CN103638483B - Blood stasis removing capsule containing Salvia miltiorrhiza and Radix Astragali, and preparation method thereof - Google Patents

Blood stasis removing capsule containing Salvia miltiorrhiza and Radix Astragali, and preparation method thereof Download PDF

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CN103638483B
CN103638483B CN201310586316.9A CN201310586316A CN103638483B CN 103638483 B CN103638483 B CN 103638483B CN 201310586316 A CN201310586316 A CN 201310586316A CN 103638483 B CN103638483 B CN 103638483B
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parts
rhizoma
radix
adjuvant
weight portion
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CN103638483A (en
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孙灵飞
徐健
柳桂英
李淑娟
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Jilin Longxin Pharmaceutical Co Ltd
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Jilin Longxin Pharmaceutical Co Ltd
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Abstract

The invention relates to a traditional Chinese medicinal preparation, and concretely relates to a blood stasis removing capsule containing Salvia miltiorrhiza and Radix Astragali, and a preparation method thereof. The capsule is composed of a traditional Chinese medicinal extract product and auxiliary materials. A weight ratio of the traditional Chinese medicinal extract product to the auxiliary materials is 10:0.2-0.8; the traditional Chinese medicinal extract product is prepared by using the following raw materials, by weight, 150 parts of Radix Astragali, 150 parts of Salvia miltiorrhiza, 75 parts of Radix Codonopsis, 75 parts of Chinese yam, 100 parts of Glabrous Greenbrier Rhizome, 75 parts of Chinese angelica, 150 parts of Millettia dielsiana, 75 parts of Semen Euryales, 150 parts of Herba Houttuyniae, 45 parts of Rhizoma Sparganii, 150 parts of Herba Patriniae, 15 parts of cinnamon, 45 parts of Rhizoma Atractylodis Macrocephalae, 22.5 parts of baked ginger, 45 parts of Fructus Toosendan, 75 parts of Sophora flavescens, 75 parts of scorpion, 45 parts of Rhizoma Curcumae, 75 parts of ground beetle and 75 parts of Corydalis tuber; and the auxiliary materials comprise, by weight, 5-10 parts of crosslinked sodium carboxymethyl cellulose, 1-3 parts of alpha-lactose and 2-6 parts of microcrystalline cellulose.

