CN1660133A - Low alcohol type concentrated soloution for nourishing yin to clear away the lung-heat, preparation method and application - Google Patents
Low alcohol type concentrated soloution for nourishing yin to clear away the lung-heat, preparation method and application Download PDFInfo
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- CN1660133A CN1660133A CN 200410094031 CN200410094031A CN1660133A CN 1660133 A CN1660133 A CN 1660133A CN 200410094031 CN200410094031 CN 200410094031 CN 200410094031 A CN200410094031 A CN 200410094031A CN 1660133 A CN1660133 A CN 1660133A
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Abstract
A low-alcohol concentrated liquid for replenishing vital essence of lung and removing endogenous pathogenic heat from it is prepared from 7 Chinese-medicinal materials including rehmannia root, liquorice, tree peony bark, white peony root, etc. Its preparing process is also disclosed. It is suitable for the most of patients.
Description
Technical field
The present invention relates to Chinese medicine preparation, particularly relate to a kind of low alcohol type concentrated soloution for nourishing yin to clear away, preparation method and make various Chinese medicine preparation with this concentrated solution.
Background technology
Syrup for nourishing and clearing lung-heat has nourishing YIN and clearing away lung-heat, the function of relieving sore-throat by clearing away heat.All have significant therapeutic effect for diseases such as the cough that causes because of the deficiency of YIN, dry laryngopharynx pain, the few expectorant of dry cough, sputum mixed with blood.
At present, the syrup for nourishing and clearing lung-heat of selling on the market has two kinds: a kind of is to contain pure type syrup for nourishing and clearing lung-heat, its preparation method is recorded in " Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation " the 15, another kind is the low alcohol type syrup for nourishing and clearing lung-heat, its preparation method does not still have record in present document.
Contain pure type syrup for nourishing and clearing lung-heat, because alcoholic acid content is 10~12%, make to ethanol allergic constitution person, child, anemia of pregnant woman, part old people, vast driver and suffer from patients such as hepatitis, hypertension, diabetes and should not take, do not satisfy the medication demand of extensive patients.At present, low alcohol type nourishing YIN and clearing away lung-heat soft capsule, the agent of low alcohol type Yin-nourishing lung-heat clearing drop pills, nourishing YIN and clearing away lung-heat tablet, nourishing YIN and clearing away lung-heat pill, nourishing YIN and clearing away lung-heat granule, nourishing YIN and clearing away lung-heat capsule are not reported yet.
Summary of the invention:
The objective of the invention is to overcome deficiency of the prior art, a kind of low alcohol type concentrated soloution for nourishing yin to clear away is provided;
Second purpose of the present invention provides a kind of preparation method of low alcohol type concentrated soloution for nourishing yin to clear away;
The 3rd purpose of the present invention provides a kind of method for preparing the agent of low alcohol type syrup for nourishing and clearing lung-heat with low alcohol type concentrated soloution for nourishing yin to clear away;
The 4th purpose of the present invention provides a kind of method for preparing the nourishing YIN and clearing away lung-heat tablet with low alcohol type concentrated soloution for nourishing yin to clear away;
The 5th purpose of the present invention provides a kind of method for preparing the nourishing YIN and clearing away lung-heat pill with low alcohol type concentrated soloution for nourishing yin to clear away;
The 6th purpose of the present invention provides a kind of method for preparing the nourishing YIN and clearing away lung-heat granule with low alcohol type concentrated soloution for nourishing yin to clear away;
The 7th purpose of the present invention provides a kind of method for preparing the nourishing YIN and clearing away lung-heat capsule with low alcohol type concentrated soloution for nourishing yin to clear away;
The 8th purpose of the present invention provides a kind of method for preparing low alcohol type nourishing YIN and clearing away lung-heat soft capsule with low alcohol type concentrated soloution for nourishing yin to clear away;
The 9th purpose of the present invention provides a kind of method for preparing the agent of low alcohol type Yin-nourishing lung-heat clearing drop pills with low alcohol type concentrated soloution for nourishing yin to clear away.
Technical scheme of the present invention is summarized as follows:
A kind of low alcohol type concentrated soloution for nourishing yin to clear away, make by following method:
(1) prepare raw material:
Radix Rehmanniae 20-32% Radix Scrophulariae 15-30% 10-20% Radix Ophiopogonis Radix Glycyrrhizae 2-8%
Cortex Moutan 5-20% Bulbus Fritillariae Cirrhosae 5-20% Radix Paeoniae Alba 5-20%, described percentage ratio is weight percentage;
(2) 1. with Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Glycyrrhizae decocting in water 1~3 time, add water weight at every turn and be 6~12 times of described four Chinese medicine gross weight, decocted 1~4 hour, merge decocting liquid, being concentrated into relative density is 1.10~1.25; 2. with concentration of volume percent be 50%~80% 6~8 times to Cortex Moutan, Bulbus Fritillariae Cirrhosae, the ethanol extraction Cortex Moutan of Radix Paeoniae Alba gross weight, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba; 3. 1. water cooking liquid and ethanol extract are 2. merged, mixing leaves standstill, and gets supernatant and precipitation, gets supernatant, reclaims ethanol, and the relative density that makes amalgamation liquid is 1.02~1.20; 4. the 4.8-7.2 percentage by volume doubly that adds Radix Rehmanniae weight in described precipitation is that the commentaries on classics of 50%~80% ethanol is molten, separation of supernatant and precipitation, to precipitate to use and change once molten again with method, the filtering precipitation, twice supernatant is merged, reclaim ethanol, it is 1.02~1.20 liquid that supernatant concentration is made relative density; 5. the amalgamation liquid that will 3. make merges with the liquid of 4. making, and mixing is made a kind of low alcohol type concentrated soloution for nourishing yin to clear away, and the mensuration temperature of described relative density is 80 ℃.
