CN1686439A - Kelu drip pill used for phlegm transforming cough suppressing and its preparation method - Google Patents
Kelu drip pill used for phlegm transforming cough suppressing and its preparation method Download PDFInfo
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- CN1686439A CN1686439A CN 200510068272 CN200510068272A CN1686439A CN 1686439 A CN1686439 A CN 1686439A CN 200510068272 CN200510068272 CN 200510068272 CN 200510068272 A CN200510068272 A CN 200510068272A CN 1686439 A CN1686439 A CN 1686439A
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Abstract
A Chinese medicine in the form of dripping pill for treating cough with sputum, cold, bronchitis, etc is prepared from 8 Chinese-medicinal materials including tendrilled fritillary bulb, loquat leaf, liquorice root, menthol, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of heat clearing away that has, lung qi dispersing, relieving asthma, the preventing phlegm from forming and stopping coughing effect, be used for cough with copious phlegm or ungratifying ejection of phlegm due to wind-heat invading the lung, the stagnation of fire in the interior, laryngopharynx swelling and pain, fullness in the chest and shortness of breath, the pharmaceutical composition of treatment for diseases such as cold cough and acute and chronic bronchitis is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 8 flavor active ingredient of Chinese herbs such as Bulbus Fritillariae Cirrhosae, Folium Eriobotryae, Radix Asteris, Herba Ephedrae, Radix Scutellariae, Pericarpium Papaveris, Radix Glycyrrhizae, Mentholum particularly.
Background technology
Cough the dew oral liquid according to what the preparation method that provides among the national drug standards WS-11419 (ZD-1419)-2002 was prepared from, be a kind of heat clearing away that has, lung qi dispersing is relievingd asthma, the preventing phlegm from forming and stopping coughing effect, be used for cough with copious phlegm or ungratifying ejection of phlegm due to wind-heat invading the lung, the stagnation of fire in the interior, laryngopharynx swelling and pain, fullness in the chest and shortness of breath, the syrups oral formulations of treatment for diseases such as cold cough and acute and chronic 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 prescription and technology and the brief description that provides among the drug standard WS-11419 (ZD-1419)-2002:
Prescription: Bulbus Fritillariae Cirrhosae 10g, Folium Eriobotryae 50g, Radix Asteris 150g, Herba Ephedrae 100g, Radix Scutellariae 50g, Pericarpium Papaveris 60g, Radix Glycyrrhizae 50g, Mentholum 0.3g, Mel 50g, sucrose 100g, sodium benzoate 3g
Method for making: above eight flavor medical materials, except that Mentholum, get Herba Ephedrae, use vapor distillation, collect distillate and medicinal liquid, standby; Six-element medical materials such as medicinal residues and all the other Bulbus Fritillariae Cirrhosaes, decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate merges with the medicinal liquid that extracts behind the volatile oil, is concentrated into relative density and is 1.10～1.15 clear paste, adding ethanol makes and contains alcohol amount to 60%, left standstill 24 hours, and filtered filtrate recycling ethanol, be concentrated into relative density and be 1.20～1.25 clear paste, add Mel, sucrose, sodium benzoate, boil, leave standstill, filter, add above-mentioned distillate and Mentholum, add water to ormal weight, promptly.
Function cures mainly: heat clearing away, lung qi dispersing is relievingd asthma, preventing phlegm from forming and stopping coughing.Be used for cough with copious phlegm or ungratifying ejection of phlegm due to wind-heat invading the lung, the stagnation of fire in the interior, laryngopharynx swelling and pain, fullness in the chest and shortness of breath, cold cough and acute and chronic bronchitis and above-mentioned card marquis person.
