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CN1682920A - Anshenning dripping pill for treating neurosism and its preparing method - Google Patents

Anshenning dripping pill for treating neurosism and its preparing method Download PDF

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Publication number
CN1682920A
CN1682920A CN 200510051495 CN200510051495A CN1682920A CN 1682920 A CN1682920 A CN 1682920A CN 200510051495 CN200510051495 CN 200510051495 CN 200510051495 A CN200510051495 A CN 200510051495A CN 1682920 A CN1682920 A CN 1682920A
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polyethylene glycol
drug extract
substrate
calming
nerves
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CN 200510051495
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CN100502903C (en
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曲韵智
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Beijing Chia Tai Green Continent Pharmaceutical Co Ltd
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Beijing Chia Tai Green Continent Pharmaceutical Co Ltd
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Abstract

The present invention relates to a kind of medicine composition, Anshenning dripping pill, with the functions of strengthening body's resistance, benefiting vital energy, invigorating spleen and kidney, and tranquilizing, and used in treating neurosism, poor appetite, ;lacking in strenght, etc. The present invention has high bioavailability, fast medicine release, fast acting, high effective content, taking convenience and low cost. The Anshenning dripping pill is prepared with three kinds of Chinese medicinal materials of manyprickle acanthopanax root, glossy ganoderma and schisandra and medicine carrier as matrix.

