CN100387250C - Dripping pills of corydalis tuber and its preparation process - Google Patents
Dripping pills of corydalis tuber and its preparation process Download PDFInfo
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- CN100387250C CN100387250C CNB2005100902548A CN200510090254A CN100387250C CN 100387250 C CN100387250 C CN 100387250C CN B2005100902548 A CNB2005100902548 A CN B2005100902548A CN 200510090254 A CN200510090254 A CN 200510090254A CN 100387250 C CN100387250 C CN 100387250C
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Abstract
The present invention discloses a medicinal composition for curing disease symptoms of coronary heart disease, angina pectoris, myocardial infarction, etc., which particularly relates an oral preparation which is prepared by using corydalis tuber of a traditional Chinese medicine as a raw material. The present invention aims to replenish the insufficiency of the existing oral medicine preparation for curing the disease symptoms and provide a corydalis tuber dripping pill which has the advantages of high biologic utilization rate, fast release of medicine, fast apparent rate, high medicine content, convenience for taking, low cost, good mouth feel, integral retain of the characteristics of the traditional Chinese medicine, and no pollution in the manufacture. The corydalis tuber dripping pill of the present invention uses corydalis tuber of the traditional Chinese medicine as the raw material which is together prepared with a medicinal carrier which serves as a matrix.
Description
Technical field
The present invention relates to a kind of blood circulation promoting and blood stasis dispelling that has, the promoting the circulation of QI analgesic effect is used for coronary heart disease, angina pectoris, acute myocardial infarction, the pharmaceutical composition of treatment for diseases such as the chest distress of old myocardial infarction, palpitation and dizziness particularly is a kind of oral formulations that feedstock production forms with the traditional Chinese medicine corydalis tuber.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The Kedaling sheet that the preparation method that provides among-the B-3167-98 is prepared from, it is a kind of blood circulation promoting and blood stasis dispelling that has, the promoting the circulation of QI analgesic effect, be used for coronary heart disease, angina pectoris, acute myocardial infarction, the oral tablet of treatment for diseases such as the chest distress of old myocardial infarction, palpitation and dizziness, through clinical verification for many years, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.Below be drug standard WS
3Prescription that provides among-the B-3167-98 and technology and brief description:
Prescription: this product is the extractum sheet of Rhizoma Corydalis through being processed into.
Method for making: get Rhizoma Corydalis, be ground into coarse powder, extract three times with 80% alcohol heating reflux, each 4 hours, merge extractive liquid, filtered, and filtrate decompression is condensed into thick paste, measures alkaloid, adds appropriate amount of auxiliary materials, the system granule, and tabletting, sugar coating, promptly.
Function cures mainly: blood circulation promoting and blood stasis dispelling, promoting the circulation of QI pain relieving.Be used for coronary heart disease, angina pectoris, acute myocardial infarction, the chest distress of old myocardial infarction, palpitation and dizziness.
Rhizoma Corydalis is the dry tuber of Papaveraceae Corydalis plant Rhizoma Corydalis (CorydalisyanhusuoW.T.Wang), have invigorate blood circulation, promoting the circulation of QI, analgesic effect, its main active is an isoquinoline alkaloid.The alkaloidal chemical research of Rhizoma Corydalis starts from nineteen twenties, up to the present from Rhizoma Corydalis, got nearly 20 of alkaloid, its type adheres to four kinds of isoquinolin type alkaloids such as protoberberine type, former tropine type, aporphine, benzo phenanthridines type separately, wherein most protoberberine types that belong to, minority is aporphine and former tropine type, has only one to be benzo phenanthridines type.It is reported: in the process that Rhizoma Corydalis germ plasm resource is studied, alkaloid in the Rhizoma Corydalis has been carried out separating preparation, get 13 alkaloid monomers from its total alkali, identified wherein 12, wherein different corybulbine (isocorybulbine) is for getting from Rhizoma Corydalis first; Saulatine is for getting from bloodroot first, and this also is to obtain isoquinolin benzazoline type (isoquinobenzazepinetype) alkaloid first from bloodroot, and this Alkaloid was only found in Menispermaceae and Berberidaceae plant in the past
[1]
Though having with its extract tetrahydropalmatine sulfate at present is the pharmaceutical preparation that feedstock production forms, the oral formulations that this dosage form gets compared with adopting the preparation of traditional preparation process technology has certain advance on technology of preparing, but the reform of Chinese medicine just had two kinds of different theories originally, wherein a kind of thinks, the modernization of Chinese medicine should be carried out under the prerequisite that keeps the Chinese medicine genuineness, wherein also belongs at present some unknown composition otherwise just might lose in preparation process.
