CN104510813A - Preparation method for Xinmaitong capsules - Google Patents

Preparation method for Xinmaitong capsules Download PDF

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CN104510813A
CN104510813A CN201510011589.XA CN201510011589A CN104510813A CN 104510813 A CN104510813 A CN 104510813A CN 201510011589 A CN201510011589 A CN 201510011589A CN 104510813 A CN104510813 A CN 104510813A
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radix
water
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filter
concentrated
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CN104510813B (en
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胡锐敏
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Jiangxi Jinshuibao Pharmaceutical Co.,Ltd.
Jiangxi Jimin Kexin Pharmaceutical Co Ltd
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JIANGXI JIMIN KEXIN JINSHUIBAO PHARMACEUTICAL CO Ltd
Jiangxi Jimin Kexin Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/21Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/482Cassia, e.g. golden shower tree
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/489Sophora, e.g. necklacepod or mamani
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/536Prunella or Brunella (selfheal)
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537Salvia (sage)
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
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    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention relates to a preparation method for Xinmaitong capsules. The method comprises the following steps: 1, crushing pseudo-ginseng, to be specific, crushing pseudo-ginseng into fine powder with granularity of 80 meshes; 2, performing extraction and inclusion on sophora japonica to obtain sophora japonica extract inclusion; 3, extracting angelica and uncaria tomentosa, adding water with the amount which is 8 times of that of angelica and uncaria tomentosa, performing decoction twice for 40 minutes every time, performing concentration to a proper amount, adding ethanol until the ethanol content is 70 percent, performing standing for 24 hours, extracting supernatant for filtration, recovering ethanol from filtrate, and performing concentration to 1.25 to 1.30; 4, extracting salvia miltiorrhiza, pueraria thomsonii, semen cassiae, pubescent holly roots, prunella vulgaris and achyranthes bidentata, to be specific, adding water, and performing decoction twice for 30-60 minutes every time, wherein the amount of water added for the first time is 8 to 12 times of that of the mixture, and the amount of water added for the second time is 8-12 times of that of the mixture; 5, mixing the pseudo-ginseng powder, the sophora japonica extract and inclusion, the extract of angelica and uncaria tomentosa, the extract of salvia miltiorrhiza, pueraria thomsonii, semen cassiae, pubescent holly roots, prunella vulgaris and achyranthes bidentata and auxiliaries, and performing capsulation on the mixture, so as to obtain the Xinmaitong capsules.

Description

A kind of preparation method of heart maitong capsule
Technical field
The present invention relates to a kind of preparation method of heart maitong capsule.Belong to medical art.
Technical background
Heart maitong capsule belongs to prior art, by Radix Angelicae Sinensis, Semen Cassiae, Ramulus Uncariae Cum Uncis, Radix Achyranthis Bidentatae, Radix Salviae Miltiorrhizae, Pachyrhizua angulatus, the Flos Sophorae Immaturus, Radix Ilicis Pubescentis, Spica Prunellae, Radix Notoginseng totally 10 kinds of Chinese crude drugs through being processed into capsule.Have blood circulation promoting and blood stasis dispelling, freeing vessels and nourishing heart, effect of hypertension and hyperlipemia, for hypertension, hyperlipemia etc.Clinical efficacy is remarkable, is widely used.
It is as follows that existing heart maitong capsule is prepared from (consumption is weight portion) heart maitong capsule prescription by following traditional Chinese medicine raw medicine:
More than [method for making] in ten taste medical materials, except Radix Notoginseng powder is broken into fine powder, the Flos Sophorae Immaturus adds after in boiling water, regulates PH to 8.5 with lime cream, decoct secondary, filter, merging filtrate, regulate PH to 4.0 ~ 5.0 with hydrochloric acid, leave standstill 24 hours, leaching precipitates, and dry, pulverize into fine powder, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis decoct with water secondary, filter, merging filtrate, be concentrated into appropriate, add ethanol and make alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, is concentrated into thick paste.The Six-elements such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, and filter, merging filtrate, is concentrated into thick paste.Above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat fine powder are mixed, makes granule, dry, make 1000 capsules, to obtain final product.
