CN100358501C - Tranquilizing wild jujube seed dripping pill and its preparing method - Google Patents
Tranquilizing wild jujube seed dripping pill and its preparing method Download PDFInfo
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- CN100358501C CN100358501C CNB2005100514932A CN200510051493A CN100358501C CN 100358501 C CN100358501 C CN 100358501C CN B2005100514932 A CNB2005100514932 A CN B2005100514932A CN 200510051493 A CN200510051493 A CN 200510051493A CN 100358501 C CN100358501 C CN 100358501C
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Abstract
The present invention relates to a medicinal composition for treating disease symptoms, such as insomnia, amnesia, dizziness, headache, etc., caused by heart-liver blood vacuity and neurasthenia. The present invention aims to overcome the disadvantages of the existing oral medicinal preparation for treating the disease symptoms and provide a jujube seed tranquilization dripping pill as a medicinal composition oral preparation having the advantages of high bioavailability, quick medicine release, quick effect taking, high medicine content, convenient administration, low price and no pollution in production. In the jujube seed tranquilization dripping pill related by the present invention is prepared from traditional Chinese medicines, such as spiny jujube seeds, red sage roots, shizandra berries, etc., as raw materials together with a medicinal carrier as a substrate after the traditional Chinese medicines are extracted to obtain extract containing active medicinal ingredients of the three traditional Chinese medicines.
Description
Technical field
The present invention relates to a kind of reinforcing the heart nourishing the liver that has, the nootropic effect of calming the nerves, be used for heart-liver blood deficiency, the insomnia forgetfulness that the neurasthenia causes, dizzy, the pharmaceutical composition of treatment for diseases such as headache is a kind of drug composition oral preparation that feedstock production forms with 3 flavor Chinese medicines such as Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis particularly.
Background technology
The sedative jujube kernel granule that is prepared from according to the preparation method that provides among the drug standard WS3-B-2164-96 promulgated by the ministries or commissions of the Central Government, be to have the reinforcing the heart nourishing the liver, the nootropic effect of calming the nerves, be used for heart-liver blood deficiency, the insomnia forgetfulness that the neurasthenia causes, dizziness, the oral granular formulation of treatment for diseases such as headache, 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 WS3-B-2164-96:
Prescription: Semen Ziziphi Spinosae (stir-fry) 250g, Radix Salviae Miltiorrhizae 50g, Fructus Schisandrae Chinensis (processed with vinegar) 50g
Method for making: above three flavors, decoct with water secondary, each 2 hours, collecting decoction filtered, and filtrate is concentrated into the clear paste that relative density is 1.10-1.20 (20).1 part of qinghuo reagent, 1 part in dextrin, mixing is made granule, drying, promptly.
Function cures mainly: reinforcing the heart nourishing the liver, the Fructus Alpiniae Oxyphyllae of calming the nerves; Be used for heart-liver blood deficiency, the insomnia forgetfulness that the neurasthenia causes, dizziness, diseases such as headache.
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 existing be used for heart-liver blood deficiency, the insomnia forgetfulness that the neurasthenia causes, dizziness, the deficiency of the oral drug preparation of treatment for diseases such as headache, 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 drug composition oral preparation tranquilizing wild jujube seed dripping pill.Tranquilizing wild jujube seed dripping pill involved in the present invention is a raw material with 3 flavor Chinese medicines such as Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, after extraction obtains containing the extract of above-mentioned 3 flavor Chinese medicine active pharmaceutical ingredients, is prepared from the pharmaceutically suitable carrier as substrate again.
Be prepared by the following technical solutions, can obtain ginseng and ophiopogon root dripping pill involved in the present invention:
[preparation method]
1. the preparation of drug extract: with g or kg is unit, according to the weight portion meter, get 5 parts of Semen Ziziphi Spinosaes (stir-fry), 1 part of Radix Salviae Miltiorrhizae, 1 part of Fructus Schisandrae Chinensis (processed with vinegar), more than 3 the flavor, decoct with water secondary, each 2 hours, collecting decoction filtered, it is 1.25～1.35 thick paste that filtrate is concentrated into relative density, or continue to make drying, be ground into dry powder, promptly.
2. substrate; Polyethylene Glycol
(1000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
Beneficial effect
The sedative jujube kernel granule that is prepared from according to the preparation method that provides among the drug standard WS3-B-2164-96 promulgated by the ministries or commissions of the Central Government, be to have the reinforcing the heart nourishing the liver, the nootropic effect of calming the nerves, be used for heart-liver blood deficiency, the insomnia forgetfulness that the neurasthenia causes, dizziness, the oral granular formulation of treatment for diseases such as headache, 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.
