CN100375612C - Blood pressure lowering dripping pills with chryanthemum flower and pearl and its preparation process - Google Patents
Blood pressure lowering dripping pills with chryanthemum flower and pearl and its preparation process Download PDFInfo
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- CN100375612C CN100375612C CNB2005100732532A CN200510073253A CN100375612C CN 100375612 C CN100375612 C CN 100375612C CN B2005100732532 A CNB2005100732532 A CN B2005100732532A CN 200510073253 A CN200510073253 A CN 200510073253A CN 100375612 C CN100375612 C CN 100375612C
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Abstract
The present invention relates to a medicine composition with a blood pressure reducing function, which is used for treating hypertension. The present invention aims to replenish the shortage of the existing oral medicine preparation for treating hypertension and provides an oral preparation, namely a pearl chrysanthemum blood pressure reducing dripping pill with the advantages of high bioavailability, quick medicine release, quick effect taking, high medicine content, convenient administration, low price and no pollution in production. The pearl chrysanthemum blood pressure reducing dripping pill provided by the present invention is prepared from the raw materials, such as wild chrysanthemum paste powder, nacreous layer powder, clonidine hydrochloride, hydrochlorothiazide, rutin, etc., and pharmaceutically acceptable carriers as the substrate.
Description
Technical field
The present invention relates to a kind of hypotensive effect that has, being used for the pharmaceutical composition of vascular hypertension treatment, is a kind of drug composition oral preparation that feedstock production forms with 5 kinds of medicines such as Flos Chrysanthemi Indici extract powder, Margarita layer powder, clonidine hydrochloride, hydrochlorothiazide, rutins particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The Zhenju Jiangya Tablet that the preparation method that provides among-the B-3925-98 is prepared from is a kind of hypotensive effect that has, and is used for the oral tablet of vascular hypertension treatment, and through clinical verification, determined curative effect is clinical and family is used for the treatment of the common drug of above-mentioned disease.
Below be drug standard WS
3Prescription that provides among-the B-3925-98 and technology and brief description:
Prescription: Flos Chrysanthemi Indici extract powder 100g, Margarita layer powder 100g, clonidine hydrochloride 30mg, hydrochlorothiazide 5g, rutin 20g
Method for making: the above five tastes, get Flos Chrysanthemi Indici extract powder, Margarita layer powder, hydrochlorothiazide, the rutin mixing, other adds 70% ethanol and dissolves clonidine hydrochloride in right amount, ethanol liquid is admixed in the above-mentioned mixed powder, after stirring repeatedly, made granule, drying, it is an amount of to add lubricant, is pressed into 1000, coating, promptly.
Function cures mainly: blood pressure lowering; Be used for vascular hypertension.
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 dust availability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention is to replenish the existing deficiency that is used for the oral drug preparation of vascular hypertension treatment, and a kind of bioavailability height is provided, and has a quick release, produce effects fast, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations blood pressure lowering dripping pills with chryanthemum flower and pearl.Blood pressure lowering dripping pills with chryanthemum flower and pearl involved in the present invention is a raw material with 5 kinds of medicines such as Flos Chrysanthemi Indici extract powder, Margarita layer powder, clonidine hydrochloride, hydrochlorothiazide, rutins, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain blood pressure lowering dripping pills with chryanthemum flower and pearl involved in the present invention:
[preparation method]
1. raw material and preparation
[preparation of Margarita layer powder]
Get the nacreous layer part of Unionidae animal hydriopsis cumingii Hyriopsis cumingli (lea), cristaria plicata Cristaria plicata (leach) shell, after cleaning, remove destratum corneum and prismatic layer part, pulverize, cross sieve No. seven, promptly;
[preparation of Flos Chrysanthemi Indici extract powder]
Get Flos Chrysanthemi Indici, decoct with water secondary, each 1 hour, collecting decoction was concentrated into the 1g medicine juice and is equivalent to the 1g crude drug, added 1 times of amount 90% ethanol, stirred evenly, and staticly settled, and the leaching supernatant concentrates, and drying is ground into fine powder, promptly;
[preparation of medicinal mixture]
Get Flos Chrysanthemi Indici extract powder 100g, Margarita layer powder 100g, clonidine hydrochloride 30mg, hydrochlorothiazide 5g, rutin 20g, the above five tastes, get Flos Chrysanthemi Indici extract powder, Margarita layer powder, hydrochlorothiazide, the rutin mixing, other adds 70% ethanol and dissolves clonidine hydrochloride in right amount, ethanol liquid is admixed in the above-mentioned mixed powder, stirred, promptly;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, medicinal mixture: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing medicinal mixture and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing medicinal mixture and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of medicinal mixture and substrate and/or emulsion and/or suspension places in the dropping-pill machine head jar, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[beneficial effect]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The Zhenju Jiangya Tablet that the preparation method that provides among-the B-3925-98 is prepared from is a kind of hypotensive effect that has, and is used for the oral tablet of vascular hypertension treatment, and through clinical verification, determined curative effect is clinical and family is used for the treatment of the common drug 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.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Blood pressure lowering dripping pills with chryanthemum flower and pearl involved in the present invention is compared with Zhenju Jiangya Tablet has following beneficial effect:
1. blood pressure lowering dripping pills with chryanthemum flower and pearl involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the mixture that contains 5 kinds of medicines such as Flos Chrysanthemi Indici extract powder, Margarita layer powder, clonidine hydrochloride, hydrochlorothiazide, rutin; 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. blood pressure lowering dripping pills with chryanthemum flower and pearl 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. blood pressure lowering dripping pills with chryanthemum flower and pearl 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 blood pressure lowering dripping pills with chryanthemum flower and pearl of the present invention.
