Summary of the invention
The purpose of this invention is to provide a kind of Dan e Fukang compound recipe and make the method for soft capsule or dispersible tablet, thereby improve the quality of products, enlarge the application of Dan e Fukang preparation, make things convenient for the patient to use.
The object of the present invention is achieved like this:
A kind of Dan e Fukang soft capsule, by
450 parts of Radix Salviae Miltiorrhizae, 250 parts of Rhizoma Curcumae, 250 parts of HERBA BUPLEURI
150 parts of Radix Notoginseng, 250 parts of Radix Paeoniae Rubra, 250 parts of Radix Angelicae Sinensis
175 parts of rhizoma sparganic, 150 parts of Rhizoma Cyperis, 100 parts in 175 portions of Radix Glycyrrhizaes of Rhizoma Corydalis,
Deng composition, it is characterized in that above-mentioned medical material through extract, concentrate, dry, make red cowherb extract dried cream powder, cooperate pharmaceutically alleged adjuvant to make soft capsule, this soft capsule comprises capsule liquid, softgel shell, and capsule liquid is made up of red cowherb extract dried cream powder 10%~65%, 35%~90% of adjuvant;
Softgel shell is made up of gelatin or Polyethylene Glycol 44.5%~68%, glycerol 1.3%, additives 0.2% and 30.5%~54.0% in water,
Above-mentioned alleged adjuvant be diluent (or claim disperse medium), suspending agent, antioxidant, surfactant and antiseptic one or more,
Above-mentioned alleged additives are one or more of antiseptic, antioxidant or anti-cross-linking agent.
Described Dan e Fukang soft capsule extracts, preparation technology is:
(1) above ten flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation (2000 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, Rhizoma Corydalis, the five tastes such as Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction filters, and filtrate is condensed into thick paste, merge above-mentioned two kinds of thick pastes, be dried to dry extract, be crushed to more than 80 orders, with diluent (or claiming disperse medium), suspending agent, antioxidant, one or more of surfactant and antiseptic etc., mix homogeneously is made capsule liquid, and is standby;
(2) get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, leave standstill in 70 ± 5 ℃ of insulations, it is standby to make the capsule material;
(3) the capsule liquid for preparing is moved in a rolling capsule machine or the system machine,, make soft capsule with the capsule material of joining.
Described adjuvant is chosen as:
Its diluent (or claiming disperse medium) comprising: one or more of oiliness disperse medium or water solublity disperse medium;
1. described oiliness disperse medium comprises: the triglyceride oils of crude vegetal (as: soybean oil, Oleum Arachidis hypogaeae semen) or long-chain and medium-chain different saturation, as: oleic acid sorbitol ester, olein: one or more of propylene glycol (90: 10), Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, Oleum Cocois C8/C10 propylene glycol ester, Oleum Cocois triglyceride, the acetylizad monoglyceride of purification, olein, glyceryl linoleate, Polyethylene Glycol glyceryl laurate ester, purification Oleum helianthi monoglyceride etc.;
2., described aqueous dispersion medium comprises: one or more of PEG400, Polyethylene Glycol 500, Macrogol 600, isopropyl alcohol, glycerol, propylene glycol and water etc.
Its diluent (or claiming disperse medium) is: 3: 1 mixture of Oleum Cocois and soybean oil; Consumption is 150~350 parts; 3~40 parts of suspending agents, 0.1~3 part of antiseptic can also add 5~30 parts of surfactants,
Preferable amount is: 210 parts of disperse medium, 15 parts of suspending agents, 0.5 part of antiseptic, 8 parts in surfactant.
Effect of the present invention:
Soft capsule is the tablet that continues, and a kind of novel form that grows up after the injection, its shell are to form with the gelatin compacting, the aqueous medicinal liquid of bag in the softgel shell.Be characterized in slower than injection onset, but than tablet, capsule, granule is rapid-action.More easy to carry than oral liquid.Because the optimization of soft capsule liquid of the present invention prescription, its content can be in human body self emulsifying to a certain degree, increase absorption area, thus the bioavailability height.Reduced patient's dose, made that compliance was higher when the patient used this medicine.But because the soft capsule complicated process of preparation has higher requirements to preparations shaping technology, need screening appropriate supplementary product kind, proportioning, just might make stay-in-grade finished product soft capsule.
