CN107625863A - Treat herbal mixture soft capsule of rheumatism bone disease and preparation method thereof - Google Patents

Treat herbal mixture soft capsule of rheumatism bone disease and preparation method thereof Download PDF

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CN107625863A
CN107625863A CN201710865562.6A CN201710865562A CN107625863A CN 107625863 A CN107625863 A CN 107625863A CN 201710865562 A CN201710865562 A CN 201710865562A CN 107625863 A CN107625863 A CN 107625863A
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parts
soft capsule
herbal mixture
bone disease
treatment
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CN107625863B (en
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朱玲
刘敏
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Wuhan Yuanda Biological Science & Technology Co Ltd
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Abstract

It is tolerant the invention provides the herbal mixture soft capsule for the treatment of rheumatism bone disease, including in flexible glue utricule and soft capsule body, it is tolerant including following Chinese medicine material in the soft capsule body:Grass leaf sweetflag rhizome, tortoise plastron, the rhizome of davallia, notopterygium root, levisticum, reticulate millettia, Chinese yam, matrimony vine, the Radix Astragali, honey, brown sugar, vitamin D, grape-kernel oil.In addition, present invention also offers the preparation method of the herbal mixture soft capsule.Chinese medicine material liver kidney selected by the herbal mixture soft capsule is the same as benefit, there is dispelling wind and eliminating dampness, relaxing tendons and activating collaterals, promoting blood circulation and removing blood stasis, swelling and pain relieving, there is significant therapeutic effect to rheumatism bone disease, cure rate is high, safe ready, have no toxic side effect, change and treat the present situation that the rheumatism bone disease course for the treatment of is long, cure rate is low in the prior art.

Description

Treat herbal mixture soft capsule of rheumatism bone disease and preparation method thereof
Technical field
The invention belongs to medicines and health protection technical field, and in particular to a kind of herbal mixture soft capsule for treating rheumatism bone disease and Its preparation method.
Background technology
Rheumatism bone disease enters human body passages through which vital energy circulates by skin pore, causes blood mainly due in wind-cold damp pathogen intrusion human body Liquid circulation is obstructed, and the passages through which vital energy circulates of people is all happy by qi and blood, and passages through which vital energy circulates is obstructed, and wind-cold damp pathogen is stifled to become silted up at the major acupuncture point of human body On, whole body acupuncture point silting will seriously shake, and have one's fingers all thumbs, and get off the obstructed of passages through which vital energy circulates silting for a long time, the lighter's then pain Unbearably, severe one is handicapped, eventually causes people's paralysis to disable.Traditional Chinese medicine thinks that rheumatism bone disease belongs to the scope of " rheumatism ", lures Sending out this sick factor is because human liver, spleen, kidney asthenia of essence and blood, and muscles and bones, which is lost, supports, the evil intrusion people of wind, cold, wet, heat in nature Body, into joint, qi and blood numbness is hindered, causes QI-blood circulation not smooth, causes blockage of main and collateral channels or phlegm-turbidity and blood stasis blood, or work and rest wound to cause Hemostasis is stagnated, passages through which vital energy circulates is obstructed, causes arthralgia, extremity numbness, anchylosis, bends the symptoms such as body is unfavorable.
At present, the treatment method of rheumatism bone disease includes two kinds of Chinese traditional treatment and western medical treatment method.Doctor trained in Western medicine is to such disease Treatment method be divided into drug therapy, physical treatment, surgical intervention, rehabilitation and special treatment etc., with western medical treatment lack Point is operation pain, is easily recurred, and long-term use of antibiotic have impact on the health of patient;Therefore, treatment rheumatism bone disease leads to Frequently with tcm methodses, the method for Chinese traditional treatment rheumatism bone disease has a variety of, generally speaking including righting and two major classes of getting rid of evils, such as dispels Wind, cold dispelling, dehumidify, moisturize, heat-clearing, purging intense heat etc.;Righting method is mainly negative and positive, qi and blood, the physiological function of internal organs in adjusting body, Strengthen itself resistance against diseases of body etc.;Method of getting rid of evils is mainly the difference according to inclined Sheng and illness because of the exopathogen such as wet that is affected by the cold And take to the ill or the treatment method such as clearing heat and detoxicating or dispelling wind and eliminating dampness cold dispelling.However, by clinical verification, in the prior art Treatment by Chinese herbs method to rheumatism bone disease can cure except small number of patients, and Most patients are only capable of relief of symptoms and can not be effective The development of symptom management.
