CN107669866A - A kind of compound kidney-nourishing tcm drug capsule and preparation method thereof - Google Patents
A kind of compound kidney-nourishing tcm drug capsule and preparation method thereof Download PDFInfo
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- CN107669866A CN107669866A CN201711180580.7A CN201711180580A CN107669866A CN 107669866 A CN107669866 A CN 107669866A CN 201711180580 A CN201711180580 A CN 201711180580A CN 107669866 A CN107669866 A CN 107669866A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/235—Foeniculum (fennel)
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- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
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- A61K36/57—Magnoliaceae (Magnolia family)
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
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Abstract
The present invention relates to drug preparation technique field, in particular to a kind of compound kidney-nourishing tcm drug capsule and preparation method thereof.Described compound kidney-nourishing tcm drug capsule is soft capsule, is made up of capsule material and capsule contents；The capsule contents include each composition of following mass ratio：Oleaginous base:Medicine:Suspending agent:Cosolvent=1:1.625~1.705:0.025~0.035:0.004~0.006.The present invention selects soft capsule dosage form, reduces granulation link, has not only further ensured the thermal degradation of heat-sensitive active material, the effect of ensure that medicine to greatest extent, and reduces the utilization of auxiliary material, the disposable dose of patient is reduced half.
Description
Technical field
The present invention relates to drug preparation technique field, in particular to a kind of compound kidney-nourishing tcm drug capsule and its preparation
Method.
Background technology
Also lack the major product that capsule is Chongqing Three Gorges sea of clouds medicine company, cure mainly：Warm kidney tonifying spleen, blood-nourishing strengthening the essence.For spleen kidney
Deficient, soreness of waist and knee joint, impotence and seminal emission, one's ears rang and spots danced before one's eyes, and essence and blood loss, human body is thin and weak, and anorexia, root of the tooth is ached.Also lack capsule
Annual sales amount exceeded 1 hundred million in 2011, and sales volume also increases with 30% growth rate at present.
But it is existing also lack capsule manufacturing techniques during use hard shell capsules formulation, due to existing in preparation process
Granulation link, can cause the thermal degradation of medicine heat-sensitive active material, and hard shell capsules auxiliary material is more, and drug administration amount is also big.
In view of this, it is special to propose the present invention.
The content of the invention
It is an object of the invention to provide a kind of compound kidney-nourishing tcm drug capsule, to solve the above problems.
In order to realize the above-mentioned purpose of the present invention, spy uses following technical scheme：
The present invention relates to a kind of compound kidney-nourishing tcm drug capsule, and the capsule is soft capsule, by capsule material and capsule contents group
Into；
The capsule contents include each composition of following mass ratio：
Oleaginous base:Medicine:Suspending agent:Cosolvent=1:(1.625~1.705):(0.025~0.035): (0.004
~0.006)；
The medicine is prepared by the raw material of following parts by weight：
245~255 parts of prepared rhizome of rehmannia, 245~255 parts of stir-baked RHIZOMA DIOSCOREAE, 161.75~171.75 parts of the root of bidentate achyranthes, the fruit of Chinese wolfberry 161.75~
171.75 parts, 161.75~171.75 parts of Fructus Corni, 245~255 parts of Poria cocos, salt process 161.75~171.75 parts of the bark of eucommia, radix glycyrrhizae
161.75~171.75 parts of RADIX POLYGALAE PREPARATA, 161.75~171.75 parts of Morinda officinalis of stir-fry, 161.75~171.75 parts of the fruit of Chinese magnoliavine, salt are processed
161.75~171.75 parts of fennel seeds, 161.75~171.75 parts of Paper mulberry Fruit, 161.75~171.75 parts of saline cistanche, grass-leaved sweetflag
245~255 parts 80.75~86.75 parts, stoning of jujube.
The present invention selects soft capsule dosage form, reduces granulation link, has not only further ensured heat-sensitive active material
Thermal degradation, the effect of ensure that medicine to greatest extent, and reduce the utilization of auxiliary material, reduce the disposable dose of patient
Half.
The present invention also designs the preparation method of compound kidney-nourishing tcm drug capsule as described above, including：
A. gelatin, glycerine, sorbierite, water are taken, colloidal sol is heated, prepares rubber；B. capsule contents are well mixed, through soft
Capsule machine is prepared into soft capsule.
Compared with prior art, beneficial effects of the present invention are：
(1) orthogonal experiment method is used, has inquired into the optimum process condition of circumfluence distillation, is analyzed by spss eighteen datas
The analysis of software, obtain the optimum process condition for also lacking capsule circumfluence distillation.Compared with former technique, extraction time was from seven days
Shortening to one day, extraction three times has been changed to secondary, not only reduces the loss of ethanol, and also improves the yield of product,
Comprehensive production integrated cost is set to save nearly 15%.
(2) by experiment of single factor, the moulding process of soft capsule is have studied, optimal raw material proportioning is obtained, passes through breast
Change technology, solve because the higher Chinese medical concrete of moisture height, multicomponent, water-soluble components should not make the technology of soft capsule
Problem.
