CN1994425B - Soft capsule of 'Sheng Mai' and preparation method thereof - Google Patents

Soft capsule of 'Sheng Mai' and preparation method thereof Download PDF

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Publication number
CN1994425B
CN1994425B CN200610165454A CN200610165454A CN1994425B CN 1994425 B CN1994425 B CN 1994425B CN 200610165454 A CN200610165454 A CN 200610165454A CN 200610165454 A CN200610165454 A CN 200610165454A CN 1994425 B CN1994425 B CN 1994425B
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preparation
soft capsule
content
softgel shell
heated
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CN1994425A (en
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徐国兵
陈卫东
朱满洲
陈卫鸿
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Abstract

The invention relates to soft capsules for restoring pulse beat and the process for preparing the capsules, wherein the effective constituents include red ginseng, lilyturf root and schisandra fruit extracts, and the contents also include oil solubility dispersing agent and suspension auxiliary agent. The advantages of the invention include convenient admission, easy carrying and high degree of hygiene.

Description

'Sheng Mai ' soft capsule and preparation method thereof
Technical field:
The present invention relates to field of pharmaceutical preparations, relate in particular to 'Sheng Mai ' soft capsule and preparation method thereof.
Background technology:
SHENGMAI YIN derives from the ancient prescription SHENGMAI SAN, is the famous ancient prescription of traditional Chinese medical science supplementing QI and nourishing YIN.This side is made up of Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis three medicines, and Radix Ginseng is sweet, and the effect of invigorating the spleen and replenishing QI, invigorating the lung and promoting the production of body fluid can be arranged; Radix Ophiopogonis, sweet, the little hardship of property, being slightly cold has the yin nourishing stomach reinforcing, and lung moistening clears away heart-fire, so be the good medicine of YIN nourishing nourishing YIN; Fructus Schisandrae Chinensis, sour, warm, have the consolidating superficial resistance arresting sweating, astringe the lung, supplementing the kidney to control the nocturnal and the antidiarrheal effect of promoting the production of body fluid.In the side with the sweet flat tonifying the lung of Radix Ginseng, to hold up vigour greatly be we's principal agent; With the sweet cold YIN nourishing and the production of body fluid promoting of Radix Ophiopogonis, clearind deficient heat and relieving restlessness is an accessory drugs; Trimethyl gallic acid convergence lung hidroschesis is an adjuvant.Three medicines share, and one mends, and are one clear, one hold back, and play the merit of supplementing QI and nourishing YIN, promoting the production of body fluid to quench thirst, strengthening superficial resistance to stop perspiration altogether, and the multiple Tianjin of gas is returned, perspiration stopped and the moon is deposited.
SHENGMAI SAN cures mainly the deficiency of both QI and YIN of thermal burn vigour, cloudy liquid loss, and disease sees that hyperhidrosis, thirsty, dry pharynx, dyspnea with rapid respiration are desired to take off, body is tired lazy, and deficient pulse is unable, dry tongue is red, no Tianjin, or prolonged illness cardiopulmonary two void, deficiency of both vital energy and Yin, the few expectorant of cough and choke, the spontaneous perspiration of losing heart, dry mouth and tougue, pulse condition void is soft.
This side is existing with Radix Ginseng Rubra (the dry root and rhizome of the cultivation product of Radix Ginseng after steaming), and Radix Ophiopogonis, Fructus Schisandrae Chinensis is included in one one of " Chinese Pharmacopoeia 2005 " version.
In recent years, along with going deep into of research, find that SHENGMAI YIN has following pharmacological action:
Improve the function of digestive system: can improving appetite. promote diet, promote proteinic synthesizing, can increase ribonucleic acid and content of glycogen in the liver; Effect to cardiovascular system: myocardial contraction is strengthened, had the effect that is similar to cardiotonic glycoside.Myocardial metabolism can be improved, cardiovascular function can be regulated. improve the effect of not normal blood circulation, can bring high blood pressure down again; Can stop the formation of scar in the blood vessel, the anticoagulation function is strengthened; Antiinflammatory, detoxifcation, improve immunity: having has stronger inhibitory action to bacillus pyocyaneus, escherichia coli, typhoid fever liver bacterium and white grapes sugar coccus; Have and reduce resistance against diseases tired, enhancing body, body immunity is improved; Can be high temperature resistant, low temperature resistant, anoxia enduring, the old people is prevented and treated heatstroke certain effect; Can excited uterine smooth muscle, strengthen the effect that rhythmicity is shunk, so to certain help is all arranged in antenatal puerperal of anemia of pregnant woman.
