CN103784726B - Yixinshu tablet and preparation method thereof - Google Patents
Yixinshu tablet and preparation method thereof Download PDFInfo
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- CN103784726B CN103784726B CN201410039772.6A CN201410039772A CN103784726B CN 103784726 B CN103784726 B CN 103784726B CN 201410039772 A CN201410039772 A CN 201410039772A CN 103784726 B CN103784726 B CN 103784726B
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Abstract
The invention discloses a kind of Yixinshu tablet, it is made up of the beneficial heart easypro dry cream, PEG 4000, cane sugar powder, carboxyrnethyl starch sodium, silica, magnesium stearate and syrup, wherein, syrup is adhesive, its viscosity is stronger, it is adaptable to which quality is loose, elastic stronger plant-based medicine, obtained tablet and powder epigranular, slice, thin piece hardness, release is superior to the particle that traditional handicraft is made.The invention also discloses the preparation method of the Yixinshu tablet, the beneficial heart relaxes dry cream in preparation process, within add and added with the method for outer addition so that color is homogeneous after tablet removes clothing film, and proterties obtains also improving medicinal infiltration rate while improvement.Again by the meticulous screening of auxiliary material, outward appearance is beautiful, and color and luster is good, and in good taste, storage period is long, and using, transport and easy to carry, price is low, and yield is high.
Description
Technical field
The present invention relates to Chinese patent medicine tablet and its preparation field, and in particular to a kind of Yixinshu tablet and preparation method thereof.
Background technology
Cardiovascular and cerebrovascular disease is to influence human health at present, one of murderous most important factor, according to the literature, often
The number of cardiovascular and cerebrovascular disease is died from more than 20,000,000 in year whole world, China nearly 400,000.The traditional Chinese medical science is accumulated in terms of the sick diagnosis and treatment
Abundant clinical experience, Chinese medicinal formulae has unique advantage in terms of cardiovascular and cerebrovascular disease is treated.Pectoralgia and the coronary heart disease heart
Angina belongs to the traditional Chinese medical science " obstruction of qi in the chest " category.Its cause of disease of the obstruction of qi in the chest is relevant with inward invasion of pathogenic cold, improper diet, disorder of emotion, body deficiency due to old age etc., presses
Syndrome can be divided into the disease types such as the turbid congestion of the stagnation of the heart blood, phlegm, phlegm stagnancy, heart kidney-yin deficiency, deficiency of both qi and yin, deficient and weak YANG QI." heart vessle-Bi symptom-complex
Resistance " is this sick principle pathological mechanism, clinical simulataneous insufficiency and excessive mostly, in the time of this empty table reality, is treated based on this disease advocates to mend
So that it is to use principle to lead to, and is mended, and main tonifying Qi is cloudy, it is intended to adjust internal organs qi and blood to contain partially and decline partially, with the card of void of effecting a permanent cure, lead to, main promoting blood circulation is logical
Sun, it is intended that the numbness resistance of network of promoting blood circulation is declared, with the marquis of reality of taking stopgap measures.
Beneficial Xinshu capsule prescription is formed with ancient prescription " Shengmai Yin " plus taste blood-activating drug, is treated both principal and secondary aspect of disease." Shengmai Yin " is treatment chest
Numbness often uses square foundation, has numerous documents to be seen in report in terms of coronary heart disease clinical research with Shengmai Yin plus taste, evident in efficacy.The beneficial heart
Capsule belongs to national essential drugs (2004), while belong to again《Basic medical insurance and work-related injury insurance Drug catalogue》2004
Version Chinese patent drug Class B, works well, convenient to take, deep to be favored by many patients.