A kind of preparation method of low alcohol type concentrated soloution for nourishing yin to clear away, form by following steps:
(1) prepare raw material:
Radix Rehmanniae 20-32% Radix Scrophulariae 15-30% 10-20% Radix Ophiopogonis Radix Glycyrrhizae 2-8%
Cortex Moutan 5-20% Bulbus Fritillariae Cirrhosae 5-20% Radix Paeoniae Alba 5-20%, described percentage ratio is weight percentage;
(2) 1. with Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Glycyrrhizae decocting in water 1~3 time, add water weight at every turn and be 6~12 times of described four Chinese medicine gross weight, decocted 1~4 hour, merge decocting liquid, being concentrated into relative density is 1.10~1.25; 2. with concentration of volume percent be 50%~80% 6~8 times to Cortex Moutan, Bulbus Fritillariae Cirrhosae, the ethanol extraction Cortex Moutan of Radix Paeoniae Alba gross weight, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba; 3. 1. water cooking liquid and ethanol extract are 2. merged, mixing leaves standstill, and gets supernatant and precipitation, gets supernatant, reclaims ethanol, and the relative density that makes amalgamation liquid is 1.02~1.20; 4. the 4.8-7.2 percentage by volume doubly that adds Radix Rehmanniae weight in described precipitation is that the commentaries on classics of 50%~80% ethanol is molten, separation of supernatant and precipitation, to precipitate to use and change once molten again with method, the filtering precipitation, twice supernatant is merged, reclaim ethanol, it is 1.02~1.20 liquid that supernatant concentration is made relative density; 5. the amalgamation liquid that will 3. make merges with the liquid of 4. making, and mixing is made a kind of low alcohol type concentrated soloution for nourishing yin to clear away, and the mensuration temperature of described relative density is 80 ℃.
Described raw material preferably selects:
Radix Rehmanniae 26.31% Radix Scrophulariae Radix Glycyrrhizae 5.26% 21.05% Radix Ophiopogonis 15.79%
Cortex Moutan 10.53% Bulbus Fritillariae Cirrhosae 10.53% Radix Paeoniae Alba 10.53%
The number of times of described decocting in water Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Glycyrrhizae preferably 2 times, decocted 3 hours for the first time, decocted 2 hours for the second time, the multiple that at every turn adds water is 10 times of described four Chinese medicine gross weight, merge decocting liquid, being concentrated into relative density is 1.17~1.20, the concentration of ethanol of described extraction Cortex Moutan, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba is preferably 60%, described consumption of ethanol is Cortex Moutan, Bulbus Fritillariae Cirrhosae, Radix Paeoniae Alba gross weight 7 times, the concentration of ethanol that adds in described precipitation commentaries on classics is molten is 70%, and addition is 6 times of Radix Rehmanniae weight.
A kind ofly prepare the method for low alcohol type syrup for nourishing and clearing lung-heat agent, form by following step with low alcohol type concentrated soloution for nourishing yin to clear away:
In the relative density of 1000 weight portions is 1.02~1.20 low alcohol type concentrated soloution for nourishing yin to clear away, add sodium benzoate, stir evenly; The simple syrup that adds the 900-1300 weight portion; Add Mentholum, stir evenly, leave standstill, make the agent of low alcohol type syrup for nourishing and clearing lung-heat, the addition of described sodium benzoate is the 0.3%-0.9% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight, the addition of Mentholum is the 0.01%-0.04% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight, and described percentage ratio is weight percentage, and the mensuration temperature of described relative density is 80 ℃.
A kind ofly prepare the method for nourishing YIN and clearing away lung-heat tablet, form by following step with low alcohol type concentrated soloution for nourishing yin to clear away:
With low alcohol type concentrated soloution for nourishing yin to clear away, drying is ground into fine powder; With wet method or dry granulation, add the 0.01%-0.04% Mentholum of concentrated solution gross weight and the magnesium stearate of grain amount 0.3%-0.6% according to a conventional method, stir evenly, compacting is wrapped film-coat in flakes, that is, described percentage ratio is weight percentage.
A kind ofly prepare the method for nourishing YIN and clearing away lung-heat pill, form by following step with low alcohol type concentrated soloution for nourishing yin to clear away:
With low alcohol type concentrated soloution for nourishing yin to clear away, drying is ground into fine powder; Add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly, water or sweet water pill according to a conventional method, drying, the bag film-coat, polishing, drying, that is, described percentage ratio is weight percentage.
A kind ofly prepare the method for nourishing YIN and clearing away lung-heat granule, form by following step with low alcohol type concentrated soloution for nourishing yin to clear away:
With low alcohol type concentrated soloution for nourishing yin to clear away, drying adds sucrose or lactose or protein sugar or xylitol according to a conventional method and makes adjuvant, makes granule, and drying is sieved; Add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly, that is, described percentage ratio is weight percentage.
A kind ofly prepare the method for nourishing YIN and clearing away lung-heat capsule, form by following step with low alcohol type concentrated soloution for nourishing yin to clear away:
With low alcohol type concentrated soloution for nourishing yin to clear away, drying is sieved according to a conventional method; Add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly, pour into capsule, that is, described percentage ratio is weight percentage.