The content of the invention
It is an object of the invention to provide a kind of herbal mixture soft capsule for treating rheumatism bone disease, between Chinese medicine material Compatibility effect, liver kidney carry out systematic auxiliary treatment with mending, to rheumatism bone disease, and therapeutic effect is notable.
The technical scheme is that a kind of herbal mixture soft capsule for treating rheumatism bone disease is provided, including flexible glue utricule With it is tolerant in soft capsule body, it is tolerant including following Chinese medicine material in the soft capsule body:Grass leaf sweetflag rhizome, tortoise plastron, the rhizome of davallia, notopterygium root, Levisticum, reticulate millettia, Chinese yam, matrimony vine, the Radix Astragali, honey, brown sugar, vitamin D, grape-kernel oil.
Further, the weight proportion of the Chinese medicine material of the herbal mixture soft capsule of above-mentioned treatment rheumatism bone disease is:Shi Chang 20~30 parts of Pu, 5~10 parts of tortoise plastron, 15~20 parts of the rhizome of davallia, 15~20 parts of notopterygium root, 15~20 parts of levisticum, reticulate millettia 5~10 Part, 10~20 parts of Chinese yam, 10~20 parts of matrimony vine, 15~20 parts of the Radix Astragali, 5~10 parts of honey, 5~10 parts of brown sugar, vitamin D 5~ 8 parts, 80~100 parts of grape-kernel oil.
The embodiment of optimization, the weight proportion of the Chinese medicine material of the herbal mixture soft capsule of above-mentioned treatment rheumatism bone disease For:20 parts of grass leaf sweetflag rhizome, 10 parts of tortoise plastron, 15 parts of the rhizome of davallia, 20 parts of notopterygium root, 20 parts of levisticum, 10 parts of reticulate millettia, 20 parts of Chinese yam, matrimony vine 15 parts, 15 parts of the Radix Astragali, 5 parts of honey, 10 parts of brown sugar, 5 parts of vitamin D, 80 parts of grape-kernel oil.
In the Chinese medicine material of the present invention:
Grass leaf sweetflag rhizome has qi-regulating, promoting blood circulation, dissipates the effect of wind dries, eased pain, for wind-cold-dampness arthralgia, swollen ulcer drug, arthritis Bitterly, traumatic injury.
Tortoise plastron is the plastron and carapace of Testudinidae animal, and mild-natured, taste is salty sweet, returns liver and kidney channel, has nourishing and suppressing Yang, kidney tonifying is good for Bone, the effect of blood-nourishing bushing;The treatment insufficiency of the kidney yang, yin asthenia generating intrinsic heat, endogenous deficient wind, the kidney deficiency atrophic debility of bones, halogen door do not conform to, deficiency of YIN-blood, Insomnia of palpitating with fear, it is forgetful.
The rhizome of davallia be Plants of Polypodiaceae Mongolian oak fern dry rhizome, warm-natured, bitter, return kidney, Liver Channel, have The strong bone of kidney tonifying, The effect of continues and hinders pain relieving, for lumbago due to the kidney deficiency, Hiccough and deaf, tooth mobility, falling winks frustrates, injured bone.
Notopterygium root:Acrid flavour is bitter, warm-natured, returns bladder, liver and kidney channel, has relieving exterior syndrome and dispelling cold, expelling wind and eliminating dampness, analgesic, the work(in sharp joint Effect, cure cold chill, and lossless, wind-cold-dampness arthralgia of having a headache, item strengthening tendons is anxious, joint ache, geomantic omen edema, skin sore, waist and knee crymodynia, Deficiency of the kidney and dyspnea, Diarrhoea.
Levisticum is the dry root of samphire Angelica pubescens, and acrid flavour is bitter, slightly warm in nature, returns kidney, bladder warp, has and dispels Wind, win the effect of wet, cold dispelling, analgesic, for diseases such as wind-cold-dampness arthralgia, soreness of waist and knee joint, trick contraction pains.
Reticulate millettia:It is bitter but sweet flavor, warm-natured, return liver and kidney channel, there is blood circulation promoting and enriching, menstruction regulating and pain relieving, the effect of relaxing tendons and activating collaterals.
Chinese yam is the dry rhizome of Dioscoreaceae plant, sweet, mild-natured, returns spleen, lung, kidney channel, has invigorating the spleen, tonifying lung, reinforces the kidney, The effect of strengthening the essence, splenasthenic diarrhea is controlled, protracted dysentery, cough due to consumptive disease, is quenched one's thirst, under seminal emission, band, frequent urination.