A kind of preparation method of Yixinshu tablet, the party are disclosed in the Chinese patent application of Publication No. CN101804152A
Method discloses 150~250g of ginseng, 150~250g of the tuber of dwarf lilyturf, 95~150g of the fruit of Chinese magnoliavine, 150~250g of the Radix Astragali, 240~285g of the red sage root,
95~150g of Ligusticum wallichii, 150~250g of hawthorn, 20~60g of microcrystalline cellulose, 1~3g of magnesium stearate, appropriate starch.Using 80% second
Alcohol pelletize, concentration of alcohol is bigger in operating process, after moistening viscosity it is lower, cause obtained wet granular mesh number have a very wide distribution and
Uneven, fine powder is more, causes occur the phenomenons such as flower piece, sliver during compressing tablet, and obtained Yixinshu tablet disintegration time is long and in storage
The phenomenons such as disintegration time limited is unqualified, stability is poor, microorganism is unqualified occur after a period of time.
The content of the invention
The invention provides a kind of Yixinshu tablet, the Yixinshu tablet disintegration time limited is short, microbial limit is qualified.
Present invention also offers a kind of preparation method of Yixinshu tablet, the preparation method operation is simple, quality controllable and suitable
In industrialized production
A kind of Yixinshu tablet, in terms of 10000, is made up of following raw material：
The easypro dry cream of the described beneficial heart is with 150~250 weight portion ginsengs, 150~250 weight portion tubers of dwarf lilyturf, 95~150 weight
Part fruit of Chinese magnoliavine, 150~250 weight portion Radixs Astragali, 240~285 weight portion reds sage root, 95~150 weight portion Ligusticum wallichiis, 150~250 weight
Part hawthorn is what raw material was extracted.
Wherein, 65~75% in 65~75% described syrup refer to the mass percent concentration of solute.
In the preparation process of tablet, the preparation of particle is a crucial step, and the quality of grain graininess directly affects compressing tablet
Effect.Because beneficial heart dry cream of relaxing is extracted with plant-based medicine, quality is loose, elastic relatively strong, general auxiliary of selection
The obtained particle of material is difficult to meet the requirement of follow-up compressing tablet.In the present invention from 65~75% syrup be adhesive, its viscosity compared with
By force, uniform in size after obtained particle is through whole grain while coordinating with carboxyrnethyl starch sodium as disintegrant, mobility is preferable, mouthfeel
Good, compressing tablet is made unilateral smooth after tablet, and the index such as disintegration time limited meets the requirements.
Wherein, the preparation method of the easypro dry cream of the described beneficial heart is as follows：
（1）Ginseng fine powder is obtained after ginseng is crushed, it is standby；
（2）The fruit of Chinese magnoliavine, the red sage root are extracted 2 times with 85% alcohol reflux, the extract solution filtration for obtaining is depressurized dense after merging
Density is reduced to for 1.15~1.12 obtain alcohol medicinal extract A；
（3）The tuber of dwarf lilyturf, the Radix Astragali, Ligusticum wallichii and hawthorn are boiled 2 times with decocting, collecting decoction, filtered, filtrate is concentrated into original volume
5~15%, 85% ethanol is added, after being sufficiently stirred for, stand overnight, sediment is filtered off, filtrate recycling ethanol is simultaneously concentrated into phase
To density 1.30~1.36, medicinal extract B is obtained；
（4）Step is added after alcohol medicinal extract A and medicinal extract B is merged（1）Described benefit is uniformly mixed so as to obtain after the ginseng fine powder for obtaining
The heart relaxes dry cream.
Wherein, the ethanol water that described 85% ethanol refers to, the concentration of volume percent of ethanol is 85%.
Step（3）In, the volume of the amount of the ethanol of 85% for being added substantially with the filtrate after concentration is equal.
Detailed operating procedure is as follows：
The taste of the above seven, takes standby after ginseng crushing fine powder.The fruit of Chinese magnoliavine, the red sage root extract 2 times, first with 85% alcohol reflux
Secondary plus 85% ethanol, 6 times of amounts, refluxing extraction 3 hours, second plus 85% ethanol, 5 times of amounts, refluxing extraction 1.5 hours, filtration merges
Filtrate, is concentrated under reduced pressure into relative density 1.15~1.12 (20 DEG C), obtains alcohol medicinal extract.Remaining tuber of dwarf lilyturf etc. adds water to cook 2 times, for the first time
Add water 10 times and measure, decoct 2.5 hours, add water for the second time 8 times and measure, decoct 1.5 hours, collecting decoction, filtration, filtrate is concentrated into
500ml, adds 85% ethanol of equivalent, after being sufficiently stirred for, stands overnight, and filters off sediment, and filtrate recycling ethanol is simultaneously concentrated into phase
To density 1.30~1.36 (80 DEG C), the easypro dry cream of the benefit heart after ginseng fine powder is added after above-mentioned two kinds of medicinal extract is merged.
