CN103784726A - Heart relaxing tablet and preparation method thereof - Google Patents
Heart relaxing tablet and preparation method thereof Download PDFInfo
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- CN103784726A CN103784726A CN201410039772.6A CN201410039772A CN103784726A CN 103784726 A CN103784726 A CN 103784726A CN 201410039772 A CN201410039772 A CN 201410039772A CN 103784726 A CN103784726 A CN 103784726A
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Abstract
The invention discloses a heart relaxing tablet which is prepared from heart relaxing dry paste, PEG (Polyethylene Glycol)-4000, sucrose powder, carboxymethyl starch sodium, silica, magnesium stearate and a sirup agent, wherein the sirup agent is an adhesive which is relatively high in viscosity and suitable for a loose botanical drug with high elasticity, the prepared tablet is uniform in particle size, and the hardness and release rate of the tablet are both better than those of particles prepared by a traditional process. The invention also discloses a preparation method of the heart relaxing tablet; during preparation, the heart relaxing dry paste is added internally and externally so that the tablet is uniform in color after a coating is removed, the characters are improved and the medicinal absorption speed is increased as well. Through elaborate selection of auxiliary materials, the heart relaxing tablet is good-looking in appearance, good in color and gloss, good in taste, long in storage period, convenient to use, transport and carry, low in cost and high in yield.
Description
Technical field
The present invention relates to Chinese patent medicine tablet and preparation field thereof, be specifically related to a kind of Yixinshu tablet and preparation method thereof.
Background technology
Cardiovascular and cerebrovascular disease is to affect at present human health, one of murderous most important factor, and according to the literature, the number that cardiovascular and cerebrovascular disease is died from the annual whole world exceedes 2,000 ten thousand, China nearly 400,000.The traditional Chinese medical science is accumulating abundant clinical experience aspect these sick diagnosis and treatment, and Chinese medicinal formulae has unique advantage aspect treatment cardiovascular and cerebrovascular disease.Chest pain and angina pectoris belong to the traditional Chinese medical science " thoracic obstruction " category.Its cause of disease of the thoracic obstruction is relevant with inward invasion of pathogenic cold, improper diet, disorder of emotion, body deficiency due to old age etc., can be divided into the disease types such as stagnation of heart-blood, the turbid Yong Sai of expectorant, phlegm stagnancy, heart deficiency of the kidney yin, deficiency of both QI and YIN, deficient and weak YANG QI by syndrome." blockage of the cardiac vessels " is the main pathomechanism of primary disease, and clinical most simulataneous insufficiency and excessive is the time of deficiency in origin table reality, treat this disease advocate in order to mend be main with, lead to for by principle, mend, main QI invigorating the moon, be intended to adjust the inclined to one side Sheng of internal organs QI and blood partially to decline, with the card of the void of effecting a permanent cure, logical, mainly invigorate blood circulation and activate yang, be intended to declare the numbness resistance of the network of promoting blood circulation, with the marquis of the reality of taking stopgap measures.
YIXINSHU JIAONANG prescription adds taste blood circulation promoting medicine with ancient prescription " SHENGMAI YIN " and forms, treating both the principal and secondary aspects of a disease." SHENGMAI YIN " is the conventional square foundation of the treatment thoracic obstruction, and adding taste with SHENGMAI YIN is having numerous documents to be seen in report aspect coronary heart disease clinical research, evident in efficacy.Heart replenishing capsule belongs to national essential drugs (2004), belongs to again " basic medical insurance and work-related injury insurance medicine catalogue " version Chinese patent medicine Class B in 2004 simultaneously, and respond well, taking convenience, is favored by extensive patients deeply.
Publication number is the preparation method that discloses a kind of Yixinshu tablet in the Chinese patent application of CN101804152A, the open Radix Ginseng 150～250g of the method, Radix Ophiopogonis 150～250g, Fructus Schisandrae Chinensis 95～150g, the Radix Astragali 150～250g, Radix Salviae Miltiorrhizae 240～285g, Rhizoma Chuanxiong 95～150g, Fructus Crataegi 150～250g, microcrystalline Cellulose 20～60g, magnesium stearate 1～3g, starch is appropriate.Adopt 80% alcohol granulation, in operating process, concentration of alcohol is larger, moistening rear viscosity is lower, cause the wet granular order number making to have a very wide distribution and inhomogeneous, fine powder is many, while causing tabletting, occur the phenomenons such as flower sheet, sliver, the Yixinshu tablet disintegration time making is long and after storage a period of time, there will be the phenomenons such as defective, poor stability disintegration, microorganism be defective.
