CN1317010C - Huoliguan dripping pill for tonifying heart and kidney and its preparing method - Google Patents
Huoliguan dripping pill for tonifying heart and kidney and its preparing method Download PDFInfo
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- CN1317010C CN1317010C CNB2005100514966A CN200510051496A CN1317010C CN 1317010 C CN1317010 C CN 1317010C CN B2005100514966 A CNB2005100514966 A CN B2005100514966A CN 200510051496 A CN200510051496 A CN 200510051496A CN 1317010 C CN1317010 C CN 1317010C
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- Medicinal Preparation (AREA)
Abstract
The present invention relates to a medical composition used for deficiency of both vital energy and yin, deficiency of hearts and kidneys, amnesia, insomnia, memory declination, coronary heart diseases, chronic hepatitis, diabetes, climacterium syndrome, etc. The present invention is used for replenishing the defects of the existing oral medical preparations for curing the diseases and provides an activating source dripping pill of oral preparations of the medical composition, which has the advantages of high biologic utilization rate, fast medicine release, fast effect, high medicine content, accurate administration measuring, low price and portability. The activating source dripping pill is made of extract products of active medicine components of four meshes of traditional Chinese medicine of ginseng stems, saponin, astragalus root, schisandra, lilyturf root, aconite, etc., which are made into the activating source dripping pill together with a medical carrier used as a base material.
Description
Technical field
The present invention relates to a kind of supplementing QI and nourishing YIN that has, the effect of heart tonifying kidney tonifying, be used for deficiency of both QI and YIN, the forgetful insomnia that heart kidney two loses, hypomnesis, coronary heart disease, chronic hepatitis, the pharmaceutical composition of treatment for diseases such as diabetes and climacteric syndrome is a kind of drug composition oral preparation that feedstock production forms to contain 4 flavor Chinese medicine active pharmaceutical ingredient extracts such as the stem and leaf of Radix Ginseng total saponins and the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata particularly.
Background technology
Join oral liquid according to the Testudinis stilbene that the preparation method that provides among the drug standard WS3-B-3277-98 promulgated by the ministries or commissions of the Central Government is prepared from, be a kind of supplementing QI and nourishing YIN that has, the effect of heart tonifying kidney tonifying is used for deficiency of both QI and YIN, the forgetful insomnia that heart kidney two loses, hypomnesis, coronary heart disease, chronic hepatitis, the syrups oral formulations of treatment for diseases such as diabetes and climacteric syndrome, 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 in the WS3-B-3277-98 drug standard:
Prescription: stem and leaf of Radix Ginseng total saponins 12.5g, Radix Astragali 25g, Fructus Schisandrae Chinensis 60g, Radix Ophiopogonis 120g, Radix Aconiti Lateralis Preparata 2.5g
Method for making: the above five tastes, with the Radix Astragali, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata decocts with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is concentrated in right amount, add triplication ethanol, precipitation is got supernatant and is reclaimed ethanol, and being concentrated into relative density is 1.10 (60 ℃ of surveys).Fructus Schisandrae Chinensis decocts with water secondary, is 1 hour for the first time, is 0.5 hour for the second time, collecting decoction, filter, filtrate is condensed into cream, adds triplication ethanol, precipitation is got supernatant and is reclaimed ethanol, and being concentrated into relative density is 1.10 (60 ℃ of surveys), merge with above-mentioned medicinal liquid, other adds simple syrup 5000ml, sorbic acid 12g, add the Stem and leaf of Radix Ginseng general glycoside, adjust total amount, stir evenly to 10000ml, filter, fill, promptly.
Function cures mainly: supplementing QI and nourishing YIN, heart tonifying kidney tonifying.Be applicable to deficiency of both QI and YIN, the forgetful insomnia that heart kidney two loses, hypomnesis, coronary heart disease, chronic hepatitis, diabetes and climacteric syndrome and the above-mentioned patient of 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.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings such as inconvenience.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention is to replenish existing be used for deficiency of both QI and YIN, the forgetful insomnia that heart kidney two loses, hypomnesis, coronary heart disease, chronic hepatitis, the deficiency of the oral drug preparation of treatment for diseases such as diabetes and climacteric syndrome, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, take accurate measurement, cheap, and portable drug composition oral preparation vigor source drop pill.
Vigor source drop pill involved in the present invention is a raw material to contain 4 flavor Chinese medicine active pharmaceutical ingredient extracts such as the stem and leaf of Radix Ginseng total saponins and the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain heart and brain drop pills involved in the present invention:
[preparation method]
1. raw material: contain 4 flavor Chinese medicine active pharmaceutical ingredient extracts such as the stem and leaf of Radix Ginseng total saponins and the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata;
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 that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.[appendix: a kind of preparation method that contains stem and leaf of Radix Ginseng total saponins, the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata effective component extracts] is unit with g or kg, according to the weight portion meter, get 5 parts of stem and leaf of Radix Ginseng total saponins, 10 parts of the Radixs Astragali, 24 parts of Fructus Schisandrae Chinensis, 48 parts of Radix Ophiopogonis, 1 part of Radix Aconiti Lateralis Preparata; More than 5 flavors, with the Radix Astragali, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata decocts with water 2 times, the 1st time 3 hours, the 2nd time 2 hours, collecting decoction filtered, filtrate is concentrated in right amount, adds 3 times of amount ethanol, precipitation is got supernatant recovery ethanol, is 1.10 being concentrated into relative density below 60 ℃; Fructus Schisandrae Chinensis decocts with water 2 times, and the 1st time is 1 hour, and the 2nd time is 0.5 hour, collecting decoction filters, and filtrate is condensed into cream, add 3 times of amount ethanol, precipitation is got supernatant and is reclaimed ethanol, being concentrated into relative density below 60 ℃ is 1.10, merge with above-mentioned medicinal liquid, add the Stem and leaf of Radix Ginseng general glycoside, stir, being decompressed to 0.1MPa, low temperature, to be condensed into relative density below 60 ℃ be 1.25～1.35 thick paste, promptly.