A kind ofly prepare the method for low alcohol type nourishing YIN and clearing away lung-heat soft capsule, form by following step with low alcohol type concentrated soloution for nourishing yin to clear away:
With low alcohol type concentrated soloution for nourishing yin to clear away, add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly; Add diluent, antioxidant, suspending agent according to a conventional method, stir, room temperature leaves standstill, and presses soft capsule promptly, and described percentage ratio is weight percentage.
A kind ofly prepare the method for low alcohol type Yin-nourishing lung-heat clearing drop pills agent with low alcohol type concentrated soloution for nourishing yin to clear away, following step is formed:
With low alcohol type concentrated soloution for nourishing yin to clear away, add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly; According to a conventional method, with substrate stearic acid or sodium stearate or Polyethylene Glycol or Lac, be 1 by weight: the ratio mixing of 1-18, splash in condensing agent vegetable oil or methyl-silicone oil or ethanol or the liquid paraffin at 50-100 ℃ and to make drop pill, natural drying, that is, described percentage ratio is weight percentage.
The various preparations that the prepared low alcohol type concentrated soloution for nourishing yin to clear away of method of the present invention is made, its ethanol content is descended, reach WHO (World Health Organization (WHO)) pharmaceutical preparation has been contained the standard (must not be higher than 1.0%) that alcohol is measured, satisfied Chinese medicine preparation requirement in line with international standards.The prepared low alcohol type syrup for nourishing and clearing lung-heat of the present invention not only is suitable for the sold inside the country outlet that also is suitable for, and helps pushing Chinese medicine to the world.
In addition, the various preparations of low alcohol type nourishing YIN and clearing away lung-heat, be applicable to most of patients,, satisfied numerous patients' medication demand particularly to ethanol allergic constitution person, child, anemia of pregnant woman, part old people, vast driver and the patient who suffers from hepatitis, hypertension, diabetes etc.
The specific embodiment
Below in conjunction with specific embodiment the present invention is further described:
Embodiment 1
1. with 5 kilograms of 20 kilograms of Radix Rehmanniae, 30 kilograms of Radix Scrophulariaes, 15 kilograms of Radix Ophiopogonis, Radix Glycyrrhizae with decocting in water 3 times, add water weight at every turn and be 6 times of described four Chinese medicine gross weight, the each decoction 1 hour merges decocting liquid, and being concentrated into relative density is 1.10-1.25 (measuring temperature is 80 ℃); 2. be 50% ethanol extraction Cortex Moutan, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba with concentration of volume percent, alcoholic acid addition be 8 times to Cortex Moutan, Bulbus Fritillariae Cirrhosae, Radix Paeoniae Alba gross weight, Cortex Moutan is 20 kilograms, 5 kilograms of Bulbus Fritillariae Cirrhosaes, 5 kilograms of the Radix Paeoniae Albas; 3. 1. water cooking liquid and ethanol extract are 2. merged, mixing leaves standstill, and gets supernatant and precipitation, gets supernatant, reclaims ethanol, and the relative density that makes amalgamation liquid is 1.02-1.20 (measuring temperature is 80 ℃); 4. 4.8 times the percentage by volume that adds Radix Rehmanniae weight in described precipitation is that the commentaries on classics of 80% ethanol is molten, separation of supernatant and precipitation, to precipitate to use and change once molten again with method, the filtering precipitation, twice supernatant is merged, reclaim ethanol, supernatant concentration is made the liquid that relative density is 1.02-1.20 (measuring temperature is 80 ℃); 5. the amalgamation liquid that will 3. make merges with the liquid of 4. making, and mixing is made a kind of low alcohol type concentrated soloution for nourishing yin to clear away.
Embodiment 2
1. with 5.26 kilograms of 26.31 kilograms of Radix Rehmanniae, 21.05 kilograms of Radix Scrophulariaes, 15.79 kilograms of Radix Ophiopogonis, Radix Glycyrrhizae with decocting in water 2 times, add water weight at every turn and be 10 times of described four Chinese medicine gross weight, decocted 3 hours for the first time, decocted 2 hours for the second time, merge decocting liquid, being concentrated into relative density is 1.17-1.20 (measuring temperature is 80 ℃); 2. be 60% ethanol extraction Cortex Moutan, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba with concentration of volume percent, alcoholic acid addition be 7 times to Cortex Moutan, Bulbus Fritillariae Cirrhosae, Radix Paeoniae Alba gross weight, Cortex Moutan is 10.53 kilograms, 10.53 kilograms of Bulbus Fritillariae Cirrhosaes, 10.53 kilograms of the Radix Paeoniae Albas; 3. 1. water cooking liquid and ethanol extract are 2. merged, mixing leaves standstill, and gets supernatant and precipitation, gets supernatant, reclaims ethanol, and the relative density that makes amalgamation liquid is 1.12-1.20 (measuring temperature is 80 ℃); 4. 6 times the percentage by volume that adds Radix Rehmanniae weight in described precipitation is that the commentaries on classics of 70% ethanol is molten, separation of supernatant and precipitation, to precipitate to use and change once molten again with method, the filtering precipitation, twice supernatant is merged, reclaim ethanol, supernatant concentration is made the liquid that relative density is 1.12-1.20 (measuring temperature is 80 ℃); 5. the amalgamation liquid that will 3. make merges with the liquid of 4. making, and mixing is made a kind of low alcohol type concentrated soloution for nourishing yin to clear away.