Description

Red astragalus root for removing blood stasis capsule and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine preparation, be specifically related to red astragalus root for removing blood stasis capsule and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Red astragalus root for removing blood stasis capsule records in " national standard for traditional Chinese medicines compilation " (Chinese patent medicine provincial standard rising national standard part surgery gynecological fascicle), it is mainly to be processed through extracting by two Ten Herbs such as the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, there is promoting blood circulation and stopping pain, effect of hard masses softening and resolving, for blood stasis due to qi deficiency, the phlegm-damp chronic pelvic inflammatory disease causing that stagnates, disease sees leucorrhoea grow in quantity person.Former technique is for Scorpio, Eupolyphaga Seu Steleophaga, Rhizoma Corydalis, Rhizoma Curcumae in prescription are dried and crushed into fine powder, all the other 16 taste medicines decoct with water three times, and each 1-3 hour, filters, is concentrated into extractum at collecting decoction, the fine powder of pulverizing and extractum are mixed to dry rear encapsulated forming.But, the water extracted immersing paste that contains the more very easily moisture absorption due to this capsule at present, dried extract powder hygroscopicity is large aborning, and poor fluidity causes capsule content uniformity large, is unfavorable for producing; And the easy moisture absorption in storage and transportation, affects the stability of medicine and causes the difficult disintegrate of medicine.
Patent CN1966052A discloses a kind of red astragalus root for removing blood stasis sheet, it improves the stability of medicine by add adjuvant carboxymethylstach sodium, starch and magnesium stearate in extractum, but this tablet exists supplementary product consumption large and improve the problems such as stabilizing effect is not obvious in actual applications.
Summary of the invention
For the technical problem of current existence, the invention provides a kind of red astragalus root for removing blood stasis capsule and preparation method thereof, this capsule moisture resistance is strong, good stability, supplementary product consumption is few and curative effect is better.
An object of the present invention is to provide a kind of red astragalus root for removing blood stasis capsule, it is made up of Chinese medicine extract and adjuvant.The weight ratio of described Chinese medicine extract and adjuvant is 10:0.2~0.8; Described Chinese medicine extract by weight portion is: 75 parts of 150 parts of the Radixs Astragali, 150 parts of Radix Salviae Miltiorrhizaes, 75 parts of Radix Codonopsis, 75 parts of Rhizoma Dioscoreaes, 100 parts of Rhizoma Smilacis Glabraes, 75 parts of Radix Angelicae Sinensis, 150 parts of Caulis Spatholobis, 75 parts of Semen Euryaless, 150 parts of Herba Houttuyniae, 45 parts of Rhizoma Sparganii, 45 parts of Rhizoma Curcumae, 75 parts of Scorpios, 150 parts of Herba Patriniae, 15 parts of Cortex Cinnamomis, 45 parts of the Rhizoma Atractylodis Macrocephalaes, 22.5 parts of Rhizoma Zingiberis Preparatums, 45 parts of Fructus Toosendans, 75 parts of Radix Sophorae Flavescentiss, 75 parts of Eupolyphaga Seu Steleophagas and Rhizoma Corydalis are made, and described adjuvant is that the cross-linked carboxymethyl cellulose of 5~10 weight portions is received, the alpha-lactose of 1~3 weight portion and the microcrystalline Cellulose of 2~6 weight portions.
In the present invention, further in embodiment, the weight ratio of described Chinese medicine extract and adjuvant is preferably 10:0.5, and the weight portion of described adjuvant is preferably that the cross-linked carboxymethyl cellulose of 8 parts is received, the alpha-lactose of 2 weight portions and the microcrystalline Cellulose of 4 weight portions.
Another object of the present invention is to provide a kind of method of preparing described red astragalus root for removing blood stasis capsule, and concrete steps are as follows:
(1) by the Scorpio of corresponding weight portion, Eupolyphaga Seu Steleophaga, Rhizoma Corydalis, the dry fine powder that is ground into respectively of Rhizoma Curcumae;
(2) Radix Astragali of corresponding weight portion, Radix Salviae Miltiorrhizae, Radix Codonopsis, Rhizoma Dioscoreae, Rhizoma Smilacis Glabrae, Radix Angelicae Sinensis, Caulis Spatholobi, Semen Euryales, Herba Houttuyniae, Rhizoma Sparganii, Herba Patriniae, Cortex Cinnamomi, the Rhizoma Atractylodis Macrocephalae, Rhizoma Zingiberis Preparatum, Fructus Toosendan and Radix Sophorae Flavescentis are decocted with water three times, be followed successively by 3 hours, 2 hours, 1 hour, filter, merging filtrate, the extractum that while being concentrated into 60 DEG C, relative density is 1.28~1.30;
(3) fine powder step (1) being obtained, the extractum mix homogeneously that step (2) obtains, dry, pulverize into Chinese medicine extract fine powder, add again the auxiliary materials and mixing of corresponding weight portion, make soft material with 60% ethanol as wetting agent, granulate, dry, incapsulate, to obtain final product.
In embodiment further, the granularity that Scorpio described in step (1) and Eupolyphaga Seu Steleophaga are pulverized is 150~250 object fine powders, the granularity that described Rhizoma Corydalis and Rhizoma Curcumae are pulverized is the fine powder of 100~150 mesh sieves, the fineness that more preferably described Scorpio and Eupolyphaga Seu Steleophaga are pulverized is 200 object fine powders, the granularity that described Rhizoma Corydalis and Rhizoma Curcumae are pulverized is the fine powder of 125 mesh sieves, water decocting condition described in step (2) is to be the water of 10 times of amounts for the first time, is the water of 8 times of amounts for the second time and for the third time.