Preferably, 65~75% described syrup are made up of water with sucrose；
Preparation method is as follows：
The water for accounting for gross weight 95~99% is added in punching slurry tank, after being heated to boiling, sucrose is put into, kept under stirring condition
Boiling 3~10 minutes, stops heating, adds 20~30 DEG C of remaining water, continues to stir 20~60 seconds, obtains described sugar
Slurry.Directly used after the syrup cooling for obtaining, now, the viscosity of syrup is suitable, can preferably be applied to the easypro dry cream of the beneficial heart
Granulation and compressing tablet.
By taking the preparation of 70% syrup as an example, concrete operations are as follows：In punching slurry tank, purified water 10480ml is added, be heated to
After boiling, 25kg sucrose is put into, boiling is heated to while stirring（100℃）After 3 minutes, stop heating and stir.Add purified water
300ml（It is cool）, stir 30 seconds, obtain final product.
Preferably, described Yixinshu tablet, in terms of 10000, is made up of following raw material：
Consider the shape and disintegration time of the product for obtaining, as further preferred, described Yixinshu tablet,
In terms of 10000, it is made up of following raw material：
As further preferred, described Yixinshu tablet, in terms of 10000, it is made up of following raw material：
As further preferred, described Yixinshu tablet, in terms of 10000, it is made up of following raw material：
Present invention also offers a kind of preparation method of described Yixinshu tablet, comprise the following steps：
（1）65~75% syrup of configuration are simultaneously let cool to room temperature, standby；
（2）The easypro dry cream of the beneficial heart crushed 100 mesh sieves, and sucrose crushed 80 mesh sieves, standby；
（3）The easypro dry cream of the beneficial heart of silica, magnesium stearate, carboxyrnethyl starch sodium, 1~5% weight is well mixed, is obtained
Supplementary material；
（4）Add the easypro dry cream of the remaining beneficial heart, PEG-4000, cane sugar powder to be well mixed by recipe quantity, add step（1）
65~75% syrup granulation arrived, in 70 DEG C of drying, whole grain adds step（3）The supplementary material for obtaining is well mixed, and compressing tablet is obtained
To described Yixinshu tablet.
In the preparation method, added within the easypro dry cream of the beneficial heart and be separately added into the method for outer addition, a small amount of beneficial heart is relaxed
Dry cream is first mixed with other auxiliary materials so that tablet shows brown uniformly after removing clothing film, and proterties is improved, it has unexpectedly been found that
Also improve medicinal infiltration rate.
Compared with the existing technology, beneficial effects of the present invention are embodied in：
1）Pelletized with 65~75% syrups, its viscosity is stronger, it is adaptable to which quality is loose, elastic stronger botanical
Thing, obtained particle is after whole grain, and slice, thin piece hardness is in good taste, and compressing tablet is made unilateral smooth, the finger such as disintegration time limited after tablet
Mark all meets the requirements.
2）Added within the easypro dry cream of the beneficial heart and prepared with the method for outer addition so that tablet shows brown uniformly after removing clothing film,
Proterties is improved, and is found surprisingly that and also improve medicinal infiltration rate.
3）By the meticulous screening of auxiliary material, made grain graininess is uniform, release, in good taste, disintegration time limited, slice, thin piece
Finish aspect has the particle being made better than traditional handicraft.
4）The method preparation time is short, material loss is few, labour intensity is low, low by outside contamination and finished particle is neat,
A small amount of personnel only need to be equipped with, more properly with large-scale production.
Specific embodiment
Present invention is explained further or illustrated by the following examples, but the embodiment for being provided should not be managed
Solution is that the scope of the present invention is construed as limiting.
