CN1686484A - Bastard feverfew throat clearing drip pill and its preparation method - Google Patents
Bastard feverfew throat clearing drip pill and its preparation method Download PDFInfo
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- CN1686484A CN1686484A CN 200510071117 CN200510071117A CN1686484A CN 1686484 A CN1686484 A CN 1686484A CN 200510071117 CN200510071117 CN 200510071117 CN 200510071117 A CN200510071117 A CN 200510071117A CN 1686484 A CN1686484 A CN 1686484A
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Abstract
A Chinese medicine in the form of dripping pill for treating sore throat and antipyresis is prepared from 7 Chinese-medicinal materials including rehmannia root, chrysanthemum flower, honeysuckle flower, liquorice root, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of promoting the production of body fluid to quench thirst that has, refrigerant refrigeration function, be used for the summer-heat excessive thirst, the pharmaceutical composition of treatment for diseases such as laryngopharynx swelling and pain is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 7 flavor active ingredient of Chinese herbs such as Radix Rehmanniae, Radix Ophiopogonis, Radix Scrophulariae, Flos Chrysanthemi, Flos Lonicerae, Semen Sterculiae Lychnophorae, Radix Glycyrrhizae particularly.
Background technology
The bastard feverfew throat clearing granule that is prepared from according to the preparation method that provides among the national drug standards WS-11119 (ZD-1119)-2002, it is a kind of promoting the production of body fluid to quench thirst that has, refrigerant refrigeration function, be used for the summer-heat excessive thirst, the oral granular formulation of treatment for diseases such as laryngopharynx swelling and pain, 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-11119 (ZD-1119)-2002:
Prescription: Radix Rehmanniae 60g, Radix Ophiopogonis 60g, Radix Scrophulariae 40g, Flos Chrysanthemi 10g, Flos Lonicerae 7g, Semen Sterculiae Lychnophorae 3g, Radix Glycyrrhizae 20g
Method for making: above seven flavors, Flos Lonicerae, Flos Chrysanthemi, Semen Sterculiae Lychnophorae boil the back with hot dipping and keep 80 ℃, and warm macerating three times each 30 minutes, filters merging filtrate; Four Chinese medicine materials such as all the other Radix Rehmanniae, decoct with water three times, each 1 hour, filter, merge with above-mentioned filtrate, being concentrated into relative density is the clear paste of 1.20 (50 ℃), add doubling dose 75% ethanol, stir evenly, left standstill 24 hours, get supernatant, be evaporated to the clear paste that relative density is 1.20 (50 ℃) below 80 ℃.With above-mentioned extractum and sucrose mixing, make soft material, make granule with 10 mesh sieves, drying is sieved, promptly.
Function cures mainly: promoting the production of body fluid to quench thirst, and refrigerant analgesic.Be used for the summer-heat excessive thirst of asthenic fire due to getting angry; Laryngopharynx swelling and pain.
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.The medicament contg of granule is also lower, takes inconvenience.
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 the existing summer-heat excessive thirst that is used for, the deficiency of the oral drug preparation of treatment for diseases such as laryngopharynx swelling and pain, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations bastard feverfew throat clearing drip pill.Bastard feverfew throat clearing 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 Radix Rehmanniae, Radix Ophiopogonis, Radix Scrophulariae, Flos Chrysanthemi, Flos Lonicerae, Semen Sterculiae Lychnophorae, Radix Glycyrrhizae, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain bastard feverfew throat clearing drip pill involved in the present invention:
[preparation method]
1. the preparation of drug extract: get Radix Rehmanniae 60g, Radix Ophiopogonis 60g, Radix Scrophulariae 40g, Flos Chrysanthemi 10g, Flos Lonicerae 7g, Semen Sterculiae Lychnophorae 3g, Radix Glycyrrhizae 20g, more than seven flavors, Flos Lonicerae, Flos Chrysanthemi, Semen Sterculiae Lychnophorae boil the back with hot dipping and keep 80 ℃, warm macerating three times, each 30 minutes, filter merging filtrate; Four Chinese medicine materials such as all the other Radix Rehmanniae decoct with water each 1 hour three times, filter, merge, be concentrated into relative density and be 1.20 clear paste with above-mentioned filtrate, add doubling dose 75% ethanol, stir evenly, left standstill 24 hours, get supernatant, to be condensed into relative density be 1.3～1.35 thick paste being decompressed to 0.1MPa below 80 ℃, or continue to make drying, be ground into dry powder, promptly;
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, 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.