Embodiment 3
1. with 2 kilograms of 32 kilograms of Radix Rehmanniae, 15 kilograms of Radix Scrophulariaes, 10 kilograms of Radix Ophiopogonis, Radix Glycyrrhizae with decocting in water 1 time, add water weight and be 8 times of described four Chinese medicine gross weight, decocted 1 hour, being concentrated into relative density is 1.10-1.25 (measuring temperature is 80 ℃);
2. be 80% ethanol extraction Cortex Moutan, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba with concentration of volume percent, alcoholic acid addition be 6 times to Cortex Moutan, Bulbus Fritillariae Cirrhosae, Radix Paeoniae Alba gross weight, Cortex Moutan is 5 kilograms, 20 kilograms of Bulbus Fritillariae Cirrhosaes, 16 kilograms of the Radix Paeoniae Albas; 3. 1. water cooking liquid and ethanol extract are 2. merged, mixing leaves standstill, and gets supernatant and precipitation, gets supernatant, reclaims ethanol, and the relative density that makes amalgamation liquid is 1.02-1.20 (measuring temperature is 80 ℃); 4. 5 times the percentage by volume that adds Radix Rehmanniae weight in described precipitation is that the commentaries on classics of 75% ethanol is molten, separation of supernatant and precipitation, to precipitate to use and change once molten again with method, the filtering precipitation, twice supernatant is merged, reclaim ethanol, supernatant concentration is made the liquid that relative density is 1.02-1.20 (measuring temperature is 80 ℃); 5. the amalgamation liquid that will 3. make merges with the liquid of 4. making, and mixing is made a kind of low alcohol type concentrated soloution for nourishing yin to clear away.
Embodiment 4
1. with 8 kilograms of 20 kilograms of Radix Rehmanniae, 15 kilograms of Radix Scrophulariaes, 20 kilograms of Radix Ophiopogonis, Radix Glycyrrhizae with decocting in water 2 times, add water weight at every turn and be 12 times of described four Chinese medicine gross weight, decocted 3 hours for the first time, decocted 2 hours for the second time, merge decocting liquid, being concentrated into relative density is 1.10-1.25 (measuring temperature is 80 ℃); 2. be 70% ethanol extraction Cortex Moutan, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba with concentration of volume percent, alcoholic acid addition be 7 times to Cortex Moutan, Bulbus Fritillariae Cirrhosae, Radix Paeoniae Alba gross weight, Cortex Moutan is 10 kilograms, 7 kilograms of Bulbus Fritillariae Cirrhosaes, 16 kilograms of the Radix Paeoniae Albas; 3. 1. water cooking liquid and ethanol extract are 2. merged, mixing leaves standstill, and gets supernatant and precipitation, gets supernatant, reclaims ethanol, and the relative density that makes amalgamation liquid is 1.02-1.20 (measuring temperature is 80 ℃); 4. 7.2 times the percentage by volume that adds Radix Rehmanniae weight in described precipitation is that the commentaries on classics of 50% ethanol is molten, separation of supernatant and precipitation, to precipitate to use and change once molten again with method, the filtering precipitation, twice supernatant is merged, reclaim ethanol, supernatant concentration is made the liquid that relative density is 1.02-1.20 (measuring temperature is 80 ℃); 5. the amalgamation liquid that will 3. make merges with the liquid of 4. making, and mixing is made a kind of low alcohol type concentrated soloution for nourishing yin to clear away.
Embodiment 5
A kind of method for preparing the agent of low alcohol type syrup for nourishing and clearing lung-heat with low alcohol type concentrated soloution for nourishing yin to clear away:
In the low alcohol type concentrated soloution for nourishing yin to clear away that 1000 kilograms of embodiment 2 make, add sodium benzoate, stir evenly; The simple syrup that adds 1162 kilograms; Add Mentholum, stir evenly, leave standstill, make the agent of low alcohol type syrup for nourishing and clearing lung-heat, the adding weight of sodium benzoate is 0.65% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight, and the adding weight of Mentholum is 0.02% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight.
Embodiment 6
A kind of method for preparing the agent of low alcohol type syrup for nourishing and clearing lung-heat with low alcohol type concentrated soloution for nourishing yin to clear away:
In the low alcohol type concentrated soloution for nourishing yin to clear away that 1000 kilograms of embodiment 1 make, add sodium benzoate, stir evenly; The simple syrup that adds 900 kilograms; Add Mentholum, stir evenly, leave standstill, make the agent of low alcohol type syrup for nourishing and clearing lung-heat, the adding weight of sodium benzoate is 0.3% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight, and the adding weight of Mentholum is 0.01% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight.
Embodiment 7
A kind of method for preparing the agent of low alcohol type syrup for nourishing and clearing lung-heat with low alcohol type concentrated soloution for nourishing yin to clear away:
In the low alcohol type concentrated soloution for nourishing yin to clear away that 1000 kilograms of embodiment 3 make, add sodium benzoate, stir evenly; The simple syrup that adds 1300 kilograms; Add Mentholum, stir evenly, leave standstill, make the agent of low alcohol type syrup for nourishing and clearing lung-heat, the adding weight of sodium benzoate is 0.9% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight, and the adding weight of Mentholum is 0.04% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight.
Embodiment 8
A kind of method for preparing the nourishing YIN and clearing away lung-heat tablet with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 2 makes, drying is ground into fine powder; According to a conventional method with wet method or dry granulation, add 0.4% magnesium stearate of 0.02% Mentholum of concentrated solution gross weight and particle weight, stir evenly, compacting in flakes, the bag film-coat, promptly.