(3) by the equivalent research of medicine, formulation is improved, reduces substantial amounts of auxiliary material, the active drug of every medicine is high
Degree concentration, makes day dose become from 15 for 6.
Embodiment
The present invention relates to a kind of compound kidney-nourishing tcm drug capsule, and the capsule is soft capsule, by capsule material and capsule contents group
Into；
The capsule contents include each composition of following mass ratio：
Oleaginous base:Medicine:Suspending agent:Cosolvent=1:(1.625~1.705):(0.025~0.035): (0.004
~0.006)；
The medicine is prepared by the raw material of following parts by weight：
245~255 parts of prepared rhizome of rehmannia, 245~255 parts of stir-baked RHIZOMA DIOSCOREAE, 161.75~171.75 parts of the root of bidentate achyranthes, the fruit of Chinese wolfberry 161.75~
171.75 parts, 161.75~171.75 parts of Fructus Corni, 245~255 parts of Poria cocos, salt process 161.75~171.75 parts of the bark of eucommia, radix glycyrrhizae
161.75~171.75 parts of RADIX POLYGALAE PREPARATA, 161.75~171.75 parts of Morinda officinalis of stir-fry, 161.75~171.75 parts of the fruit of Chinese magnoliavine, salt are processed
161.75~171.75 parts of fennel seeds, 161.75~171.75 parts of Paper mulberry Fruit, 161.75~171.75 parts of saline cistanche, grass-leaved sweetflag
245~255 parts 80.75~86.75 parts, stoning of jujube；
It is furthermore preferred that the capsule contents include each composition of following mass ratio：
Oleaginous base:Medicine:Suspending agent:Cosolvent=1:1.665:0.03:0.005.
Preferably, compound kidney-nourishing tcm drug capsule as described above, the oleaginous base are selected from soybean oil or peanut oil；It is more excellent
Elect soybean oil as.
Preferably, compound kidney-nourishing tcm drug capsule as described above, the suspending agent are beeswax.
Preferably, compound kidney-nourishing tcm drug capsule as described above, the cosolvent are tween；Preferably Tween-80.
Preferably, compound kidney-nourishing tcm drug capsule as described above, the medicine are the dry powder drug of 80~120 mesh；It is more excellent
Elect 100 mesh as.
Preferably, compound kidney-nourishing tcm drug capsule as described above, the material component of the capsule material include following mass ratio
Each composition：
Gelatin：Intermixture：Water=1:(0.83~1.03):(1.5~1.7)；Wherein described intermixture is that mass ratio is (18
~20):1 glycerine：Sorbierite；
It is furthermore preferred that the material component of the capsule material of the capsule includes each composition of following mass ratio：
Gelatin：Intermixture：Water=1:0.93:1.6；Wherein described intermixture is that mass ratio is 19:1 glycerine：Sorbierite.
Preferably, compound kidney-nourishing tcm drug capsule as described above, food coloring is also contained in the capsule material；
Preferably, the food coloring include light blue, indigo, lemon yellow, sunset yellow, erythrosine, famille rose, amaranth,
Tomato red, greyish purple, tender leaf is green, the one or more in cacao brown.
Preferably, compound kidney-nourishing tcm drug capsule as described above, the food coloring for account for the capsule material quality 0.4%~
0.6% amaranth；More preferably 0.5% amaranth.
Preferably, compound kidney-nourishing tcm drug capsule as described above, the medicine are prepared by the following method to obtain：
1) stir-baked RHIZOMA DIOSCOREAE is crushed to obtain yam flour by, and the stoning jujube is added water to cook into peeling obtains jujube paste；
2) fruit of Chinese magnoliavine, grass-leaved sweetflag, salt are processed fennel seeds extracting in water by, and volatile oil and the dregs of a decoction are obtained after distillation；
The dregs of a decoction, prepared rhizome of rehmannia, the root of bidentate achyranthes, the fruit of Chinese wolfberry, Fructus Corni, Poria cocos, salt are processed into the bark of eucommia, radix glycyrrhizae RADIX POLYGALAE PREPARATA, fry Morinda offcinalis How
My god, Paper mulberry Fruit, herba cistanches ethanol is heated to reflux extraction and obtains leachate；
3) will be mixed to get medicine after the yam flour, jujube paste, leachate mixing, drying with the volatile oil；
Wherein, step 1) with 2) without sequencing.
This product major function：Warm kidney tonifying spleen, blood-nourishing strengthening the essence.Damaged for spleen kidney deficiency, soreness of waist and knee joint, impotence and seminal emission, tinnitus mesh
Dizzy, essence and blood loss, human body is thin and weak, and anorexia, root of the tooth is ached.
Preferably, compound kidney-nourishing tcm drug capsule as described above, in step 1), the stoning jujube adds water to cook peeling
Specially stoning jujube adds 2.5~3.5 times of amount decoctings to boil 25min~35min, extrudes the peeling of 30~50 mesh sieves；
More preferably stoning jujube adds 3 times of amount decoctings to boil 30min, extrudes the peeling of 40 mesh sieves.