[beneficial effect]
The bastard feverfew throat clearing granule that is prepared from according to the preparation method that provides among the national drug standards WS-11119 (ZD-1119)-2002, it is a kind of promoting the production of body fluid to quench thirst that has, refrigerant refrigeration function, be used for the summer-heat excessive thirst, the oral granular formulation of treatment for diseases such as laryngopharynx swelling and pain, 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.The medicament contg of granule is also lower, takes inconvenience.
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.
Bastard feverfew throat clearing drip pill involved in the present invention is compared with the bastard feverfew throat clearing granule has following beneficial effect:
1. bastard feverfew throat clearing drip pill involved in the present invention; utilize surfactant to be substrate; with contain Radix Rehmanniae; Radix Ophiopogonis; Radix Scrophulariae; Flos Chrysanthemi; Flos Lonicerae; Semen Sterculiae Lychnophorae; the extract of 7 flavor Chinese medicine active pharmaceutical ingredients such as Radix Glycyrrhizae 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. bastard feverfew throat clearing 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. bastard feverfew 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 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 bastard feverfew throat clearing drip pill of the present invention.
[first group: the test of single-matrix]
1. raw material: it is standby to make the extract dry powder that contains 7 flavor Chinese medicine active pharmaceutical ingredients such as Radix Rehmanniae, Radix Ophiopogonis, Radix Scrophulariae, Flos Chrysanthemi, Flos Lonicerae, Semen Sterculiae Lychnophorae, Radix Glycyrrhizae 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 bastard feverfew throat clearing drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared bastard feverfew throat clearing 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 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 bastard feverfew throat clearing 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 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 bastard feverfew throat clearing 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 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. raw material: it is standby to make the extract dry powder that contains 7 flavor Chinese medicine active pharmaceutical ingredients such as Radix Rehmanniae, Radix Ophiopogonis, Radix Scrophulariae, Flos Chrysanthemi, Flos Lonicerae, Semen Sterculiae Lychnophorae, Radix Glycyrrhizae 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 bastard feverfew throat clearing 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 | ????65 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????83 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 6000 | ????50.0 | ????82 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 10000 | ????50.0 | ????84 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????85 | ????＜30 | ????＞10 | ++ |
| Span 40 | ????50.0 | ????62 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????50.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????50.0 | ????72 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ????50.0 | ????62 | ????＞30 | ????＞10 | ++ |
| Sodium stearate | ????50.0 | ????62 | ????＞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 | ????74 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????25.0 | ????87 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Span 40 | ????25.0 | ????74 | ????＜30 | ????＞10 | +++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????25.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????73 | ????＞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 | ????80 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????10.0 | ????90 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Span 40 | ????10.0 | ????75 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????75 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????72 | ????＞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 | ????83 | ????＜30 | ????＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????84 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????83 | ????＜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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????89 | ????＜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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????88 | ????＜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 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????88 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????90 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????89 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????50 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????88 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????90 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????90 | ????＜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 (5)
1. one kind is used for the summer-heat excessive thirst, the pharmaceutical composition bastard feverfew throat clearing drip pill of treatment for diseases such as laryngopharynx swelling and pain, with the extract that contains Radix Rehmanniae, Radix Ophiopogonis, Radix Scrophulariae, Flos Chrysanthemi, Flos Lonicerae, Semen Sterculiae Lychnophorae, Radix Glycyrrhizae etc. 7 flavor active ingredient of Chinese herbs is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 the preparation of drug extract: get Radix Rehmanniae 60g, Radix Ophiopogonis 60g, Radix Scrophulariae 40g, Flos Chrysanthemi 10g, Flos Lonicerae 7g, Semen Sterculiae Lychnophorae 3g, Radix Glycyrrhizae 20g, more than seven flavors, Flos Lonicerae, Flos Chrysanthemi, Semen Sterculiae Lychnophorae boil the back with hot dipping and keep 80 ℃, warm macerating three times, each 30 minutes, filter merging filtrate; Four Chinese medicine materials such as all the other Radix Rehmanniae decoct with water each 1 hour three times, filter, merge, be concentrated into relative density and be 1.20 clear paste with above-mentioned filtrate, add doubling dose 75% ethanol, stir evenly, left standstill 24 hours, get supernatant, to be condensed into relative density be 1.3～1.35 thick paste being decompressed to 0.1MPa below 80 ℃, or continue to make drying, be ground into dry powder, promptly;
1.2 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;
1.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. bastard feverfew throat clearing drip pill as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
3. any bastard feverfew throat clearing drip pill as claimed in claim 1 or 2 is characterized in that: describedly contain the extract of Radix Rehmanniae, Radix Ophiopogonis, Radix Scrophulariae, Flos Chrysanthemi, Flos Lonicerae, Semen Sterculiae Lychnophorae, Radix Glycyrrhizae etc. 7 flavor active ingredient of Chinese herbs and the mixed proportion of substrate is 1: 1～1: 5.