Because existing heart maitong capsule has significant curative effect to treatment hypertension, hyperlipemia, but the content degraded that this product exists, draw the moist problem such as stronger, make this product there is greater risk qualitatively, be unfavorable for the sales promotion of product.
The invention provides a kind of heart maitong capsule new process formula, the technological parameter in original formulation is optimized, the stability of this kind is significantly improved.
Summary of the invention
The object of the present invention is to provide a kind of preparation method of heart maitong capsule.The present invention also aims to bag and technology that a kind of Huai Goat is provided.The present invention also aims to the anti-hygroscopic technology that a kind of capsule is provided.
The preparation method of heart maitong capsule of the present invention, is characterized in that comprising the steps:
1. Radix Notoginseng is pulverized; Pulverized by Radix Notoginseng, obtaining granularity is 80 object fine powders;
2. the Flos Sophorae Immaturus extracts enclose; Obtain Huai Goat clathrate;
3. the extraction of Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis; Add 8 times amount soak by water secondaries, each 40 minutes, be concentrated into appropriate.Adding ethanol makes alcohol content be 70%, leaves standstill 24 hours, and get supernatant and filter, filtrate recycling ethanol, is concentrated into 1.25-1.30.
4. the extraction of Radix Salviae Miltiorrhizae, Pachyrhizua angulatus, Semen Cassiae, Radix Ilicis Pubescentis, Spica Prunellae, Radix Achyranthis Bidentatae Six-element medicine; Decoct with water secondary, each 30-60 minute, add water 8-12 times amount for the first time, the 2nd the 8-12 times amount that adds water.
5. the extract of the extract of above-mentioned gained Radix Notoginseng medicated powder, Huai Goat clathrate, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis and Radix Salviae Miltiorrhizae, Pachyrhizua angulatus, Semen Cassiae, Radix Ilicis Pubescentis, Spica Prunellae, Radix Achyranthis Bidentatae Six-element medicine and adjuvant mixing, encapsulated and get final product.
The Flos Sophorae Immaturus of the present invention extracts, and adopts hot reflux technology to extract, with 8 times amount water extraction 2 times, and each 30 minutes, PH control 8.5, merge extractive liquid, concentrate drying and get final product.
Huai Goat of the present invention, needs to carry out cyclodextrin inclusion compound further.Method is as follows: get beta-schardinger dextrin-100 parts and add appropriate water, add Huai Goat alcoholic solution 10 parts, stirring and dissolving, adopt colloid mill mill certain hour, be cooled to-1 ~ 15 DEG C, filter, obtain solids 30 ~ 40 DEG C of dryings, obtain Huai Goat clathrate.
Therefore, heart maitong capsule of the present invention, the clathrate of Huai Goat just wherein adopted.
Heart maitong capsule prepared by method of the present invention, has excellent technique effect, its technical scheme be through screening obtain, screening process is as follows:
Process optimization is carried out in the extraction of the step 2. Flos Sophorae Immaturus, adopts hot reflux technology.With the rutin rate of transform for inspection target carries out orthogonal experiment by 4 factor 3 levels, experimental result and variance analysis are in table 1, table 2, table 3.
Table 1 affects 4 factor 3 water-glasses that the Flos Sophorae Immaturus extracts
The orthogonal design table that table 2 screens about extraction factor
Table 3 affects the variance analysis of the factor extracting the rate of transform
Visible by analysis, extraction time, quantity of solvent have a significant impact prescription, and can show that Extraction technique combined with extraction time according to average is 30 minutes, and Extraction solvent is water, quantity of solvent is 8 times amount is best collocation, carries out process optimization by this scheme to formula.Owing to have employed hot reflux technology, increase substantially the content rate of transform of medical material, shortened process route, avoid the potential problems that the hydrochloric acid introduced in former technique brings product quality.Therefore optimised process is: adopt hot reflux technology to extract, with 8 times amount water extraction 2 times, and each 30 minutes, PH control 8.5.