Preferably, compound kidney-nourishing tcm drug capsule as described above, in step 2), the fruit of Chinese magnoliavine, grass-leaved sweetflag, salt are processed
During fennel seeds extracting in water, add the amount of water and the fruit of Chinese magnoliavine, grass-leaved sweetflag, salt to process the solid-to-liquid ratio of fennel seeds gross mass be 1g：7mL
~9mL, extraction time are 5h~7h；
It is furthermore preferred that the solid-to-liquid ratio that the amount of added water processs fennel seeds gross mass with the fruit of Chinese magnoliavine, grass-leaved sweetflag, salt is 1g：
8mL, extraction time 6h.
Preferably, compound kidney-nourishing tcm drug capsule as described above, in step 2), when the ethanol is heated to reflux extracting
Concentration of alcohol is 65v/v%~75v/v%；The solid-to-liquid ratio of the addition of preferred alcohol and material to be extracted is 1g：4mL~5mL；
It is furthermore preferred that in step 2), the concentration of alcohol when ethanol is heated to reflux extracting is 70 v/v%.
Preferably, compound kidney-nourishing tcm drug capsule as described above, in step 2), when the ethanol is heated to reflux extracting
The single-trial extraction time is 110min~130min；
It is furthermore preferred that in step 2), extraction time when ethanol is heated to reflux extraction for 115min~
125min, 120min can also be selected.
Preferably, compound kidney-nourishing tcm drug capsule as described above, in step 2), when the ethanol is heated to reflux extracting
Extracting temperature is 65 DEG C~75 DEG C；More preferably 68 DEG C~72 DEG C, 70 DEG C can also be selected.
Preferably, compound kidney-nourishing tcm drug capsule as described above, in step 2), when the ethanol is heated to reflux extracting
Extraction time is 1~3 time；More preferably 2 times.
The invention further relates to the preparation method of compound kidney-nourishing tcm drug capsule as described above, including：
A. gelatin, glycerine, sorbierite, water are taken, colloidal sol is heated, prepares rubber；B. capsule contents are well mixed, through soft
Capsule machine is prepared into soft capsule.
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the present invention.It is unreceipted specific in embodiment
Condition person, the condition suggested according to normal condition or manufacturer are carried out.Agents useful for same or the unreceipted production firm person of instrument, it is
The conventional products obtained can be bought by city.
Embodiment 1
1. prescription：
Prepared rhizome of rehmannia：250g；Chinese yam (stir-fry)：250g；The root of bidentate achyranthes：166.75g；The fruit of Chinese wolfberry：166.75g；Fructus Corni：166.75g；
Poria cocos：250g；The bark of eucommia (salt is processed)：166.75g；Polygala (liquorice)： 166.75g；Morinda officinalis (stir-fry)：166.75g；The fruit of Chinese magnoliavine：
166.75g；Fennel seeds (salt is processed)： 166.75g；Paper mulberry Fruit：166.75g；Saline cistanche：66.75g；Grass-leaved sweetflag：83.75g；Jujube
(stoning)：250g.
2. preparation method：The five tastes of the above ten, Chinese yam are ground into fine powder, cross 130 mesh sieves, and jujube adds 3.5 times of amount decoctings to boil
35min, the peeling of 30 mesh sieves was extruded, it is standby that jujube paste is made；The fruit of Chinese magnoliavine, grass-leaved sweetflag, fennel seeds add 7 times of amount water extraction volatile oil
5h, the another device of the aqueous solution after distillation are collected, heat at medicinal 65 DEG C of the 4 times of amount 65v/v% ethanol of ten tastes such as the dregs of a decoction and remaining prepared rhizome of rehmannia
Refluxing extraction 3 times, each 110min, merge leachate, reclaim ethanol, mixed with jujube paste, yam flour and be dried under reduced pressure rear and volatilization
Oil is mixed to get medicine.The dry cream of the medicine is worn into 80 mesh powder, appropriate soybean oil, beeswax, Tween-80 is added and mixes system
Into soft capsule 1000, produce.
This product every is containing the fruit of Chinese magnoliavine with schizandrin A (C24H32O6) meter, 0.1mg must not be less than.
Specification：Every dress 0.5g.
Usage and dosage：Orally, once two grains, 2~3 times on the one.
Wherein soybean oil:The dry powder of the medicine:Beeswax:Tween-80=1:1.705:0.025:0.004；
The material component of the capsule material of the capsule is mainly each composition of following mass ratio：
Gelatin：Intermixture：Water=1:0.83:1.7；Wherein described intermixture is that mass ratio is 20:1 glycerine：Sorbierite；
Also containing the amaranth for accounting for the capsule material quality 0.4% in the capsule material.
Embodiment 2
1. prescription：With embodiment 1.
