CN1686342A - Herminium drip pill and its preparation method - Google Patents
Herminium drip pill and its preparation method Download PDFInfo
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- CN1686342A CN1686342A CN 200510055388 CN200510055388A CN1686342A CN 1686342 A CN1686342 A CN 1686342A CN 200510055388 CN200510055388 CN 200510055388 CN 200510055388 A CN200510055388 A CN 200510055388A CN 1686342 A CN1686342 A CN 1686342A
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Abstract
A Chinese medicine in the form of dripping pills for nourishing Qi and Yin, and treating weakness is prepared from the powdered saponin of monorchid herminium herb and medicinal carrier. Its perparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of effect with supplementing QI and nourishing YIN, be used for the prolonged illness weakness of deficiency of both QI and YIN, disease is seen nervous, breathe hard, weak, the pharmaceutical composition of symptom treatments such as xerostomia is a kind of drug composition oral preparation that feedstock production forms with Herba Herminii saponin's powder particularly.
Background technology
The vibration source oral liquid that is prepared from according to the preparation method that provides among the national drug standards WS-10355 (ZD-0355)-2002, it is a kind of effect with supplementing QI and nourishing YIN, the prolonged illness weakness that is used for deficiency of both QI and YIN, disease is seen nervous, breathes hard, and is weak, the syrups oral formulations of symptom treatments such as xerostomia, 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 WS-10355 (ZD-0355)-2002 drug standard:
Prescription: Herba Herminii saponin's powder 2.5g, Mel 700g, sorbic acid 2g, sodium citrate 6g
Method for making: get Herba Herminii saponin's powder, add ethanol and make dissolving, make Herba Herminii saponin's alcoholic solution of 20mg/ml.Cold preservation 48 hours filters, and filtrate adds the water accent and contains the alcohol amount to 80%, regulate pH value to 9.0, cold preservation 24 hours filters, filtrate recycling ethanol is dissolved in water, and regulates pH value to 6.5, heated and boiled is to molten entirely, and cold preservation 24 hours filters, filtrate adds Mel, sorbic acid, sodium citrate, residue ethanol successively, add water to ormal weight, packing, promptly.
Function cures mainly: supplementing QI and nourishing YIN.Be used for the prolonged illness weakness of deficiency of both QI and YIN, disease is seen nervous, breathes hard, and is weak, xerostomia etc.
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 the existing prolonged illness weakness that is used for deficiency of both QI and YIN, and disease is seen nervous, breathe hard, weak, the deficiency of the oral drug preparation of symptom treatments such as xerostomia provides a kind of bioavailability height, and has a quick release, quick produce effects, the medicament contg height is taken accurate measurement, cheap, and portable (vibration source) Herminium drip pill.
Herminium drip pill involved in the present invention is a raw material with Herba Herminii saponin's powder, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain Herminium drip pill involved in the present invention:
[preparation method]
1. active pharmaceutical ingredient: Herba Herminii saponin's powder;
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, by weight, and Herba Herminii saponin's powder: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing Herba Herminii saponin's powder and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing Herba Herminii saponin's powder 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 Herba Herminii saponin's powder and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[beneficial effect]
The vibration source oral liquid that is prepared from according to the preparation method that provides among the national drug standards WS-10355 (ZD-0355)-2002, it is a kind of effect with supplementing QI and nourishing YIN, the prolonged illness weakness that is used for deficiency of both QI and YIN, disease is seen nervous, breathes hard, and is weak, the syrups oral formulations of symptom treatments such as xerostomia, 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.
Herminium drip pill involved in the present invention is compared with the vibration source oral liquid has following beneficial effect:
1. Herminium drip pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with Herba Herminii saponin's powder, 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. Herminium drip 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. Herminium drip 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 Herminium drip pill of the present invention.
First group: the test of single-matrix
1. active pharmaceutical ingredient: Herba Herminii saponin's powder;
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, Tween 80, 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 Herba Herminii saponin's powder: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the Herminium drip pill of different size.