Clinical effectiveness: Dan e Fukang preparation treatment seriousness dysmenorrhea clinical observation
Dysmenorrhea is common gynecological disease and frequently-occurring disease, also is one of gynecological's emergency case, pertinacious disease.Mostly occur before menstruation, when passing through or after passing through, mainly show as lower abdomen and lumbosacral having an intense pain, the whole body is uncomfortable, often with the menstrual cycle outbreak, the collapse symptom occurs because of sharp ache sometimes; This disease not only more sees, but also can bring out other gynaecopathia, directly affects work and life.Dysmenorrhea is gynecological clinic commonly encountered diseases, frequently-occurring disease.The morbidity of dysmenorrhea is many by stagnation of QI-blood, and is inaccessible obstructed, stagnation of QI and blood may bring about pain.So blood circulation promoting and blood stasis dispelling, pain relieving is the main rule of treatment primary disease.Dan e Fukang preparation function blood circulation promoting and blood stasis dispelling, depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving, softening the hard mass eliminate indigestion.Treatment dysmenorrhea curative effect is better.
1 data and method
1.1 physical data
Group |
Total routine number |
Age (year) |
The course of disease (year) |
Soft capsule group dispersible tablet group matched group |
38 41 39 |
27.52±8.6 27.14±8.4 27.88±8.8 |
6.88±4.76 6.52±4.32 6.12±4.38 |
Treatment group and matched group compare, and patient age, the course of disease are learned check by statistics, and Ridit analyzes: P>0.05, difference does not have significance.
1.2 diagnostic criteria
All patients all meet " disease of tcm diagnosis criterion of therapeutical effect " middle dysmenorrhea diagnostic criteria that State Administration of Traditional Chinese Medicine issued in 1994.Clinical primary symptom is: 1. through preceding or cold-type pain in the lower abdomen during menstruation; 2. tenderness or like warm pain relieved by pressing, pain alleviated while getting warmth: 3. delayed menstrual period, amount is few, and color secretly has piece, blockage of menstruation.Cold blood stasis has the cold general pain of fear concurrently, the history of catching cold, or aversion to cold usually, extremity are not warm, purplish tongue or ecchymosis is arranged, thin lingual fur from or greasy certainly, deep and tense pulse or heavy etc.All possess primary symptom more than one, holds concurrently disease more than two, and two above persons of tongue arteries and veins all can be used as the observation case.
1.3 case exclusion standard
1. merge hysteromyoma, serious disease persons such as cardiovascular and cerebrovascular vessel, liver, kidney and hemopoietic system; 2. psychotic; 3. to this medicine allergy sufferers; 4. do not meet the standard of including in, not medication in accordance with regulations, can't judge curative effect or data not umbra sound curative effect and safe judgement person.
1.4 Therapeutic Method
The soft capsule group: oral Dan e Fukang soft capsule, each 4-6 grain, every day 2 times, 10-15 days begin before menstruation, and serveing on 10-15 days is a course of treatment.
The dispersible tablet group: oral Dan e Fukang dispersible tablet, each 4-6 sheet, every day 2 times, 10-15 days begin before menstruation, and serveing on 10-15 days is a course of treatment.
Matched group: oral DANER FUKANG JIANGAO, each 10-15g, every day 2 times, 10-15 days begin before menstruation, and serveing on 10-15 days is a course of treatment.
1.5 efficacy assessment standard reference literature.
The standards of grading of dysmenorrhea:, adopt the disease associated methods to keep the score with reference to " new Chinese medicine clinical research guideline " and " tcm clinical practice disease diagnosis criterion of therapeutical effect "; Dysmenorrhea weight grade scale: severe: more than 14 minutes; Moderate: 8~13 minutes; Slightly: below 8 minutes.
1.6 criterion of therapeutical effect: with reference to " new Chinese medicine clinical research guideline〉and<up-to-date domestic and international medical diagnosis on disease standard " formulate.Recovery from illness: clinical symptoms, sign disappear, and integration is 0, and continuous 3 menstrual cycle do not recur; Produce effects: clinical symptoms, sign disappear, and the treatment integration reduces below 2/3 than the preceding integration of treatment; Effectively: clinical symptoms, sign all alleviate, and the treatment integration reduces below 1/3 than the preceding integration of treatment; Invalid: as not have before and after the treatment and improve.
2 results
Table 2 case curative effect of disease relatively
Group |
Total routine number |
Recovery from illness |
Produce effects |
Effectively |
Invalid |
Total effective rate (%) |
Soft capsule group dispersible tablet group matched group |
38 41 39 |
6 7 5 |
12 13 11 |
18 19 18 |
2 2 5 |
94.73 95.12 87.18 |
Each group compares in curative effect and matched group, learns check by statistics, and Ridit analyzes: P<0.05, difference has significance.
2.2 cardinal symptom sees Table 3 through the variation of row pain integration before and after two groups of treatments.
