CN1315462C - Throat clearing drip pill and its preparation method - Google Patents
Throat clearing drip pill and its preparation method Download PDFInfo
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- CN1315462C CN1315462C CNB2005100633556A CN200510063355A CN1315462C CN 1315462 C CN1315462 C CN 1315462C CN B2005100633556 A CNB2005100633556 A CN B2005100633556A CN 200510063355 A CN200510063355 A CN 200510063355A CN 1315462 C CN1315462 C CN 1315462C
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Abstract
The present invention relates to a medical composition having the functions of expelling wind, relieving exterior syndromes, clearing away heat and toxic material and clearing throats and used for curing pharyngalgia, dry throats, hoarse voice, fever aversion to wind, cough, etc. The present invention aims to overcome the defects in the existing oral medicines used for curing the diseases and provides a throat-clearing dripping pill having the advantages of high biologic utilization rate, rapid medicine release, instant effect, small side and toxic effect, high medicine content, accurate administration dosage, convenient administration, low price and no pollution in the production process. The throat-clearing dripping pill is prepared from extracts of active medicine components of 8 meshes of traditional Chinese medicines comprising japanese peristrophe herb, coral ardisia root, thinleaf adina root, glutinous rice vine root, arrowshaped tinospora root, balloonflower root, mint, menthol, etc., and a medicinal carrier used as a base material.
Description
Technical field
The present invention relates to a kind of have dispelling wind to relieve the exterior syndrome, heat-clearing and toxic substances removing, clearing throat effect, the pharmaceutical composition that is used for treatment for diseases such as pharyngalgia, dry pharynx, hoarseness, fever and aversion to wind, cough is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 8 flavor Chinese medicine active pharmaceutical ingredients such as Herba Peristrophes, Radix Ardisiae Crenatae, Radix Gei japonici, root of Herba Gonostegiae hirtae, Radix Tinosporae, Radix Platycodonis, Herba Menthae, Mentholum particularly.
Background technology
The throat clearing sheet that is prepared from according to the prescription that provides among the national drug standards WS-10068 (ZD-0068)-2002 and extraction process, be a kind of have dispelling wind to relieve the exterior syndrome, heat-clearing and toxic substances removing, clearing throat effect, the tablet class oral formulations that is used for symptom treatments such as pharyngalgia, dry pharynx, hoarseness, fever and aversion to wind, cough, 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-mentioned disease.
Below be the prescription and the extraction process of the throat clearing sheet that provides among the drug standard WS-10068 (ZD-0068)-2002:
Prescription: Herba Peristrophes 211g, Radix Ardisiae Crenatae 126g, Radix Gei japonici 158g, root of Herba Gonostegiae hirtae 158g, Radix Tinosporae 63g, Radix Platycodonis 126g, Herba Menthae 158g, Mentholum 5g, starch 50g, sucrose 400g.
Method for making: above eight flavors, except that Mentholum, seven flavor vapor distillations such as all the other Herba Peristrophess extract volatile oil, aqueous solution after distillation device is in addition collected, medicinal residues decoct with water 1.5 hours, filter, and merge with above-mentioned aqueous solution, being evaporated to relative density is the clear paste of 1.10～1.12 (60 ℃), add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, filter, decompression filtrate recycling ethanol, and be concentrated into the clear paste that relative density is 1.25～1.30 (70 ℃); Add starch, sucrose, make granule, drying.Other gets Mentholum, adds ethanol and makes dissolving in right amount, sprays in the granule, sprays into above-mentioned volatile oil again, mixing, and airtight 2 hours, promptly.