2. preparation method：The five tastes of the above ten, Chinese yam are ground into fine powder, cross 110 mesh sieves, and jujube adds 2.5 times of amount decoctings to boil
25min, the peeling of 50 mesh sieves was extruded, it is standby that jujube paste is made；The fruit of Chinese magnoliavine, grass-leaved sweetflag, fennel seeds add 9 times of amount water extraction volatile oil
7h, the another device of the aqueous solution after distillation are collected, heat at medicinal 75 DEG C of the 5 times of amount 75v/v% ethanol of ten tastes such as the dregs of a decoction and remaining prepared rhizome of rehmannia
Refluxing extraction 1 time, each 130min, merge leachate, reclaim ethanol, mixed with jujube paste, yam flour and be dried under reduced pressure rear and volatilization
Oil is mixed to get medicine.The dry cream of the medicine is worn into 120 mesh powder, appropriate soybean oil, beeswax, Tween-80 is added and mixes
Soft capsule 1000 is made, produces.
This product every is containing the fruit of Chinese magnoliavine with schizandrin A (C24H32O6) meter, 0.1mg must not be less than.
Specification：Every dress 0.5g.
Usage and dosage：Orally, once two grains, 2~3 times on the one.
Wherein soybean oil:The dry powder of the medicine:Beeswax:Tween-80=1:1.625:0.035:0.006；
The material component of the capsule material of the capsule is mainly each composition of following mass ratio：
Gelatin：Intermixture：Water=1:1.03:1.5；Wherein described intermixture is that mass ratio is 18:1 glycerine：Sorbierite；
Also containing the amaranth for accounting for the capsule material quality 0.6% in the capsule material.
Embodiment 3
1. prescription：With embodiment 1.
2. preparation method：The five tastes of the above ten, Chinese yam are ground into fine powder, cross 120 mesh sieves, and jujube adds 3 times of amount decoctings to boil 30 points
Clock, the peeling of 40 mesh sieves was extruded, it is standby that jujube paste is made；The fruit of Chinese magnoliavine, grass-leaved sweetflag, fennel seeds add 8 times of amount water extraction volatile oil 6 small
When, the another device of the aqueous solution after distillation is collected, and heat is returned at medicinal 5,4 times of amounts, 70 DEG C of 75% ethanol of ten tastes such as the dregs of a decoction and remaining prepared rhizome of rehmannia
Flow extraction twice, 2 hours every time, merge leachate, reclaim ethanol, mixed with jujube paste, yam flour and be dried under reduced pressure rear and volatile oil
It is mixed to get medicine.The dry cream of the medicine is worn into 100 mesh powder, appropriate soybean oil, beeswax, Tween-80 is added and mixes system
Into soft capsule 1000, produce.
This product every is containing the fruit of Chinese magnoliavine with schizandrin A (C24H32O6) meter, 0.1mg must not be less than.
Specification：Every dress 0.5g.
Usage and dosage：Orally, once two grains, 2~3 times on the one.
Wherein soybean oil:The dry powder of the medicine:Beeswax:Tween-80=1:1.665:0.03:0.005；
The material component of the capsule material of the capsule is mainly each composition of following mass ratio：
Gelatin：Intermixture：Water=1:0.93:1.6；Wherein described intermixture is that mass ratio is 19:1 glycerine：Sorbierite；
Also containing the amaranth for accounting for the capsule material quality 0.5% in the capsule material.
Experimental example
1.1 also lack soft capsule circumfluence distillation orthogonal test
1.1.1 test material
Raw material：Prepared rhizome of rehmannia, the root of bidentate achyranthes, the fruit of Chinese wolfberry, Fructus Corni, Poria cocos, polygala, Morinda officinalis, saline cistanche, Paper mulberry Fruit, the bark of eucommia
(proportioning is shown in embodiment 1).
Reagent：Ethanol
1.1.2 test method
By prepared rhizome of rehmannia, the root of bidentate achyranthes, the fruit of Chinese wolfberry, Fructus Corni, Poria cocos, polygala, Morinda officinalis, saline cistanche, Paper mulberry Fruit, the bark of eucommia by also few
Mixed after the ratio processing of capsule prescription, it is standby.A certain amount of mixture is taken, is extracted using alcohol heat reflux method, the use of ethanol
Amount is based on cold-maceration.Total paste volume and 70% ethanol leaching paste volume are detected, when investigating concentration of alcohol, Extracting temperature, extraction respectively
Between and influence of the extraction time to extraction effect.Before extraction time is investigated, using the design method of orthogonal test, design
Orthogonal test horizontal 3- factors -3-, it is determined that optimal extraction conditions.The design of experiment is as shown in the table：
On the basis of optimum extraction condition is determined, the influence for wiping extraction time to paste-forming rate is examined, determines extraction time.