Embodiment 9
A kind of method for preparing the nourishing YIN and clearing away lung-heat tablet with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 1 makes, drying is ground into fine powder; According to a conventional method with wet method or dry granulation, add 0.3% magnesium stearate of 0.01% Mentholum of concentrated solution gross weight and particle weight, stir evenly, compacting in flakes, the bag film-coat, promptly.
Embodiment 10
A kind of method for preparing the nourishing YIN and clearing away lung-heat tablet with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 3 makes, drying is ground into fine powder; According to a conventional method with wet method or dry granulation, add 0.6% magnesium stearate of 0.04% Mentholum of concentrated solution gross weight and particle weight, stir evenly, compacting in flakes, the bag film-coat, promptly.
Embodiment 11
A kind of method for preparing the nourishing YIN and clearing away lung-heat pill with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 2 makes, drying is ground into fine powder; Add 0.02% Mentholum of concentrated solution gross weight, stir evenly, water or sweet water pill according to a conventional method, drying, the bag film-coat, polishing, drying, promptly.
Embodiment 12
A kind of method for preparing the nourishing YIN and clearing away lung-heat pill with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 1 makes, drying is ground into fine powder; Add 0.04% Mentholum of concentrated solution gross weight, stir evenly, water or sweet water pill according to a conventional method, drying, the bag film-coat, polishing, drying, promptly.
Embodiment 13
A kind of method for preparing the nourishing YIN and clearing away lung-heat pill with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 3 makes, drying is ground into fine powder; Add 0.01% Mentholum of concentrated solution gross weight, stir evenly, water or sweet water pill according to a conventional method, drying, the bag film-coat, polishing, drying, promptly.
Embodiment 14
A kind of method for preparing the nourishing YIN and clearing away lung-heat granule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 2 makes, drying adds sucrose according to a conventional method and makes adjuvant, makes granule, and drying is sieved; Add 0.02% Mentholum of concentrated solution gross weight, stir evenly, promptly.
Embodiment 15
A kind of method for preparing the nourishing YIN and clearing away lung-heat granule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 1 makes, drying adds lactose according to a conventional method and makes adjuvant, makes granule, and drying is sieved; Add 0.01% Mentholum of concentrated solution gross weight, stir evenly, promptly.
Embodiment 16
A kind of method for preparing the nourishing YIN and clearing away lung-heat granule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 4 makes, drying adds protein sugar according to a conventional method and makes adjuvant, makes granule, and drying is sieved; Add 0.02% Mentholum of concentrated solution gross weight, stir evenly, promptly.
Embodiment 17
A kind of method for preparing the nourishing YIN and clearing away lung-heat granule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 4 makes, drying adds xylitol according to a conventional method and makes adjuvant, makes granule, and drying is sieved; Add 0.04% Mentholum of concentrated solution gross weight, stir evenly, promptly.
Embodiment 18
A kind of method for preparing the nourishing YIN and clearing away lung-heat capsule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 2 makes, drying is sieved according to a conventional method; Add 0.02% Mentholum of concentrated solution gross weight, stir evenly, pour into capsule, promptly.
Embodiment 19
A kind of method for preparing the nourishing YIN and clearing away lung-heat capsule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 1 makes, drying is sieved according to a conventional method; Add 0.01% Mentholum of concentrated solution gross weight, stir evenly, pour into capsule, promptly.
Embodiment 20
A kind of method for preparing the nourishing YIN and clearing away lung-heat capsule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 3 makes, drying is sieved according to a conventional method; Add 0.04% Mentholum of concentrated solution gross weight, stir evenly, pour into capsule, promptly.
Embodiment 21
A kind of method for preparing low alcohol type nourishing YIN and clearing away lung-heat soft capsule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 2 makes, add 0.02% Mentholum of concentrated solution gross weight, stir evenly; Add diluent, antioxidant, suspending agent according to a conventional method, stir, room temperature leaves standstill, and presses soft capsule promptly.
Embodiment 22
A kind of method for preparing low alcohol type nourishing YIN and clearing away lung-heat soft capsule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 3 makes, add 0.01% Mentholum of concentrated solution gross weight, stir evenly; Add diluent, antioxidant, suspending agent according to a conventional method, stir, room temperature leaves standstill, and presses soft capsule promptly.
Embodiment 23
A kind of method for preparing low alcohol type nourishing YIN and clearing away lung-heat soft capsule with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 4 makes, add 0.04% Mentholum of concentrated solution gross weight, stir evenly; Add diluent, antioxidant, suspending agent according to a conventional method, stir, room temperature leaves standstill, and presses soft capsule promptly.
Embodiment 24
A kind of method for preparing the agent of low alcohol type Yin-nourishing lung-heat clearing drop pills with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 2 makes, add 0.01% Mentholum of concentrated solution gross weight, stir evenly; According to a conventional method, with the substrate stearic acid, be 1: 1 ratio mixing by weight, splash in the condensing agent vegetable oil at 75 ℃ and make drop pill, natural drying, promptly.
Embodiment 25
A kind of method for preparing the agent of low alcohol type Yin-nourishing lung-heat clearing drop pills with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 2 makes, add 0.04% Mentholum of concentrated solution gross weight, stir evenly; According to a conventional method, with the substrate sodium stearate, be 1: 18 ratio mixing by weight, splash in the condensing agent methyl-silicone oil at 50 ℃ and make drop pill, natural drying, promptly.