Tranquilizing wild jujube seed dripping pill involved in the present invention is compared with the sedative jujube kernel granule has following beneficial effect;
1. tranquilizing wild jujube seed dripping pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 3 flavor active ingredient of Chinese herbs such as Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis; 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. tranquilizing wild jujube seed dripping 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. tranquilizing wild jujube seed dripping 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 tranquilizing wild jujube seed dripping pill of the present invention.
First group: the test of single-matrix
1. the preparation of drug extract: it is standby to make the extract dry powder that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis earlier according to [preparation method 1];
2. substrate: Polyethylene Glycol
(1000,2000,4000,6000,8000,10000,20000), 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. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the tranquilizing wild jujube seed dripping pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared tranquilizing wild jujube seed dripping pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared tranquilizing wild jujube seed dripping pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared tranquilizing wild jujube seed dripping pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 3.
Second group; The test of mixed-matrix
1. the preparation of drug extract: it is standby to make the extract dry powder that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis earlier according to [preparation method 1];
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 tranquilizing wild jujube seed dripping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Semen Ziziphi Spinosae 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 Semen Ziziphi Spinosae 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 tranquilizing wild jujube seed dripping 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 tranquilizing wild jujube seed dripping 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 tranquilizing wild jujube seed dripping 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 tranquilizing wild jujube seed dripping 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 tranquilizing wild jujube seed dripping 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 tranquilizing wild jujube seed dripping 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 tranquilizing wild jujube seed dripping 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 | 54 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 50.0 | 62 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 73 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 75 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 74 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 77 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 69 | ＜30 | ＞10 | + |
| Poloxamer | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 70 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 73 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 62 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 60 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 61 | ＞30 | ＞10 | + |
| Lac | 50.0 | 61 | ＞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 | 72 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 25.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 90 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 82 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 88 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium | 25.0 | 83 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 76 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 71 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 71 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 71 | ＞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 | 74 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 10.0 | 81 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 91 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 84 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 84 | ＜30 | ＞10 | +++ |
| Sodium lauryl sulphate | 10.0 | 78 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 75 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 73 | ＞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 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 79 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 73 | ＜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 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 83 | ＜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 | 82 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 90 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 89 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 92 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 87 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 88 | ＜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 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 93 | ＜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 (2)
1. one kind is used for heart-liver blood deficiency, the insomnia forgetfulness that the neurasthenia causes, and dizziness, the tranquilizing wild jujube seed dripping pill of headache treatment for diseases is a raw material with Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis 3 flavor Chinese medicines, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) according to the weight portion meter, get 5 parts of Semen Ziziphi Spinosae (parched)s, 1 part of Radix Salviae Miltiorrhizae, 1 part of processed with vinegar Fructus Schisandrae Chinensis, more than 3 the flavor, decoct with water secondary, each 2 hours, collecting decoction filters, and it is 1.25～1.35 thick paste that filtrate is concentrated into relative density, or continue to make drying, be ground into dry powder, promptly get the extract that contains Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis effective ingredient, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, and the ratio of described extract substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described extract and substrate, be placed on heating while stirring in the heating container, until the fused solution or emulsion or the suspension that obtain containing described extract and substrate, standby;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃;
When (5) treating that dropping-pill machine head and condensing agent reach described state of temperature respectively, will contain fused solution or the emulsion or the suspension of described extract and substrate, place in the water dropper jar of drop pill machine, and splash in the condensing agent and shrink molding promptly.
2. tranquilizing wild jujube seed dripping pill as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| CN103330761B (en) * | 2013-06-04 | 2015-06-03 | 江振鸣 | Preparation method for jujube kernel nerve-calming liquid |
| CN104435295A (en) * | 2014-11-06 | 2015-03-25 | 辽宁中医药大学 | Medicine composition containing active ingredients of jujube kernel tranquilizing pellets |
| CN108607017A (en) * | 2018-06-08 | 2018-10-02 | 辽宁仙草堂药业有限公司 | A kind of preparation method of ZAOREN ANSHEN YE |
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| CN1435206A (en) * | 2002-01-30 | 2003-08-13 | 贵州仙灵药业股份有限公司 | Sedative jujube kernel capsule |
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| CN1435206A (en) * | 2002-01-30 | 2003-08-13 | 贵州仙灵药业股份有限公司 | Sedative jujube kernel capsule |
Non-Patent Citations (2)
| Title |
|---|
| . 中华人民共和国卫生部药典委员会.中华人民共和国卫生部药品标准中药成方制剂第十一册. 1996 * |
| 固体分散技术大滴丸极具发展前景的现代中药制剂. 曲韵智.医药经济报. 2004 * |
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