1.1.3 result and analysis
Optimization of orthogonal test extraction conditions when, we have investigated 3 factors to total paste volume and leaching paste volume respectively
Influence, experimental result and analysis result are as shown in the table：
The experimental result of table 1
Table 1.1Tests of Between-Subjects Effects
Dependent Variable:Total paste volume
A.R Squared=.989 (Adjusted R Squared=.955)
The concentration of alcohol of table 1.2
Dependent Variable:Total paste volume
The Extracting temperature (DEG C) of table 1.3
Dependent Variable:Total paste volume
The extraction time of table 1.4 (min)
Dependent Variable:Total paste volume
Table 1.5Tests of Between-Subjects Effects
Dependent Variable:Soak paste volume
A.R Squared=.935 (Adjusted R Squared=.742)
The concentration of alcohol of table 1.6
Dependent Variable:Soak paste volume
The Extracting temperature (DEG C) of table 1.7
Dependent Variable:Soak paste volume
The extraction time of table 1.8 (min)
Dependent Variable:Soak paste volume
Table one is the initial data measured according to Orthogonal Experiment and Design, passes through the result such as table after the analysis of spss software processings
It is 1.1-1.8 shown.It can be seen that by table 1.1：Influence power of three factors to total paste volume is different, compares III type square
With understand, the influence concentration of alcohol ＞ extraction time ＞ Extracting temperatures to total paste-forming rate.Observation table 1.2,1.3,1.4 can be drawn
The optimum level of 3 factors is：Concentration of alcohol is 65%, extraction time 120min, Extracting temperature are 70 DEG C.
It can be seen that by table 1.5：Three factors also differ to the influence for soaking paste-forming rate, compare III type quadratic sum and understand,
Influence extraction time ＞ Extracting temperature ＞ concentration of alcohol to soaking paste-forming rate.Observation table 1.6,1.7,1.8 can draw 3 because
Element optimum level be：Concentration of alcohol is 75%, extraction time 120min, Extracting temperature are 70 DEG C.
Also lack capsule extraction process quality control during, we mainly investigate alcohol extract total amount number
(alcohol extract=extract dry cream amount * alcohol extracts percentage composition), it is more, the alcohol leaching of requirement alcohol extract total amount as far as possible
The height that thing content is tried one's best, and total extract dry cream amount is controlled in certain scope as far as possible.Knowable to the data of comprehensive Tables 1 and 2, most
Good extraction conditions are：Concentration of alcohol is 75%, extraction time 120min, Extracting temperature are 70 DEG C.
The determination of 1.2 extraction times
1.2.1 test material
Raw material：Prepared rhizome of rehmannia, the root of bidentate achyranthes, the fruit of Chinese wolfberry, Fructus Corni, Poria cocos, polygala, Morinda officinalis, saline cistanche, Paper mulberry Fruit, the bark of eucommia.
Reagent：Ethanol
1.2.2 test method
Prepared rhizome of rehmannia, the root of bidentate achyranthes, the fruit of Chinese wolfberry, Fructus Corni, Poria cocos, polygala, Morinda officinalis, saline cistanche, Paper mulberry Fruit, the bark of eucommia are pressed into original side
Mixed after ratio processing, it is standby.Cold-maceration is respectively adopted and heat reflow method extracts raw material 3 times, examines respective paste-forming rate.
1.2.3 result and analysis
Cold-maceration and heat reflow method extraction raw material is respectively adopted, the testing result record of paste-forming rate is as under table 2：
The comparison of 2 two kinds of extracting method paste-forming rates of table
| Extracting method | Extract for the first time | Second of extraction | Third time is extracted |
| Cold-maceration | 11% | 5% | 1% |
| Heat reflow method | 18% | 3% | 0.2% |
As seen from the experiment, when extracting first time, the paste-forming rate of heat reflow method has bright than the paste-forming rate of cold-maceration
Raising is shown, has gone up seven percentage points.Since second, the paste-forming rate of heat reflow method is less than cold-maceration, to carrying for the third time
When taking, the paste-forming rate of circumfluence distillation is only 0.2%, illustrates raw material extraction close to complete.
We can draw in summary, using water bath reflux method, extract effect twice than cold-maceration extraction three times
Effect also to get well, which not only improves the economic value of raw material, the time of extraction has also been saved for us, has added production
Energy.
1.3 also lack soft capsule Study on Forming
1.3.1 test material
Soybean oil, active compound dry powder, beeswax, glycerine, gelatin, Tween-80, other auxiliary materials are pharmaceutical grade.
1.3.2 test method
The optimum proportioning of content and capsule material major ingredient is determined respectively by testing, with reference to former Dosing Regimens, with acquisition
Parameter is pelletized, and finally carries out slaking test, examines whether it meets regulation.
1.3.3 result and analysis
Experiment 1：The screening of suspending agent dosage.
There are some researches show the stability of the dosage of oily species, the thickness of medicinal powder and wetting agent to soft capsule content
Have a great impact, therefore, with reference on the basis of numerous documents and materials, we soybean oil is elected to be this soft capsule solvent,
Active compound dry cream crushed 100 mesh sieves, and the dosage of wetting agent Tween-80 is the 0.5% of solvent.