Description

The neurasthenic drip pills and preparation method thereof of calming the nerves of a kind of treatment
Technical field
The present invention relates to a kind of strengthening the body resistance that has, replenishing QI to invigorate the spleen, the tonifying the kidney for tranquilization effect, be used for the neurasthenia, inappetence, the pharmaceutical composition of treatment for diseases such as general weakness is a kind of drug composition oral preparation that feedstock production forms with 3 flavor Chinese medicines such as Radix Et Caulis Acanthopanacis Senticosi, Ganoderma, Fructus Schisandrae Chinensis particularly.
Background technology
The peaceful syrup of calming the nerves that is prepared from according to the preparation method that provides among the drug standard WS3-B-0276-90 promulgated by the ministries or commissions of the Central Government, it is a kind of strengthening the body resistance that has, replenishing QI to invigorate the spleen, the tonifying the kidney for tranquilization effect is used for the neurasthenia, inappetence, the syrups oral formulations of treatment for diseases such as general weakness, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be prescription and technology and the brief description that provides in the WS3-B-0276-90 drug standard:
Prescription: Radix Et Caulis Acanthopanacis Senticosi extractum 20g, Ganoderma 50g, Fructus Schisandrae Chinensis 25g
Method for making: above three flavors, Ganoderma, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60% alcohol dipping secondary, each 170-200ml, each week, stir once every day, and gradation filters, the medicinal residues squeezing, and press liquor and filtrate merge, add Radix Et Caulis Acanthopanacis Senticosi extractum, stir evenly, static 24h divides and gets supernatant; Get sucrose 300g and make simple syrup, merge with above-mentioned solution, adding preservative agent is an amount of, adds water to 1000ml, stirs evenly, promptly.
Function cures mainly: strengthening the body resistance, replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization.Be used for the neurasthenia, inappetence, general weakness 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, be to replenish the existing neurasthenia that is used for, inappetence, the deficiency of the oral drug preparation of treatment for diseases such as general weakness provides a kind of bioavailability height, and has a quick release, quick produce effects, the medicament contg height is taken accurate measurement, cheap, and the portable drug composition oral preparation drip pills of calming the nerves.
The drip pills of calming the nerves involved in the present invention is a raw material with 3 flavor Chinese medicines such as Radix Et Caulis Acanthopanacis Senticosi, Ganoderma, Fructus Schisandrae Chinensis, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain the drip pills of calming the nerves involved in the present invention:
[preparation method]
1. the preparation of drug extract: with g or kg is unit, according to the weight portion meter, gets 4 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 10 parts of Ganodermas, 5 parts of Fructus Schisandrae Chinensis; More than three the flavor, Ganoderma, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60% alcohol dipping secondary, each week, stir once every day, and gradation filters, the medicinal residues squeezing, press liquor and filtrate merge, add Radix Et Caulis Acanthopanacis Senticosi extractum and also make evenly, be condensed into relative density and be 1.25~1.35 thick paste, or continue to make drying, be ground into dry powder, promptly.
2. substrate: Polyethylene Glycol (1000~20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1~1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50~90) ℃, the temperature cooling of condensing agent also remains on (40~-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
It is an amount of that [appendix: a kind of preparation method of Radix Et Caulis Acanthopanacis Senticosi extractum] gets Radix Et Caulis Acanthopanacis Senticosi, decocts with water 4 times, and each 1 hour, collecting decoction filtered, and filtrate is condensed into extractum, promptly.
What provide above is a kind of preparation method of common Radix Et Caulis Acanthopanacis Senticosi extractum, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
Beneficial effect
The peaceful oral liquid of calming the nerves that is prepared from according to the preparation method that provides among the drug standard WS3-B-0276-90 promulgated by the ministries or commissions of the Central Government, it is a kind of strengthening the body resistance that has, replenishing QI to invigorate the spleen, the tonifying the kidney for tranquilization effect is used for the neurasthenia, inappetence, the syrups oral formulations of treatment for diseases such as general weakness, 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.
The drip pills of calming the nerves involved in the present invention is compared with the peaceful syrup of calming the nerves has following beneficial effect:
1. the drip pills of calming the nerves involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Et Caulis Acanthopanacis Senticosi, Ganoderma, Fructus Schisandrae Chinensis; 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. the drip pills of calming the nerves 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. the drip pills of calming the nerves 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 the drip pills of calming the nerves of the present invention.
First group: the test of single-matrix
1. raw material: it is standby to make the extract dry powder that contains 3 flavor active ingredient of Chinese herbs such as Radix Et Caulis Acanthopanacis Senticosi, Ganoderma, Fructus Schisandrae Chinensis earlier according to [appendix] and [preparation method 1];
2. substrate: Polyethylene Glycol (1000,2000,4000,6000,8000,10000,20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1~1: 9;
4. the process that provides according to [preparation method] 4~7 is prepared, and can obtain the drip pills of calming the nerves of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning the prepared drip pills of calming the nerves in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol 1000, Polyethylene Glycol 2000, Polyethylene Glycol 4000, Polyethylene Glycol 6000, Polyethylene Glycol 8000, Polyethylene Glycol 10000, Polyethylene Glycol 20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning the prepared drip pills of calming the nerves in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol 1000, Polyethylene Glycol 2000, Polyethylene Glycol 4000, Polyethylene Glycol 6000, Polyethylene Glycol 8000, Polyethylene Glycol 10000, Polyethylene Glycol 20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning the prepared drip pills of calming the nerves in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol 1000, Polyethylene Glycol 2000, Polyethylene Glycol 4000, Polyethylene Glycol 6000, Polyethylene Glycol 8000, Polyethylene Glycol 10000, Polyethylene Glycol 20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. raw material: it is standby to make the extract dry powder that contains 3 flavor active ingredient of Chinese herbs such as Radix Et Caulis Acanthopanacis Senticosi, Ganoderma, Fructus Schisandrae Chinensis earlier according to [appendix] and [preparation method 1];