Embodiment 1
Prescription:In terms of 10000
Preparation method:
（1）The taste of the above seven, takes standby after 1500g ginseng crushing fine powders.The 950g fruit ofs Chinese magnoliavine, the 2400g reds sage root with 85% ethanol
Refluxing extraction 2 times, adds 85% ethanol, 6 times of amounts, refluxing extraction 3 hours, second plus 85% ethanol, 5 times of amounts, refluxing extraction for the first time
1.5 hours, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.15~1.12 (20 DEG C), obtains alcohol medicinal extract.Again by 1500g wheats
Winter, the 1500g Radixs Astragali, 950g Ligusticum wallichiis and 1500g hawthorn add water to cook 2 times, add water for the first time 10 times and measure（Weight）, decoct 2.5 small
When, add water for the second time 8 times and measure, decoct 1.5 hours, collecting decoction, filtration, filtrate is concentrated into 3500ml, adds 85% second of equivalent
Alcohol, after being sufficiently stirred for, stands overnight, and filters off sediment, and filtrate recycling ethanol is simultaneously concentrated into relative density 1.30~1.36 (80
DEG C), will above-mentioned two kinds of medicinal extract merge after add that ginseng fine powder is well mixed to be obtained the beneficial heart and relax dry cream.
（2）In punching slurry tank, purified water 10480ml is added, after being heated to boiling, put into 25kg sucrose, heated while stirring
To boiling（100℃）After 3 minutes, purified water 300ml is added（It is cool）, stir 30 seconds, 70% syrup is obtained final product, let cool to room temperature, it is standby
With.
（3）The easypro dry cream of the beneficial heart crushed 100 mesh sieves, and sucrose crushed 80 mesh sieves, standby.
（4）Silica 43g, magnesium stearate 25g, carboxyrnethyl starch sodium 86g, the easypro dry cream 50g of the beneficial heart are well mixed, it is standby
With.
（5）Easypro dry cream 1900g, PEG-4000150.5g of the beneficial heart, cane sugar powder 1000g are weighed by recipe quantity to be well mixed, plus
Enter the 70% syrup granulation of recipe quantity, in 70 DEG C of drying, whole grain is eventually adding step（3）Supplementary material is well mixed, compressing tablet,
It is coated, plastic-aluminum, packaging is obtained final product.
Embodiment 2
Prescription:In terms of 10000
Preparation method:
（1）The beneficial heart relaxes dry cream extraction with embodiment 1.
（2）70% syrup is with embodiment 1.
（3）The easypro dry cream of the beneficial heart crushed 100 mesh sieves, and sucrose crushed 80 mesh sieves, standby.
（4）Silica 50g, magnesium stearate 35g, carboxyrnethyl starch sodium 90g, the easypro dry cream 50g of the beneficial heart are well mixed, it is standby
With.
（5）Easypro dry cream 1800g, PEG-4000160g of the beneficial heart, cane sugar powder 1100g are weighed by recipe quantity to be well mixed, add
The 70% syrup granulation of recipe quantity, in 70 DEG C of drying, whole grain is eventually adding step（3）Supplementary material is well mixed, compressing tablet, is coated,
Plastic-aluminum, packaging is obtained final product.
Embodiment 3
Prescription:In terms of 10000
Preparation method：
（1）The beneficial heart relaxes dry cream extraction with embodiment 1.
（2）70% syrup is with embodiment 1.
（3）The easypro dry cream of the beneficial heart crushed 100 mesh sieves, and sucrose crushed 80 mesh sieves, standby.
（4）Silica 30g, magnesium stearate 25g, carboxyrnethyl starch sodium 80g, the easypro dry cream 50g of the beneficial heart are well mixed, it is standby
With.
（5）Easypro dry cream 2150g, PEG-4000130g of the beneficial heart, cane sugar powder 800g are weighed by recipe quantity to be well mixed, at addition
The 70% syrup granulation of side's amount, in 70 DEG C of drying, whole grain is eventually adding step（3）Supplementary material is well mixed, compressing tablet, is coated, aluminium
Modeling, packaging is obtained final product.