Traditional decocting process easily makes medical material local temperature too high, can not complete desorbing, dissolving, diffusion very well.Adopt hot reflux technology, Extraction solvent constantly can carry out desorbing, dissolving, diffusion with medical material, and then reaches the effect fully extracted.This technology is that solvent is added on powder continuously, and from top to bottom by medical material layer, the solutes content in medical material maintains higher gradient, the solute high speed stripping in medical material with solutes content in solvent, until complete stripping, has the advantages that extraction efficiency is high.Extracting solution stops suction concentrator, concentrated indirect steam passes on cooler, concentrate and proceed, until be condensed into extractum, release for subsequent use, due to the stripping of solute high speed, extraction time is short, and concentrated and extraction is carried out simultaneously, and concentrated economic benefits and social benefits of taking concentrate, this technology energy rapid concentration extracting solution, energy savings effectively.Therefore medical material is shorter than traditional time to concentrated ointment, utilization rate of equipment and installations is high.This technical operation, for drop in extraction pot by medical material, adds medical material some water, and open extraction pot and lead directly to and jacket steam valve, after making medicinal material extract certain hour, extracting solution suction concentrator concentrates.The surface that medical material fallen by hot solvent is extracted, and completes a continuous extraction and concentration.
In order to improve the stability of Huai Goat in heart maitong capsule, carry out following preferred process:
Get beta-schardinger dextrin-100 parts and add appropriate water, add Huai Goat alcoholic solution 10 parts, stirring and dissolving, adopt colloid mill mill certain hour, be cooled to-1 ~ 15 DEG C, filter, obtain solids 30 ~ 40 DEG C of dryings, obtain Huai Goat clathrate.In table 4
Huai Goat clathrate preparation table in table 4 heart maitong capsule
According to the balance of material and reasonably apply, with clathrate 5 is the most reasonable.
Investigate the stability of clathrate and non-clathrate
The assay method of rutin content in Huai Goat:
[assay] measures according to high performance liquid chromatography (annex VI D).
Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are filler; With acetonitrile-methanol-water-glacial acetic acid (50:100:350:13) for mobile phase, column temperature 40 DEG C; Determined wavelength 254nm.Theoretical cam curve calculates by rutin, should be not less than 3000.
The preparation precision of reference substance solution takes control substance of Rutin 10mg, puts in 50ml measuring bottle, with a small amount of methanol ultrasonic dissolution, with methanol dilution to scale, shakes up, then draws 2ml and be diluted to 10ml, obtains (1ml is containing rutin 40 μ g).
The content under this product content uniformity item is got in the preparation of need testing solution, and mixing, gets 0.1g, accurately weighed, put in tool plug conical flask, precision adds methanol 50ml, weighed weight, supersound process 30 minutes, lets cool, weighed weight again, supply the weight of less loss with methanol, filter, get subsequent filtrate, filter with microporous filter membrane (0.45 μm), to obtain final product.
Algoscopy is accurate respectively draws reference substance solution and each 10 μ l of need testing solution, injection liquid chromatography, measures, to obtain final product.
Scheme 1: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, decoct secondary again, each 30 minutes, filter, merging filtrate, PH to 4.0 ~ 5.0 are regulated with hydrochloric acid, leave standstill 24 hours, leaching precipitates, dry, be ground into fine powder, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, and filter, merging filtrate, is concentrated into thick paste.Above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat fine powder are mixed, makes granule, dry, make 1000 capsules.
Scheme 2: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, adopt circumfluence distillation technology, decoct secondary again, , each 30 minutes, receive cream, dry, be ground into fine powder, clathrate is prepared in the ratio of 7 parts of Huai Goat and 100 parts of beta-schardinger dextrin-s, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, and filter, merging filtrate, is concentrated into thick paste.Above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat clathrate fine powder are mixed, makes granule, dry, make 1000 capsules.