The present invention has groped to obtain the preferred plan of ratio of adjuvant and consumption by lot of experiments research, adopt above-mentioned adjuvant can overcome the hygroscopic problem of extractum, and improve greatly the stability of red astragalus root for removing blood stasis capsule, and content of active component in every capsules is stable, difference is little.In addition, have four taste Chinese medicines to be used as medicine with full medical material in the present invention, its smashing fineness is a key parameter, and in itself and compound medicine, the homogeneous degree of various compositions and the content uniformity of capsule are closely bound up.The present invention has groped to obtain the suitable fineness of the full medical material of four taste Chinese medicines by continuous test, significantly improved the powder characteristics of capsule 's content, has ensured the homogeneity of compound medicine and the stability of content uniformity.
Detailed description of the invention
To further describe to illustrate the present invention below in detail.It is pointed out that following explanation is only illustrating of the technical scheme claimed to the present invention, the not any restriction to these technical schemes.The content that protection scope of the present invention is recorded with appended claims is as the criterion.
embodiment 1
Step 1: Scorpio 75g, Rhizoma Curcumae 45g, Eupolyphaga Seu Steleophaga 75g and Rhizoma Corydalis 75g are dried and crushed into fine powder, cross 100 mesh sieves for subsequent use;
Step 2: the Radix Astragali 150g of corresponding weight portion, Radix Salviae Miltiorrhizae 150g, Radix Codonopsis 75g, Rhizoma Dioscoreae 75g, Rhizoma Smilacis Glabrae 100g, Radix Angelicae Sinensis 75g, Caulis Spatholobi 150g, Semen Euryales 75g, Herba Houttuyniae 150g, Rhizoma Sparganii 45g, Herba Patriniae 150g, Cortex Cinnamomi 15g, Rhizoma Atractylodis Macrocephalae 45g, Rhizoma Zingiberis Preparatum 22.5g, Fructus Toosendan 45g and Radix Sophorae Flavescentis 75g are decocted with water three times, be followed successively by add 10 times of amounts water extraction 3 hours, add 8 times of amounts water extraction 2 hours, add the water extraction 1 hour of 8 times of amounts, filter, merging filtrate, the extractum that while being concentrated into 60 DEG C, relative density is 1.28~1.30;
Step 3: by fine powder and extractum mix homogeneously, dry, (fineness of Scorpio and Eupolyphaga Seu Steleophaga is 150 orders to be ground into Chinese medicine extract fine powder, the fineness of Rhizoma Corydalis and Rhizoma Curcumae is 100 orders), add again the auxiliary materials and mixing of corresponding weight portion, the weight ratio of Chinese medicine extract fine powder and adjuvant is 10:0.2, the microcrystalline Cellulose of the cross-linking sodium carboxymethyl cellulose that consists of 5 weight portions of adjuvant, the alpha-lactose of 1 weight portion and 2 weight portions; Make soft material with 60% ethanol as wetting agent, granulate, dry, incapsulate, to obtain final product.
embodiment 2-6
Except following table parameter, other preparation technologies, with embodiment 1, specifically see the following form:
the study on the stability of red astragalus root for removing blood stasis capsule prepared by embodiment 7 embodiment 1-3
Investigate correlated samples stability according to the stability guideline of 2010 editions two annex of Chinese Pharmacopoeia, investigated respectively under 36 months, 25 DEG C of 25 DEG C of placements and relative humidity 75% condition and placed the medicine stability of 60 days.Adopt HPLC method to measure the content of astragaloside, tetrahydropalmatine and salvianolic acid B in capsule.
In addition, for embodying the superiority of capsule of the present invention, ad hoc fixed following comparative example:
Comparative example 1: do not add any adjuvant, other are with embodiment 3;
Comparative example 2: adjuvant prescription is with patent CN1966052A, and other are with embodiment 3;
Comparative example 3: Chinese medicine extract is with supplementary product consumption than being 10:1, and other are with embodiment 3;
The weight ratio of 4: three kinds of adjuvants of comparative example is 4:1:1, and other are with embodiment 3;
The weight ratio of 5: three kinds of adjuvants of comparative example is 15:3:10, and other are with embodiment 3;
Place each group Effective Component of Chinese Medicine content (n=10) after 36 months for 25 DEG C
Figure 527249DEST_PATH_IMAGE002
Under 25 DEG C and relative humidity 75% condition, place and within 60 days, respectively organize afterwards Effective Component of Chinese Medicine content (n=10)
Figure 2013105863169100002DEST_PATH_IMAGE003
In addition, get sample after above-mentioned test, require to carry out detection disintegration with reference to 2010 editions one annex XII A of Chinese Pharmacopoeia, result is as follows:
Place 36 months for 25 DEG C
Figure 444389DEST_PATH_IMAGE004
Under 25 DEG C and relative humidity 75% condition, place 60 days
Figure 2013105863169100002DEST_PATH_IMAGE005
the angle of repose of red astragalus root for removing blood stasis capsule prepared by embodiment 8 embodiment 1-3 and content uniformity test
Adopt fixed funnel method (Xi Nianzhu edits " pharmaceutics " third edition) to measure the angle of repose of the front granule of sample fill, and measure the content uniformity of sample according to pertinent regulations under 2010 editions annex I L items of Chinese Pharmacopoeia.
The grain graininess of 6: four taste pulverizing Chinese medicines of comparative example is 100 orders, and other are with embodiment 1
The grain graininess of 7: four taste pulverizing Chinese medicines of comparative example is 250 orders, and other are with embodiment 1
The grain graininess of 8: four taste pulverizing Chinese medicines of comparative example is 100 orders, and other are with embodiment 2
The grain graininess of 9: four taste pulverizing Chinese medicines of comparative example is 250 orders, and other are with embodiment 2
The grain graininess of 10: four taste pulverizing Chinese medicines of comparative example is 100 orders, and other are with embodiment 3
The grain graininess of 11: four taste pulverizing Chinese medicines of comparative example is 250 orders, and other are with embodiment 3
Result is as follows:
Content of the present invention only for example understands some claimed specific embodiments; the technical characterictic of recording in one of them or more technical scheme can be with one or more technical schemes be combined arbitrarily; these technical schemes that obtain through combination are also in the application's protection domain, just as these technical schemes that obtain through combination have specifically been recorded in the disclosure of invention.

