CN100490781C - Pharmaceutical composition for treating qi and blood deficiency and its preparation method - Google Patents

Pharmaceutical composition for treating qi and blood deficiency and its preparation method Download PDF

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CN100490781C
CN100490781C CNB2006100081377A CN200610008137A CN100490781C CN 100490781 C CN100490781 C CN 100490781C CN B2006100081377 A CNB2006100081377 A CN B2006100081377A CN 200610008137 A CN200610008137 A CN 200610008137A CN 100490781 C CN100490781 C CN 100490781C
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CN1843434A (en
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徐新盛
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BEIJING HUAZHONGSIKANG PHARMACEUTICAL TECHNOLOGY Co Ltd
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Abstract

The invention relates to a pharmaceutical composition for treating Qi-blood deficiency and process for preparation, wherein the composition mainly comprises donkey-hide gelatin, prepared rehmannia root, Codonopsis pilosula, cane sugar, citric acid, potassium sorbate and sodium alginate.

Description

A kind of pharmaceutical composition and preparation technology thereof who treats QI and blood deficiency
Invention field
The present invention relates to a kind of pharmaceutical composition and preparation technology thereof, particularly a kind of pharmaceutical composition and preparation technology thereof who treats QI and blood deficiency.
Background technology
Deficiency of both QI and blood mostly is insufficiency of vital energy and blood in the body, and limbs internal organs hundred arteries and veins lose in the general name of moistening the multiple weak syndrome of whole body of supporting and occurring.
The medicine that is used for the treatment of all diseases of QI and blood deficiency is many, but its dosage form of medicine that better treatment qi-blood deficiency syndrome arranged is relatively dull, and a lot of dosage forms are difficult for being accepted by patient, and clinical application is abundant, for the selection that medical personnel and patient provide less.Whether convenient the pharmaceutical preparation of treatment QI and blood deficiency is from mouthfeel, bioavailability or take aspect such as and all remain further to be improved.
Summary of the invention
The object of the invention is to disclose a kind of pharmaceutical composition and preparation technology thereof.
The present invention seeks to be achieved through the following technical solutions:
Pharmaceutical composition of the present invention is to make by following bulk drugs:
Colla Corii Asini 30-70 weight portion Radix Rehmanniae Preparata 130-270 weight portion Radix Codonopsis 60-150 weight portion.
Above-mentioned three flavor crude drug preferred weight proportionings are as follows:
Colla Corii Asini 50 weight portion Radix Rehmanniae Preparata 200 weight portion Radix Codonopsis 100 weight portions;
Colla Corii Asini 35 weight portion Radix Rehmanniae Preparata 260 weight portion Radix Codonopsis, 65 weight portions or
Colla Corii Asini 65 weight portion Radix Rehmanniae Preparata 135 weight portion Radix Codonopsis 145 weight portions.
Get the above-mentioned three flavor crude drug of pharmaceutical composition of the present invention, add conventional adjuvant, be prepared into clinical acceptable various dosage forms according to common process, as: gel preparation, oral liquid, capsule, drop pill, granule, tablet, soft capsule, slow releasing agent or lyophilized injectable powder.
Above-mentioned three flavor crude drug also can add sucrose, citric acid, sodium alginate, the potassium sorbate four flavor raw materials of following weight portion and make gel preparation:
Sodium alginate 5-15 weight portion sucrose 30-80 weight portion citric acid 1-3 weight portion potassium sorbate 0.5-2 weight portion.
The preferred weight proportioning of above-mentioned gel preparation raw material is as follows:
Sodium alginate 10 weight portion sucrose 50 weight portion citric acid 2 weight portion potassium sorbate 1 weight portion;
Sodium alginate 5 weight portion sucrose, 75 weight portion citric acid 1 weight portion potassium sorbate, 2 weight portions or sodium alginate 15 weight portion sucrose 35 weight portion citric acid 3 weight portion potassium sorbate 0.5 weight portion.
The preparation technology of pharmaceutical composition gel preparation of the present invention is as follows:
Get Colla Corii Asini, Radix Rehmanniae Preparata and Radix Codonopsis three flavor raw medicinal materials, Colla Corii Asini is ground into fine powder, standby; All the other two flavors add 6-10 times of water gaging at every turn and decoct 1-3 time, and each 2-4 hour, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.25~1.30 down, adds the water dilution of 400-900 weight portion, filters, and gets clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds the water heating for dissolving of 50-160 weight portion, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, add the water stirring and boil the gel that is 1.05-1.15 to 75~95 ℃ of following relative densities.
The preferred for preparation technology of pharmaceutical composition gel preparation of the present invention is as follows:
Get Colla Corii Asini, Radix Rehmanniae Preparata and Radix Codonopsis three flavor raw medicinal materials, Colla Corii Asini is ground into fine powder, standby; All the other two flavors add 6 times of water gagings at every turn and decoct 2 times, and each 3 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.27 down, adds the dilution of 650 weight parts waters, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds the water heating for dissolving of 100 weight portions, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, adding that water stirs and boil to 80 ℃ of following relative densities is 1.08 gel.
The preferred for preparation technology of pharmaceutical composition gel preparation of the present invention is as follows:
Get Colla Corii Asini, Radix Rehmanniae Preparata and Radix Codonopsis three flavor raw medicinal materials, Colla Corii Asini is ground into fine powder, standby; All the other two flavors add 7 times of water gagings at every turn and decoct 1 time, and each 4 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.25 down, adds the dilution of 450 weight parts waters, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds the water heating for dissolving of 150 weight portions, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, adding that water stirs and boil to 90 ℃ of following relative densities is 1.13 gel.
The preferred for preparation technology of pharmaceutical composition gel preparation of the present invention is as follows:
Get Colla Corii Asini, Radix Rehmanniae Preparata and Radix Codonopsis three flavor raw medicinal materials, Colla Corii Asini is ground into fine powder, standby; All the other two flavors add 10 times of water gagings at every turn and decoct 3 times, and each 2 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.30 down, adds the dilution of 850 weight parts waters, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds the water heating for dissolving of 50 weight portions, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, adding that water stirs and boil to 80 ℃ of following relative densities is 1.07 gel.
The content of polysaccharide maintains about 24.5mg/g in the pharmaceutical composition gel preparation of the present invention, and the technology repeatability is good; The flour extraction average that Colla Corii Asini is pulverized is about 95%; And gel hardness is moderate, little acid, and moderate being easy to of sugariness accepted by the patient.Enriched clinical application, for medical personnel and patient provide more more options.And pharmaceutical composition gel of the present invention makes mouthfeel better, and bioavailability is higher, takes convenient.
Following experimental example and embodiment are used to further specify but are not limited to the present invention.
The test of 1 pharmaceutical composition gel of experimental example water extraction process
The water extraction process trial test
Take by weighing this pharmaceutical composition crude drug: Radix Rehmanniae Preparata 200g, Radix Codonopsis 100g, 300g adds 8 times of water gagings at every turn and decocts twice, each 3 hours altogether, collecting decoction filters, and filtrate is concentrated into relative density for descending 1.25 thick paste at 60 ℃, amount is 212.3g, measures the content of polysaccharide, is 24.3mg/g.
Water extraction process is to demonstration test when
With reference to trial test, take by weighing this pharmaceutical composition crude drug at every turn: Radix Rehmanniae Preparata 200g, Radix Codonopsis 100g, amount to 300g, take by weighing nine parts.The design amount of water is three kinds of levels of 6,8,10 times of amounts, each horizontal triplicate test.Every part of medical material decocts with water twice according to the amount of water of design, and each 3 hours, collecting decoction filtered, and filtrate is condensed into relative density at 60 ℃ of thick pastes of 1.25~1.30 down, claims to decide weight, measures the wherein content of polysaccharide.The results are shown in Table 1.
Table 1 water extraction is to demonstration test (n=9) when
Figure C200610008137D00061
Conclusion: by data in the last table as can be seen, the average total amount of polysaccharide that adds 6,8,10 times of water gagings does not have tangible difference, considers production cost, determines that the best is each 6 times of water gagings decoctions twice, each 3 hours of adding.Result of the test shows, the polysaccharide total amount no significant difference that this pharmaceutical composition gel water extraction process obtains, and the data opposing parallel, the technology repeatability is good.
2 pharmaceutical composition gels of experimental example Colla Corii Asini is pulverized the flour extraction test
Take Colla Corii Asini medical material 50g according to primary standard, take by weighing three parts, every part of medical material was pulverized 80 mesh sieves repeatedly with the high speed Universalpulverizer respectively, claimed the weight of donkey-hide gelatin fine powder, calculated flour extraction, the results are shown in Table 2.
The flour extraction test that table 2 Colla Corii Asini is pulverized
Figure C200610008137D00071
Conclusion: the flour extraction average that Colla Corii Asini is pulverized meets the requirements about 95%.Feed intake with donkey-hide gelatin fine powder in the preparation.
The test of 3 pharmaceutical composition gel preparations of experimental example moulding process