Summary of the invention
The invention provides a kind of Yixinshu tablet, this Yixinshu tablet disintegration is short, microbial limit is qualified.
The present invention also provides a kind of preparation method of Yixinshu tablet, and this preparation method operation is simple, quality controllable and be suitable for suitability for industrialized production
A kind of Yixinshu tablet, in 10000, made by following raw material:
The dry cream of described YIXINSHU forms as raw material extracts take 150～250 weight portion Radix Ginsengs, 150～250 weight portion Radix Ophiopogonis, 95～150 weight portion Fructus Schisandrae Chinensis, 150～250 weight portion Radixs Astragali, 240～285 weight portion Radix Salviae Miltiorrhizaes, 95～150 weight portion Rhizoma Chuanxiongs, 150～250 weight portion Fructus Crataegis.
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 granule is a crucial step, and the quality of grain graininess directly affects the effect of tabletting.Because the dry cream of YIXINSHU is to extract in plant-based medicine, quality is loose, elasticity is stronger, and the granule of selecting general adjuvant to make is difficult to meet the requirement of follow-up tabletting.In the present invention, selecting 65～75% syrup is binding agent, and its viscosity is stronger, coordinates take carboxymethylstach sodium as disintegrating agent simultaneously, the granule making is after granulate, and evenly, mobility is better for size, mouthfeel is good, and tabletting is made after tablet unilateral smooth, and the indexs such as disintegration meet the requirements.
Wherein, the preparation method of the described dry cream of YIXINSHU is as follows:
(1) by obtaining Radix Ginseng fine powder after Radix Ginseng pulverizing, for subsequent use;
(2) by 85% alcohol reflux 2 times for Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, the extracting solution obtaining filters, and is evaporated to density and is 1.15～1.12 and obtain alcohol extractum A after merging;
(3) Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong and Fructus Crataegi water are decocted 2 times, collecting decoction, filters, and filtrate is concentrated into 5～15% of original volume, add again 85% ethanol, after fully stirring, hold over night, elimination precipitate, filtrate recycling ethanol is also concentrated into relative density 1.30～1.36, obtains extractum B;
(4) will after the Radix Ginseng fine powder that add step (1) to obtain after alcohol extractum A and extractum B merging, mix and obtain the described dry cream of YIXINSHU.
Wherein, the ethanol water that described 85% ethanol refers to, the concentration of volume percent of ethanol is 85%.
In step (3), the amount of 85% the ethanol adding roughly with concentrated after the volume of filtrate equate.
Detailed operating procedure is as follows:
Above seven tastes, get after Radix Ginseng crushing fine powder for subsequent use.85% alcohol reflux 2 times for Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, adds 6 times of amounts of 85% ethanol, reflux, extract, 3 hours for the first time, add for the second time 5 times of amounts of 85% ethanol, reflux, extract, 1.5 hours, filters, merging filtrate, is evaporated to relative density 1.15～1.12 (20 ℃), obtains alcohol extractum.Decoct with water 2 all the other Radix Ophiopogonis etc., adds water for the first time 10 times and measure, and decocts 2.5 hours, add water for the second time 8 times and measure, decoct collecting decoction 1.5 hours, filter, filtrate is concentrated into 500ml, adds 85% ethanol of equivalent, after fully stirring, hold over night, elimination precipitate, filtrate recycling ethanol is also concentrated into relative density 1.30～1.36 (80 ℃), after adding Radix Ginseng fine powder after above-mentioned two kinds of extractum merging, obtains the dry cream of YIXINSHU.
As preferably, 65～75% described syrup are made up of water and sucrose;
Preparation method is as follows:
In punching slurry tank, add the water that accounts for gross weight 95～99%, after being heated to boil, drop into sucrose, under stirring condition, keep boiling 3～10 minutes, stop heating, then add 20～30 ℃ of remaining water, continue to stir 20～60 seconds, obtain described syrup.The cooling rear direct use of syrup obtaining, now, the viscosity of syrup is suitable, can be applied to preferably granulation and the tabletting of the dry cream of YIXINSHU.
With the example that is prepared as of 70% syrup, concrete operations are as follows: in punching slurry tank, add purified water 10480ml, after being heated to boil, drop into 25kg sucrose, be heated to while stirring boil (100 ℃) after 3 minutes, stop heating and stir.Add again the purified water 300ml(cool), stir 30 seconds, to obtain final product.