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.It is low that oral liquid also has a medicament contg, and dose is not accurate enough and take inconvenient shortcoming.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention, be to replenish existing cough with copious phlegm or the ungratifying ejection of phlegm that is used for due to wind-heat invading the lung, the stagnation of fire in the interior, laryngopharynx swelling and pain, fullness in the chest and shortness of breath, the deficiency of the oral drug preparation of treatment for diseases such as cold cough and acute and chronic bronchitis, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, accurate measurement, taking convenience, cheap, and free of contamination aborning oral formulations is coughed the dew drop pill.The dew drop pill of coughing involved in the present invention is a raw material with the extract that contains 8 flavor active ingredient of Chinese herbs such as Bulbus Fritillariae Cirrhosae, Folium Eriobotryae, Radix Asteris, Herba Ephedrae, Radix Scutellariae, Pericarpium Papaveris, Radix Glycyrrhizae, Mentholum, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain compound cynomorium drip pill involved in the present invention:
[preparation method]
1. raw material: the extract that contains 8 flavor active ingredient of Chinese herbs such as Bulbus Fritillariae Cirrhosae, Folium Eriobotryae, Radix Asteris, Herba Ephedrae, Radix Scutellariae, Pericarpium Papaveris, Radix Glycyrrhizae, 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 Radix Astragali 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, to contain the fused solution of drug extract and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, 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 8 flavor active ingredient of Chinese herbs preparation method of extract such as Bulbus Fritillariae Cirrhosae that contain] gets Bulbus Fritillariae Cirrhosae 100g, Folium Eriobotryae 500g, Radix Asteris 1500g, Herba Ephedrae 1000g, Radix Scutellariae 500g, Pericarpium Papaveris 600g, Radix Glycyrrhizae 500g, Mentholum 3g, more than eight the flavor medical materials, except that Mentholum, get Herba Ephedrae, use vapor distillation, collect distillate and medicinal liquid, standby; Six-element medical materials such as medicinal residues and all the other Bulbus Fritillariae Cirrhosaes, decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and the medicinal liquid behind filtrate and the extraction volatile oil merges, be concentrated into relative density and be 1.1～1.2 clear paste, add ethanol and make and contain alcohol amount, left standstill 24 hours, filter to 60%, filtrate recycling ethanol, be concentrated into relative density and be 1.20～1.25 clear paste, add above-mentioned distillate and Mentholum, being decompressed to 0.1MPa, being condensed into relative density below 60 ℃ is 1.3～1.35 thick paste, or make drying under the same conditions, 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]
Cough the dew oral liquid according to what the preparation method that provides among the national drug standards WS-11419 (ZD-1419)-2002 was prepared from, be a kind of heat clearing away that has, lung qi dispersing is relievingd asthma, the preventing phlegm from forming and stopping coughing effect, be used for cough with copious phlegm or ungratifying ejection of phlegm due to wind-heat invading the lung, the stagnation of fire in the interior, laryngopharynx swelling and pain, fullness in the chest and shortness of breath, the syrups oral formulations of treatment for diseases such as cold cough and acute and chronic 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.It is low that oral liquid also has a medicament contg, and dose is not accurate enough and take inconvenient shortcoming.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Involved in the present invention coughing revealed drop pill and revealed oral liquid and compare and have following beneficial effect with coughing:
1. the dew drop pill of coughing involved in the present invention; utilize surfactant to be substrate; with contain Bulbus Fritillariae Cirrhosae; Folium Eriobotryae; Radix Asteris; Herba Ephedrae; Radix Scutellariae; Pericarpium Papaveris; Radix Glycyrrhizae; the extract of 8 flavor active ingredient of Chinese herbs such as Mentholum is made solid dispersion together; make medicine be molecule; colloid or microcrystalline state are 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, performance is efficient; quick-acting effects etc.
2. the dew drop pill of coughing 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. the dew drop pill of coughing 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, be described further with regard to the preparation method of revealing drop pill of coughing of the present invention with several groups of specific embodiments.
[first group: the test of single-matrix]
1. raw material: it is standby to make the extract dry powder that contains 8 flavor Chinese medicine active pharmaceutical ingredients such as Bulbus Fritillariae Cirrhosae, Folium Eriobotryae, Radix Asteris, Herba Ephedrae, Radix Scutellariae, Pericarpium Papaveris, Radix Glycyrrhizae, 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, coughs the dew extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and what can obtain different size coughs the dew drop pill.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning the prepared dew drop pill of coughing 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 the prepared dew drop pill of coughing 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 the prepared dew drop pill of coughing 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. raw material: it is standby to make the extract dry powder that contains 8 flavor Chinese medicine active pharmaceutical ingredients such as Bulbus Fritillariae Cirrhosae, Folium Eriobotryae, Radix Asteris, Herba Ephedrae, Radix Scutellariae, Pericarpium Papaveris, Radix Glycyrrhizae, 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 what can obtain different size coughs the dew drop pill.