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C 17H 35COO (CH 2CH 2O) nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C 2H 4O) a(C 3H 6O) b(C 2H 4O) cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C 6H 10O 5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1~1: 9;
4. the process that provides according to [preparation method] 4~7 is prepared, and can obtain the drip pills of calming the nerves of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and the mixed-matrix prepared drip pills of calming the nerves when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: substrate=1: 1)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyethylene Glycol 1000 ????50.0 ????60 ????<30 ????>10 +
Polyethylene Glycol 2000 ????50.0 ????69 ????<30 ????>10 +
Polyethylene Glycol 4000 ????50.0 ????77 ????<30 ????>10 +
Polyethylene Glycol 6000 ????50.0 ????83 ????<30 ????>10 ++
Polyethylene Glycol 8000 ????50.0 ????83 ????<30 ????>10 ++
Polyethylene Glycol 10000 ????50.0 ????84 ????<30 ????>10 ++
Polyethylene Glycol 20000 ????50.0 ????84 ????<30 ????>10 ++
Polyoxyethylene stearate 40 esters ????50.0 ????79 ????<30 ????>10 ++
Betacyclodextrin ????50.0 ????74 ????<30 ????>10 +
Poloxamer ????50.0 ????78 ????<30 ????>10 ++
Carboxymethyl starch sodium ????50.0 ????73 ????<30 ????>10 +
Sodium lauryl sulphate ????50.0 ????67 ????>30 ????>10 ++
Stearic acid ????50.0 ????56 ????>30 ????>10 ++
Sodium stearate ????50.0 ????56 ????>30 ????>10 ++
Glycerin gelatine ????50.0 ????55 ????>30 ????>10 +
Lac ????50.0 ????54 ????>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 ????70 ????<30 ????>10 ++
Polyethylene Glycol 2000 ????25.0 ????79 ????<30 ????>10 ++
Polyethylene Glycol 4000 ????25.0 ????88 ????<30 ????<10 +++
Polyethylene Glycol 6000 ????25.0 ????90 ????<30 ????<10 +++
Polyethylene Glycol 8000 ????25.0 ????91 ????<30 ????<10 +++
Polyethylene Glycol 10000 ????25.0 ????91 ????<30 ????<10 +++
Polyethylene Glycol 20000 ????25.0 ????92 ????<30 ????<10 +++
Polyoxyethylene stearate 40 esters ????25.0 ????90 ????<30 ????<10 ++
Betacyclodextrin ????25.0 ????84 ????<30 ????>10 ++
Poloxamer ????25.0 ????92 ????<30 ????<10 +++
Carboxymethyl starch sodium ????25.0 ????88 ????<30 ????<10 +++
Sodium lauryl sulphate ????25.0 ????77 ????<30 ????>10 ++
Stearic acid ????25.0 ????73 ????>30 ????>10 +++
Sodium stearate ????25.0 ????72 ????>30 ????>10 +++
Glycerin gelatine ????25.0 ????68 ????>30 ????>10 +++
Lac ????25.0 ????68 ????>30 ????>10 +++
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyethylene Glycol 1000 ????10.0 ????76 ????<30 ????>10 ++
Polyethylene Glycol 2000 ????10.0 ????85 ????<30 ????>10 ++
Polyethylene Glycol 4000 ????10.0 ????88 ????<30 ????<10 +++
Polyethylene Glycol 6000 ????10.0 ????92 ????<30 ????<10 +++
Polyethylene Glycol 8000 ????10.0 ????92 ????<30 ????<10 +++
Polyethylene Glycol 10000 ????10.0 ????93 ????<30 ????<10 +++
Polyethylene Glycol 20000 ????10.0 ????93 ????<30 ????<10 +++
Polyoxyethylene stearate 40 esters ????10.0 ????91 ????<30 ????<10 ++
Betacyclodextrin ????10.0 ????88 ????<30 ????<10 ++
Poloxamer ????10.0 ????92 ????<30 ????<10 +++
Carboxymethyl starch sodium ????10.0 ????85 ????<30 ????>10 +++
Sodium lauryl sulphate ????10.0 ????83 ????<30 ????>10 +++
Stearic acid ????10.0 ????81 ????>30 ????>10 +++
Sodium stearate ????10.0 ????76 ????>30 ????>10 +++
Glycerin gelatine ????10.0 ????75 ????>30 ????>10 +++
Lac ????10.0 ????75 ????>30 ????>10 +++
The group practices of table 4 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 ????50 ????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 ????75 ????<30 ????>10 +
The group practices of table 5 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 ????25 ????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 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 ????10 ????91 ????<30 ????<10 +++
Poloxamer: Polyethylene Glycol=1: 1 ????10 ????91 ????<30 ????<10 +++
Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 ????10 ????88 ????<30 ????<10 +++
Betacyclodextrin: Polyethylene Glycol=1: 1 ????10 ????84 ????<30 ????>10 +++
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 ????50 ????91 ????<30 ????<10 +++
Poloxamer: Polyethylene Glycol=1: 5 ????50 ????91 ????<30 ????<10 +++
Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 ????50 ????90 ????<30 ????<10 +++
Betacyclodextrin: Polyethylene Glycol=1: 5 ????50 ????88 ????<30 ????<10 ++
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 ????25 ????93 ????<30 ????<10 +++
Poloxamer: Polyethylene Glycol=1: 5 ????25 ????94 ????<30 ????<10 +++
Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 ????25 ????92 ????<30 ????<10 +++
Betacyclodextrin: Polyethylene Glycol=1: 5 ????25 ????88 ????<30 ????<10 +++
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 ????10 ????93 ????<30 ????<10 +++
Poloxamer: Polyethylene Glycol=1: 5 ????10 ????93 ????<30 ????<10 +++
Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 ????10 ????91 ????<30 ????<10 +++
Betacyclodextrin: Polyethylene Glycol=1: 5 ????10 ????87 ????<30 ????<10 +++
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 ????50 ????91 ????<30 ????<10 +++
Poloxamer: Polyethylene Glycol=1: 10 ????50 ????91 ????<30 ????<10 +++
Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 ????50 ????88 ????<30 ????<10 +++
Betacyclodextrin: Polyethylene Glycol=1: 10 ????50 ????84 ????<30 ????>10 +++
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 ????25 ????92 ????<30 ????<10 +++
Poloxamer: Polyethylene Glycol=1: 10 ????25 ????92 ????<30 ????<10 +++
Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 ????25 ????89 ????<30 ????<10 +++
Betacyclodextrin: Polyethylene Glycol=1: 10 ????25 ????88 ????<30 ????<10 +++
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
The substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 ????10 ????92 ????<30 ????<10 +++
Poloxamer: Polyethylene Glycol=1: 10 ????10 ????92 ????<30 ????<10 +++
Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 ????10 ????92 ????<30 ????<10 +++
Betacyclodextrin: Polyethylene Glycol=1: 10 ????10 ????90 ????<30 ????<10 +++
1. can be seen by the result in the table: when the ratio of drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.