Comparative example 1
Prescription：
Ginseng crushing is taken, 100 mesh sieves are crossed, using pulsation vacuum sterilizer at 134 DEG C, sterilize standby in 1 hour under 0.21Mpa
With；Take the fruit of Chinese magnoliavine, the red sage root plus 5 times of 85% alcohol refluxs of amount to extract 2 times, 3 hours for the first time, second 1.5 hours, filtration merged
Filtrate, at 50 DEG C, after ethanol is recovered under reduced pressure under -0.08MPa, and is concentrated into relative density 1.12~1.15 by filtrate（20℃）,
Obtain alcohol medicinal extract；Add the decocting of 8 times of amounts to boil 2 times the tuber of dwarf lilyturf, the Radix Astragali, Ligusticum wallichii, hawthorn, 2.5 hours for the first time, second 1.5 hours, close
And liquid of boiling medicine, filtering, filtrate is concentrated into about 650ml, adds the ethanol of equivalent 85%, after being sufficiently stirred for, stands overnight, and filters, filtrate
At 70 DEG C, relative density 1.30~1.36 is recovered under reduced pressure after ethanol and is concentrated under -0.08Mpa（70℃）Obtain the water extracted immersing paste；Will
After above-mentioned two kinds of medicinal extract merges, above-mentioned ginseng fine powder is added, and add microcrystalline cellulose, be well mixed, 16 mesh are crossed with 80% ethanol
Wet sieving diameter is pelletized, and is dried at 50 DEG C, crosses 20 mesh sieve whole grains, and dry particl adds magnesium stearate, and adds starch appropriate, regulation total amount to
380g, is mixed evenly, and is pressed into 1000, and film coating obtains final product Yixinshu tablet.
Comparative example 2
Prescription：
Except making recipe quantity into above amount, other operating procedures are consistent with comparative example 1.
Comparative example 3
Prescription：
Except making recipe quantity into above amount, other operating procedures are consistent with comparative example 1.
Comparative example 4
Except 70% syrup is substituted for into PVP, other operating procedures are consistent with embodiment 1.Comparative example 5
Except carboxyrnethyl starch sodium is substituted for into Ac-Di-Sol, other operating procedure embodiments 1 are consistent.
Comparative example 6
Except step（4）In 50g benefit the heart relax dry cream be not added with, step（5）In relax dry cream addition of the beneficial heart be 1950g,
Other operating procedure embodiments 1 are consistent.
Yixinshu tablet prepared by the Yixinshu tablet and comparative example 1~5 prepared to embodiment 1~3 carries out quality inspection, respectively
The testing result of project such as table 1.
The related check data of the Yixinshu tablet of table 1
From the testing result in table 1, disintegration of tablet time limit of the invention and microbial limit, hardness, moisture are excellent
In comparative example 1（That is the Chinese patent application of Publication No. CN101804152A）The tablet of preparation.The easypro dry cream of the beneficial heart is dividedly in some parts,
Influence whether disintegration time limited and proterties.
After Yixinshu tablet prepared by Yixinshu tablet and comparative example 1~5 prepared by embodiment 1~3 is stored 6 months, enter
Row disintegration time limited, sliver, the comparing of microbial limit, the disintegration of tablet time limit, microbial limit detection method respectively according to
Version in 2010《Chinese Pharmacopoeia》One annex I A methods detection, as a result such as table 2.
Table 2
As shown in Table 2, there is not underproof phenomenon in disintegration time limited after tablet of the invention is stored 6 months, therefore of the invention
Better than prior art.