Matrimony vine:It is mild-natured, sweet, return liver and kidney channel, there is the effect of nourishing liver and kidney, benefiting shrewd head, for consumption consumptive loss, waist Knee joint soreness, dizziness and tinnitus, Heat Diabetes, blood deficiency chlorosis, blurred vision.
The Radix Astragali:Sweet, slightly warm in nature, return lung, spleen, liver and kidney channel, there is invigorating qi for strengthening superficies, diuretic and maintain drug, apocenosis, expelling pus and promoting granulation The effect of, for treatment deficiency of vital energy weak, anorexia and loose stool, the sinking of qi of middle-jiao, rush down prolapse of the anus for a long time, uterine bleeding of having blood in stool, exterior deficiency spontaneous perspiration, ulcer is difficult to burst, long Burst and do not hold back, blood deficiency chlorosis, Heat Diabetes;Pharmacological research proves that astragalus polyose is one of main active of the Radix Astragali, can conduct Immunopotentiating agent or conditioning agent, there is enhancing Abwehrkraft des Koepers, promote antibody synthesis, bidirectional modulation blood glucose and protection cardiovascular system The effect such as system.
Brown sugar:It is warm-natured, sweet, Return liver, the spleen channel, there is blood-enrich, invigorating the spleen warm stomach, slow middle analgesic, the work to activate blood circulation and disperse blood clots With;Brown sugar contains growth in humans and develops indispensable malic acid, riboflavin, carrotene, nicotinic acid and trace element manganese, zinc, chromium Etc. various elements, easily it is digested.
Vitamin D can promote calcium uptake.
Grape-kernel oil contains the mineral matters such as potassium needed by human, sodium, calcium and various fat-soluble and water soluble vitamin, simultaneously Vitamin E is rich in grape-kernel oil, there is stronger inoxidizability, can effectively extend shelf life of products.
Grass leaf sweetflag rhizome, gas Bao Qingfang, acrid flavour and warm, Xin Kaifangization, temperature victory is raw, has slit phlegm of having one's ideas straightened out, vital energy regualting and blood circulation-promoting, dissipates wind The work(of clearing damp.Grass leaf sweetflag rhizome is longer than scattered wind clearing damp, and the rhizome of davallia is longer than Yi Shen Hua Yu, and the Radix Astragali is longer than invigorating qi for strengthening superficies, and three medicines share, empty Take into account in fact, have complementary advantages, bring out the best in each other;The pungent scattered dry temperature of hardship of levisticum is logical, and its property is eased up, and benefaction blood system, is longer than wind-damp dispelling, can be passed through Qi and blood, waist and knee is dredged, descending leg foot is kind to control few the moon volt wind headache, waist-leg knee foot arthralgia pain due to rheumatism etc., controls the inferior portion partially;Notopterygium root is worked hard Temperature, the clear property of gas is strong, and dispersing strength is strong, and benefaction qi leel, plastid is light clearly, can directly upper mountain peak top, row limb arm is kind to control top ailment said due to cold or exposure, especially with Shoulder back of the body podomere pain person is preferred.Two medicine phases 5, one controls the few cloudy volt wind of foot, and one controls sufficient sun urticaria, and mutual reinforcement between help is simultaneous up and down to control, Both expelling wind and eliminating dampness, numbness relieving and pain relieving effect had been enhanced, has looked after sick position, then compatibility tortoise plastron, reticulate millettia, Chinese yam, Chinese holly up and down in table again Qi, based on promoting blood circulation and removing blood stasis, help to tonify Qi of the kidney, it is comprehensive to be directed to the interpretation of the cause, onset and process of an illness, send medicine compatibility, clear layer.
In addition, present invention also offers the preparation method of the herbal mixture soft capsule of above-mentioned treatment rheumatism bone disease, including such as Lower step:
1) grass leaf sweetflag rhizome, tortoise plastron, the rhizome of davallia, notopterygium root, levisticum, reticulate millettia, Chinese yam, matrimony vine and the Radix Astragali of parts by weight meter, powder are taken Broken sieving, obtain mixing traditional Chinese medicine powder.
2) water of 8~12 times of its weight is added to the mixing traditional Chinese medicine powder obtained by step 1), is decocted 1.5~2 hours, husky cloth mistake Filter to obtain first time extract solution;Residue adds 5~8 times of amount decoctings to boil 1~1.5 hour again, filters to obtain second of extract solution, merges twice Be placed in after extract solution in ceramic cylinder cool down it is standby.
3) take the honey of parts by weight meter and brown sugar to be added in the extract solution cooled down in step 2), stir, in obtaining Medicament extracting solution.