[result of the test]
Test 4: in order to observe drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 drug extract and the mixed-matrix prepared mass discrepancy of coughing the dew drop 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 | ??67 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??86 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??50.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 10000 | ??50.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??87 | ??＜30 | ??＜10 | ??++ |
| Span 40 | ??50.0 | ??61 | ??＜30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??88 | ??＜30 | ??＜10 | ??+ |
| Poloxamer | ??50.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Sodium lauryl sulphate | ??50.0 | ??73 | ??＞30 | ??＞10 | ??++ |
| Stearic acid | ??50.0 | ??60 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | ??50.0 | ??61 | ??＞30 | ??＞10 | ??++ |
| Glycerin gelatine | ??50.0 | ??61 | ??＞30 | ??＞10 | ??+ |
| Lac | ??50.0 | ??62 | ??＞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 | ??67 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??25.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??68 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??25.0 | ??78 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??25.0 | ??77 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??25.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??25.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??25.0 | ??73 | ??＞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 | ??84 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??10.0 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??10.0 | ??78 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??92 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??10.0 | ??79 | ??＜30 | ??＞10 | ??+++ |
| Stearic acid | ??10.0 | ??77 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | ??73 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??10.0 | ??74 | ??＞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 | ??84 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??82 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??50 | ??76 | ??＜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 | ??84 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??10 | ??89 | ??＜30 | ??＞10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??10 | ??83 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ??50 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??50 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??50 | ??87 | ??＜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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??25 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??25 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??25 | ??88 | ??＜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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??10 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??10 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??10 | ??89 | ??＜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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??50 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??50 | ??89 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ??25 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??25 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??25 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??25 | ??87 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ??10 | ??92 | ??＜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 | ??89 | ??＜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 (6)
1. a pharmaceutical composition that is used for preventing phlegm from forming and stopping coughing is coughed the dew drop pill, with the extract that contains Bulbus Fritillariae Cirrhosae, Folium Eriobotryae, Radix Asteris, Herba Ephedrae, Radix Scutellariae, Pericarpium Papaveris, Radix Glycyrrhizae, Mentholum etc. 8 flavor active ingredient of Chinese herbs is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 substrate: 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, above-mentioned carrier one or more mixture wherein;
1.2 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. the dew drop pill of coughing as claimed in claim 1, it is characterized in that the described extract that contains 8 flavor active ingredient of Chinese herbs such as Bulbus Fritillariae Cirrhosae, Folium Eriobotryae, Radix Asteris, Herba Ephedrae, Radix Scutellariae, Pericarpium Papaveris, Radix Glycyrrhizae, Mentholum is made by following method: get Bulbus Fritillariae Cirrhosae 100g, Folium Eriobotryae 500g, Radix Asteris 1500g, Herba Ephedrae 1000g, Radix Scutellariae 500g, Pericarpium Papaveris 600g, Radix Glycyrrhizae 500g, Mentholum 3g, more than eight the flavor medical materials, except that Mentholum, get Herba Ephedrae, use vapor distillation, collect distillate and medicinal liquid, standby; Six-element medical materials such as medicinal residues and all the other Bulbus Fritillariae Cirrhosaes, decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and the medicinal liquid behind filtrate and the extraction volatile oil merges, be concentrated into relative density and be 1.1～1.2 clear paste, add ethanol and make and contain alcohol amount, left standstill 24 hours, filter to 60%, filtrate recycling ethanol, be concentrated into relative density and be 1.20～1.25 clear paste, add above-mentioned distillate and Mentholum, being decompressed to 0.1MPa, being condensed into relative density below 60 ℃ is 1.3～1.35 thick paste, or make drying under the same conditions, be ground into dry powder promptly.