Exponential integral comparison before and after the treatment of table 3 case (X ± S)
Group |
Observation index |
The example number |
Integration before the treatment |
Treatment back integration |
Difference |
The soft capsule group |
Abdominal pain during menstruation |
38 |
2.68±0.79 |
0.54±0.31 |
2.14±0.62 |
Dispersible tablet group matched group |
41 39 |
2.73±0.82 2.65±1.93 |
0.59±0.23 0.64±0.33 |
2.24±0.69 2.01±0.53 |
Own control is relatively learned check by statistics before and after each group treatment, and Ridit analyzes: P<0.05, and difference has significance; Each group treatment integration improves situation and matched group compares, and learns check by statistics, and Ridit analyzes: P>0.05, difference does not have significance.
3 discuss
The seriousness dysmenorrhea is that a kind of morbidity urgency, sharp ache, the state of an illness are urgent, needs the clinical disease of treatment in time.The general strong analgesics or spasmolytic even anesthesia quasi drugs of adopting sued and laboured more, with alleviating pain.Dan e Fukang preparation is to be principal agent with the Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, holds concurrently and makes up with the kidney invigorating prescription.Dan e Fukang soft capsule, Dan e Fukang dispersible tablet, DANER FUKANG JIANGAO treatment dysmenorrhea total effective rate reach 92.38%, and red cowherb soft capsule, Dan e Fukang dispersible tablet treatment dysmenorrhea curative effect are better than DANER FUKANG JIANGAO.
Specific embodiment:
The preparation of the extract of embodiment 1 medical material:
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
More than ten the flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation (2000 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, Rhizoma Corydalis, the five tastes such as Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction, filter, filtrate is concentrated into thick paste, merges above-mentioned two kinds of thick pastes, dry, be crushed to more than 80 orders, promptly get medicinal substances extract, standby.
Be the medicinal substances extract of preparation soft capsule, dispersible tablet, drop pill.
Embodiment 2 Dan e Fukang soft capsules
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
(1) make medicinal substances extract by embodiment 1, with one or more of diluent (or claim disperse medium), suspending agent, antioxidant, surfactant and antiseptic etc., mix homogeneously is made capsule liquid, and is standby;
Capsule liquid is made up of red cowherb extract dried cream powder 10%~65%, 35%~90% of adjuvant;
Ratio of adjuvant:
Disperse medium Oleum Cocois 210g,
Suspending agent ethyl cellulose 15g,
The antiseptic ethylparaben, 0.5g,
Surfactant soybean lecithin 8g
Adjuvant is selected:
Disperse medium can also be one or more of oiliness disperse medium or water solublity disperse medium except that Oleum Cocois;
1. described oiliness disperse medium comprises: the triglyceride oils of crude vegetal (as: soybean oil, Oleum Arachidis hypogaeae semen) or long-chain and medium-chain different saturation, as: oleic acid sorbitol ester, olein: one or more of propylene glycol (90: 10), Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, Oleum Cocois C8/C10 propylene glycol ester, Oleum Cocois triglyceride, the acetylizad monoglyceride of purification, olein, glyceryl linoleate, Polyethylene Glycol glyceryl laurate ester, purification Oleum helianthi monoglyceride etc.;
2., described aqueous dispersion medium comprises: one or more of PEG400, Polyethylene Glycol 500, Macrogol 600, isopropyl alcohol, glycerol, propylene glycol and water etc.
Suspending agent except that ethyl cellulose can also be: can increase the solid matter of disperse medium viscosity, and as Cera Flava, or aluminum monostearate, or the Ka Baibo resin etc.; Or the best was used Ka Baibo portions of resin Cera Flava 1: 1;
Antiseptic is: glycerol, or propylene glycol, or methyl parahydroxybenzoate, or ethylparaben, or propyl p-hydroxybenzoate, or butyl p-hydroxybenzoate, or benzyl p-hydroxybenzoate, or in the P-hydroxybenzoic acid phenyl ester one or more; Or the best benzyl p-hydroxybenzoate that uses.
(2) get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, leave standstill in 70 ± 5 ℃ of insulations, it is standby to make the capsule material;
Softgel shell is made up of gelatin or Polyethylene Glycol 44.5%, glycerol 1.3%, additives 0.2% and water 54.0%,
(3) the capsule liquid for preparing is moved in a rolling capsule machine or the system machine,, make 1000 of soft capsules with the capsule material of joining.
Embodiment 3 Dan e Fukang soft capsules
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
(1) make medicinal substances extract by embodiment 1, with one or more of diluent (or claim disperse medium), suspending agent, antioxidant, surfactant and antiseptic etc., mix homogeneously is made capsule liquid, and is standby;
Capsule liquid is made up of red cowherb extract dried cream powder 10%, adjuvant 90%;
Ratio of adjuvant:
Disperse medium PEG400 150g,
Suspending agent Cera Flava 3g,
The antiseptic propyl p-hydroxybenzoate, 0.1g,
Surfactant soybean lecithin 5g
(2) get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, leave standstill in 70 ± 5 ℃ of insulations, it is standby to make the capsule material;
Softgel shell is made up of gelatin or Polyethylene Glycol 68%, glycerol 1.3%, additives 0.2% and water 30.5%,
(3) the capsule liquid for preparing is moved in a rolling capsule machine or the system machine,, make 1000 of soft capsules with the capsule material of joining.