Using beeswax as suspending agent, different amounts of beeswax is added in the suspension of soybean oil active compound powder, is stood, and is observed, note
The time of sedimentation layering occurs for record, and the comparison of passage time can determine the optimum proportioning of suspending agent, as a result as shown in table 3.1：
The suspending agent dosage the selection result of table 3.1
| Test sequence number | Suspending agent % | Settle separation time h |
| 1 | 0 | 0.4 |
| 2 | 1 | 6 |
| 3 | 3 | 24 |
| 4 | 5 | 32 |
As seen from the experiment, suspending agent dosage is bigger, and the time that suspension occurs needed for sedimentation layering is longer, suspension
Stability it is better.When the mass fraction of suspending agent and solvent reaches more than 3%, you can effectively avoid the suspension before encystation
In solid matter settle, and the good fluidity of suspension, such as continue to increase supensoid agent dosage, then suspension is glutinous
Degree increase, poor fluidity, therefore the mass fraction of determination suspending agent beeswax and solvent is 3%.
The instructions of taking of hard shell capsules is：The tablet of 0.42g specifications, three times per day, one time five.It is big to there is dose, takes
With it is inconvenient the problems such as.The soft capsule newly developed needs to increase the drugloading rate of single medicine, and the mass ratio of the suspension of content is：
Soybean oil:Active compound powder:Beeswax:Tween-80=1:1.665:0.03:When 0.005, calculated by 0.5g specifications, 6 soft capsules
Drugloading rate can reach the purpose for being reduced not decreasing effect equivalent to 15 of hard shell capsules.
Test the determination of 2 soft capsule material major ingredients proportioning
Soft capsule is a relatively new type preparation, by the quantitative pressure injection of various indefinite form medicines and can be encapsulated in cyst membrane,
Form the seal capsule of all size.Compared with other formulations, it has, and bioavilability is high, content is accurate, uniformity is good, outer
The features such as shape is attractive in appearance.In recent years, with the progress of science and technology, the research on soft capsule carries out like a raging fire, achieves
Numerous achievements.In terms of capsule material proportioning, there are some researches show the proportioning of major ingredient is：Gelatin：Glycerine：Water=1:0.93:When 1.6,
Softgel shell shaping is good, there is larger dissolution rate；In terms of the selection of additives, the screening of 0.5% amaranth to capsule is added
Photosensitiveness and its color perception all have good effect.Therefore, this experiment compares gelatin with major ingredient：Glycerine：Water=1:0.93:1.6
The amaranth of addition 0.5% is primary condition, using additives sorbierite as variable, determines capsule material most by investigating disintegration duration
Good proportioning, specific experiment method reference《Chinese Pharmacopoeia 2010》In disintegration time mensuration method, experimental result is as shown in table 3.2：
The soft capsule material major ingredient proportioning test result of table 3.2
| Test sequence number | Sorbierite substitutes the amount of glycerine | It is disintegrated duration (h) |
| 1 | 1% | 1.5 |
| 2 | 3% | 0.8 |
| 3 | 5% | 0.3 |
| 4 | 7% | 0.1 |
| 5 | 9% | ＜ 0.1 |
Test result indicates that when the amount that sorbierite substitutes glycerine reaches more than 5%, the disintegration time of capsule is less than
0.3h, meet the standard that country is less than 1h to capsule disintegration time, it is contemplated that cost factor, we are by additives sorbierite
Addition is set to 5%.
In summary, the proportioning of soft capsule material is defined as：Gelatin：Intermixture (glycerine：Sorbierite)：Water=1:0.93
(19:1):1.6, then add 0.5% amaranth.
The performance rating of two, soft capsules
2.1 soft capsule qualities are examined
Using hard capsule as control, according to the quality standard of soft capsule, the indices of soft capsule are detected, testing result is such as
Shown in table 4：
The soft capsule quality assay of table 4
As shown in Table 4, hard shell capsules and the character of soft capsule meet pharmacopeia on relevant criterion as defined in disintegration time limited；Differentiate
Characteristic features and spot are detected under；In terms of schizandrin A content detection, soft capsule improves than the content of hard shell capsules
More than 2.5 times, that is to say, that the content of schizandrin A is with basically identical in five hard shell capsules in 2 soft capsules, really
Realize decrement not decreasing effect；In other indexs, soft capsule and hard shell capsules are consistent, and meet the relevant criterion of country.
The long-term stable experiment of 2.2 soft capsules
2.2.1 test material
The experimental chemical that soft capsule finished product and other coherent detections need.
2.2.2 test method
Press《Chinese medicine, crude drug stability study technological guidance's principle》Phase in state's food medicine prison [2006] No. 278 files of note
Close regulation and carry out experimental design, check item is then detected by this soft capsule quality standard.