To 1,2, No. 3 thick paste amount under the demonstration test item when, the average thick paste amount of raw medicinal material is 205.1g with reference to water extraction in the experimental example 1, and average every bag of thick paste amount is about 2.051g; Pulverize flour extraction test following No. three a donkey-hide gelatin fine powder amount with reference to Colla Corii Asini in the experimental example 2, the crude drug Colla Corii Asini can be ground into donkey-hide gelatin fine powder 47.5g, and average every bag of amount is 0.475g; Get 10 bags of amounts at every turn, promptly get thick paste 20.51g at every turn, add the suitable quantity of water dilution, filter, add donkey-hide gelatin fine powder 4.75g, sodium alginate, Icing Sugar, steviosin, aspartame, citric acid, potassium sorbate etc., add water to ormal weight, 80~90 ℃ of insulations are also stirred 40~50min, take out, cool off under the room temperature, promptly; Observe the character and the taste of gel.
1. the addition of sodium alginate and citric acid test
Do the preliminary preparation of gel, to determine the amount of sodium alginate, the 20.51g thick paste is got in each test, add the suitable quantity of water dilution, filter, add citric acid respectively, mouth is tasted its flavor, add Icing Sugar, sodium alginate, donkey-hide gelatin fine powder and potassium sorbate again, add water to 105g, 80~90 ℃ of insulations are also stirred 40~50min, take out, cool off under the room temperature, observe the gel forming situation and taste its mouthfeel.The results are shown in following table.
The addition test of table 3 citric acid and sodium alginate
Figure C200610008137D00081
Conclusion: when medicinal liquid added 0.2% citric acid, the little acid of medicinal liquid mouthfeel continued to add citric acid medicinal liquid peracid again, and the patient is difficult for accepting, and is unfavorable for the molding of gel; When medicinal liquid added 1.0% sodium alginate, the gel that makes was neither too hard, nor too soft, determined that therefore the addition of citric acid is 0.2%, and the addition of sodium alginate is 1.0%.
2. the screening of sweeting agent and consumption thereof
It is 20.51g that 10 bags of amount extraction thick pastes are got in each test, add the suitable quantity of water dilution, filter, add Icing Sugar, steviosin, aspartame, citric acid, mouthful gustation road according to following table, choose the good person of taste and add potassium sorbate, sodium alginate and donkey-hide gelatin fine powder, add water to 105g, 80~90 ℃ of insulations are also stirred 40~50min, take out, cool off under the room temperature, observe the character of gel and taste its mouthfeel.
Table 4 prescription screening table
Conclusion: do not add before potassium sorbate, sodium alginate and the donkey-hide gelatin fine powder, No. 2 sweet excessively, selects 1,3,4, No. 5 test specimen to add potassium sorbate, sodium alginate and donkey-hide gelatin fine powder and make gel, and 1,3, No. 4 sweet, and No. 5 sugariness is moderate, and mouthfeel is good.
Following embodiment all can realize the described effect of above-mentioned experimental example.
Embodiment 1:
Colla Corii Asini 50g, Radix Rehmanniae Preparata 200g, Radix Codonopsis 100g.
Get the above-mentioned raw materials medicine, add conventional adjuvant,, make tablet according to common process.
Embodiment 2:
Colla Corii Asini 35g, Radix Rehmanniae Preparata 260g, Radix Codonopsis 65g.
Get the above-mentioned raw materials medicine, add conventional adjuvant,, make capsule according to common process.
Embodiment 3:
Colla Corii Asini 65g, Radix Rehmanniae Preparata 135g, Radix Codonopsis 145g.
Get the above-mentioned raw materials medicine, add conventional adjuvant,, make lyophilized injectable powder according to common process.
Embodiment 4:
Colla Corii Asini 50g, Radix Rehmanniae Preparata 200g, Radix Codonopsis 100g, sodium alginate 10g, sucrose 50g, citric acid 2g, potassium sorbate 1g.
Get Colla Corii Asini and be ground into fine powder, standby; Radix Rehmanniae Preparata, Radix Codonopsis add 6 times of water gagings at every turn and decoct 2 times, and each 3 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.27 down, adds the dilution of 650g water, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds 100g water heating for dissolving, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, add water and stir, boil to being 1.13 o'clock 90 ℃ of its relative densities, the insulation fill is made gel, every packed 10g.
Embodiment 5:
Colla Corii Asini 35g, Radix Rehmanniae Preparata 260g, Radix Codonopsis 65g, sodium alginate 5g, sucrose 75g, citric acid 1g, potassium sorbate 2g.
Get Colla Corii Asini and be ground into fine powder, standby; Radix Rehmanniae Preparata, Radix Codonopsis add 7 times of water gagings at every turn and decoct 1 time, and each 4 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.25 down, adds the dilution of 450g water, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds 150g water heating for dissolving, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, add water and stir, boil to being 1.13 o'clock 90 ℃ of its relative densities, the insulation fill is made gel, every packed 10g.
Embodiment 6:
Colla Corii Asini 65g, Radix Rehmanniae Preparata 135g, Radix Codonopsis 145g, sodium alginate 15g, sucrose 35g, citric acid 3g, potassium sorbate 0.5g.
Get Colla Corii Asini and be ground into fine powder, standby; Radix Rehmanniae Preparata, Radix Codonopsis add 10 times of water gagings at every turn and decoct 3 times, and each 2 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.30 down, adds the dilution of 850g water, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds 50g water heating for dissolving, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, add water and stir, boil to being 1.07 o'clock 80 ℃ of its density, the insulation fill is made gel, every packed 10g.