As preferably, described Yixinshu tablet, in 10000, made by following raw material:
Consider shape and the disintegration time of the product obtaining, as further preferred, described Yixinshu tablet, in 10000, made by following raw material:
As further preferred, described Yixinshu tablet, in 10000, made by following raw material:
As further preferred, described Yixinshu tablet, in 10000, made by following raw material:
The present invention also provides a kind of preparation method of described Yixinshu tablet, comprises the following steps:
(1) configure 65～75% syrup and let cool to room temperature, for subsequent use;
(2) broken mistake 100 mesh sieves of YIXINSHU dried cream powder, sucrose was pulverized 80 mesh sieves, for subsequent use;
(3) by dry the YIXINSHU of silicon dioxide, magnesium stearate, carboxymethylstach sodium, 1～5% weight cream mix homogeneously, obtain supplementary material;
(4) add the dry cream of remaining YIXINSHU, PEG-4000, cane sugar powder mix homogeneously by recipe quantity, add 65～75% syrup that step (1) obtains to granulate, in 70 ℃ of oven dry, granulate, the supplementary material mix homogeneously that adds again step (3) to obtain, tabletting obtains described Yixinshu tablet.
In this preparation method, the dry cream of YIXINSHU to be to add respectively interior adding with the method adding outward, and dry a small amount of YIXINSHU cream is first mixed with other adjuvants, tablet removed after clothing film aobvious brown even, character improves, and is surprised to find that and has also improved medicinal infiltration rate.
Compared with the existing technology, beneficial effect of the present invention is embodied in:
1) granulate with 65～75% syrups, its viscosity is stronger, is applicable to the plant-based medicine that quality is loose, elasticity is stronger, the granule making after granulate, slice, thin piece hardness, mouthfeel is good, tabletting is made after tablet unilateral smooth, and the indexs such as disintegration all meet the requirements.
2) the method preparation that the dry cream of YIXINSHU adds and add outward with interior, makes tablet remove that aobvious after clothing film brown evenly character improves, and unexpected discovery also improves medicinal infiltration rate.
3), by the meticulous screening of adjuvant, made grain graininess is even, release, and mouthfeel is good, disintegration, slice, thin piece fineness aspect have and be better than the granule that traditional handicraft is made.
4) the method preparation time is short, material loss is few, labor intensity is low, be subject to that outside contamination is low and finished particle is neat, only needs to be equipped with a small amount of personnel, more suitable for large-scale production.
The specific embodiment
Further explain by the following examples or explanation content of the present invention, but the embodiment providing should not be understood to protection domain of the present invention to be construed as limiting.
Embodiment 1
Prescription: in 10000
Preparation method:
(1) above seven tastes, get after 1500g Radix Ginseng crushing fine powder for subsequent use.85% alcohol reflux 2 times for 950g Fructus Schisandrae Chinensis, 2400g Radix Salviae Miltiorrhizae, add for the first time 6 times of amounts of 85% ethanol, reflux, extract, 3 hours, add for the second time 5 times of amounts of 85% ethanol, reflux, extract, 1.5 hours, filters merging filtrate, be evaporated to relative density 1.15～1.12 (20 ℃), obtain alcohol extractum.Again 1500g Radix Ophiopogonis, the 1500g Radix Astragali, 950g Rhizoma Chuanxiong and 1500g Fructus Crataegi are decocted with water 2 times, add water for the first time 10 times and measure (weight), decoct 2.5 hours, 8 times of amounts for the second time add water, decoct 1.5 hours, collecting decoction, filter, filtrate is concentrated into 3500ml, adds 85% ethanol of equivalent, after fully stirring, hold over night, elimination precipitate, filtrate recycling ethanol is also concentrated into relative density 1.30～1.36 (80 ℃), after above-mentioned two kinds of extractum are merged, adds Radix Ginseng fine powder mix homogeneously to obtain the dry cream of YIXINSHU again.
(2) in punching slurry tank, add purified water 10480ml, after being heated to boil, drop into 25kg sucrose, be heated to while stirring boil (100 ℃) after 3 minutes, then add the purified water 300ml(cool), stir 30 seconds, obtain 70% syrup, let cool to room temperature, for subsequent use.
(3) broken mistake 100 mesh sieves of YIXINSHU dried cream powder, sucrose was pulverized 80 mesh sieves, for subsequent use.
(4) by silicon dioxide 43g, magnesium stearate 25g, carboxymethylstach sodium 86g, the dry cream 50g of YIXINSHU mix homogeneously, for subsequent use.
(5) take the dry cream 1900g of YIXINSHU, PEG-4000150.5g, cane sugar powder 1000g mix homogeneously by recipe quantity, add 70% syrup of recipe quantity to granulate, in 70 ℃ of oven dry, granulate, finally adds step (3) supplementary material mix homogeneously, tabletting, coating, plastic-aluminum, packs and get final product.