Claims (6)

1. a red astragalus root for removing blood stasis capsule, it is made up of Chinese medicine extract and adjuvant, it is characterized in that, and the weight ratio of described Chinese medicine extract and adjuvant is 10:0.2~0.8; Described Chinese medicine extract by weight portion is: 75 parts of 150 parts of the Radixs Astragali, 150 parts of Radix Salviae Miltiorrhizaes, 75 parts of Radix Codonopsis, 75 parts of Rhizoma Dioscoreaes, 100 parts of Rhizoma Smilacis Glabraes, 75 parts of Radix Angelicae Sinensis, 150 parts of Caulis Spatholobis, 75 parts of Semen Euryaless, 150 parts of Herba Houttuyniae, 45 parts of Rhizoma Sparganii, 150 parts of Herba Patriniae, 15 parts of Cortex Cinnamomis, 45 parts of the Rhizoma Atractylodis Macrocephalaes, 22.5 parts of Rhizoma Zingiberis Preparatums, 45 parts of Fructus Toosendans, 75 parts of Radix Sophorae Flavescentiss, 75 parts of Scorpios, 45 parts of Rhizoma Curcumae, 75 parts of Eupolyphaga Seu Steleophagas and Rhizoma Corydalis are made; Described adjuvant is that the cross-linked carboxymethyl cellulose of 5~10 weight portions is received, the alpha-lactose of 1~3 weight portion and the microcrystalline Cellulose of 2~6 weight portions.
2. capsule according to claim 1, is characterized in that, the weight ratio of described Chinese medicine extract and adjuvant is preferably 10:0.5.
3. capsule according to claim 1, is characterized in that, the weight portion of described adjuvant is preferably that the cross-linked carboxymethyl cellulose of 8 parts is received, the alpha-lactose of 2 weight portions and the microcrystalline Cellulose of 4 weight portions.
4. a method of preparing red astragalus root for removing blood stasis capsule claimed in claim 1, is characterized in that, concrete steps are as follows:
(1) by the Scorpio of corresponding weight portion, Eupolyphaga Seu Steleophaga, Rhizoma Corydalis, the dry fine powder that is ground into respectively of Rhizoma Curcumae; The granularity that described Scorpio and Eupolyphaga Seu Steleophaga are pulverized is 150~250 object fine powders, and the granularity that described Rhizoma Corydalis and Rhizoma Curcumae are pulverized is the fine powder of 100~150 mesh sieves;
(2) Radix Astragali of corresponding weight portion, Radix Salviae Miltiorrhizae, Radix Codonopsis, Rhizoma Dioscoreae, Rhizoma Smilacis Glabrae, Radix Angelicae Sinensis, Caulis Spatholobi, Semen Euryales, Herba Houttuyniae, Rhizoma Sparganii, Herba Patriniae, Cortex Cinnamomi, the Rhizoma Atractylodis Macrocephalae, Rhizoma Zingiberis Preparatum, Fructus Toosendan and Radix Sophorae Flavescentis are decocted with water three times, be followed successively by 3 hours, 2 hours, 1 hour, filter, merging filtrate, the extractum that while being concentrated into 60 DEG C, relative density is 1.28~1.30;
(3) fine powder step (1) being obtained, the extractum mix homogeneously that step (2) obtains, dry, pulverize into Chinese medicine extract fine powder, add again the auxiliary materials and mixing of corresponding weight portion, make soft material with 60% ethanol as wetting agent, granulate, dry, incapsulate, to obtain final product.
5. method according to claim 4, is characterized in that, the granularity that described Scorpio and Eupolyphaga Seu Steleophaga are pulverized is 200 object fine powders, and the granularity that described Rhizoma Corydalis and Rhizoma Curcumae are pulverized is the fine powder of 125 mesh sieves.
6. method according to claim 4, is characterized in that, water decocting condition described in step (2) is to be the water of 10 times of amounts for the first time, is the water of 8 times of amounts for the second time and for the third time.
CN201310586316.9A 2013-11-21 2013-11-21 Blood stasis removing capsule containing Salvia miltiorrhiza and Radix Astragali, and preparation method thereof Expired - Fee Related CN103638483B (en)

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