Claims (6)

1, a kind of pharmaceutical composition gel preparation for the treatment of QI and blood deficiency, it is characterized in that it is Colla Corii Asini 50 weight portions by following weight proportion, Radix Rehmanniae Preparata 200 weight portions, Radix Codonopsis 100 weight portions, sodium alginate 10 weight portions, sucrose 50 weight portions, citric acid 2 weight portions, potassium sorbate 1 weight portion and water are made.
2, the preparation method of pharmaceutical composition gel preparation as claimed in claim 1 is characterized in that the preparation method of gel preparation is:
Get Colla Corii Asini and be ground into fine powder, standby; Radix Rehmanniae Preparata, Radix Codonopsis add 6 times of water gagings at every turn and decoct 2 times, and each 3 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.27 down, adds the dilution of 650 weight parts waters, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds 100 weight parts water heating for dissolving, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, add water and stir, boil to being 1.13 o'clock 90 ℃ of its relative densities, gel is made in the insulation fill.
3, a kind of pharmaceutical composition gel preparation for the treatment of QI and blood deficiency, it is characterized in that it is Colla Corii Asini 35 weight portions by following weight proportion, Radix Rehmanniae Preparata 260 weight portions, Radix Codonopsis 65 weight portions, sodium alginate 5 weight portions, sucrose 75 weight portions, citric acid 1 weight portion, potassium sorbate 2 weight portions and water are made.
4, the preparation method of pharmaceutical composition gel preparation as claimed in claim 3 is characterized in that the preparation method of gel preparation is:
Get Colla Corii Asini and be ground into fine powder, standby; Radix Rehmanniae Preparata, Radix Codonopsis add 7 times of water gagings at every turn and decoct 1 time, and each 4 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.25 down, adds the dilution of 450 weight parts waters, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds 150 weight parts water heating for dissolving, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, add water and stir, boil to being 1.13 o'clock 90 ℃ of its relative densities, gel is made in the insulation fill.
5, a kind of pharmaceutical composition gel preparation for the treatment of QI and blood deficiency, it is characterized in that it is Colla Corii Asini 65 weight portions by following weight proportion, Radix Rehmanniae Preparata 135 weight portions, Radix Codonopsis 145 weight portions, sodium alginate 15 weight portions, sucrose 35 weight portions, citric acid 3 weight portions, potassium sorbate 0.5 weight portion and water are made.
6, the preparation method of pharmaceutical composition gel preparation as claimed in claim 5 is characterized in that the preparation method of gel preparation is:
Get Colla Corii Asini and be ground into fine powder, standby; Radix Rehmanniae Preparata, Radix Codonopsis add 10 times of water gagings at every turn and decoct 3 times, and each 2 hours, collecting decoction filtered, and filtrate is concentrated into relative density at 60 ℃ of thick pastes of 1.30 down, adds the dilution of 850 weight parts waters, filter, clear paste filtrate; Other gets sucrose, citric acid and potassium sorbate, adds 50 weight parts water heating for dissolving, filters, and joins in the above-mentioned clear paste filtrate; Add sodium alginate and donkey-hide gelatin fine powder again, add water and stir, boil to being 1.07 o'clock 80 ℃ of its density, gel is made in the insulation fill.
CNB2006100081377A 2006-02-21 2006-02-21 Pharmaceutical composition for treating qi and blood deficiency and its preparation method Expired - Fee Related CN100490781C (en)

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CN105535091A (en) * 2016-01-16 2016-05-04 白云兵 Qi and blood reinforcing medicine
CN107412427A (en) * 2017-08-31 2017-12-01 湖南东健药业有限公司 A kind of Control for Ejiao Buxue particle and preparation method thereof

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国家药品监督管理局国家中成药标准汇编中成药地方标准上升国家标准部分. 国家药品监督管理局. 2002 *

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