[result of the test]
Test 1: for observe Herba Herminii saponin's powder and different substrates when 1: 1 the proportioning prepared Herminium drip pill in qualitative difference, according to 1: 1 ratio, with Herba Herminii saponin's powder respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, Tween 80, 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 Herba Herminii saponin's powder and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe Herba Herminii saponin's powder and different substrates when 1: 3 the proportioning prepared Herminium drip pill in qualitative difference, according to 1: 3 ratio, with Herba Herminii saponin's powder respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, Tween 80, 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 Herba Herminii saponin's powder and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe Herba Herminii saponin's powder and different substrates when 1: 9 the proportioning prepared Herminium drip pill in qualitative difference, according to 1: 9 ratio, with Herba Herminii saponin's powder respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, Tween 80, 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 Herba Herminii saponin's powder and different substrates, and obtain 16 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. active pharmaceutical ingredient: Herba Herminii saponin's powder
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 Herba Herminii saponin's powder: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the Herminium drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip 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 Herba Herminii saponin's powder are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are 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 Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip 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 Herba Herminii saponin's powder are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip pill mass discrepancy 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 Herba Herminii saponin's powder are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip pill mass discrepancy 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 Herba Herminii saponin's powder are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip pill mass discrepancy 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 Herba Herminii saponin's powder are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip pill mass discrepancy 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 Herba Herminii saponin's powder are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip pill mass discrepancy 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 Herba Herminii saponin's powder 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 pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip pill mass discrepancy 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 Herba Herminii saponin's powder 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 pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe Herba Herminii saponin's powder and mixed-matrix prepared Herminium drip pill mass discrepancy 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 Herba Herminii saponin's powder 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 pharmaceutical composition experiment that 4 Herba Herminii saponins powder and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 Herba Herminii saponin powder and single-matrix
(Herba Herminii saponin's powder: 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 | ??75 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 6000 | ??50.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??50.0 | ??90 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Span 40 | ??50.0 | ??65 | ??＜30 | ??＞10 | ??+ |
| Tween 80 | ??50.0 | ??65 | ??＞30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Betacyclodextrin | ??50.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Poloxamer | ??50.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Carboxymethyl starch sodium | ??50.0 | ??75 | ??＜30 | ??＞10 | ??+ |
| Sodium lauryl sulphate | ??50.0 | ??77 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??50.0 | ??56 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | ??50.0 | ??58 | ??＞30 | ??＞10 | ??++ |
| Glycerin gelatine | ??50.0 | ??57 | ??＞30 | ??＞10 | ??+ |
| Lac | ??50.0 | ??54 | ??＞30 | ??＞10 | ??+ |
The group practices of table 2 Herba Herminii saponin powder and single-matrix
(Herba Herminii saponin's powder: 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 | ??78 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??25.0 | ??92 | ??＜30 | ??＞10 | ??+++ |
| Polyethylene Glycol 6000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??70 | ??＜30 | ??＞10 | ??++ |
| Tween 80 | ??25.0 | ??70 | ??＜30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin | ??25.0 | ??87 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium | ??25.0 | ??83 | ??＜30 | ??＞10 | ??++ |
| Sodium lauryl sulphate | ??25.0 | ??81 | ??＜30 | ??＞10 | ??+++ |
| Stearic acid | ??25.0 | ??73 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??25.0 | ??72 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??25.0 | ??69 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??25.0 | ??69 | ??＞30 | ??＞10 | ??+++ |
The group practices of table 3 Herba Herminii saponin powder and single-matrix
(Herba Herminii saponin's powder: 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 | ??80 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??10.0 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 6000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??10.0 | ??71 | ??＜30 | ??＞10 | ??+++ |
| Tween 80 | ??10.0 | ??71 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin | ??10.0 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium | ??10.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Sodium lauryl sulphate | ??10.0 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Stearic acid | ??10.0 | ??77 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | ??76 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??10.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
The group practices of table 4 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ??50 | ??84 | ??＜30 | ??＞10 | ??++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??50 | ??84 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??80 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??50 | ??76 | ??＜30 | ??＞10 | ??+ |
The group practices of table 5 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: 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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??25 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??25 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??25 | ??85 | ??＜30 | ??＞10 | ??++ |
The group practices of table 6 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: 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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??10 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??10 | ??84 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 7 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??50 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??50 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??50 | ??84 | ??＜30 | ??＞10 | ??++ |
The group practices of table 8 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: 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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??25 | ??91 | ??＜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 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: 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 | ??86 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 10 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??50 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??50 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??50 | ??83 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 11 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: 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 | ??93 | ??＜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 | ??88 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 12 Herba Herminii saponin powder and mixed-matrix
(Herba Herminii saponin's powder: 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 | ??91 | ??＜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 Herba Herminii saponin's powder 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 Herba Herminii saponin's powder 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 Herba Herminii saponin's powder and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves is not clearly.
