CN1682921A - 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
- Publication number
- CN1682921A CN1682921A CN 200510051496 CN200510051496A CN1682921A CN 1682921 A CN1682921 A CN 1682921A CN 200510051496 CN200510051496 CN 200510051496 CN 200510051496 A CN200510051496 A CN 200510051496A CN 1682921 A CN1682921 A CN 1682921A
- Authority
- CN
- China
- Prior art keywords
- polyethylene glycol
- radix
- substrate
- drug extract
- drop pill
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of medicine composition, vitality source dripping pill, for treating insomnia, hypomnesis, coronary heart disease, chronic hepatitis, diabetes, climacteric syndrome, etc. caused by vital energy and yin deficiency and heart and kidney deficiency. The present invention has high bioavailability, fast medicine release, fast acting, high effective content, taking convenience and low cost. The vitality source dripping pill is prepared with four kinds of Chinese medicinal materials of astragalus root, schisandra, ophiopogon root, aconite root and medicine carrier as matrix.
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 with the extract that contains 5 flavor Chinese medicine active pharmaceutical ingredients such as Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Codonopsis, the Radix Astragali; 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. 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, 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 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 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: 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 (6)
1. one kind is 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 vigor source drop pill of treatment for diseases such as diabetes and climacteric syndrome is a raw material with the extract that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as the stem and leaf of Radix Ginseng total saponins and the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 substrate: Polyethylene Glycol
(1000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned carrier one or more mixture wherein;
1.2 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. vigor as claimed in claim 1 source drop pill, it is characterized in that described to contain 4 flavor Chinese medicine active pharmaceutical ingredient preparation method of extract such as stem and leaf of Radix Ginseng total saponins and the Radix Astragali, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Radix Aconiti Lateralis Preparata as follows: with g or kg is unit, 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.
3. vigor as claimed in claim 1 source drop pill 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 vigor source drop pill, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
5. the preparation method of a vigor source drop pill is made of following process:
5.1 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;
5.2 substrate: Polyethylene Glycol
(1000～20000), 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 drug extract and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug 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 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 and shrink molding promptly.
6. as the preparation method of vigor source 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 |
|---|---|---|---|
| CNB2005100514966A CN1317010C (en) | 2005-03-08 | 2005-03-08 | Huoliguan dripping pill for tonifying heart and kidney and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100514966A CN1317010C (en) | 2005-03-08 | 2005-03-08 | Huoliguan dripping pill for tonifying heart and kidney and its preparing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1682921A true CN1682921A (en) | 2005-10-19 |
| CN1317010C CN1317010C (en) | 2007-05-23 |
Family
ID=35262540
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100514966A Expired - Fee Related CN1317010C (en) | 2005-03-08 | 2005-03-08 | Huoliguan dripping pill for tonifying heart and kidney and its preparing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1317010C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2012528144A (en) * | 2009-05-26 | 2012-11-12 | 株式会社アモーレパシフィック | Saponin bioavailability enhancing composition |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1201751C (en) * | 2000-05-31 | 2005-05-18 | 李春凯 | Traditional Chinese medicine prepn. for warming heart and inducing arteries and veins contg. ginseng and monkshood |
-
2005
- 2005-03-08 CN CNB2005100514966A patent/CN1317010C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2012528144A (en) * | 2009-05-26 | 2012-11-12 | 株式会社アモーレパシフィック | Saponin bioavailability enhancing composition |
| US10172900B2 (en) | 2009-05-26 | 2019-01-08 | Amorepacific Corporation | Composition with improved bioavailabilty of saponin and method for improving the bioavailability of saponin |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1317010C (en) | 2007-05-23 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1686478A (en) | Cough suppressing phlegm transforming drip pill and its preparation method | |
| CN1682923A (en) | Body strengthening dripping pill for invigorating qi and refreshing and its preparing method | |
| CN100341489C (en) | Xianling gubao dripping pills having functions of reinforcing kidney strengthening bone, and its prepn method | |
| CN1682918A (en) | Tranquilizing wild jujube seed dripping pill and its preparing method | |
| CN1307980C (en) | Lemai dripping pill for treating cardiovascular diseases and its preparing method | |
| CN100341487C (en) | 'Shuanghuang' antiphlogistic drop pill in use relieving inflammation and preparation method | |
| CN100344314C (en) | Xinnaoshu dripping pill for invigorating qi and nourishing yin and its preparing method | |
| CN1292741C (en) | Ginseng and schisandra fruit dripping pill and its preparing method | |
| CN1292737C (en) | Oral administration dripping pill for nourishing heart to calm mind and its preparing method | |
| CN1292736C (en) | Dripping pill made from haw, chrysanthemum and Chinese wolfberry fruit and its preparing method | |
| CN1316959C (en) | Acanthopanax bark-ginseng-Chinese angelica root-astragalus root dripping pill and its preparing method | |
| CN1317010C (en) | Huoliguan dripping pill for tonifying heart and kidney and its preparing method | |
| CN1301101C (en) | Oral drip pill used for cough suppressing phlegm transforming and its preparation method | |
| CN1682920A (en) | Anshenning dripping pill for treating neurosism and its preparing method | |
| CN1307983C (en) | Mai-an dripping pill for treating hyperlipoproteinemia and its preparing method | |
| CN1682806A (en) | Ginseng and fleece-flower root dripping pill and its preparing method | |
| CN1686521A (en) | Psoriasis drip pill and its preparation method | |
| CN1686340A (en) | Gastrodia brain arousing drip pill for nourishing liver and kidney and its preparation method | |
| CN1686339A (en) | Compound cynomorium drip pill and its preparation method | |
| CN1686454A (en) | Xiaoke drip pill used for suppressing cough and transforming phlegm and its preparation method | |
| CN1686477A (en) | Lonicera flower mango drip pill and its preparation method | |
| CN1292740C (en) | Ginseng and Chinese angelica root dripping pill and its preparing method | |
| CN1292739C (en) | Shenerwuwei dripping pill for benefiting qi and nourishing yin and its preparing method | |
| CN1686518A (en) | Ganoderma astragalus drip pill for treating heart spleen vacuity and its preparation method | |
| CN1686338A (en) | Shuxin anshen drip pill used for fortifying brain quieting heart and its preparation method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20070523 |