[first group: the test of single-matrix]
1. raw material: the mixture dry powder that makes 5 kinds of medicines such as containing Flos Chrysanthemi Indici extract powder, Margarita layer powder, clonidine hydrochloride, hydrochlorothiazide, rutin according to [preparation method 1] is standby;
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
1000, Polyethylene Glycol
6000, Polyethylene Glycol
10000Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning; With g or kg is unit, by weight, and medicinal mixture: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the blood pressure lowering dripping pills with chryanthemum flower and pearl of different size.
[result of the test]
Test 1: for observe medicinal mixture and different substrates when 1: 1 the proportioning prepared blood pressure lowering dripping pills with chryanthemum flower and pearl in qualitative difference, according to 1: 1 ratio, with medicinal mixture respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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 13 pharmaceutical compositions experiments that contain medicinal mixture and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe medicinal mixture and different substrates when 1: 3 the proportioning prepared blood pressure lowering dripping pills with chryanthemum flower and pearl in qualitative difference, according to 1: 3 ratio, with medicinal mixture respectively with cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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 13 pharmaceutical compositions experiments that contain medicinal mixture and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe medicinal mixture and different substrates when 1: 9 the proportioning prepared blood pressure lowering dripping pills with chryanthemum flower and pearl in qualitative difference, according to 1: 9 ratio, with medicinal mixture respectively with cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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 13 pharmaceutical compositions experiments that contain medicinal mixture and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. raw material: the mixture dry powder that makes 5 kinds of medicines such as containing Flos Chrysanthemi Indici extract powder, Margarita layer powder, clonidine hydrochloride, hydrochlorothiazide, rutin according to [preparation method 1] is 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, 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 CarboxymethylstachSodium, starch generate 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 blood pressure lowering dripping pills with chryanthemum flower and pearl of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and mixed-matrix prepared blood pressure lowering dripping pills with chryanthemum flower and pearl 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 medicinal mixture 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 medicinal mixture 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 medicinal mixture and single-matrix
(medicinal mixture: 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 | 66 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 50.0 | 83 | <30 | >10 | + |
| Polyethylene Glycol 6000 | 50.0 | 83 | <30 | >10 | + |
| Polyethylene Glycol 10000 | 50.0 | 83 | <30 | >10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 82 | <30 | >10 | ++ |
| Span 40 | 50.0 | 62 | <30 | >10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 75 | <30 | >10 | ++ |
| Poloxamer | 50.0 | 77 | <30 | >10 | ++ |
| Sodium lauryl sulphate | 50.0 | 76 | >30 | >10 | ++ |
| Stearic acid | 50.0 | 65 | >30 | >10 | ++ |
| Sodium stearate | 50.0 | 63 | >30 | >10 | ++ |
| Glycerin gelatine | 50.0 | 64 | >30 | >10 | + |
| Lac | 50.0 | 65 | >30 | >10 | + |
The group practices of table 2 medicinal mixture and single-matrix
(medicinal mixture: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 25.0 | 72 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 25.0 | 87 | <30 | <10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 88 | <30 | <10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 88 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 87 | <30 | <10 | +++ |
| Span 40 | 25.0 | 76 | <30 | >10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 87 | <30 | <10 | ++ |
| Poloxamer | 25.0 | 89 | <30 | <10 | +++ |
| Sodium lauryl sulphate | 25.0 | 74 | <30 | >10 | ++ |
| Stearic acid | 25.0 | 73 | >30 | >10 | +++ |
| Sodium stearate | 25.0 | 73 | >30 | >10 | +++ |
| Glycerin gelatine | 25.0 | 71 | >30 | >10 | +++ |
| Lac | 25.0 | 70 | >30 | >10 | +++ |
The group practices of table 3 medicinal mixture and single-matrix
(medicinal mixture: 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 | 83 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 10.0 | 89 | <30 | <10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 90 | <30 | <10 | +++ |
| Span 40 | 10.0 | 75 | <30 | <10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 87 | <30 | <10 | ++ |
| Poloxamer | 10.0 | 99 | <30 | <10 | +++ |
| Sodium lauryl sulphate | 10.0 | 74 | <30 | >10 | +++ |
| Stearic acid | 10.0 | 76 | >30 | >10 | +++ |
| Sodium stearate | 10.0 | 76 | >30 | >10 | +++ |
| Glycerin gelatine | 10.0 | 73 | >30 | >10 | +++ |
| Lac | 10.0 | 73 | >30 | >10 | +++ |
The group practices of table 4 medicinal mixture and mixed-matrix
(medicinal mixture: 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 | 83 | <30 | >10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 78 | <30 | >10 | + |
The group practices of table 5 medicinal mixture and mixed-matrix