4. the preparation method of a red bastard feverfew throat clearing drip pill is characterized in that being made of following process:
4.1 the preparation of drug extract: get Radix Rehmanniae 60g, Radix Ophiopogonis 60g, Radix Scrophulariae 40g, Flos Chrysanthemi 10g, Flos Lonicerae 7g, Semen Sterculiae Lychnophorae 3g, Radix Glycyrrhizae 20g, more than seven flavors, Flos Lonicerae, Flos Chrysanthemi, Semen Sterculiae Lychnophorae boil the back with hot dipping and keep 80 ℃, warm macerating three times, each 30 minutes, filter merging filtrate; Four Chinese medicine materials such as all the other Radix Rehmanniae decoct with water each 1 hour three times, filter, merge, be concentrated into relative density and be 1.20 clear paste with above-mentioned filtrate, add doubling dose 75% ethanol, stir evenly, left standstill 24 hours, get supernatant, to be condensed into relative density be 1.3～1.35 thick paste being decompressed to 0.1MPa below 80 ℃, or continue to make drying, be ground into dry powder, promptly;
4.2 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;
4.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4.4, accurately take by weighing drug 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;
4.5 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 ℃;
4.6 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.
5. as the preparation method of bastard feverfew throat clearing drip pill as described in the claim 4, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| CNB200510071117XA CN100382786C (en) | 2005-05-20 | 2005-05-20 | Bastard feverfew throat clearing drip pill and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510071117XA CN100382786C (en) | 2005-05-20 | 2005-05-20 | Bastard feverfew throat clearing drip pill and its preparation method |
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| CN100382786C CN100382786C (en) | 2008-04-23 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101049345B (en) * | 2007-05-17 | 2010-08-11 | 贵州本草堂药业有限公司 | A preparation for treating disease of oral cavity and gorge, and preparation method |
| CN1954868B (en) * | 2005-10-27 | 2010-11-24 | 贵州百祥制药有限责任公司 | Yinju Qingyan Preparation for treating disease by flaring-up of fire of deficiency type and quality control method |
| CN1973884B (en) * | 2006-12-07 | 2011-11-23 | 李永胜 | Bobei throat-fitting buccal tablet |
| CN102973792A (en) * | 2012-12-27 | 2013-03-20 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Preparation method of dripping pill for clearing away heat and toxicity and nourishing yin and relieving sore throat |
-
2005
- 2005-05-20 CN CNB200510071117XA patent/CN100382786C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1954868B (en) * | 2005-10-27 | 2010-11-24 | 贵州百祥制药有限责任公司 | Yinju Qingyan Preparation for treating disease by flaring-up of fire of deficiency type and quality control method |
| CN1973884B (en) * | 2006-12-07 | 2011-11-23 | 李永胜 | Bobei throat-fitting buccal tablet |
| CN101049345B (en) * | 2007-05-17 | 2010-08-11 | 贵州本草堂药业有限公司 | A preparation for treating disease of oral cavity and gorge, and preparation method |
| CN102973792A (en) * | 2012-12-27 | 2013-03-20 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Preparation method of dripping pill for clearing away heat and toxicity and nourishing yin and relieving sore throat |
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| Publication number | Publication date |
|---|---|
| CN100382786C (en) | 2008-04-23 |
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