Yet owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional extract oral dosage form, as traditional ball, loose, cream, pellet etc., medicament contg is low, dose is big, mouthfeel is poor, and tablet, capsule, granule (electuary) 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 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 is to replenish existing be used for coronary heart disease, angina pectoris, acute myocardial infarction, the deficiency of the oral drug preparation of treatment for diseases such as the chest distress of old myocardial infarction, palpitation and dizziness provides a kind of bioavailability height, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, mouthfeel is good, and complete reservation the characteristics of Chinese medicine, free of contamination aborning dripping pills of corydalis tuber.Dripping pills of corydalis tuber involved in the present invention is a raw material with the traditional Chinese medicine corydalis tuber, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain dripping pills of corydalis tuber involved in the present invention:
[preparation method]
1. the preparation of drug extract: with g or kg is unit, and it is an amount of to get Rhizoma Corydalis, is ground into coarse powder, extracts three times with 80% alcohol heating reflux, is not less than 2 hours at every turn, and merge extractive liquid, filters, and filtrate decompression is condensed into relative density greater than 1.2 thick paste, promptly; Or continue to make drying, be ground into dry powder, promptly;
2. substrate: be selected from polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, the mixture of one or more in above-mentioned pharmaceutically suitable carrier;
3. proportioning: measuring alkaloids content in the drug extract in advance, calculate according to alkaloids content, is unit with g or kg, drug extract: substrate=1: 1～1: 9;
Ratio more practical in the practice is: drug extract: substrate=1: 1～1: 5;
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, TZDW-1 type drop pill machine as 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, to contain fused solution and/or the emulsion and/or the suspension of drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, cooling is shunk and is shaped, promptly.
Annotate 1: described condensing agent is any one or the two or more mixture in liquid paraffin, methyl-silicone oil, the vegetable oil.
[beneficial effect]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The Kedaling sheet that the preparation method that provides among-the B-3167-98 is prepared from, it is a kind of blood circulation promoting and blood stasis dispelling that has, the promoting the circulation of QI analgesic effect, be used for coronary heart disease, angina pectoris, acute myocardial infarction, the oral tablet of treatment for diseases such as the chest distress of old myocardial infarction, palpitation and dizziness, through clinical verification for many years, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Yet owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional extract oral dosage form, as traditional ball, loose, cream, pellet etc., medicament contg is low, dose is big, mouthfeel is poor, and tablet, capsule, granule (electuary) 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 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.
Dripping pills of corydalis tuber involved in the present invention is compared with the Kedaling sheet has following beneficial effect:
1. dripping pills of corydalis tuber involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains the traditional Chinese medicine corydalis tuber effective ingredient, make medicine be molecule, colloid or microcrystalline state and be scattered in the substrate, the total surface area of medicine increases; and substrate is hydrophilic; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. dripping pills of corydalis tuber 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. dripping pills of corydalis tuber 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. dripping pills of corydalis tuber involved in the present invention, except that having possessed above-mentioned advantage, also complete reservation whole effective ingredient of Chinese medicine, thereby also just kept the essential characteristics of Chinese medicine, also turned useful exploration into for the modern times of Chinese medicine preparation.
5. 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;
Simultaneously, 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 dripping pills of corydalis tuber of the present invention.
