CN1686340A - Gastrodia brain arousing drip pill for nourishing liver and kidney and its preparation method - Google Patents
Gastrodia brain arousing drip pill for nourishing liver and kidney and its preparation method Download PDFInfo
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Abstract
A Chinese medicine in the form of dripping pills for treating headache, dizziness, hypomnesia, insomnia, etc is prepared from 6 Chinese-medicinal materials including gastrodia tuber, earthworm, polygala root, cistanche, etc.
Description
Technical field
The present invention relates to a kind of nourishing the liver and kidney that has, suppressing the hyperactive liver to relieve the wind syndrome, the removing obstruction in the collateral to relieve pain effect, be used for deficiency of the liver and kindey, the pharmaceutical composition of treatment for diseases such as headache, dizziness, hypomnesis, insomnia, bradykinesia, tinnitus, the soreness of waist due to disturbing on the liver-wind is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 6 flavor active ingredient of Chinese herbs such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches particularly.
Background technology
The gastrodia tuber refreshment capsule that is prepared from according to the preparation method that provides among the national drug standards WS-11293 (ZD-1293)-2002, it is a kind of nourishing the liver and kidney that has, suppressing the hyperactive liver to relieve the wind syndrome, the removing obstruction in the collateral to relieve pain effect, be used for deficiency of the liver and kindey, the oral capsule preparation of treatment for diseases such as headache, dizziness, hypomnesis, insomnia, bradykinesia, tinnitus, the soreness of waist due to disturbing on the liver-wind is 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-11293 (ZD-1293)-2002:
Prescription: Rhizoma Gastrodiae 300g, Pheretima 200g, Rhizoma Acori Graminei 300g, Radix Polygalae 200g, Radix Rehmanniae Preparata 100g, Herba Cistanches 100g
Method for making: above Six-element, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, gradation filters, merging filtrate, and being concentrated into relative density is the clear paste of 1.10～1.15 (90 ℃), cooling, add ethanol and make and contain alcohol amount and reach 60%, left standstill 48 hours, filter.Pheretima filters with 60% ethanol merceration 72 hours, and filtrate merges with above-mentioned filtrate, and recovery ethanol is standby.Rhizoma Gastrodiae powder is broken into fine powder, adds in the above-mentioned medicinal liquid, and fully mixing is dried below 80 ℃, is ground into fine powder, incapsulates, promptly.
Function cures mainly: nourishing the liver and kidney, suppressing the hyperactive liver to relieve the wind syndrome, removing obstruction in the collateral to relieve pain.Be used for deficiency of the liver and kindey, diseases such as headache, dizziness, hypomnesis, insomnia, bradykinesia, tinnitus, the soreness of waist due to disturbing on the liver-wind.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.
In addition, conventional peroral dosage form 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 deficiency of the liver and kindey that is used for, the deficiency of the oral drug preparation of treatment for diseases such as headache, dizziness, hypomnesis, insomnia, bradykinesia, tinnitus, the soreness of waist due to disturbing on the liver-wind, 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 drug preparation gastrodia tuber refreshment drop pill.Gastrodia tuber refreshment drop pill involved in the present invention is a raw material with the extract that contains 6 flavor active ingredient of Chinese herbs such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain gastrodia tuber refreshment drop pill involved in the present invention:
[preparation method]
1. raw material: the extract that contains 6 flavor Chinese medicine active pharmaceutical ingredients such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches;
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 6 flavor active ingredient of Chinese herbs preparation method of extract such as Rhizoma Gastrodiae that contain] is unit with g or kg, according to the weight portion meter, takes by weighing 3 parts in Rhizoma Gastrodiae, 2 parts of Pheretimas, 3 parts of Rhizoma Acori Graminei, 2 parts of Radix Polygalaes, 1 part of Radix Rehmanniae Preparata, 1 part of Herba Cistanches; More than 6 flavors, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches decoct with water 2 times, the 1st time 1.5 hours, the 2nd time 1 hour, gradation filtered, merging filtrate is standby; Pheretima filters with 60% ethanol merceration 72 hours, and filtrate recycling ethanol merges with preceding filtrate, Rhizoma Gastrodiae powder is broken into fine powder, adds in the above-mentioned medicinal liquid, abundant mixing is 1.3～1.35 thick paste being condensed into relative density below 80 ℃, or continue to make drying, be ground into fine 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]
The gastrodia tuber refreshment capsule that is prepared from according to the preparation method that provides among the national drug standards WS-11293 (ZD-1293)-2002, it is a kind of nourishing the liver and kidney that has, suppressing the hyperactive liver to relieve the wind syndrome, the removing obstruction in the collateral to relieve pain effect, be used for deficiency of the liver and kindey, the oral capsule preparation of treatment for diseases such as headache, dizziness, hypomnesis, insomnia, bradykinesia, tinnitus, the soreness of waist due to disturbing on the liver-wind is 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.