3. the dew drop pill of coughing as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
4. as claim 1 or 3 described any dew drop pill of coughing, it is characterized in that: describedly contain the extract of Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis etc. 3 flavor active ingredient of Chinese herbs and the mixed proportion of substrate is 1: 1～1: 5.
5. cough the preparation method of revealing drop pill for one kind, it is characterized in that constituting by following process:
5.1 raw material: the extract that contains 8 flavor active ingredient of Chinese herbs such as Bulbus Fritillariae Cirrhosae, Folium Eriobotryae, Radix Asteris, Herba Ephedrae, Radix Scutellariae, Pericarpium Papaveris, Radix Glycyrrhizae, Mentholum;
5.2 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;
5.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
5.4, accurately take by weighing Radix Astragali extract and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing Radix Astragali extract and substrate and/or emulsion and/or suspension;
5.5 adjust the temperature control system of 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 ℃;
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 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 and shrink molding promptly.
6. as coughing the preparation method of revealing drop pill as described in the claim 5, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| CN 200510068272 CN1301103C (en) | 2005-05-08 | 2005-05-08 | Kelu drip pill used for phlegm transforming cough suppressing and its preparation method |
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|---|---|---|---|
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| Publication Number | Publication Date |
|---|---|
| CN1686439A true CN1686439A (en) | 2005-10-26 |
| CN1301103C CN1301103C (en) | 2007-02-21 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101664485B (en) * | 2009-09-30 | 2011-07-20 | 北京大北农科技集团股份有限公司 | Traditional Chinese medicine for treating respiratory disease of livestock and preparation method thereof |
| CN102357184A (en) * | 2011-10-25 | 2012-02-22 | 陕西步长制药有限公司 | Traditional Chinese medicine preparation for treating cough and preparation method thereof |
| CN102357181A (en) * | 2011-10-25 | 2012-02-22 | 陕西步长制药有限公司 | Traditional Chinese medicine composition for treating cough and preparation method thereof |
| CN102357182A (en) * | 2011-10-25 | 2012-02-22 | 陕西步长制药有限公司 | Traditional Chinese medicament for curing cough and preparation method thereof |
| CN102357183A (en) * | 2011-10-25 | 2012-02-22 | 陕西步长制药有限公司 | Traditional Chinese medicament for curing cough and preparation method thereof |
| CN104815145A (en) * | 2015-04-15 | 2015-08-05 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine cough syrup and preparation method thereof |
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2005
- 2005-05-08 CN CN 200510068272 patent/CN1301103C/en not_active Expired - Fee Related
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101664485B (en) * | 2009-09-30 | 2011-07-20 | 北京大北农科技集团股份有限公司 | Traditional Chinese medicine for treating respiratory disease of livestock and preparation method thereof |
| CN102357184A (en) * | 2011-10-25 | 2012-02-22 | 陕西步长制药有限公司 | Traditional Chinese medicine preparation for treating cough and preparation method thereof |
| CN102357181A (en) * | 2011-10-25 | 2012-02-22 | 陕西步长制药有限公司 | Traditional Chinese medicine composition for treating cough and preparation method thereof |
| CN102357182A (en) * | 2011-10-25 | 2012-02-22 | 陕西步长制药有限公司 | Traditional Chinese medicament for curing cough and preparation method thereof |
| CN102357183A (en) * | 2011-10-25 | 2012-02-22 | 陕西步长制药有限公司 | Traditional Chinese medicament for curing cough and preparation method thereof |
| CN102357184B (en) * | 2011-10-25 | 2013-06-12 | 陕西步长高新制药有限公司 | Traditional Chinese medicine preparation for treating cough and preparation method thereof |
| CN102357181B (en) * | 2011-10-25 | 2013-06-12 | 陕西步长高新制药有限公司 | Traditional Chinese medicine composition for treating cough and preparation method thereof |
| CN102357183B (en) * | 2011-10-25 | 2013-06-12 | 陕西步长高新制药有限公司 | Traditional Chinese medicament for curing cough and preparation method thereof |
| CN104815145A (en) * | 2015-04-15 | 2015-08-05 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine cough syrup and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN1301103C (en) | 2007-02-21 |
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