Be explained as follows in the appended throat clearing sheet description:
Nomenclature of drug: throat clearing sheet;
Main component: Herba Peristrophes, Radix Ardisiae Crenatae, Radix Gei japonici, root of Herba Gonostegiae hirtae, Radix Tinosporae, Radix Platycodonis, Herba Menthae, Mentholum;
Function cures mainly: have dispelling wind to relieve the exterior syndrome, heat-clearing and toxic substances removing, clearing throat effect, be used for pharyngalgia, dry pharynx, hoarseness, fever and aversion to wind, cough or the like symptom;
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 deficiency that is used for the oral drug preparation of symptom treatments such as pharyngalgia, dry pharynx, hoarseness, fever and aversion to wind, cough, provide a kind of bioavailability height, release fast, produce effects fast, toxic and side effects is little, and the medicament contg height, taking dose is accurate, taking convenience, cheap, and free of contamination aborning throat clearing drip pill.Throat clearing drip pill involved in the present invention, with the extract that contains Herba Peristrophes, Radix Ardisiae Crenatae, Radix Gei japonici, root of Herba Gonostegiae hirtae, Radix Tinosporae, Radix Platycodonis, Herba Menthae, Mentholum etc. 8 flavor Chinese medicine active pharmaceutical ingredients is raw material, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain throat clearing drip pill involved in the present invention:
[preparation method]
1. raw material---contain the extract of 8 flavor Chinese medicine active pharmaceutical ingredients such as Herba Peristrophes, Radix Ardisiae Crenatae, Radix Gei japonici, root of Herba Gonostegiae hirtae, Radix Tinosporae, Radix Platycodonis, Herba Menthae, Mentholum;
2. substrate---Polyethylene Glycol
(1000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning---with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract 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, fused solution and/or emulsion and/or the suspension and the abundant mixing of Mentholum that will contain drug extract and substrate, 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.
[appendix: contain Herba Peristrophes, Radix Ardisiae Crenatae etc. 8 flavor Chinese medicine active pharmaceutical ingredient preparation method of extract] get Herba Peristrophes 211g, Radix Ardisiae Crenatae 126g, Radix Gei japonici 158g, root of Herba Gonostegiae hirtae 158g, Radix Tinosporae 63g, Radix Platycodonis 126g, Herba Menthae 158g, Mentholum 5g, more than eight the flavor medical materials, except that Mentholum, seven flavor vapor distillations such as all the other Herba Peristrophess extract volatile oil, aqueous solution after distillation device is in addition collected, medicinal residues decoct with water 1.5 hours, filter, merge with above-mentioned aqueous solution, in being evaporated to relative density below 60 ℃ is 1.10～1.15 clear paste, adding ethanol makes and contains alcohol amount and reach 60%, left standstill 24 hours, filter, decompression filtrate recycling ethanol, and be 1.25～1.35 clear paste in being concentrated into relative density below 70 ℃; Or continue to be ground into dry powder, promptly dry below 60 ℃.
What provide above is a kind of preparation method of common drug extract, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
Beneficial effect
The throat clearing sheet that is prepared from according to the prescription that provides among the national drug standards WS-10068 (ZD-0068)-2002 and extraction process, be a kind of have dispelling wind to relieve the exterior syndrome, heat-clearing and toxic substances removing, clearing throat effect, the tablet class oral formulations that is used for symptom treatments such as pharyngalgia, dry pharynx, hoarseness, fever and aversion to wind, cough, 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-mentioned 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.
Throat clearing drip pill involved in the present invention is compared with the throat clearing sheet, has following beneficial effect:
1. throat clearing drip pill involved in the present invention; utilize surfactant etc. to be substrate; make solid dispersion with containing 8 flavor Chinese medicine active pharmaceutical ingredient extracts such as Herba Peristrophes, Radix Ardisiae Crenatae, Radix Gei japonici, root of Herba Gonostegiae hirtae, Radix Tinosporae, Radix Platycodonis, Herba Menthae, Mentholum; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; medicine 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. throat clearing drip pill involved in the present invention contacts promptly with saliva and to dissolve rapidly, and is absorbed by oral mucosa, and is not only rapid-action, and the influence of not taken food, and promptly all can containing take after meal ante cibum, and local application's onset is faster.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. throat clearing drip 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, 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 throat clearing drip pill of the present invention.
