concentrated in right amount, spraying drying powder-forming; Rhizoma Paridis is ground into fine powder, sieves; Mentholum, Borneolum Syntheticum and above-mentioned dry powder mixing, promptly;
2. substrate---Polyethylene Glycol
(1000～20000), any one or two or more 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 medicine dry powder: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing medicine dry powder and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing 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. when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, will contain the fused solution of medicine dry powder and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, splash in the condensing agent;
Condensing agent can be in liquid paraffin, methyl-silicone oil, vegetable oil, the water any one or multiple;
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 national drug standards WS
3The larynx that prescription that provides among-the B-4012-98 and extraction process the are prepared from buccal tablet that relaxes, it is a kind of heat-clearing and toxic substances removing that has, the moistening lung and nourishing throat effect, be used for laryngopharynx swelling and pain, itching throat, dry pharynx such as cough at the buccal tablet of symptom treatment, through clinical verification for many years, 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.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.
Larynx drop pills involved in the present invention is compared with the easypro buccal tablet of larynx, has following beneficial effect:
1. larynx drop pills involved in the present invention; utilize surfactant etc. to be substrate; make solid dispersion with 4 flavor Chinese medicines such as Fructus Phyllanthi, Rhizoma Paridis, Mentholum, Borneolum Syntheticum; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; 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. larynx 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, and local application's onset is faster.This one side has not only kept the advantage of buccal tablet, has more than buccal tablet again to be easy to containing, the bioavailability height.Can not produce any residual harmful substance yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously at gastric.
3. larynx 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.
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, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of larynx drop pills of the present invention.
First group: the test of single-matrix
1. it is standby to make the dry powder that contains 4 flavor Chinese medicines such as Fructus Phyllanthi powder, Rhizoma Paridis, Mentholum, Borneolum Syntheticum earlier according to [preparation method] 1;
2. substrate: Polyethylene Glycol
(1000～20000), 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 the process of [preparation method] 4～7 again, promptly can make the larynx drop pills of all size.
[result of the test]
Test 1: for observe medicine dry powder and different substrates when 1: 1 the proportioning prepared larynx drop pills in qualitative difference, according to 1: 1 ratio, with medicine dry powder respectively with Polyethylene Glycol
1000, 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 16 pharmaceutical compositions experiments that contain medicine dry powder and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe medicine dry powder and different substrates when 1: 3 the proportioning prepared larynx drop pills in qualitative difference, according to 1: 3 ratio, with medicine dry powder respectively with Polyethylene Glycol
1000, 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 16 pharmaceutical compositions experiments that contain medicine dry powder and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe medicine dry powder and different substrates when 1: 9 the proportioning prepared larynx drop pills in qualitative difference, according to 1: 9 ratio, with medicine dry powder respectively with Polyethylene Glycol
1000, 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 16 pharmaceutical compositions experiments that contain medicine dry powder and different substrates, and obtain 16 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. it is standby to make the dry powder that contains 4 flavor Chinese medicines such as Fructus Phyllanthi powder, Rhizoma Paridis, Mentholum, Borneolum Syntheticum earlier according to [preparation method] 1;
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.
[result of the test]
Test 4: for observe medicine dry powder and mixed-matrix when 1: 1 the proportioning prepared larynx drop pills in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared larynx drop pills in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: for observe medicine dry powder and mixed-matrix when 1: 9 the proportioning prepared larynx drop pills in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe medicine dry powder and mixed-matrix when 1: 1 the proportioning prepared larynx drop pills in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe medicine dry powder and mixed-matrix when 1: 3 the proportioning prepared larynx drop pills in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe medicine dry powder and mixed-matrix when 1: 9 the proportioning prepared larynx drop pills in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: in order to observe larynx drop pills that medicine dry powder and mixed-matrix make when 1: 1 the proportioning in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: in order to observe larynx drop pills that medicine dry powder and mixed-matrix make when 1: 3 the proportioning in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: in order to observe larynx drop pills that medicine dry powder and mixed-matrix make when 1: 9 the proportioning in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio medicine dry powder is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 medicines dry powder and mixed-matrixes are constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 medicine dry powder and single-matrix
(medicine dry powder: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 50.0 | 70 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 50.0 | 63 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 72 | ＜30 | ＞10 | + |
| Poloxamer | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 73 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 68 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 55 | ＞30 | ＞10 | +++ |
| Sodium stearate | 50.0 | 54 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 50.0 | 55 | ＞30 | ＞10 | +++ |
| Lac | 50.0 | 52 | ＞30 | ＞10 | +++ |
The group practices of table 2 medicine dry powder and single-matrix
(medicine dry powder: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 25.0 | 63 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 25.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 86 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 91 | ＜30 | ＜10 | ++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 92 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 82 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 80 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 25.0 | 77 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 72 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 71 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 72 | ＞30 | ＞10 | +++ |
The group practices of table 3 medicine dry powder and single-matrix
(medicine dry powder: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 77 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 10.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 93 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 88 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 83 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 77 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 74 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 73 | ＞30 | ＞10 | +++ |
The group practices of table 4 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 85 | ＜30 | ＜10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 86 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: poly-second two ferment=1: 1 | 50 | 81 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 78 | ＜30 | ＞10 | + |
The group practices of table 5 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 86 | ＜30 | ＞10 | ++ |
The group practices of table 6 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 84 | ＜30 | ＞10 | +++ |
The group practices of table 7 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 94 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 83 | ＜30 | ＞10 | ++ |
The group practices of table 8 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 95 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 89 | ＜30 | ＜10 | ++ |
The group practices of table 9 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 95 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 94 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 10 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 82 | ＜30 | ＞10 | +++ |
The group practices of table 11 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 25 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 87 | ＜30 | ＜10 | +++ |
The group practices of table 12 medicine dry powder and mixed-matrix
(medicine dry powder: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 90 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of medicine dry powder and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of medicine dry powder and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of medicine dry powder and substrate is 1: 9, though the rounding rate, the ball method of double differences is different and index such as hardness has raising, and is not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. one kind is used for laryngopharynx swelling and pain, and itching throat, dry pharynx such as cough at the larynx drop pills of treatment for diseases, are raw material of Chinese medicine with Fructus Phyllanthi powder, Rhizoma Paridis, Mentholum, Borneolum Syntheticum, are prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) get fresh Fructus Phyllanthi, enucleation is squeezed the juice, and filters, and filtrate is concentrated in right amount, spraying drying powder-forming; Rhizoma Paridis is ground into fine powder, sieves; Mentholum, Borneolum Syntheticum are pulverized, and with above-mentioned dry powder mixing, promptly get mixed material, and be standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, and the ratio of described mixed material and substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described raw material and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described raw material and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at-5 ℃～40 ℃;
When (5) treating that dropping-pill machine head and condensing agent reach described state of temperature respectively, will contain the fused solution of described raw material 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 and be shaped promptly.
2. larynx drop pills as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100086198A CN100367937C (en) | 2005-02-28 | 2005-02-28 | Throat dripping pill for clearing away heat and toxic material and its preparing method |
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| CNB2005100086198A CN100367937C (en) | 2005-02-28 | 2005-02-28 | Throat dripping pill for clearing away heat and toxic material and its preparing method |
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| CN100367937C true CN100367937C (en) | 2008-02-13 |
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