CN1301101C - Oral drip pill used for cough suppressing phlegm transforming and its preparation method - Google Patents
Oral drip pill used for cough suppressing phlegm transforming and its preparation method Download PDFInfo
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- CN1301101C CN1301101C CN 200510068269 CN200510068269A CN1301101C CN 1301101 C CN1301101 C CN 1301101C CN 200510068269 CN200510068269 CN 200510068269 CN 200510068269 A CN200510068269 A CN 200510068269A CN 1301101 C CN1301101 C CN 1301101C
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Abstract
The present invention relates to a medicinal composition having the functions of relieving coughs and eliminating phlegm and normally used for treating diseases such as coughs with copious phlegm, bronchitis, etc. The present invention aims to overcome the defects of the existing oral medicinal preparation for treating the diseases and provide a cough-relieving and phlegm-eliminating drop pill with the advantages of high bioavailability, quick medicine release, high effectual speed, high medicine content, accurate administration dose, low price and portability. The cough-relieving and phlegm-eliminating drop pill is prepared by using extract of active ingredients of seven traditional Chinese medicines such as loquat leaf, platycodon root, tendrilleaf fritillary bulb, root of straight ladybell, polygala, green tea, menthol, etc. and a medicinal vector used as a matrix.
Description
Technical field
The present invention relates to a kind of cough-suppressing phlegm-dispelling functions that has, be usually used in cough ant phlegm, the pharmaceutical composition of treatment for diseases such as bronchitis is a kind of drug composition oral preparation that feedstock production forms to contain 7 flavor active ingredient of Chinese herbs extracts such as Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, Mentholum particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The cough syrup that the preparation method that provides among-the B-3900-98 is prepared from is a kind of cough-suppressing phlegm-dispelling functions that has, and is usually used in cough ant phlegm, the syrups oral formulations of treatment for diseases such as bronchitis, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be WS
3Prescription that provides in-B-3900-98 the drug standard and technology and brief description:
Prescription: Folium Eriobotryae 11.5g, Radix Platycodonis 20g, Bulbus Fritillariae Cirrhosae 7.75g, Radix Adenophorae (Radix Glehniae) 2g, Radix Polygalae 5g, green tea 0.8g, Mentholum 0.4g
Method for making: above seven flavors, except that Mentholum, all the other Six-elements are ground into coarse powder, sieve, mixing, the percolation that shines (appendix IO) under fluid extract and the extractum item with 33% ethanol carries out percolation, collects and filters liquid to 200ml, add strong ammonia solution 0.5ml, filter, other get chloroform 3.45g and ethanol an amount of, mixing, add Mentholum and stir, add ethanol to 20ml; Get sucrose 650g, after adding water heating and dissolving, it is an amount of to add sodium benzoate and caramel, filters while hot, be chilled to room temperature after, under agitation add above-mentioned two kinds of medicinal liquids, mixing adds water to 1000ml, promptly.
Function cures mainly: eliminating phlegm and stopping cough; Be used for cough ant phlegm, diseases such as bronchitis.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings such as inconvenience.
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 cough ant phlegm that is used for, the deficiency of the oral drug preparation of treatment for diseases such as bronchitis, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, take accurate measurement, cheap, and portable cough suppressing phlegm transforming drip pill.
Cough suppressing phlegm transforming drip pill involved in the present invention is a raw material with the extract that contains 7 flavor active ingredient of Chinese herbs such as Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, Mentholum, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain cough suppressing phlegm transforming drip pill involved in the present invention:
[preparation method]
1. raw material: the extract thick paste or the dry powder that contain 7 flavor active ingredient of Chinese herbs such as Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, Mentholum;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, 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 that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, fused solution and/or the emulsion and/or the suspension 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 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.
[appendix: a kind of preparation method of extract that contains 7 kinds of active ingredient of Chinese herbs such as Folium Eriobotryae]
Get Folium Eriobotryae 230g, Radix Platycodonis 400g, Bulbus Fritillariae Cirrhosae 155g, Radix Adenophorae (Radix Glehniae) 40g, Radix Polygalae 100g, green tea 16g, Mentholum 8g, more than seven the flavor, except that Mentholum, all the other Six-elements are ground into coarse powder, sieve, mixing, carry out percolation with 33% ethanol with reference to the percolation under 2000 editions Pharmacopoeia of People's Republic of China appendix IO fluid extracts and the extractum item, collection is filtered and is added Mentholum when liquid is concentrated into flowing soaking paste, stirring makes evenly, is 1.3～1.35 thick paste being decompressed to 0.1MPa, being condensed into relative density below 60 ℃, or continues to make drying, be ground into dry powder, promptly.
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]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The cough syrup that the preparation method that provides among-the B-3900-98 is prepared from is a kind of cough-suppressing phlegm-dispelling functions that has, and is usually used in cough ant phlegm, the syrups oral formulations of treatment for diseases such as bronchitis, through clinical verification, determined curative effect is the common drug 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.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings such as inconvenience.
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.