Clinically, SHENGMAI YIN is widely used for treating the heart, cerebrovascular disease (coronary heart disease, angina pectoris, apoplexy, acute myocardial infarction, cerebral infarction etc.), arrhythmia, heart failure, viral myocarditis, pulmonary heart disease, serious symptom pulmonary heart disease, essential hypotension etc.In addition, SHENGMAI YIN also is used for the auxiliary treatment of tumor, reduces the serious toxicity that is caused by chemotherapy, alleviates patient's misery, improves life quality.
Based on the SHENGMAI YIN prescription, the SHENGMAI YIN dosage form of having developed has three kinds of SHENGMAI ZHUSHEYE, SHENGMAI YIN KOUFUYE, SHENGMAI JIAONANG, existing dosage form and prescription are formed, some defectives in use expose gradually, not high as stability, storage period is short, and bioavailability is low, dose is big etc., and these problems need effectively be solved.
Summary of the invention:
The objective of the invention is on SHENGMAI YIN prescription and preparation method thereof basis, to use the soft capsule preparation technology, a kind of SHENGMAI YIN soft capsule preparation and preparation technology thereof are provided.
The invention provides a kind of 'Sheng Mai ' soft capsule preparation, form by softgel shell and content, content comprises oil-soluble dispersant, suspending agent and effective ingredient, described effective ingredient is the extract of Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis, described effective ingredient accounts for 10~90% of content gross weight, and more preferably 12~55%, most preferred is 16~36%.
Oil-soluble dispersant described in the present invention is selected from one or more the mixture in the vegetable oil, as salad oil, soybean oil, Oleum Arachidis hypogaeae semen, Semen Maydis oil, Oleum Gossypii semen, olive oil, Oleum Sesami, almond oil, peach kernel oil, Oleum Camelliae, Oleum Helianthi, Oleum sesami, Testa oryzae oil, Petiolus Trachycarpi oil, Oleum Cocois.Preferably salad oil, soybean oil, to account for the total restatement of content, its consumption is 20~90%, more preferably 28~85%, most preferred is 33~75%.
Suspending agent described in the present invention is selected from Cera Flava, haze tallow, spermaceti, insect wax, Cera Flava, rice bran wax, sugarcane wax, hydroxypropyl emthylcellulose, ethyl cellulose, chitin or their mixed system.Cera Flava preferably wherein, insect wax, Cera Flava, with the total restatement of content, its consumption is 1~20%, preferably 2~15%, be more preferably 4~12%.
Soft capsule preparation of the present invention, also can select to add an amount of antiseptic, described antiseptic be selected from propylene glycol, glycerol, methyl hydroxybenzoate, ethyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben, sodium diacelate, sorbic acid, sorbic acid methyl ester, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, benzyl alcohol, in one or more, be preferably methyl hydroxybenzoate, propylparaben.By weight, be 0.1~0.5%, preferably 0.18~0.35%.
Therefore soft capsule content of the present invention consists of:
The extract 10~90% of Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis,
Oil-soluble dispersant 28~85%
Suspending agent 1~20%
Antiseptic 0~0.5%
Preferably
The extract 12~55% of Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis
Oil-soluble dispersant 20~90%
Suspending agent 2~15%
Antiseptic 0~0.35%
Be more preferably
The extract 16~36% of Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis
Oil-soluble dispersant 33~75%
Suspending agent 4~12%
Antiseptic 0.18~0.35%
Wherein the extract of Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis derives from prior art, as with the preparation of the method in the Chinese Pharmacopoeia, also can extract processing according to existing document.
Wherein oil-soluble dispersant and suspending agent also are prior aries, all can buy from the market to obtain.
The most preferred prescription composition of the present invention is to obtain through screening, and it consists of: the extract fine powder 20g of Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis, and salad oil 75g, Cera Flava 5g makes 100g.
Soft capsule preparation of the present invention, described softgel shell is made up of sizing material, plasticizer, solvent, opacifier, coloring agent, and wherein sizing material is selected from arabic gum, carrageenin, the preferred gelatin of gelatin; Plasticizer is selected from one or more in glycerol, xylitol, sorbitol, the sorbic acid methyl ester; Solvent is selected water; Opacifier is selected from ferroso-ferric oxide, titanium dioxide; Coloring agent is selected the food grade pigment.In the softgel shell, sizing material: plasticizer: the part by weight of water is 1: 0.01-3: 0.1-3, preferably 1: 0.5-6: 0.5-3; The glue that sizing material, plasticizer, water are formed: opacifier: the part by weight of coloring agent is 1: 0.005-0.03: 0.00005-0.0003, preferably 1: 0.01-0.02: 0.0001-0.0003.
Soft capsule preparation of the present invention, its preparation method is as follows:
1, preparation active component