Embodiment 2
Prescription: in 10000
Preparation method:
(1) the dry cream of YIXINSHU extracts with embodiment 1.
(2) 70% syrup are with embodiment 1.
(3) broken mistake 100 mesh sieves of YIXINSHU dried cream powder, sucrose was pulverized 80 mesh sieves, for subsequent use.
(4) by silicon dioxide 50g, magnesium stearate 35g, carboxymethylstach sodium 90g, the dry cream 50g of YIXINSHU mix homogeneously, for subsequent use.
(5) take the dry cream 1800g of YIXINSHU, PEG-4000160g, cane sugar powder 1100g mix homogeneously by recipe quantity, add 70% syrup of recipe quantity to granulate, in 70 ℃ of oven dry, granulate, finally adds step (3) supplementary material mix homogeneously, tabletting, coating, plastic-aluminum, packs and get final product.
Embodiment 3
Prescription: in 10000
Preparation method:
(1) the dry cream of YIXINSHU extracts with embodiment 1.
(2) 70% syrup are with embodiment 1.
(3) broken mistake 100 mesh sieves of YIXINSHU dried cream powder, sucrose was pulverized 80 mesh sieves, for subsequent use.
(4) by silicon dioxide 30g, magnesium stearate 25g, carboxymethylstach sodium 80g, the dry cream 50g of YIXINSHU mix homogeneously, for subsequent use.
(5) take the dry cream 2150g of YIXINSHU, PEG-4000130g, cane sugar powder 800g mix homogeneously by recipe quantity, add 70% syrup of recipe quantity to granulate, in 70 ℃ of oven dry, granulate, finally adds step (3) supplementary material mix homogeneously, tabletting, coating, plastic-aluminum, packs and get final product.
Comparative example 1
Prescription:
Get Radix Ginseng and pulverize, cross 100 mesh sieves, use pulsation vacuum sterilizer at 134 ℃, under 0.21Mpa, sterilizing is for subsequent use after 1 hour; Get Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae and add 5 times of amount 85% alcohol reflux 2 times, 3 hours for the first time, 1.5 hours for the second time, filter, merging filtrate, at 50 ℃, under-0.08MPa after decompression recycling ethanol, and filtrate is concentrated into relative density 1.12～1.15(20 ℃), obtain alcohol extractum; Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi are added to 8 times of water gagings to be decocted 2 times, 2.5 hours for the first time, 1.5 hours for the second time, merge the liquid of boiling medicine, filter, filtrate is concentrated into about 650ml, adds equivalent 85% ethanol, after fully stirring, hold over night, filter, filtrate is at 70 ℃, under-0.08Mpa after decompression recycling ethanol and be concentrated into relative density 1.30～1.36(70 ℃) the water extracted immersing paste; After above-mentioned two kinds of extractum are merged, add above-mentioned Radix Ginseng fine powder, and add microcrystalline Cellulose, mix homogeneously, crosses 16 mesh sieve wet granulations with 80% ethanol, dry at 50 ℃, cross 20 mesh sieve granulate, dry granule adds magnesium stearate, and it is appropriate to add starch, regulates total amount to 380g, be mixed evenly, be pressed into 1000, film coating, obtains Yixinshu tablet.
Comparative example 2
Prescription:
Except recipe quantity being made into above amount, other operating procedures are consistent with comparative example 1.
Comparative example 3
Prescription:
Except recipe quantity being made into above amount, other operating procedures are consistent with comparative example 1.
Comparative example 4
Except 70% syrup is replaced to polyvidone, other operating procedures are consistent with embodiment 1.Comparative example 5
Except carboxymethylstach sodium is replaced to cross-linking sodium carboxymethyl cellulose, embodiment 1 is consistent for other operating procedures.
Comparative example 6
Except the dry cream of 50g YIXINSHU in step (4) does not add, the dry cream addition of YIXINSHU in step (5) is 1950g, and embodiment 1 is consistent for other operating procedures.
The Yixinshu tablet of the Yixinshu tablet to embodiment 1～3 preparation and comparative example 1～5 preparation carries out quality inspection, and the testing result of projects is as table 1.
The related check data of table 1 Yixinshu tablet
From the testing result in table 1, it is that publication number is the Chinese patent application of CN101804152A that disintegration of tablet time limit of the present invention and microbial limit, hardness, moisture are all better than comparative example 1() tablet prepared.The dry cream of YIXINSHU adds in batches, can have influence on disintegration and character.