First group: the test of single-matrix
1. it is standby to make the dry powder that contains 8 flavor Chinese medicine active pharmaceutical ingredients such as Herba Peristrophes, Radix Ardisiae Crenatae, Radix Gei japonici, root of Herba Gonostegiae hirtae, Radix Tinosporae, Radix Platycodonis, Herba Menthae, Mentholum in advance according to [appendix];
2. substrate: Polyethylene Glycol
(1000～20000), pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the throat clearing drip pill of all size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared throat clearing drip pill in qualitative difference, according to 1: 1 ratio, with drug extract 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, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared throat clearing drip pill in qualitative difference, according to 1: 3 ratio, with drug extract 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, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared throat clearing drip pill in qualitative difference, according to 1: 9 ratio, with drug extract 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, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract 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 8 flavor Chinese medicine active pharmaceutical ingredients such as Herba Peristrophes, Radix Ardisiae Crenatae, Radix Gei japonici, root of Herba Gonostegiae hirtae, Radix Tinosporae, Radix Platycodonis, Herba Menthae, Mentholum in advance according to [appendix];
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 drug extract and mixed-matrix when 1: 1 the proportioning prepared throat clearing drip pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared throat clearing drip pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, 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 drug extract and mixed-matrix when 1: 9 the proportioning prepared throat clearing drip pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared throat clearing drip pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared throat clearing drip pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared throat clearing drip pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, 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: in order to observe throat clearing drip pill that drug extract 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 drug extract 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 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: in order to observe throat clearing drip pill that drug extract 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 drug extract 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 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: in order to observe throat clearing drip pill that drug extract 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 drug extract 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 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 1000 | 50.0 | 70 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 50.0 | 87 | ＜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 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 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 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 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 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 | 85 | ＜30 | ＜10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 86 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 81 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 78 | ＜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 | 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 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 | 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 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 | 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 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 | 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 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 | 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 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 | 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 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 | 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 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 | 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 drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is only comparatively desirable, 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 (2)
1. a throat clearing drip pill is a raw material with Herba Peristrophes, Radix Ardisiae Crenatae, Radix Gei japonici, root of Herba Gonostegiae hirtae, Radix Tinosporae, Radix Platycodonis, Herba Menthae, Mentholum, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) gets Herba Peristrophes 211g, Radix Ardisiae Crenatae 126g, Radix Gei japonici 158g, root of Herba Gonostegiae hirtae 158g, Radix Tinosporae 63g, Radix Platycodonis 126g, Herba Menthae 158g, Mentholum 5g, more than eight the flavor medical materials, except that Mentholum, seven flavor vapor distillations such as all the other Herba Peristrophess extract volatile oil, aqueous solution after distillation device is in addition collected, medicinal residues decoct with water 1.5 hours, filter, merging with above-mentioned aqueous solution, is 1.10～1.15 clear paste in being evaporated to relative density below 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, left standstill 24 hours, filter, decompression filtrate recycling ethanol, and be 1.25～1.35 clear paste in being concentrated into relative density below 70 ℃; Or continue to be ground into dry powder dry below 60 ℃, promptly get the extract that contains pharmaceutically active ingredient in described eight flavors, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium; With g or kg is unit, and the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, describedly contains that the extract of pharmaceutically active ingredient and the ratio of substrate are 1: 3 in eight flavors;
(3) according to aforementioned proportion, accurately take by weighing described extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described extract 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 remains on 50 ℃～90 ℃, and the condensing agent cooling also remains on-5 ℃～40 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, fused solution and/or emulsion and/or the suspension and the abundant mixing of Mentholum that will contain described extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink shaping promptly.
2. throat clearing drip pill 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 |
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| CNB2005100633556A CN1315462C (en) | 2005-04-08 | 2005-04-08 | Throat clearing drip pill and its preparation method |
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|---|---|---|---|
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| CN111686085B (en) * | 2020-06-30 | 2022-09-06 | 贵州益佰女子大药厂有限责任公司 | Preparation method of throat clearing preparation |
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Non-Patent Citations (3)
| Title |
|---|
| 中药药剂学，"滴丸" 范碧亭主编，380.383，上海科学技术出版社 1997 * |
| 国家药品监督管理局国家中成药标准汇编 中成药地方标准上升国家标准部分 耳鼻喉科分册 国家药品监督管理局，211.212，国家药品监督管理局 2002 * |
| 国家药品监督管理局国家中成药标准汇编 中成药地方标准上升国家标准部分 耳鼻喉科分册 国家药品监督管理局，211.212，国家药品监督管理局 2002;中药药剂学，"滴丸" 范碧亭主编，380.383，上海科学技术出版社 1997 * |
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