[selection of prescription]
1. raw material: according to the method that [preparation method 1] provided, make the drug extract dry powder that contains the traditional Chinese medicine corydalis tuber effective ingredient in advance, standby;
2. single-matrix: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac etc.;
3. composite substrate: with g or kg is unit, by weight, selects carriers such as Polyethylene Glycol, polyoxyethylene stearate 40 esters, carboxymethyl starch sodium, betacyclodextrin, tween to carry out composite test;
3.1 the combination of two kinds of different substrates: with g or kg is unit, by weight, gets 1 part polyoxyethylene stearate 40 esters or betacyclodextrin or carboxymethyl starch sodium or tween, makes up with 1～10 part Polyethylene Glycol, and Polyethylene Glycol wherein is meant Polyethylene Glycol
1000～Polyethylene Glycol
20000In any one or two or more mixture;
3.2 the combination of three kinds of different substrates: with g or kg is unit, by weight, get 1 part polyoxyethylene stearate 40 esters and 0.5～5 part carboxymethyl starch sodium (or betacyclodextrin or tween) and 1～10 part Polyethylene Glycol and make up, Polyethylene Glycol wherein is meant Polyethylene Glycol
1000～Polyethylene Glycol
20000In any one or two or more mixture;
3.3 the combination of four kinds of different substrates: with g or kg is unit, by weight, get 1 part polyoxyethylene stearate 40 esters and 0.5～5 part carboxymethyl starch sodium (or betacyclodextrin) and make up with 0.5～5 part tween and 1～10 part Polyethylene Glycol, Polyethylene Glycol wherein is a Polyethylene Glycol
1000～Polyethylene Glycol
20000In one or more mixture;
4. alkaloids content in the mensuration drug extract is calculated according to alkaloids content, is unit with g or kg, drug extract: substrate=1: 1～1: 9;
5. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the dripping pills of corydalis tuber of different size.
Test the test of a single-matrix
Cooperating prepared dripping pills of corydalis tuber in qualitative difference with different substrates in order to observe drug extract, is unit with g or kg, according to 1: 1,1: 3,1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, matrix phases such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac cooperate, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and different substrates, and obtain 3 groups of different experimental results and see Table 1～table 3.
Test the composite test of 2 two kinds of different substrates
Cooperate prepared dripping pills of corydalis tuber in qualitative difference in order to observe drug extract with two kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) or betacyclodextrin (beta cyclodextrin) or carboxymethyl starch sodium or tween, respectively with 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 4～table 6.
Test the composite test of three or three kinds of different substrates
Cooperate prepared dripping pills of corydalis tuber in qualitative difference in order to observe drug extract with three kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) respectively with 0.5 part, 3 parts, 5 parts beta cyclodextrin (or carboxymethyl starch sodium or tween), and 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 7～table 9.
Test the composite test of four or four kinds of different substrates
Cooperate prepared dripping pills of corydalis tuber in qualitative difference in order to observe drug extract with four kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) respectively with 0.5 part, 3 parts, 5 parts beta cyclodextrin (or carboxymethyl starch sodium), and 0.5 part, 3 parts, 5 parts tween, and 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 10～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 | 67 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 61 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 63 | ＜30 | ＞10 | ++ |
| Stearic acid | 50.0 | 61 | ＞30 | ＞10 | +++ |
| Sodium stearate | 50.0 | 61 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 50.0 | 60 | ＞30 | ＞10 | ++ |
| Lac | 50.0 | 59 | ＞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 | 87 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 65 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 76 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 73 | ＞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 | 85 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 66 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 85 | ＜30 | ＞10 | ++ |
| Poloxamer | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 76 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 76 | ＞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 two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 50.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 50.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 50.0 | 88 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50.0 | 85 | ＜30 | ＞10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50.0 | 86 | ＜30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 50.0 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 5 drug extract and two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 25.0 | 87 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25.0 | 82 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25.0 | 86 | ＞30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 25.0 | 80 | ＞30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 25.0 | 82 | ＞30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 25.0 | 81 | ＞30 | ＞10 | ++ |