Method for making with reference to Chinese Pharmacopoeia version (an one) in 2005 SHENGMAI YIN is carried out extraction of active ingredients, promptly gets Radix Ginseng Rubra 100g, Radix Ophiopogonis 200g, Fructus Schisandrae Chinensis 100g, be ground into coarse powder, adopt percolation, make solvent with 65% ethanol, flood after 24 hours, carry out percolation, collect the about 4500ml of liquid that filters, it is 1.25 clear paste that concentrating under reduced pressure becomes relative density, be dried to powder below 80 ℃, getting SHENGMAI YIN extract fine powder effective ingredient.
2, the preparation of content: get SHENGMAI YIN extract fine powder and mix, can add or adding preservative agent not, be heated to 60~120 ℃, mix, be incubated standby to evenly with dispersant, suspensoid.
3, the preparation of softgel shell: get sizing material, water is an amount of, mix homogeneously; Other gets plasticizer and water mix homogeneously, be heated to fusion after, add the glue material solution prepare, be heated to molten condition under stirring, behind mix homogeneously and the evacuation, be incubated standby.
4, preparation of soft capsule: above-mentioned content that makes and softgel shell material are made soft capsule through encapsulating machine, after drying, promptly.
The soft capsule of the present invention composition of preferably filling a prescription has the bioavailability height, steady quality, and dosage is accurate, and mouthfeel is good, easily swallows characteristics such as health safe to carry.Particularly the present invention forms through the most preferred prescription that screening obtains, and it is similar best that technique effect reaches.
The specific embodiment:
The preparation method of 'Sheng Mai ' soft capsule of the present invention is described with example below, but not with this as limitation of the present invention.
Embodiment 1:
The preparation of content: get SHENGMAI YIN extract fine powder 20g, salad oil 75g, Cera Flava 5g mixes, and is heated to 80 ℃, mixes to evenly, makes suspension and is incubated standby.
The preparation of softgel shell: get gelatin 2g, glycerol 0.6g, water is an amount of, mix homogeneously, be heated to 70~80 ℃ of fusions after, add opacifier, coloring agent is an amount of, mix and evacuation after, insulation is standby down in 50 ℃.
Preparation of soft capsule: above-mentioned content that makes and softgel shell material are made soft capsule through encapsulating machine, after drying, promptly.
Embodiment 2:
The preparation of content: get SHENGMAI YIN extract fine powder 16g, salad oil 78g, Cera Flava 6g mixes, and is heated to 70 ℃, mixes to evenly, makes suspension and is incubated standby.
The preparation of softgel shell: get gelatin 2g, 0.5ml water mix homogeneously; Other gets sorbitol 1g and suitable quantity of water mix homogeneously, be heated to 46 ℃ of fusions after, add the gelatin solution prepare, stir down and be heated to 50 ℃, behind mix homogeneously and the evacuation, be incubated standby down in 50 ℃.
Preparation of soft capsule: above-mentioned content that makes and softgel shell material are made soft capsule through encapsulating machine, after drying, promptly.
Embodiment 3:
The preparation of content: get SHENGMAI YIN extract fine powder 26g, soybean oil 70g, insect wax 4g mixes, and is heated to 80 ℃, mixes to evenly, makes suspension and is incubated standby.
The preparation of softgel shell: get gelatin 2g, 0.5ml water mix homogeneously; Other gets sorbitol 1g and suitable quantity of water mix homogeneously, be heated to 46 ℃ of fusions after, add the gelatin solution prepare, stir down and be heated to 50 ℃, behind mix homogeneously and the evacuation, be incubated standby down in 50 ℃.
Preparation of soft capsule: above-mentioned content that makes and softgel shell material are made soft capsule through encapsulating machine, after drying, promptly.
Embodiment 4:
The preparation of content: get SHENGMAI YIN extract fine powder 15g, soybean oil 75g, Cera Flava 10g mixes, and is heated to 85 ℃, mixes to evenly, makes suspension and is incubated standby.
The preparation of softgel shell: get gelatin 2g and suitable quantity of water mix homogeneously; Other gets sorbitol 1.2g and suitable quantity of water mix homogeneously, be heated to 50 ℃ of fusions after, add the gelatin solution prepare, stir down and be heated to 50 ℃, behind mix homogeneously and the evacuation, be incubated standby down in 50 ℃.
Preparation of soft capsule: above-mentioned content that makes and softgel shell material are made soft capsule through encapsulating machine, after drying, promptly.
Embodiment 5:
The preparation of content: get SHENGMAI YIN extract fine powder 20g, salad oil 85g, insect wax 5g mixes, and is heated to 75 ℃, mixes to evenly, makes suspension and is incubated standby.
The preparation of softgel shell: get gelatin 2g, 0.5ml water mix homogeneously; Other gets sorbitol 1.5g and suitable quantity of water mix homogeneously, be heated to 45 ℃ of fusions after, add the gelatin solution prepare, stir down and be heated to 50 ℃, behind mix homogeneously and the evacuation, be incubated standby down in 48 ℃.
Preparation of soft capsule: above-mentioned content that makes and softgel shell material are made soft capsule through encapsulating machine, after drying, promptly.