Accelerated stability is investigated and be the results are shown in Table 5
In table 5 heart maitong capsule, the content accelerated stability of 6 months of Huai Goat rutin is investigated
Result shows: effective than direct Huai Goat of the stability of clathrate.Add the stability of rutin content in Huai Goat.
The extraction of the step 4. Six-element medicine such as Radix Salviae Miltiorrhizae carries out process optimization, with the content of puerarin for Testing index, in table 6.
The Six-element medicine extraction processes such as table 6 Radix Salviae Miltiorrhizae are investigated
Draw decoction 2 times by data analysis, each 60 minutes, the mean transferred rate of the content of its puerarin is far above other group.On the multiple of amount of water, 10 times with 8 times group with 12 times and 10 times of groups almost consistent in the content rate of transform, from save energy and reduce the cost angle analysis, as the best: the multiple that adds water is 10 times and 8 times, decocting time 60 minutes/time.Receive cream proportion 1.25-1.30.
Because heart maitong capsule is for being wet granulation, paste containing amount is comparatively large, and granule draws moist stronger.For this situation, carry out and anti-draw moist technology, from step 5., 8. step carry out, and carries out process optimization to draw moist data for reference index.In table 7.
Table 7 draws moist technique investigation table
Method of granulating Granule moisture content (%) Draw moist (%)
Standard technology method for making 4.5 11
Standard technology method for making 3 11
Standard technology method for making 1.5 12
Moistureproof coating-Eudragit L100 4.5 4
Moistureproof coating-Eudragit L100 3 3
Moistureproof coating-Eudragit L100 1.5 4
Moistureproof coating-Kollicaot IR 4.5 3
Moistureproof coating-Kollicaot IR 3 4
Moistureproof coating-Kollicaot IR 1.5 3
Spray-drying pelleting machine (Inner adds anti-blushing agent) 4.5 2
Spray-drying pelleting machine (Inner adds anti-blushing agent) 3 1
Spray-drying pelleting machine (Inner adds anti-blushing agent) 1.5 1
As can be seen from upper table data: it is moist that moistureproof coating-Eudragit L100 and Kollicaot IR and spray-drying pelleting machine all can effectively reduce drawing of granule, associate without larger with the moisture content of particle drying.From one-tenth originally, used Eudragit L100 more reasonable.But through moistureproof coating granule its draw moist still > 2%, therefore need 8. increase a moisture-proof cover in step, qualified to ensure capsule moisture content before the deadline.As the best, step 5. in charging in total mass percent concentration of clear paste and adjuvant control 16%, and anti-blushing agent is pressed 2% of grain amount, be mixed with the alcoholic solution of 3%, mixing inlet temperature with the mixture of clear paste and adjuvant, to control at air temperature be 175 DEG C, and feed rate controls at 22ml/mim.
Scheme 1: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, decoct secondary again, each 30 minutes, filter, merging filtrate, PH to 4.0 ~ 5.0 are regulated with hydrochloric acid, leave standstill 24 hours, leaching precipitates, dry, be ground into fine powder, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, and filter, merging filtrate, is concentrated into thick paste.Above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat fine powder are mixed, makes granule, dry, make 1000 capsules.
Scheme 2:: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, adopt circumfluence distillation technology, decoct secondary again, each 30 minutes, receive cream, dry, be ground into fine powder, clathrate is prepared in the ratio of 7 parts of Huai Goat and 100 parts of beta-schardinger dextrin-s, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, each 60 minutes, and add water 10 times amount for the first time, the 2nd 8 times amount that add water, and filter, merging filtrate, is concentrated into the thick paste of relative density 1.25-1.30.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat clathrate fine powder, Eudragit L100 solution, mixing, granulates, dry, makes 1000 capsules.