Gastrodia tuber refreshment drop pill involved in the present invention is compared with the gastrodia tuber refreshment granule has following beneficial effect:
1. gastrodia tuber refreshment drop pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 6 flavor Chinese medicine active pharmaceutical ingredients such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches; 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. gastrodia tuber refreshment drop 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. gastrodia tuber refreshment drop 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 gastrodia tuber refreshment drop 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 6 flavor active ingredient of Chinese herbs such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches earlier according to [appendix];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, 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 gastrodia tuber refreshment drop pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared gastrodia tuber refreshment drop 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 polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, 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 gastrodia tuber refreshment drop 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 polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, 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 gastrodia tuber refreshment drop 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 polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, 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 6 flavor active ingredient of Chinese herbs such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches 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 gastrodia tuber refreshment drop pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 the mass discrepancy of drug extract and mixed-matrix prepared gastrodia tuber refreshment 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 | ??68 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??84 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 6000 | ??50.0 | ??85 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 10000 | ??50.0 | ??85 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Span 40 | ??50.0 | ??63 | ??＜30 | ??＞10 | ??++ |
| Tween 80 | ??50.0 | ??62 | ??＜30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??78 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin | ??50.0 | ??74 | ??＜30 | ??＞10 | ??+ |
| Poloxamer | ??50.0 | ??79 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium | ??50.0 | ??76 | ??＜30 | ??＞10 | ??+ |
| Sodium lauryl sulphate | ??50.0 | ??73 | ??＞30 | ??＞10 | ??++ |
| Stearic acid | ??50.0 | ??61 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | ??50.0 | ??61 | ??＞30 | ??＞10 | ??++ |
| Glycerin gelatine | ??50.0 | ??61 | ??＞30 | ??＞10 | ??+ |
| Lac | ??50.0 | ??60 | ??＞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 | ??75 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??70 | ??＜30 | ??＞10 | ??+++ |
| Tween 80 | ??25.0 | ??70 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Betacyclodextrin | ??25.0 | ??82 | ??＜30 | ??＞10 | ??++ |
| Poloxamer | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium | ??25.0 | ??84 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??25.0 | ??77 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??25.0 | ??76 | ??＞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 | ??82 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??10.0 | ??90 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??10.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??10.0 | ??72 | ??＜30 | ??＜10 | ??+++ |
| Tween 80 | ??10.0 | ??70 | ??＜30 | ??＜10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Betacyclodextrin | ??10.0 | ??85 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium | ??10.0 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??10.0 | ??77 | ??＜30 | ??＞10 | ??+++ |
| Stearic acid | ??10.0 | ??76 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | ??72 | ??＞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 | ??84 | ??＜30 | ??＞10 | ??++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??50 | ??84 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??80 | ??＜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 | ??90 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??10 | ??88 | ??＜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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??50 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??50 | ??88 | ??＜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 | ??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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??10 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??10 | ??91 | ??＜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 | ??92 | ??＜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 | ??88 | ??＜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 | ??93 | ??＜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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??10 | ??91 | ??＜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 (6)