Claims (6)
1. a kind of Yixinshu tablet, it is characterised in that in terms of 10000, be made up of following raw material：
The easypro dry cream of the described beneficial heart is with 150~250 weight portion ginsengs, 150~250 weight portion tubers of dwarf lilyturf, 95~150 weight portions five
Taste, 150~250 weight portion Radixs Astragali, 240~285 weight portion reds sage root, 95~150 weight portion Ligusticum wallichiis, 150~250 weight portion mountains
Short, bristly hair or beard is what raw material was extracted；
The preparation method of the easypro dry cream of the described beneficial heart is as follows：
(1) ginseng fine powder is obtained after ginseng is crushed, it is standby；
(2) fruit of Chinese magnoliavine, the red sage root are extracted 2 times with 85% alcohol reflux, the extract solution filtration for obtaining is concentrated under reduced pressure into after merging
Density obtains alcohol medicinal extract A for 1.15~1.12；
(3) tuber of dwarf lilyturf, the Radix Astragali, Ligusticum wallichii and hawthorn are boiled 2 times with decocting, collecting decoction, filter, filtrate be concentrated into original volume 5~
15%, 85% ethanol is added, after being sufficiently stirred for, stand overnight, sediment is filtered off, filtrate recycling ethanol is simultaneously concentrated into relative
Density 1.30~1.36, obtains medicinal extract B；
(4) the described beneficial heart is uniformly mixed so as to obtain after the ginseng fine powder that addition step (1) is obtained after alcohol medicinal extract A and medicinal extract B is merged to relax
Dry cream.
2. Yixinshu tablet according to claim 1, it is characterised in that 65~75% described syrup are by water and sucrose system
Into；
Preparation method is as follows：
The water for accounting for gross weight 95~99% is added in punching slurry tank, after being heated to boiling, sucrose is put into, boiling is kept under stirring condition
3~10 minutes, stop heating, add 20~30 DEG C of remaining water, continue to stir 20~60 seconds, obtain described syrup.
3. Yixinshu tablet according to claim 1, it is characterised in that in terms of 10000, be made up of following raw material：
4. Yixinshu tablet according to claim 1, it is characterised in that in terms of 10000, be made up of following raw material：
5. Yixinshu tablet according to claim 1, it is characterised in that in terms of 10000, be made up of following raw material：
6. the preparation method of the Yixinshu tablet according to any one of claim 1~2, comprises the following steps：
(1) 65~75% syrup for configuring are let cool to room temperature, it is standby；
(2) the easypro dry cream of the beneficial heart crushed 100 mesh sieves, and sucrose crushed 80 mesh sieves, standby；
(3) the easypro dry cream of the beneficial heart of silica, magnesium stearate, carboxyrnethyl starch sodium, 1~5% weight is well mixed, obtains former auxiliary
Material；
(4) add the easypro dry cream of the remaining beneficial heart, PEG-4000, cane sugar powder to be well mixed by recipe quantity, add what step (1) was obtained
65~75% syrup are pelletized, and in 70 DEG C of drying, whole grain adds the supplementary material that step (3) obtains and is well mixed, and compressing tablet obtains institute
The Yixinshu tablet stated.
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| CN201410039772.6A CN103784726B (en) | 2014-01-27 | 2014-01-27 | Yixinshu tablet and preparation method thereof |
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|---|---|---|---|
| CN201410039772.6A CN103784726B (en) | 2014-01-27 | 2014-01-27 | Yixinshu tablet and preparation method thereof |
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| CN103784726A CN103784726A (en) | 2014-05-14 |
| CN103784726B true CN103784726B (en) | 2017-06-13 |
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| CN106226435B (en) * | 2016-08-29 | 2018-11-30 | 江苏康缘药业股份有限公司 | A kind of fingerprint atlas detection method of Yixinshu tablet saponin component |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804152A (en) * | 2010-03-23 | 2010-08-18 | 中山尊隆药业有限公司 | Yixinshu tablet |
| CN101804151A (en) * | 2010-03-23 | 2010-08-18 | 中山尊隆药业有限公司 | Method for preparing Yixinshu tablets |
-
2014
- 2014-01-27 CN CN201410039772.6A patent/CN103784726B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804152A (en) * | 2010-03-23 | 2010-08-18 | 中山尊隆药业有限公司 | Yixinshu tablet |
| CN101804151A (en) * | 2010-03-23 | 2010-08-18 | 中山尊隆药业有限公司 | Method for preparing Yixinshu tablets |
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