Scheme 3:: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, adopt circumfluence distillation technology, decoct secondary again, each 30 minutes, receive cream, dry, be ground into fine powder, clathrate is prepared in the ratio of 7 parts of Huai Goat and 100 parts of beta-schardinger dextrin-s, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, each 60 minutes, and add water 10 times amount for the first time, the 2nd 8 times amount that add water, and filter, merging filtrate, is concentrated into the thick paste of relative density 1.25-1.30.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat clathrate fine powder, Eudragit L100 solution, mixing, granulates, dry, makes 1000 capsules.A moisture barrier bag is increased during packaging.
Scheme 4:: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, adopt circumfluence distillation technology, decoct secondary again, each 30 minutes, receive cream, dry, be ground into fine powder, clathrate is prepared in the ratio of 7 parts of Huai Goat and 100 parts of beta-schardinger dextrin-s, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, each 60 minutes, and add water 10 times amount for the first time, the 2nd 8 times amount that add water, and filter, merging filtrate, is concentrated into the thick paste of relative density 1.25-1.30.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat clathrate fine powder, 3%Eudragit L100 alcoholic solution, spray dryer is used to granulate dry, in charging, total mass percent concentration of clear paste and adjuvant controls 16%, and anti-blushing agent is pressed 2% of grain amount, be mixed with the alcoholic solution of 3%, mixing inlet temperature with the mixture of clear paste and adjuvant, to control at air temperature be 175 DEG C, feed rate controls at 22ml/mim, makes 1000 capsules.Accelerated stability is investigated and be the results are shown in Table 8
The accelerated stability data of above-mentioned 4 schemes of table 8
Draw from above-mentioned all data analysiss: the invention has the advantages that: products obtained therefrom oxidation resistance is strong, stability strong, stable curative effect; Integrated artistic is easy to operation, is suitable for applying.
The present invention, by continuing to optimize the technique of prescription, improves the rate of transform of rutin in the Flos Sophorae Immaturus, and adopts inclusion technique to improve the stability of Huai Goat, adopts anti-stability of drawing moist technology raising capsule simultaneously.Curative effect does not reduce simultaneously, and the stability of heart maitong capsule significantly improves.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail.
Embodiment 1: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, decoct secondary again, each 30 minutes, filter, merging filtrate, PH to 4.0 ~ 5.0 are regulated with hydrochloric acid, leave standstill 24 hours, leaching precipitates, dry, be ground into fine powder, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, and filter, merging filtrate, is concentrated into thick paste.Above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat fine powder are mixed, makes granule, dry, make 1000 capsules.Packaging, to obtain final product.
Embodiment 2: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, adopt circumfluence distillation technology, decoct secondary again, each 30 minutes, receive cream, dry, be ground into fine powder, clathrate is prepared in the ratio of 7 parts of Huai Goat and 100 parts of beta-schardinger dextrin-s, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, and filter, merging filtrate, is concentrated into the thick paste of relative density 1.25-1.30.Above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat clathrate fine powder are mixed, makes granule, dry, make 1000 capsules.Packaging, to obtain final product.
Embodiment 3: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, adopt circumfluence distillation technology, decoct secondary again, each 30 minutes, receive cream, dry, be ground into fine powder, clathrate is prepared in the ratio of 7 parts of Huai Goat and 100 parts of beta-schardinger dextrin-s, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, each 60 minutes, and add water 10 times amount for the first time, the 2nd 8 times amount that add water, and filter, merging filtrate, is concentrated into thick paste.Above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat clathrate fine powder are mixed, makes granule, dry, make 1000 capsules.
Embodiment 4: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, adopt circumfluence distillation technology, decoct secondary again, each 30 minutes, receive cream, dry, be ground into fine powder, clathrate is prepared in the ratio of 7 parts of Huai Goat and 100 parts of beta-schardinger dextrin-s, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, each 60 minutes, and add water 10 times amount for the first time, the 2nd 8 times amount that add water, and filter, merging filtrate, is concentrated into the thick paste of relative density 1.25-1.30.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat clathrate fine powder, 3%Eudragit L100 alcoholic solution, mixing, granulates, dry, makes 1000 capsules.Packaging, to obtain final product.