Embodiment 4 Dan e Fukang soft capsule Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
(1) make medicinal substances extract by embodiment 1, with one or more of diluent (or claim disperse medium), suspending agent, antioxidant, surfactant and antiseptic etc., mix homogeneously is made capsule liquid, and is standby;
Capsule liquid is made up of red cowherb extract dried cream powder 35%, adjuvant 65%;
Ratio of adjuvant:
Disperse medium Oleum Cocois 350g,
Suspending agent ethyl cellulose 40g,
The antiseptic ethylparaben, 3g,
Surfactant soybean lecithin 30g
(2) get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, leave standstill in 70 ± 5 ℃ of insulations, it is standby to make the capsule material;
Softgel shell is made up of gelatin or Polyethylene Glycol 50%, glycerol 1.3%, additives 0.2% and water 48.5%,
(3) the capsule liquid for preparing is moved in a rolling capsule machine or the system machine,, make 1000 of soft capsules with the capsule material of joining.
Embodiment 5 Dan e Fukang preparation of soft capsule
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
Disperse medium Oleum Cocois 210g,
Suspending agent ethyl cellulose 15g,
The antiseptic ethylparaben, 0.5g,
Surfactant soybean lecithin 8g
Adjuvant is selected:
Disperse medium can also be one or more of oiliness disperse medium or water solublity disperse medium except that Oleum Cocois;
1. described oiliness disperse medium comprises: the triglyceride oils of crude vegetal (as: soybean oil, Oleum Arachidis hypogaeae semen) or long-chain and medium-chain different saturation, as: oleic acid sorbitol ester, olein: one or more of propylene glycol (90: 10), Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, Oleum Cocois C8/C10 propylene glycol ester, Oleum Cocois triglyceride, the acetylizad monoglyceride of purification, olein, glyceryl linoleate, Polyethylene Glycol glyceryl laurate ester, purification Oleum helianthi monoglyceride etc.;
2., described aqueous dispersion medium comprises: one or more of PEG400, Polyethylene Glycol 500, Macrogol 600, isopropyl alcohol, glycerol, propylene glycol and water etc.
Suspending agent except that ethyl cellulose can also be: can increase the solid matter of disperse medium viscosity, and as Cera Flava, or aluminum monostearate, or the Ka Baibo resin etc.; Or the best was used Ka Baibo portions of resin Cera Flava 1: 1;
Antiseptic is: glycerol, or propylene glycol, or methyl parahydroxybenzoate, or ethylparaben, or propyl p-hydroxybenzoate, or butyl p-hydroxybenzoate, or benzyl p-hydroxybenzoate, or in the P-hydroxybenzoic acid phenyl ester one or more; Or the best benzyl p-hydroxybenzoate that uses.
Emulsifying agent is a medicinal emulsifier.As soybean lecithin.
(1) make medicinal substances extract by embodiment 1, with one or more of diluent (or claim disperse medium), suspending agent, antioxidant, surfactant and antiseptic etc., mix homogeneously is made capsule liquid, and is standby;
(2) get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, leave standstill in 70 ± 5 ℃ of insulations, it is standby to make the capsule material;
Softgel shell is made up of gelatin or Polyethylene Glycol 50%, glycerol 1.3%, additives 0.2% and water 48.5%,
(3) the capsule liquid for preparing is moved in a rolling capsule machine or the system machine,, make soft capsule, make 1000 with the capsule material of joining.
Embodiment 6 Dan e Fukang preparation of soft capsule
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
Make medicinal substances extract by embodiment 1
Disperse medium Polyethylene Glycol 350g,
The suspending agent ethyl cellulose: Ka Baibo resin 40g,
The antiseptic butyl p-hydroxybenzoate, 3g,
Surfactant Tween 80 30g
Medical material is made medicinal substances extract by embodiment 1, makes 1000 of soft capsules by embodiment 2 or 3 or 4.
Embodiment 7 Dan e Fukang preparation of soft capsule
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
Make medicinal substances extract by embodiment 1
The disperse medium Oleum Cocois: 3: 1 150g of soybean oil,
The suspending agent ethyl cellulose: Ka Baibo resin 3g,
The antiseptic butyl p-hydroxybenzoate, 0.1g,
Surfactant Tween 80 5g
Medical material is made medicinal substances extract by embodiment 1, makes 1000 of soft capsules by embodiment 2 or 3 or 4.