Beneficial effect
Join oral liquid according to the Testudinis stilbene that the preparation method that provides among the drug standard WS3-B-3277-98 promulgated by the ministries or commissions of the Central Government is prepared from, be a kind of supplementing QI and nourishing YIN that has, the effect of heart tonifying kidney tonifying is used for deficiency of both QI and YIN, the forgetful insomnia that heart kidney two loses, hypomnesis, coronary heart disease, chronic hepatitis, the syrups oral formulations of treatment for diseases such as diabetes and climacteric syndrome, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings such as inconvenience.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Vigor source drop pill involved in the present invention is compared with vigor source oral liquid has following beneficial effect:
1. vigor source drop pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion, make medicine be molecule, colloid or microcrystalline state to be scattered in the substrate with the extract that contains Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Codonopsis, the Radix Astragali etc. 5 flavor Chinese medicine active pharmaceutical ingredients; 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. vigor source 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. vigor source 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 vigor of the present invention source drop pill.
First group: the test of single-matrix
1. the preparation of drug extract: make earlier according to [appendix] that to contain stem and leaf of Radix Ginseng total saponins, the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata effective component extracts dry powder standby,
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, drug extract: substrate=1: 1～1: 9,
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the vigor source drop pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared vigor source drop 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 vigor source drop 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 vigor source drop 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 15 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: make earlier according to [appendix] that to contain stem and leaf of Radix Ginseng total saponins, the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata effective component extracts dry powder standby;
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 vigor source 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 vigor source 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 vigor source 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 vigor source 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 vigor source 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 vigor source 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 vigor source 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 vigor source drop pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe drug extract and mixed-matrix prepared vigor source drop pill of poor quality when 1: 3 the proportioning. different, 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 vigor source 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 | 56 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 50.0 | 66 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 78 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 74 | ＜30 | ＞10 | + |
| Poloxamer | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 73 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 69 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 60 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 59 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 56 | ＞30 | ＞10 | + |
| Lac | 50.0 | 56 | ＞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 | 65 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 2000 | 25.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 91 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 78 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 68 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 68 | ＞30 | ＞10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 75 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 2000 | 10.0 | 85 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 90 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 87 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 84 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 82 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 80 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 75 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 75 | ＞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 | 78 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 74 | ＜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 | 89 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 88 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 85 | ＜30 | ＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 85 | ＜30 | ＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 87 | ＜30 | ＜10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 92 | ＜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 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 84 | ＜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 | 88 | ＜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 | 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 | 90 | ＜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 has supplementing QI and nourishing YIN, and heart tonifying kidney tonifying effect oral administration dripping pill is a raw material with stem and leaf of Radix Ginseng total saponins, the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1), gets 5 parts of stem and leaf of Radix Ginseng total saponins, 10 parts of the Radixs Astragali, 24 parts of Fructus Schisandrae Chinensis, 48 parts of Radix Ophiopogonis, 1 part of Radix Aconiti Lateralis Preparata according to the weight portion meter; More than 5 flavors, with the Radix Astragali, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata decocts with water 2 times, the 1st time 3 hours, the 2nd time 2 hours, collecting decoction filtered, filtrate is concentrated in right amount, adds 3 times of amount ethanol, precipitation is got supernatant recovery ethanol, is 1.10 being concentrated into relative density below 60 ℃; Fructus Schisandrae Chinensis decocts with water 2 times, and the 1st time is 1 hour, and the 2nd time is 0.5 hour, collecting decoction filters, and filtrate is condensed into cream, add 3 times of amount ethanol, precipitation is got supernatant and is reclaimed ethanol, being concentrated into relative density below 60 ℃ is 1.10, merges with above-mentioned medicinal liquid, adds the Stem and leaf of Radix Ginseng general glycoside, stir, being decompressed to 0.1MPa, low temperature, to be condensed into relative density below 60 ℃ be 1.25～1.35 thick paste, promptly gets the extract that contains pharmaceutically active ingredient in above-mentioned 5 flavors, 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 drug extract and substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃;
(5) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively when reaching described state, will contain fused solution and/or the emulsion and/or the suspension of described extract and substrate, places in the water dropper jar of drop pill machine, splashes in the condensing agent and shrinks molding promptly.
2. oral administration 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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| Title |
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| 中华人民共和国药品标准中药成方制剂 中华人民共和国药典委员会，185，1998 * |
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