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 (5)
1. prolonged illness weakness that is used for deficiency of both QI and YIN, disease is seen nervous, breathes hard, and is weak, the pharmaceutical composition Herminium drip pill of symptom treatments such as xerostomia is a raw material with Herba Herminii saponin's powder, is prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 active pharmaceutical ingredient: Herba Herminii saponin's powder;
1.1 substrate: 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, above-mentioned carrier one or more mixture wherein;
1.2 proportioning: with g or kg is unit, by weight, and Herba Herminii saponin's powder: substrate=1: 1～1: 9.
2. Herminium drip pill as claimed in claim 1 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.
3. any Herminium drip pill as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
4. the preparation method of a Herminium drip pill is characterized in that being made of following process:
4.1 active pharmaceutical ingredient: Herba Herminii saponin's powder;
4.2 substrate: 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, above-mentioned carrier one or more mixture wherein;
4.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4.4, accurately take by weighing Herba Herminii saponin's powder 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;
4.5 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 ℃;
4.6 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 Herba Herminii saponin's powder and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
5. as the preparation method of Herminium drip pill as described in the claim 4, 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 |
|---|---|---|---|
| CN 200510055388 CN1686342A (en) | 2005-03-21 | 2005-03-21 | Herminium drip pill and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510055388 CN1686342A (en) | 2005-03-21 | 2005-03-21 | Herminium drip pill and its preparation method |
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| Publication Number | Publication Date |
|---|---|
| CN1686342A true CN1686342A (en) | 2005-10-26 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101966292A (en) * | 2010-10-07 | 2011-02-09 | 吉林省集安益盛药业股份有限公司 | Sugarless Chinese medicinal oral liquid and preparation method thereof |
| CN102485259A (en) * | 2010-12-03 | 2012-06-06 | 吉林吉春制药有限公司 | Preparation method and application of ginseng fruit medicinal dispersing tablets and buccal tablets |
| CN103585466A (en) * | 2013-11-21 | 2014-02-19 | 吉林大学 | Sapodilla saponin composite precursor liposome and preparation method thereof |
| CN112999167A (en) * | 2021-03-01 | 2021-06-22 | 深圳前海九华国际投资控股有限公司 | Ginseng seed quick-release pellet and preparation method thereof |
-
2005
- 2005-03-21 CN CN 200510055388 patent/CN1686342A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101966292A (en) * | 2010-10-07 | 2011-02-09 | 吉林省集安益盛药业股份有限公司 | Sugarless Chinese medicinal oral liquid and preparation method thereof |
| CN101966292B (en) * | 2010-10-07 | 2014-02-26 | 吉林省集安益盛药业股份有限公司 | Sugarless Chinese medicinal oral liquid and preparation method thereof |
| CN102485259A (en) * | 2010-12-03 | 2012-06-06 | 吉林吉春制药有限公司 | Preparation method and application of ginseng fruit medicinal dispersing tablets and buccal tablets |
| CN103585466A (en) * | 2013-11-21 | 2014-02-19 | 吉林大学 | Sapodilla saponin composite precursor liposome and preparation method thereof |
| CN103585466B (en) * | 2013-11-21 | 2016-04-06 | 吉林大学 | Herba Herminii saponin's composite precursor liposome and preparation method |
| CN112999167A (en) * | 2021-03-01 | 2021-06-22 | 深圳前海九华国际投资控股有限公司 | Ginseng seed quick-release pellet and preparation method thereof |
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