4) into the Chinese medicine extract obtained by step 3) inoculating bifidobacterium, lactic acid bacteria and saccharomycete mixed bacteria liquid, stir After mixing uniformly shading normal temperature storage fermentation 7~10 days is sealed with red cloth.
5) take step 4) ferment after zymotic fluid, boiling sterilization, be concentrated under reduced pressure into relative density as 1.20~1.25 (50 DEG C Heat is surveyed), obtain thick paste;
6) above-mentioned thick paste is taken, is placed in spray drying unit and is spray-dried, and is crushed with universal mill, is sieved, Obtain dry extract;
7) by the gelatin of certain mass number, glycerine, purified water additionization glue tank, stirring heating, treat that gelatin is completely molten After change, 75~80 DEG C are continuously heating to, insulated and stirred, it is 2.5~3.5 ten thousand mpas to be evacuated to viscosity, obtains glue;Again by glue Liquid crosses 60~80 mesh sieves, moves into storage glue tank, 55~65 DEG C of insulations, stands 4~6 hours, standby.
8) gained dry extract and vitamin D in step 6) are well mixed and are dissolved in grape-kernel oil and soft capsule is made It is tolerant in vivo.
9) encapsulating machine is used, the soft capsule content prepared with glue prepared by step 7) with step 8) is prepared into specification For the soft capsule of 0.6g/ grains, dry, produce herbal mixture soft capsule.
Further, 10~20 mesh sieves be crushed in the step 1).
Further, the mass ratio of Bifidobacterium, lactic acid bacteria and saccharomycete is 1 in the step 4):1:1.5, Mixed Microbes Liquid inoculum concentration is 1~2.5%.
Further, spray drying condition in the step 6):Feed liquor temperature of charge is 70~80 DEG C, feed speed 55 ~65mL/min, EAT are 128~150 DEG C, and leaving air temp is 65~75 DEG C.
Further, glue raw material proportioning is 20~25 parts of gelatin in the step 7), 8~10 parts of glycerine, purified water 20 ~25 parts.
Both from the rhizome of plant, extract Chinese medicine by extraction process by water has many Chinese medicines in compound prescription of the present invention Composition is imitated, recycles microorganism deep fermentation that the plant cell remained in extract solution is carried out into broken wall treatment, improves active ingredient Extraction efficiency, while reduce toxic side effect of the Chinese medicine to human body;It is beneficial to the growth of microorganism, hair after water extract addition brown sugar Secondary metabolite caused by ferment can with active ingredient depth integration, it is not volatile;Liquid grape-kernel oil in soft capsule can The active ingredient of Chinese medicine is dissolved in wherein, starvation, it is anti-oxidant to be advantageous to preserve for a long time, while add fat-soluble dimension Raw plain D can promote calcareous absorption, it is promoting blood circulation and removing blood stasis, dissipate wind clearing damp while, increase calcareous and bone density in vivo, repair impaired Joint, adjust mend in all directions, mutually collaboration.
Beneficial effects of the present invention:
(1) the Chinese medicine material liver kidney selected by the herbal mixture soft capsule of this treatment rheumatism bone disease provided by the invention is same Mend, there is dispelling wind and eliminating dampness, relaxing tendons and activating collaterals, promoting blood circulation and removing blood stasis, swelling and pain relieving, there is significant therapeutic effect to rheumatism bone disease, Cure rate is high, safe ready, has no toxic side effect, and changes and treats that the rheumatism bone disease course for the treatment of is long, cure rate is low shows in the prior art Shape.
(2) preparation method of the herbal mixture soft capsule of this treatment rheumatism bone disease provided by the invention is sent out using microorganism Ferment characteristic, by tolerant Chinese medicine material extract solution liquid depth fermentation synthesis secondary metabolite in soft capsule body, strengthen extract Functional characteristic, and the growth of Chinese yam, matrimony vine energy stimulation of bifidobacteria simultaneously, the Radix Astragali can promote the growth of lactic acid bacteria, brown sugar and honeybee Honey is the carbon source of culture medium, and the growth of Mixed Microbes can synthesize the active ingredient in Chinese medical extract, so as to significantly improve effectively into The concentration and content divided.
Embodiment
The technical scheme in the embodiment of the present invention is clearly and completely described below, it is clear that described embodiment Only part of the embodiment of the present invention, rather than whole embodiments.Based on the embodiment in the present invention, the common skill in this area All other embodiment that art personnel are obtained under the premise of creative work is not made, belong to the model that the present invention protects Enclose.