The group practices of table 6 drug extract and two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 10.0 | 87 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 10.0 | 90 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10.0 | 84 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10.0 | 87 | ＞30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 10.0 | 79 | ＞30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 10.0 | 81 | ＞30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 10.0 | 82 | ＞30 | ＞10 | ++ |
The group practices of table 7 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 50.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 50.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 50.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 50.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 50.0 | 85 | ＜30 | ＞10 | ++ |
The group practices of table 8 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 25.0 | 86 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 10.0 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 10 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 50.0 | 85 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 50.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 50.0 | 85 | ＜30 | ＞10 | ++ |
The group practices of table 11 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 25.0 | 85 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 25.0 | 87 | ＜30 | ＜10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 25.0 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 12 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 10.0 | 88 | ＜30 | ＜10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 10.0 | 88 | 30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 10.0 | 86 | ＜30 | ＜10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 10.0 | 88 | ＜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 hardness etc. 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. the cardiopathic dripping pills of corydalis tuber of treatment is a raw material with the Rhizoma Corydalis, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
1.1 the preparation of drug extract: with g or kg is unit, and it is an amount of to get Rhizoma Corydalis, is ground into coarse powder, extract three times with 80% alcohol heating reflux, be not less than 2 hours, merge extractive liquid, at every turn, filter, filtrate decompression is condensed into relative density greater than 1.2 thick paste, promptly; Or continue to make drying, be ground into dry powder, promptly;
1.2 described substrate is selected from two or more mixture in Polyethylene Glycol, polyoxyethylene stearate 40 esters, beta cyclodextrin, carboxymethyl starch sodium, the tween;
1.3 proportioning: measuring alkaloids content in the drug extract in advance, calculate according to alkaloids content, is unit with g or kg, drug extract: substrate=1: 3;
1.4, accurately take by weighing described extract and substrate according to aforementioned proportion, be placed on heating while stirring in the heating container, until the fused solution that obtains containing described extract and substrate, or emulsion, or suspension, standby;
1.5 adjust the temperature control system of drop pill machine, make the water dropper heating of drop pill machine and maintain the temperature at 50 ℃～90 ℃, the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃;
1.6 when treating that the temperature of dropping-pill machine head and condensing agent reaches described state respectively, will contain the fused solution of described extract and substrate, or emulsion, or suspension, place in the water dropper jar of drop pill machine, splash into to shrink in the condensing agent and be shaped, promptly.
2. dripping pills of corydalis tuber as claimed in claim 1 is characterized in that: described substrate is the mixture of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium or beta cyclodextrin or tween and Polyethylene Glycol, and its mixed proportion is 1: 1～1: 10.
3. dripping pills of corydalis tuber as claimed in claim 1 is characterized in that: described substrate is the mixture of polyoxyethylene stearate 40 esters, beta cyclodextrin or carboxymethyl starch sodium or tween and Polyethylene Glycol, and its mixed proportion is 1: 0.5: 1～1: 5: 10.
4. dripping pills of corydalis tuber as claimed in claim 1 is characterized in that: described substrate is the mixture of polyoxyethylene stearate 40 esters, beta cyclodextrin or carboxymethyl starch sodium, tween and Polyethylene Glycol, and its mixed proportion is 1: 0.5: 0.5: 1～1: 5: 5: 10.
5. dripping pills of corydalis tuber as claimed in claim 1 is characterized in that: described Polyethylene Glycol is selected from Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000In any one or two or more mixture.
6. dripping pills of corydalis tuber 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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Non-Patent Citations (3)
| Title |
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| 中华人民共和国卫生部药品标准中药成方制剂 第十七册：可达灵片. 卫生部药典委员会，第53页，化学工业出版社. 1998 中药药剂学. 范碧亭主编，第380-381页，上海科技出版社. 1997 |
| 中华人民共和国卫生部药品标准中药成方制剂 第十七册：可达灵片. 卫生部药典委员会，第53页，化学工业出版社. 1998 * |
| 中药药剂学. 范碧亭主编，第380-381页，上海科技出版社. 1997 * |
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