Claims (6)

1. one kind is used for the neurasthenia, and inappetence, the pharmaceutical composition of treatment for diseases such as the general weakness drip pills of calming the nerves is a raw material with 3 flavor Chinese medicines such as Radix Et Caulis Acanthopanacis Senticosi, Ganoderma, Fructus Schisandrae Chinensis, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 the preparation of drug extract: with g or kg is unit, according to the weight portion meter, gets 4 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 10 parts of Ganodermas, 5 parts of Fructus Schisandrae Chinensis; More than three the flavor, Ganoderma, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60% alcohol dipping secondary, each week, stir once every day, and gradation filters, the medicinal residues squeezing, press liquor and filtrate merge, add Radix Et Caulis Acanthopanacis Senticosi extractum and also make evenly, be condensed into relative density and be 1.25~1.35 thick paste, or continue to make drying, be ground into dry powder, promptly.
1.1 substrate: Polyethylene Glycol (1000~20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned carrier one or more mixture wherein;
1.2 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1~1: 9.
2. the drip pills of calming the nerves as claimed in claim 1, it is characterized in that described Radix Et Caulis Acanthopanacis Senticosi extractum is made by following method: it is an amount of to get Radix Et Caulis Acanthopanacis Senticosi, decocts with water 4 times, and each 1 hour, collecting decoction filtered, and filtrate is condensed into extractum, promptly.
3. the drip pills of calming the nerves 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.
4. as claim 1 or 3 described any drip pills of calming the nerves, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1~1: 5.
5. the preparation method of the drip pills of calming the nerves is characterized in that being made of following process:
5.1 the preparation of drug extract: with g or kg is unit, according to the weight portion meter, gets 4 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 10 parts of Ganodermas, 5 parts of Fructus Schisandrae Chinensis; More than three the flavor, Ganoderma, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60% alcohol dipping secondary, each week, stir once every day, and gradation filters, the medicinal residues squeezing, press liquor and filtrate merge, add Radix Et Caulis Acanthopanacis Senticosi extractum and also make evenly, be condensed into relative density and be 1.25~1.35 thick paste, or continue to make drying, be ground into dry powder, promptly.
5.2 substrate: Polyethylene Glycol (1000~20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned carrier one or more mixture wherein;
5.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1~1: 9;
5.4, accurately take by weighing drug extract and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5.5 adjust the temperature control system of drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃~90 ℃, the temperature cooling of condensing agent also remains on 40 ℃~-5 ℃;
5.6 when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
6. as the preparation method of the drip pills of calming the nerves as described in the claim 5, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
CNB2005100514951A 2005-03-08 2005-03-08 Anshenning dripping pill for treating neurosism and its preparing method Expired - Fee Related CN100502903C (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101804099A (en) * 2010-04-12 2010-08-18 山东大学威海分校 Preparation and sedative effect of acanthopanax fruit compound tablet
CN109820915A (en) * 2019-04-01 2019-05-31 黑龙江双兰星制药有限公司 The peaceful oral solution of Sugarless type tranquilizing the mind and preparation method thereof for treating neurasthenia, insomnia

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101804099A (en) * 2010-04-12 2010-08-18 山东大学威海分校 Preparation and sedative effect of acanthopanax fruit compound tablet
CN109820915A (en) * 2019-04-01 2019-05-31 黑龙江双兰星制药有限公司 The peaceful oral solution of Sugarless type tranquilizing the mind and preparation method thereof for treating neurasthenia, insomnia

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