Embodiment 5: Radix Notoginseng 6 grams is ground into 80 object fine powders, the Flos Sophorae Immaturus 100 grams adds after in 8 times amount boiling water, PH to 8.5 is regulated with lime cream, adopt circumfluence distillation technology, decoct secondary again, each 30 minutes, receive cream, dry, be ground into fine powder, clathrate is prepared in the ratio of 7 parts of Huai Goat and 100 parts of beta-schardinger dextrin-s, Radix Angelicae Sinensis 185 grams, Ramulus Uncariae Cum Uncis 125 grams adds 8 times amount soak by water secondaries, each 40 minutes, filter, merging filtrate, be concentrated into appropriate, adding ethanol makes alcohol content be 70%, leave standstill 24 hours, get supernatant to filter, filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.25-1.30.The Six-elements (totally 700 grams) such as all the other Radix Salviae Miltiorrhizaes decoct with water secondary, each 60 minutes, and add water 10 times amount for the first time, the 2nd 8 times amount that add water, and filter, merging filtrate, is concentrated into the thick paste of relative density 1.25-1.30.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline Cellulose, 1% magnesium stearate, Huai Goat clathrate fine powder, 3%Eudragit L100 alcoholic solution, spray dryer is used to granulate dry, in charging, total mass percent concentration of clear paste and adjuvant controls 16%, and anti-blushing agent is pressed 2% of grain amount, be mixed with the alcoholic solution of 3%, mixing inlet temperature with the mixture of clear paste and adjuvant, to control at air temperature be 175 DEG C, feed rate controls at 22ml/mim, makes 1000 capsules.Packaging, to obtain final product.

Claims (1)

1. a preparation method for heart maitong capsule, is characterized in that comprising the steps:
1. Radix Notoginseng is pulverized; Pulverized by Radix Notoginseng, obtaining granularity is 80 object fine powders;
2. the Flos Sophorae Immaturus extracts enclose; Obtain Huai Goat clathrate;
3. the extraction of Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis; Add 8 times amount soak by water secondaries, each 40 minutes, be concentrated into appropriate.Adding ethanol makes alcohol content be 70%, leaves standstill 24 hours, and get supernatant and filter, filtrate recycling ethanol, is concentrated into 1.25-1.30.
4. the extraction of Radix Salviae Miltiorrhizae, Pachyrhizua angulatus, Semen Cassiae, Radix Ilicis Pubescentis, Spica Prunellae, Radix Achyranthis Bidentatae Six-element medicine; Decoct with water secondary, each 30-60 minute, add water 8-12 times amount for the first time, the 2nd the 8-12 times amount that adds water.
5. the extract of the extract of above-mentioned gained Radix Notoginseng medicated powder, Huai Goat clathrate, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis and Radix Salviae Miltiorrhizae, Pachyrhizua angulatus, Semen Cassiae, Radix Ilicis Pubescentis, Spica Prunellae, Radix Achyranthis Bidentatae Six-element medicine and adjuvant mixing, encapsulated and get final product.
Wherein, the described Flos Sophorae Immaturus extracts enclose, and step is as follows: by 8 times of water gaging reflux, extract, 2 times, each 30 minutes, PH controlled 8.5, merge extractive liquid, concentrate drying, get beta-schardinger dextrin-100 parts and add water, add the alcoholic solution 10 parts of Huai Goat, stirring and dissolving, employing colloid mill grinds, be cooled to-1 ~ 15 DEG C, filter, obtain solids, 30 ~ 40 DEG C of dryings, obtain Huai Goat clathrate.
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CN113599363A (en) * 2021-08-24 2021-11-05 江西济民可信药业有限公司 Preparation method of Xinmaitong capsules
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CN115487225A (en) * 2022-09-21 2022-12-20 江西济民可信药业有限公司 Preparation method of sophora flower bud extract
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