(medicinal mixture: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 90 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 88 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | <30 | >10 | ++ |
The group practices of table 6 medicinal mixture and mixed-matrix
(medicinal mixture: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 90 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 89 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 85 | <30 | >10 | +++ |
The group practices of table 7 medicinal mixture and mixed-matrix
(medicinal mixture: 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 | 89 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 88 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 86 | <30 | <10 | ++ |
The group practices of table 8 medicinal mixture and mixed-matrix
(medicinal mixture: 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 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | <30 | <10 | +++ |
The group practices of table 9 medicinal mixture and mixed-matrix
(medicinal mixture: 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 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 91 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 89 | <30 | <10 | +++ |
The group practices of table 10 medicinal mixture and mixed-matrix
(medicinal mixture: 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 | 91 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 88 | <30 | >10 | +++ |
The group practices of table 11 medicinal mixture and mixed-matrix
(medicinal mixture: 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 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 92 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 87 | <30 | <10 | +++ |
The group practices of table 12 medicinal mixture and mixed-matrix
(medicinal mixture: 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 | 89 | <30 | <10 | +++ |
1. can be seen by the result in the table: when the ratio of medicinal mixture 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 medicinal mixture 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 medicinal mixture 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. a blood pressure lowering dripping pills with chryanthemum flower and pearl for the treatment of vascular hypertension is a raw material with Flos Chrysanthemi Indici extract powder, Margarita layer powder, clonidine hydrochloride, hydrochlorothiazide, rutin, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) raw material and preparation
[preparation of Margarita layer powder]
Get the nacreous layer part of Unionidae animal hydriopsis cumingii, cristaria plicata shell, after cleaning, remove destratum corneum and prismatic layer part, pulverize, cross sieve No. seven, promptly;
[preparation of Flos Chrysanthemi Indici extract powder]
Get Flos Chrysanthemi Indici, decoct with water secondary, each 1 hour, collecting decoction was concentrated into the 1g medicine juice and is equivalent to the 1g crude drug, added 1 times of amount 90% ethanol, stirred evenly, and staticly settled, and the leaching supernatant concentrates, and drying is ground into fine powder, promptly;
[preparation of medicinal mixture]
Get Flos Chrysanthemi Indici extract powder 100g, Margarita layer powder 100g, clonidine hydrochloride 30mg, hydrochlorothiazide 5g, rutin 20g, the above five tastes, get Flos Chrysanthemi Indici extract powder, Margarita layer powder, hydrochlorothiazide, the rutin mixing, other adds 70% ethanol and dissolves clonidine hydrochloride in right amount, and ethanol liquid is admixed in the above-mentioned mixed powder, stirs, promptly get the extract that contains Flos Chrysanthemi Indici extract powder, Margarita layer powder, clonidine hydrochloride, hydrochlorothiazide, rutin effective ingredient, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, and by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10; Describedly contain the extract of Flos Chrysanthemi Indici extract powder, Margarita layer powder, clonidine hydrochloride, hydrochlorothiazide, rutin effective ingredient and the ratio of substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described mixture and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described mixture 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 ℃;
When (5) treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, fused solution and/or the emulsion and/or the suspension that will contain medicinal mixture and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
2. blood pressure lowering dripping pills with chryanthemum flower and pearl as claimed in claim 1 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 |
|---|---|---|---|
| CNB2005100732532A CN100375612C (en) | 2005-06-03 | 2005-06-03 | Blood pressure lowering dripping pills with chryanthemum flower and pearl and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100732532A CN100375612C (en) | 2005-06-03 | 2005-06-03 | Blood pressure lowering dripping pills with chryanthemum flower and pearl and its preparation process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1698797A CN1698797A (en) | 2005-11-23 |
| CN100375612C true CN100375612C (en) | 2008-03-19 |
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| CN102973627A (en) * | 2011-09-02 | 2013-03-20 | 天圣制药集团股份有限公司 | Preparation method of pearl layer powder-wild chrysanthemum cream powder hypotensive tablet |
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Non-Patent Citations (2)
| Title |
|---|
| 中华人民共和国卫生部药品标准（中药成方制剂）第十二册. 中华人民共和国卫生部药典委员会，392，中华人民共和国卫生部. 2002 * |
| 中药药剂学. 范碧亭，380-381，上海科学技术出版社. 1997 * |
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| CN1698797A (en) | 2005-11-23 |
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