Embodiment 26
A kind of method for preparing the agent of low alcohol type Yin-nourishing lung-heat clearing drop pills with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 2 makes, add 0.03% Mentholum of concentrated solution gross weight, stir evenly; According to a conventional method, with the substrate Polyethylene Glycol, be 1: 5 ratio mixing by weight, splash in the condensing agent liquid paraffin at 100 ℃ and make drop pill, natural drying, promptly.
Embodiment 27
A kind of method for preparing the agent of low alcohol type Yin-nourishing lung-heat clearing drop pills with low alcohol type concentrated soloution for nourishing yin to clear away:
With the low alcohol type concentrated soloution for nourishing yin to clear away that embodiment 1 makes, add 0.03% Mentholum of concentrated solution gross weight, stir evenly; According to a conventional method, with substrate Lac, be 1: 10 ratio mixing by weight, splash in the condensing agent ethanol at 50 ℃ and make drop pill, natural drying, promptly.
Embodiment 28
The quality determination of low alcohol type syrup for nourishing and clearing lung-heat agent product
(1) character: this product is tan translucent liquid; Gas is refrigerant, sweet, little hardship of distinguishing the flavor of.
(2) differentiate: carry out the menthol qualitative detection with gas chromatograph.
Chromatographic condition and system suitability test are immobile phase with methyl silicone rubber (SE-30), and coating concentration is 10%, and column temperature is 150 ℃, and theoretical cam curve is pressed the menthol peak and calculated, and should be not less than 1500.
Menthol reference substance 15mg is got in the preparation of reference substance solution, and accurate the title decides, and in the 10ml measuring bottle, adds dissolve with methanol and is diluted to scale, shakes up, as reserve liquid.Get reserve liquid 1ml, in the 5ml measuring bottle, add methanol and be diluted to scale, shake up, in contrast product solution.
The preparation of need testing solution is got this product 10ml in separatory funnel, adds ether 20ml, and jolting divides and gets ether layer to evaporating dish, volatilizes, and the residue dissolve with methanol moves in the 5ml measuring bottle, adds reserve liquid 1ml, and is diluted to scale with methanol, shakes up.
Algoscopy is got reference substance solution and need testing solution 1 μ l sample introduction, measures peak area (or peak height value), and the peak area of need testing solution (or peak height value) should be greater than reference substance solution.
(3) check: 1. amount of alcohol detects with gas chromatograph.
The test of chromatographic condition and system suitability with diameter be divinylbenzene-EST type porous polymer beads of 0.25~0.18mm as carrier, column temperature is 120~150 ℃.
The preparation precision of reference substance solution is measured the dehydrated alcohol 1.0ml of constant temperature to 20 ℃, and thin up becomes 100ml, mixing, promptly.
An amount of constant temperature to 20 of test sample ℃ is got in the preparation of need testing solution, promptly.
Algoscopy is got reference substance solution and each 2 μ l of need testing solution, annotates sample 2 times continuously respectively, calculates the peak area meansigma methods, and need testing solution should be less than reference substance solution.
Low alcohol type syrup for nourishing and clearing lung-heat agent (embodiment 2 preparations) determination of alcohol content:
Sample number | ??1 | ????2 | ????3 | ????4 | ????5 | ????6 | ???7 | ????8 | ????9 | ???10 |
Contain the alcohol amount | ?0.3% | ??0.4% | ??0.4% | ??0.1% | ??0.3% | ??0.3% | ?0.2% | ??0.1% | ??0.1% | ??0.7% |
Low alcohol type syrup for nourishing and clearing lung-heat agent (embodiment 1 preparation) determination of alcohol content:
Sample number | ????1 | ????2 | ????3 | ????4 | ????5 | ????6 | ????7 | ????8 | ???9 | ????10 |
Contain the alcohol amount | ?0.7% | ??0.7% | ??0.5% | ??0.6% | ??0.9% | ??0.9% | ??0.9% | ??0.4% | ?0.3% | ??0.3% |
Low alcohol type syrup for nourishing and clearing lung-heat agent (embodiment 3 preparations) determination of alcohol content:
Sample number | ????1 | ????2 | ????3 | ????4 | ????5 | ???6 | ????7 | ????8 | ????9 | ???10 |
Contain the alcohol amount | ??0.3% | ??0.6% | ??0.9% | ??0.4% | ??0.3% | ?0.5% | ??0.7% | ??0.7% | ??0.5% | ??0.9% |
2. relative density: 1.14-1.20 (25 ℃ of surveys).
3. loading amount: get 5 of test samples, content is poured into respectively in corrigent dry graduated cylinder, read the loading amount of each container contents, average loading amount 〉=120ml, each container loading amount 〉=116.4ml.
4. microbial check: antibacterial≤100/ml, mycete≤100/ml, escherichia coli: demodicid mite must not detect, live: must not detect.
(4) assay: carry out paeoniflorin content with high performance liquid chromatography and measure.
Chromatographic condition and system suitability test with the octadecylsilane bonding mutually silica gel be filler, acetonitrile-water-glacial acetic acid (160: 840: 10) is mobile phase, flow velocity 1ml/ branch, and the detection wavelength is 236nm, 40 ℃ of column temperatures, theoretical cam curve calculate by the peoniflorin peak should be not less than 2000.
Peoniflorin reference substance 10mg is got in the preparation of reference substance solution, and accurate the title decides, and puts in the measuring bottle, adds dissolve with methanol and is diluted to the solution that every 1ml contains 0.2mg, in contrast product solution.