2.2.3 result and analysis
Three batches of testing results are as shown in the table：
Nomenclature of drug：Also lack soft capsule lot number:110601 terms of packings:
Nomenclature of drug：Also lack soft capsule lot number:110602 terms of packings:
Nomenclature of drug：Also lack soft capsule lot number:110603 terms of packings:
It can be learnt by the testing result of three batches of medicines：For storage time below 6 months, this soft capsule quality is stable：Outside
See well, content is yellowish-brown oily liquids, there is special smell without significant change；Examined under all discriminating detections
Go out distinctive microscopic features and characteristic spot；Disintegration time is respectively less than 1 hour, reaches the requirement of national relevant regulations；Every
Contained n-butanol extract has exceeded 100mg, has reached 120mg or so；Schizandrin A contained by every exceedes
0.1mg, more than 0.16mg is reached；Bacterium, mould and saccharomycete, the limit test of Escherichia coli meet the requirements.But with
The extension of time, soft capsule shows serious wild effect：Softgel shell gradually becomes tide, adhesion, content leaks, during disintegration
Between significantly increase etc..The reason for supposition causes its unstable mainly has two：First, the glycerol content in capsule shells is very high, have
Very strong water imbibition, by becoming tide, adhesion after constantly absorbing water, finally result in the leakage of content；Although second, in softgel shell
The entrance that sorbierite effectively prevents extraneous oxygen is with the addition of, but due to content complicated component, it is possible to spontaneous hair
Raw oxidation reaction, generates aldehyde material, promotes the cross linking of gelatin in softgel shell, forms the polymer of macromolecular, prevents
The entrance of hydrone, extend disintegration time.At present, by adjusting the proportioning of content, adding the methods of suitable excipients, solution
Certainly soft capsule long term stability problem.
Also lack therapeutic effect of the capsule to perimenopausal syndrome
Applicant convenes 90 one's mid-50s to suffer from the female subjects of perimenopausal syndrome, is randomly divided into 3 groups, respectively
For blank control group, experimental group and contrast groups.Wherein blank control group takes placebo, and what contrast groups were taken is commercially available weight
The production of Three Gorges sea of clouds medicine company limited company is celebrated, Chinese medicines quasi-word also lacks capsule, the medicine of 0.42g specifications for Z50020249's
Piece, three times per day, one time five；What experimental group was taken be 3 groups of preparations of embodiment new technology also lack capsule, three times per day, one
Secondary two.Contrast groups and experimental group are persistently taken 30 days.The content of estrogen in experimenter's serum is extracted after 30 days, specifically
Testing result is referring to table 1；2 are shown in Table to the therapeutic effect of perimenopausal syndrome.
According to the testing result of table 1, by comparing blank control group and experimental group, prepared by the embodiment of the present invention 3 goes back
Few capsule can significantly increase the ability that subject secretes estradiol, oestrone and estriol；And comparative experiments group can with contrast groups
Know, the hard shell capsules being prepared compared to old technology, the soft capsule of new technology is become apparent from due to the lifting of preparation technology, drug effect.
Table 1 also lacks influence of the capsule to estrogen content in subject's body
| Estradiol (ng/mL) | Oestrone (ng/mL) | Estriol (ng/mL) | |
| Blank control group | 30.1 | 0.27 | 0.35 |
| Experimental group | 58.2 | 1.53 | 1.57 |
| Contrast groups | 39.9 | 0.87 | 0.74 |
The present invention evaluates the quality of life of patient using perimenopausal syndrome quality of life assessment scale (MENQOL).
The scale is that Canadian scholar Hilditch in 1996 is developed, totally 29 entries.Emphasis of the present invention is to angiokinesis
Symptom and sexual life symptom are evaluated.Project score is as shown in table 2.
Table 2
| Project | Group | Number of cases | Before intervention | After medication 30 days |
| Vasomotor symptoms | Experimental group | 30 | 5.02±0.83 | 2.42±0.75 |
| Blank control group | 30 | 4.95±1.12 | 4.81±0.71 | |
| Contrast groups | 30 | 4.97±0.89 | 3.26±1.13 | |
| Sexual life symptom | Experimental group | 30 | 3.69±0.96 | 1.69±0.83 |
| Blank control group | 30 | 3.72±1.11 | 3.78±1.03 | |
| Contrast groups | 30 | 3.70±0.83 | 2.20±0.86 |
As a result show：Experimental group and contrast groups take medicine 30 days after vasomotor symptoms and sexual life symptoms score less than sky
White control group, there is statistical significance (p ＜ 0.05), but experimental group drug effect is considerably better than contrast groups, illustrates that new medicine making method can show
Write and improve drug effect, there is the effect of notable to perimenopausal syndrome.
Also lack therapeutic effect of the capsule to male's sexual
90 50 years old or so male subjects are convened, are randomly divided into 3 groups, respectively blank control group, experimental group and right
Compare group.Wherein blank control group takes placebo, and what contrast groups were taken is the commercially available limited public affairs of Chongqing Three Gorges sea of clouds medicine company share
Department production, Chinese medicines quasi-word be Z50020249 also lack capsule, the tablet of 0.42g specifications, three times per day, one time five；Experiment
What group was taken be 3 groups of preparations of embodiment new technology also lack capsule, three times per day, once two.Contrast groups and experimental group are held
It is continuous to take 30 days.The content of testosterone in experimenter's serum is extracted after 30 days, is passed through international index of erectile function table (IIEF-5)
The sexual function of subject is evaluated, specific testing result is referring to table 2.
According to the testing result of table 3, comparative experiments group is understood with blank group, and prepared by the embodiment of the present invention 3 also lacks glue
Capsule can significantly increase the ability and sexual function of subject's Testosterone Secretion；And comparative experiments group is understood with contrast groups, compared to old work
The hard shell capsules that skill is prepared, the soft capsule of new technology are become apparent from due to the lifting of preparation technology, drug effect.