Cough suppressing phlegm transforming drip pill involved in the present invention is compared with the cough syrup made from same recipe has following beneficial effect:
1. cough suppressing phlegm transforming drip pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 7 flavor active ingredient of Chinese herbs such as Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, Mentholum; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. cough suppressing phlegm transforming drip 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. cough suppressing phlegm transforming 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 compares with oral liquid, 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 cough suppressing phlegm transforming drip pill of the present invention.
[first group: the test of single-matrix]
1. the preparation of drug extract: it is standby to make the extract dry powder that contains 7 flavor active ingredient of Chinese herbs such as Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, Mentholum earlier according to [appendix];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, 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. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the cough suppressing phlegm transforming drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared cough suppressing phlegm transforming drip pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared cough suppressing phlegm transforming drip pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared cough suppressing phlegm transforming drip pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the preparation of drug extract: it is standby to make the extract dry powder that contains 7 flavor active ingredient of Chinese herbs such as Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, Mentholum earlier 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. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the cough suppressing phlegm transforming drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 1 the proportioning, 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 different with the 4 kinds respectively mixing matrix phases of drug extract are mixed 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 experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 3 the proportioning, 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 different with the 4 kinds respectively mixing matrix phases of drug extract are mixed 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 experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 9 the proportioning, 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 different with the 4 kinds respectively mixing matrix phases of drug extract are mixed 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 experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 1 the proportioning, 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 different with the 4 kinds respectively mixing matrix phases of drug extract are mixed 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 experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 3 the proportioning, 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 different with the 4 kinds respectively mixing matrix phases of drug extract are mixed 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 experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 9 the proportioning, 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 different with the 4 kinds respectively mixing matrix phases of drug extract are mixed 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 experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 1 the proportioning, 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 respectively 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 experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 3 the proportioning, 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 respectively 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 experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough suppressing phlegm transforming drip pill when 1: 9 the proportioning, 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 respectively 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 experiments and the results are shown in 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 4000 | 50.0 | 88 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 87 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 87 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 86 | ＜30 | ＜10 | ++ |
| Span 40 | 50.0 | 65 | ＜30 | ＞10 | + |
| Polyoxyethylene stearate 40 esters | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 86 | ＜30 | ＜10 | ++ |
| Sodium lauryl sulphate | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Stearic acid | 50.0 | 65 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 62 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 59 | ＞30 | ＞10 | + |
| Lac | 50.0 | 57 | ＞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 | 76 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 90 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 73 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Poloxamer | 25.0 | 89 | ＜30 | ＜10 | ++ |
| Sodium lauryl sulphate | 25.0 | 82 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 75 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 68 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 68 | ＞30 | ＞10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 91 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 75 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 88 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 84 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 80 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 79 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 76 | ＞30 | ＞10 | +++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 84 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 79 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 77 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 85 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 86 | ＜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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 86 | ＜30 | ＜10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 86 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 89 | ＜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 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 86 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 86 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 87 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1: 9, 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 (2)
1. a cough suppressing phlegm transforming drip pill that is used for treatment for diseases such as bronchitis is a raw material with Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, Mentholum, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) gets Folium Eriobotryae 230g, Radix Platycodonis 400g, Bulbus Fritillariae Cirrhosae 155g, Radix Adenophorae (Radix Glehniae) 40g, Radix Polygalae 100g, green tea 16g, Mentholum 8g, more than seven the flavor, except that Mentholum, all the other Six-elements are ground into coarse powder, sieve, mixing, carry out percolation with 33% ethanol with reference to the percolation under 2000 editions Pharmacopoeia of People's Republic of China appendix IO fluid extracts and the extractum item, collection is filtered and is added Mentholum when liquid is concentrated into flowing soaking paste, stirring makes evenly, be decompressed to 0.1MPa, be condensed into relative density below 60 ℃ and be 1.3～1.35 thick paste, or continue to make drying, be ground into dry powder, promptly get and contain Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, the extract of Mentholum, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, and by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10; Describedly contain the extract of Folium Eriobotryae, Radix Platycodonis, Bulbus Fritillariae Cirrhosae, Radix Adenophorae (Radix Glehniae), Radix Polygalae, green tea, Mentholum and the ratio of substrate is 1: 3;
(3) accurately take by weighing described extract and substrate according to aforementioned proportion, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing drug 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 40 ℃～-5 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, will contain fused solution and/or the emulsion and/or the suspension of described extract and substrate, place in the water dropper jar of drop pill machine, and splash in the condensing agent and shrink molding promptly.
2. cough suppressing phlegm transforming 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 |
|---|---|---|---|
| CN 200510068269 CN1301101C (en) | 2005-05-08 | 2005-05-08 | Oral drip pill used for cough suppressing phlegm transforming and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510068269 CN1301101C (en) | 2005-05-08 | 2005-05-08 | Oral drip pill used for cough suppressing phlegm transforming and its preparation method |
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| Publication Number | Publication Date |
|---|---|
| CN1686436A CN1686436A (en) | 2005-10-26 |
| CN1301101C true CN1301101C (en) | 2007-02-21 |
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| CN102870920A (en) * | 2012-10-16 | 2013-01-16 | 张家港市绿色中药饮片有限公司 | Health tea formula |
| CN103461610A (en) * | 2013-09-30 | 2013-12-25 | 叶新 | Health-care loquat leaf tea |
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