The accurate this product 5ml that draws of the preparation of need testing solution puts in the 25ml measuring bottle,, shakes up to scale with 50% ethanol dilution, through 0.45 μ m filtering with microporous membrane, promptly.
Algoscopy gets need testing solution 10 μ l and reference substance liquid 10 μ l inject high performance liquid chromatograph respectively, presses the external standard peak area method and calculates content of paeoniflorin, promptly.
The every 1ml of this product contains peoniflorin (C
23H
28O
11) must not be less than 0.3mg.
Claims (10)
1. low alcohol type concentrated soloution for nourishing yin to clear away is characterized in that being made by following method:
(1) prepare raw material:
Radix Rehmanniae 20-32% Radix Scrophulariae 15-30% 10-20% Radix Ophiopogonis Radix Glycyrrhizae 2-8%
Cortex Moutan 5-20% Bulbus Fritillariae Cirrhosae 5-20% Radix Paeoniae Alba 5-20%, described percentage ratio is weight percentage;
(2) 1. with Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Glycyrrhizae decocting in water 1~3 time, add water weight at every turn and be 6~12 times of described four Chinese medicine gross weight, decocted 1~4 hour, merge decocting liquid, being concentrated into relative density is 1.10~1.25; 2. with concentration of volume percent be 50%~80% 6~8 times to Cortex Moutan, Bulbus Fritillariae Cirrhosae, the ethanol extraction Cortex Moutan of Radix Paeoniae Alba gross weight, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba; 3. 1. decocting liquid and ethanol extract are 2. merged, mixing leaves standstill, and gets supernatant and precipitation, gets supernatant, reclaims ethanol, and the relative density that makes amalgamation liquid is 1.02~1.20; 4. the 4.8-7.2 percentage by volume doubly that adds Radix Rehmanniae weight in described precipitation is that the commentaries on classics of 50%~80% ethanol is molten, separation of supernatant and precipitation, to precipitate to use and change once molten again with method, the filtering precipitation, twice supernatant is merged, reclaim ethanol, it is 1.02~1.20 liquid that supernatant concentration is made relative density; 5. the amalgamation liquid that will 3. make merges with the liquid of 4. making, and mixing is made a kind of low alcohol type concentrated soloution for nourishing yin to clear away, and the mensuration temperature of described relative density is 80 ℃.
2. the preparation method of a low alcohol type concentrated soloution for nourishing yin to clear away is characterized in that being made up of following steps:
(1) prepare raw material:
Radix Rehmanniae 20-32% Radix Scrophulariae 15-30% 10-20% Radix Ophiopogonis Radix Glycyrrhizae 2-8%
Cortex Moutan 5-20% Bulbus Fritillariae Cirrhosae 5-20% Radix Paeoniae Alba 5-20%, described percentage ratio is weight percentage;
(2) 1. with Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Glycyrrhizae decocting in water 1~3 time, add water weight at every turn and be 6~12 times of described four Chinese medicine gross weight, decocted 1~4 hour, merge decocting liquid, being concentrated into relative density is 1.10~1.25; 2. with concentration of volume percent be 50%~80% 6~8 times to Cortex Moutan, Bulbus Fritillariae Cirrhosae, the ethanol extraction Cortex Moutan of Radix Paeoniae Alba gross weight, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba; 3. 1. decocting liquid and ethanol extract are 2. merged, mixing leaves standstill, and gets supernatant and precipitation, gets supernatant, reclaims ethanol, and the relative density that makes amalgamation liquid is 1.02~1.20; 4. the 4.8-7.2 percentage by volume doubly that adds Radix Rehmanniae weight in described precipitation is that the commentaries on classics of 50%~80% ethanol is molten, separation of supernatant and precipitation, to precipitate to use and change once molten again with method, the filtering precipitation, twice supernatant is merged, reclaim ethanol, it is 1.02~1.20 liquid that supernatant concentration is made relative density; 5. the amalgamation liquid that will 3. make merges with the liquid of 4. making, and mixing is made a kind of low alcohol type concentrated soloution for nourishing yin to clear away, and the mensuration temperature of described relative density is 80 ℃.
3. the preparation method of a kind of low alcohol type concentrated soloution for nourishing yin to clear away according to claim 2 is characterized in that described raw material is:
Radix Rehmanniae 26.31% Radix Scrophulariae Radix Glycyrrhizae 5.26% 21.05% Radix Ophiopogonis 15.79%
Cortex Moutan 10.53% Bulbus Fritillariae Cirrhosae 10.53% Radix Paeoniae Alba 10.53%
The number of times of described decocting in water Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Glycyrrhizae is 2 times, decocted 3 hours for the first time, decocted 2 hours for the second time, the multiple that at every turn adds water is 10 times of described four Chinese medicine gross weight, merge decocting liquid, being concentrated into relative density is 1.17~1.20, the concentration of ethanol of described extraction Cortex Moutan, Bulbus Fritillariae Cirrhosae, the Radix Paeoniae Alba is 60%, described consumption of ethanol is Cortex Moutan, Bulbus Fritillariae Cirrhosae, Radix Paeoniae Alba gross weight 7 times, the concentration of ethanol that adds in described precipitation commentaries on classics is molten is 70%, and addition is 6 times of Radix Rehmanniae weight.