Table 3 also lacks influence of the capsule to testosterone levels in subject's body and international erection index
| Testosterone (μ g/L) | International index of erectile function | |
| Blank group | 3.2 | 12 |
| Experimental group | 4.7 | 22 |
| Contrast groups | 3.8 | 17 |
Finally it should be noted that：Various embodiments above is merely illustrative of the technical solution of the present invention, rather than its limitations；To the greatest extent
The present invention is described in detail with reference to foregoing embodiments for pipe, but it will be understood by those within the art that：Its
The technical scheme described in foregoing embodiments can still be modified, either to which part or all technical characteristic
Carry out equivalent substitution；And these modifications or replacement, the essence of appropriate technical solution is departed from various embodiments of the present invention skill
The scope of art scheme.
Claims (10)
1. a kind of compound kidney-nourishing tcm drug capsule, it is characterised in that the capsule is soft capsule, by capsule material and capsule contents group
Into；
The capsule contents include each composition of following mass ratio：
Oleaginous base:Medicine:Suspending agent:Cosolvent=1:1.625~1.705:0.025~0.035:0.004~0.006；
The medicine is prepared by the raw material of following parts by weight：
245~255 parts of prepared rhizome of rehmannia, 245~255 parts of stir-baked RHIZOMA DIOSCOREAE, 161.75~171.75 parts of the root of bidentate achyranthes, the fruit of Chinese wolfberry 161.75~
171.75 parts, 161.75~171.75 parts of Fructus Corni, 245~255 parts of Poria cocos, salt process 161.75~171.75 parts of the bark of eucommia, radix glycyrrhizae
161.75~171.75 parts of RADIX POLYGALAE PREPARATA, 161.75~171.75 parts of Morinda officinalis of stir-fry, 161.75~171.75 parts of the fruit of Chinese magnoliavine, salt are processed small
161.75~171.75 parts of fennel, 161.75~171.75 parts of Paper mulberry Fruit, 161.75~171.75 parts of saline cistanche, grass-leaved sweetflag
245~255 parts 80.75~86.75 parts, stoning of jujube.
2. compound kidney-nourishing tcm drug capsule according to claim 1, it is characterised in that the oleaginous base be selected from soybean oil or
Peanut oil.
3. compound kidney-nourishing tcm drug capsule according to claim 1, it is characterised in that the suspending agent is beeswax.
4. compound kidney-nourishing tcm drug capsule according to claim 1, it is characterised in that the cosolvent is tween；Preferably
Tween-80.
5. compound kidney-nourishing tcm drug capsule according to claim 1, it is characterised in that the medicine is the medicine of 80~120 mesh
Thing dry powder.
6. compound kidney-nourishing tcm drug capsule according to claim 1, it is characterised in that the material component of the capsule material is included such as
Each composition of lower mass ratio：
Gelatin：Intermixture：Water=1:0.83~1.03:1.5~1.7；Wherein described intermixture is that mass ratio is 18~20:1
Glycerine：Sorbierite.
7. compound kidney-nourishing tcm drug capsule according to claim 6, it is characterised in that also containing edible color in the capsule material
Element；
Preferably, the food coloring includes light blue, indigo, lemon yellow, sunset yellow, erythrosine, famille rose, amaranth, tomato
It is red, greyish purple, tender leaf is green, the one or more in cacao brown.
8. compound kidney-nourishing tcm drug capsule according to claim 7, it is characterised in that the food coloring is to account for the capsule material
The amaranth of quality 0.4%~0.6%.
9. compound kidney-nourishing tcm drug capsule according to claim 1, it is characterised in that the system by the following method of the medicine
It is standby to obtain：
1) stir-baked RHIZOMA DIOSCOREAE is crushed to obtain yam flour by, and the stoning jujube is added water to cook into peeling obtains jujube paste；
2) fruit of Chinese magnoliavine, grass-leaved sweetflag, salt are processed fennel seeds extracting in water by, and volatile oil and the dregs of a decoction are obtained after distillation；
The dregs of a decoction, prepared rhizome of rehmannia, the root of bidentate achyranthes, the fruit of Chinese wolfberry, Fructus Corni, Poria cocos, salt are processed into the bark of eucommia, radix glycyrrhizae RADIX POLYGALAE PREPARATA, fry Morinda officinalis, paper mulberry
Real son, herba cistanches ethanol are heated to reflux extraction and obtain leachate；
3) will be mixed to get medicine after the yam flour, jujube paste, leachate mixing, drying with the volatile oil；
Wherein, step 1) with 2) without sequencing.
10. the preparation method of any one of the claim 1~9 compound kidney-nourishing tcm drug capsule, it is characterised in that including：
A. gelatin, glycerine, sorbierite, water are taken, colloidal sol is heated, prepares rubber；B. capsule contents are well mixed, through soft capsule
Machine is prepared into soft capsule.
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