1. one kind is used for deficiency of the liver and kindey, the pharmaceutical composition gastrodia tuber refreshment drop pill of treatment for diseases such as headache, dizziness, hypomnesis, insomnia, bradykinesia, tinnitus, the soreness of waist due to disturbing on the liver-wind, with the extract that contains Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches etc. 6 flavor active ingredient of Chinese herbs is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 raw material: the extract that contains 6 flavor active ingredient of Chinese herbs such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches;
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. gastrodia tuber refreshment drop pill as claimed in claim 1, it is characterized in that the described extract that contains 6 flavor active ingredient of Chinese herbs such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches is made by following method: with g or kg is unit, according to the weight portion meter, take by weighing 3 parts in Rhizoma Gastrodiae, 2 parts of Pheretimas, 3 parts of Rhizoma Acori Graminei, 2 parts of Radix Polygalaes, 1 part of Radix Rehmanniae Preparata, 1 part of Herba Cistanches; More than 6 flavors, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches decoct with water 2 times, the 1st time 1.5 hours, the 2nd time 1 hour, gradation filtered, merging filtrate is standby; Pheretima filters with 60% ethanol merceration 72 hours, and filtrate recycling ethanol merges with preceding filtrate, Rhizoma Gastrodiae powder is broken into fine powder, adds in the above-mentioned medicinal liquid, abundant mixing is 1.3～1.35 thick paste being condensed into relative density below 80 ℃, or continue to make drying, be ground into fine 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.
3. gastrodia tuber refreshment drop 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.
4. as claim 1 or 3 described any gastrodia tuber refreshment drop pill, it is characterized in that: describedly contain the extract of Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches etc. 6 flavor active ingredient of Chinese herbs and the mixed proportion of substrate is 1: 1～1: 5.
5. the preparation method of a gastrodia tuber refreshment drop pill is characterized in that being made of following process:
5.1 raw material: the extract that contains 6 flavor active ingredient of Chinese herbs such as Rhizoma Gastrodiae, Pheretima, Rhizoma Acori Graminei, Radix Polygalae, Radix Rehmanniae Preparata, Herba Cistanches;
5.2 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;
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 the preparation method of gastrodia tuber refreshment 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100553867A CN100358504C (en) | 2005-03-21 | 2005-03-21 | Gastrodia brain arousing drip pill for nourishing liver and kidney and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100553867A CN100358504C (en) | 2005-03-21 | 2005-03-21 | Gastrodia brain arousing drip pill for nourishing liver and kidney and its preparation method |
Publications (2)
| Publication Number | Publication Date |
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| CN1686340A true CN1686340A (en) | 2005-10-26 |
| CN100358504C CN100358504C (en) | 2008-01-02 |
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|---|---|---|---|
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1981852B (en) * | 2005-11-09 | 2010-05-12 | 北京奇源益德药物研究所 | Tall gastrodia tuber preparation with resuscitation-inducing function, its making and quality controlling method |
| CN104306745A (en) * | 2014-10-31 | 2015-01-28 | 云南永孜堂制药有限公司 | Quality control method for rhizoma gastrodiae capsule |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1257743C (en) * | 2004-06-01 | 2006-05-31 | 云南永孜堂制药有限公司 | Composite gastrodia luber medicine and its preparation and use |
-
2005
- 2005-03-21 CN CNB2005100553867A patent/CN100358504C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1981852B (en) * | 2005-11-09 | 2010-05-12 | 北京奇源益德药物研究所 | Tall gastrodia tuber preparation with resuscitation-inducing function, its making and quality controlling method |
| CN104306745A (en) * | 2014-10-31 | 2015-01-28 | 云南永孜堂制药有限公司 | Quality control method for rhizoma gastrodiae capsule |
| CN104306745B (en) * | 2014-10-31 | 2017-07-18 | 云南永孜堂制药有限公司 | A kind of detection method of gastrodia tuber refreshment capsule |
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| CN100358504C (en) | 2008-01-02 |
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