4. method for preparing the agent of low alcohol type syrup for nourishing and clearing lung-heat with low alcohol type concentrated soloution for nourishing yin to clear away, it is characterized in that forming: in the relative density of 1000 weight portions is 1.02~1.20 low alcohol type concentrated soloution for nourishing yin to clear away, add sodium benzoate, stir evenly by following step; The simple syrup that adds the 900-1300 weight portion; Add Mentholum, stir evenly, leave standstill, make the agent of low alcohol type syrup for nourishing and clearing lung-heat, the addition of described sodium benzoate is the 0.3%-0.9% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight, the addition of Mentholum is the 0.01%-0.04% of low alcohol type concentrated soloution for nourishing yin to clear away gross weight, and described percentage ratio is weight percentage, and the mensuration temperature of described relative density is 80 ℃.
5. one kind prepares the method for nourishing YIN and clearing away lung-heat tablet with low alcohol type concentrated soloution for nourishing yin to clear away, and it is characterized in that being made up of following step: with low alcohol type concentrated soloution for nourishing yin to clear away, drying is ground into fine powder; With wet method or dry granulation, add the 0.01%-0.04% Mentholum of concentrated solution gross weight and the magnesium stearate of grain amount 0.3%-0.6% according to a conventional method, stir evenly, compacting is wrapped film-coat in flakes, that is, described percentage ratio is weight percentage.
6. one kind prepares the method for nourishing YIN and clearing away lung-heat pill with low alcohol type concentrated soloution for nourishing yin to clear away, and it is characterized in that being made up of following step: with low alcohol type concentrated soloution for nourishing yin to clear away, drying is ground into fine powder; Add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly, water or sweet water pill according to a conventional method, drying, the bag film-coat, polishing, drying, that is, described percentage ratio is weight percentage.
7. one kind prepares the method for nourishing YIN and clearing away lung-heat granule with low alcohol type concentrated soloution for nourishing yin to clear away, it is characterized in that being made up of following step: with low alcohol type concentrated soloution for nourishing yin to clear away, and drying, add sucrose or lactose or protein sugar or xylitol according to a conventional method and make adjuvant, make granule, drying is sieved; Add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly, that is, described percentage ratio is weight percentage.
8. one kind prepares the method for nourishing YIN and clearing away lung-heat capsule with low alcohol type concentrated soloution for nourishing yin to clear away, and it is characterized in that being made up of following step: with low alcohol type concentrated soloution for nourishing yin to clear away, drying is sieved according to a conventional method; Add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly, pour into capsule, that is, described percentage ratio is weight percentage.
9. one kind prepares the method for low alcohol type nourishing YIN and clearing away lung-heat soft capsule with low alcohol type concentrated soloution for nourishing yin to clear away, it is characterized in that being made up of following step: with low alcohol type concentrated soloution for nourishing yin to clear away, add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly; Add diluent, antioxidant, suspending agent according to a conventional method, stir, room temperature leaves standstill, and presses soft capsule promptly, and described percentage ratio is weight percentage.
10. one kind prepares the method for low alcohol type Yin-nourishing lung-heat clearing drop pills agent with low alcohol type concentrated soloution for nourishing yin to clear away, it is characterized in that being made up of following step: with low alcohol type concentrated soloution for nourishing yin to clear away, add the 0.01%-0.04% Mentholum of concentrated solution gross weight, stir evenly; According to a conventional method, with substrate stearic acid or sodium stearate or Polyethylene Glycol or Lac, be 1 by weight: the ratio mixing of 1-18, splash in condensing agent vegetable oil or methyl-silicone oil or ethanol or the liquid paraffin at 50-100 ℃ and to make drop pill, natural drying, that is, described percentage ratio is weight percentage.
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Cited By (3)
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CN103893525A (en) * | 2012-12-28 | 2014-07-02 | 天津中新药业研究中心 | Preparation technique of traditional Chinese medicine composition for nourishing yin, clearing away lung-heat, clearing heat and relieving sore throat |
CN103893526A (en) * | 2012-12-28 | 2014-07-02 | 天津中新药业研究中心 | Preparation method of traditional Chinese medicine composition for nourishing yin, clearing away lung-heat, clearing heat and relieving sore throat |
CN103893528A (en) * | 2012-12-28 | 2014-07-02 | 天津中新药业研究中心 | Traditional Chinese medicine composition for nourishing yin, clearing away lung-heat, clearing heat and relieving sore throat and preparation method thereof |
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CN1362221A (en) * | 2001-01-08 | 2002-08-07 | 杨孟君 | Nano medicine for nourishing Yin and clearing away lung heat and its preparation |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103893525A (en) * | 2012-12-28 | 2014-07-02 | 天津中新药业研究中心 | Preparation technique of traditional Chinese medicine composition for nourishing yin, clearing away lung-heat, clearing heat and relieving sore throat |
CN103893526A (en) * | 2012-12-28 | 2014-07-02 | 天津中新药业研究中心 | Preparation method of traditional Chinese medicine composition for nourishing yin, clearing away lung-heat, clearing heat and relieving sore throat |
CN103893528A (en) * | 2012-12-28 | 2014-07-02 | 天津中新药业研究中心 | Traditional Chinese medicine composition for nourishing yin, clearing away lung-heat, clearing heat and relieving sore throat and preparation method thereof |
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Address after: 300380 Yumen Road, Xiqing District, Tianjin Patentee after: Lerentang Pharmaceutical Factory of Jinyao Darentang Group Co.,Ltd. Address before: 300380 Yumen Road, Xiqing District, Tianjin Patentee before: Letrentang pharmaceutical factory of Tianjin Zhongxin Pharmaceutical Group Co.,Ltd. |