Claims (2)

1. a 'Sheng Mai ' soft capsule is made up of softgel shell and content, it is characterized in that, and described content, it consists of: the extract fine powder 20g of Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis, salad oil 75g, Cera Flava 5g makes 100g.
2. the preparation method of the described 'Sheng Mai ' soft capsule of claim 1 is characterized in that, step is as follows:
1) preparation active component
Method for making with reference to Chinese Pharmacopoeia version SHENGMAI YIN in 2005 is carried out the extraction of effective ingredient, promptly gets recipe quantity Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis, is ground into coarse powder, adopt percolation to carry out percolation, collect percolate, concentrating under reduced pressure, drying gets SHENGMAI YIN extract fine powder effective ingredient;
2) preparation of content: get SHENGMAI YIN extract fine powder 20g, salad oil 75g, Cera Flava 5g mixes, and is heated to 80 ℃, mixes to evenly, makes suspension and is incubated standby;
3) preparation of softgel shell: get gelatin 2g, glycerol 0.6g, water is an amount of, mix homogeneously, be heated to 70~80 ℃ of fusions after, add opacifier, coloring agent is an amount of, mix and evacuation after, insulation is standby down in 50 ℃;
4) preparation of soft capsule: above-mentioned content that makes and softgel shell material are made soft capsule through encapsulating machine, after drying, promptly.
CN200610165454A 2006-12-20 2006-12-20 Soft capsule of 'Sheng Mai' and preparation method thereof Expired - Fee Related CN1994425B (en)

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CN105168434B (en) * 2015-08-14 2019-04-02 湖北坤艳药业有限责任公司 A kind of health care product and preparation method thereof of complementary reducing blood lipid
CN105166887B (en) * 2015-08-14 2018-04-20 湖北坤艳药业有限责任公司 A kind of health care product auxiliary material and its application
CN105079438B (en) * 2015-09-11 2018-08-10 山东大学 A kind of pharmaceutical preparation for treating vital myocarditis

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1634342A (en) * 2004-09-30 2005-07-06 浙江天一堂集团有限公司 Soft capsule for activating pulse and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1634342A (en) * 2004-09-30 2005-07-06 浙江天一堂集团有限公司 Soft capsule for activating pulse and preparation method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
赵杨等.生脉饮化学成分研究.中草药 6.2006,6835.
赵杨等.生脉饮化学成分研究.中草药 6.2006,6835. *

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