The Yixinshu tablet of the Yixinshu tablet of embodiment 1～3 preparation and comparative example 1～5 preparation was stored after 6 months, carry out the comparison of disintegration, sliver, microbial limit, the detection method of disintegration of tablet time limit, microbial limit detects according to appendix I A method of version " Chinese Pharmacopoeia " in 2010 respectively, and result is as table 2.
Table 2
As shown in Table 2, tablet of the present invention is stored and is not occurred underproof phenomenon disintegration after 6 months, therefore the present invention is better than prior art.
Claims (8)
1. a Yixinshu tablet, is characterized in that, in 10000, is made up of following raw material:
The dry cream of described YIXINSHU forms as raw material extracts take 150～250 weight portion Radix Ginsengs, 150～250 weight portion Radix Ophiopogonis, 95～150 weight portion Fructus Schisandrae Chinensis, 150～250 weight portion Radixs Astragali, 240～285 weight portion Radix Salviae Miltiorrhizaes, 95～150 weight portion Rhizoma Chuanxiongs, 150～250 weight portion Fructus Crataegis.
2. Yixinshu tablet according to claim 1, is characterized in that, 65～75% described syrup are made up of water and sucrose;
Preparation method is as follows:
In punching slurry tank, add the water that accounts for gross weight 95～99%, after being heated to boil, drop into sucrose, under stirring condition, keep boiling 3～10 minutes, stop heating, then add 20～30 ℃ of remaining water, continue to stir 20～60 seconds, obtain described syrup.
3. Yixinshu tablet according to claim 1, is characterized in that, the preparation method of the described dry cream of YIXINSHU is as follows:
(1) by obtaining Radix Ginseng fine powder after Radix Ginseng pulverizing, for subsequent use;
(2) by 85% alcohol reflux 2 times for Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, the extracting solution obtaining filters, and is evaporated to density and is 1.15～1.12 and obtain alcohol extractum A after merging;
(3) Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong and Fructus Crataegi water are decocted 2 times, collecting decoction, filters, and filtrate is concentrated into 5～15% of original volume, add again 85% ethanol, after fully stirring, hold over night, elimination precipitate, filtrate recycling ethanol is also concentrated into relative density 1.30～1.36, obtains extractum B;
(4) will after the Radix Ginseng fine powder that add step (1) to obtain after alcohol extractum A and extractum B merging, mix and obtain the described dry cream of YIXINSHU.
4. Yixinshu tablet according to claim 1, is characterized in that, in 10000, is made up of following raw material:
5. Yixinshu tablet according to claim 1, is characterized in that, in 10000, is made up of following raw material:
6. Yixinshu tablet according to claim 1, is characterized in that, in 10000, is made up of following raw material:
7. Yixinshu tablet according to claim 1, is characterized in that, in 10000, is made up of following raw material:
8. according to the preparation method of the Yixinshu tablet described in claim 1～7 any one, comprise the following steps:
(1) 65～75% syrup of configuration are let cool to room temperature, for subsequent use;
(2) broken mistake 100 mesh sieves of YIXINSHU dried cream powder, sucrose was pulverized 80 mesh sieves, for subsequent use;
(3) by dry the YIXINSHU of silicon dioxide, magnesium stearate, carboxymethylstach sodium, 1～5% weight cream mix homogeneously, obtain supplementary material;
(4) add the dry cream of remaining YIXINSHU, PEG-4000, cane sugar powder mix homogeneously by recipe quantity, add 65～75% syrup that step (1) obtains to granulate, in 70 ℃ of oven dry, granulate, the supplementary material mix homogeneously that adds again step (3) to obtain, tabletting obtains described Yixinshu tablet.
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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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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106226435A (en) * | 2016-08-29 | 2016-12-14 | 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 |
|---|---|---|---|---|
| CN101804151A (en) * | 2010-03-23 | 2010-08-18 | 中山尊隆药业有限公司 | Method for preparing Yixinshu tablets |
| CN101804152A (en) * | 2010-03-23 | 2010-08-18 | 中山尊隆药业有限公司 | Yixinshu tablet |
-
2014
- 2014-01-27 CN CN201410039772.6A patent/CN103784726B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804151A (en) * | 2010-03-23 | 2010-08-18 | 中山尊隆药业有限公司 | Method for preparing Yixinshu tablets |
| CN101804152A (en) * | 2010-03-23 | 2010-08-18 | 中山尊隆药业有限公司 | Yixinshu tablet |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106226435A (en) * | 2016-08-29 | 2016-12-14 | 江苏康缘药业股份有限公司 | A kind of fingerprint atlas detection method of Yixinshu tablet saponin component |
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