Embodiment 1:
The present embodiment provides a kind of herbal mixture soft capsule for treating rheumatism bone disease, and its preparation process is as follows:
First, weigh grass leaf sweetflag rhizome 200g, tortoise plastron 100g, rhizome of davallia 150g, notopterygium root 200g, levisticum 200g, reticulate millettia 100g, Chinese yam 200g, matrimony vine 150g, Radix Astragali 150g, crushed 10 mesh sieves, be added into the water of 10 times of amounts, decoct 1 hour, husky cloth filtering Obtain first time extract solution;Residue adds 6 times of amount decoctings to boil 1 hour again, filters to obtain second of extract solution, and it is rearmounted to merge extract solution twice Cooled down in ceramic cylinder;50g honey and 100g brown sugar are added into the extract solution after cooling, stirs, obtains Chinese medicine extract.
Then, into above-mentioned Chinese medicine extract inoculating bifidobacterium, lactic acid bacteria and saccharomycete mixed bacteria liquid, stir Shading normal temperature storage fermentation 7~10 days is sealed with red cloth afterwards, the wherein mass ratio of Bifidobacterium, lactic acid bacteria and saccharomycete is 1:1: 1.5, mixed bacteria liquid inoculum concentration is 1%;Take the zymotic fluid after fermentation, boiling sterilization, be concentrated under reduced pressure into relative density for 1.20~ 1.25 (50 DEG C heat survey), obtain medicinal extract, are placed in spray drying unit and are spray-dried, and obtain medicinal powder, in spray-drying process, Feed liquor temperature of charge is 70~80 DEG C, and feed speed is 55~65mL/min, and EAT is 128~150 DEG C, and leaving air temp is 65~75 DEG C.
Secondly, take 250g gelatin, 100ml glycerine and 200ml purified waters in the lump in addition glue tank, stirring heating, treat bright After glue is completely melt, 78 DEG C are continuously heating to, insulated and stirred, it is 2.5~3.5 ten thousand mpas to be evacuated to viscosity, obtains glue;Will The glue crosses 80 mesh sieves, moves into storage glue tank, 60 DEG C of insulations, stand 6 hours it is standby.
Finally, by medicinal powder obtained above and 50g vitamin Ds be well mixed and be dissolved in 800g grape-kernel oils be made it is soft Capsule body content;Using encapsulating machine, glue obtained above is prepared into specification with the soft capsule content prepared is The soft capsule of 0.6g/ grains, dry, produce.
The usage and dosage of the herbal mixture soft capsule of the treatment rheumatism bone disease:Human oral's recommended amounts are 2 times a day, every time 3, adult's body weight is calculated by 60kg, converts into dosage 0.045g/kgbw.
Embodiment 2:
A kind of herbal mixture soft capsule for treating rheumatism bone disease is present embodiments provided, the quality of its Chinese medicine material is:Stone Calamus 300g, tortoise plastron 50g, rhizome of davallia 200g, notopterygium root 150g, levisticum 150g, reticulate millettia 50g, Chinese yam 100g, matrimony vine 100g, Huang Stilbene 200g, honey 100g, brown sugar 50g, vitamin D 80g, grape-kernel oil 1000g.
The preparation method of the herbal mixture soft capsule of the present embodiment treatment rheumatism bone disease is same as Example 1.
Experimental example
1st, material and method
1.1 experimental animals and environment:SPF levels female sd inbred rats 60, body weight about 300g;Experiment condition is barrier environment, Experimental situation temperature is 22~24 DEG C during experiment, humidity 52~58%.
1.2 feed formulas (%):Low calcium casein 23.0, DL- METHIONINE 0.3, cornstarch 32.0, sucrose 30.0 are fine Dimension 5.0, corn oil 5.0, mixed mineral salt 3.5, mixed vitamin 1.0, two choline tartrates 0.2.
1.3 key instrument:SD-1000C bone mineral measuring instruments.
1.4 experimental method
1.4.1 ovary is cut off:Nembutal sodium solution is injected intraperitoneally with 30mg/kgbw dosage in rat, and anesthesia is laggard Row Bilateral oophorectomy, postoperative muscle inject the penicillin of 20,000 units, for three days on end;Sham-operation group is only cut off after opening abdominal cavity 0.5g or so fat, retain bilateral ovaries;5 days after rat ovary excision, vaginal smear examination is carried out, rejects ovary excision not Complete rat.
1.4.2 dosage group selection gives mode with tested material:Experimental animal is randomly divided into six groups by body weight:Sham-operation Group, ovary excision+solvent control group, ovary excision+calcium carbonate control group, ovary excision+sample low dose group, ovary excision+ Sample middle dose group, ovary excision+sample high dose group.According to human oral's recommended amounts, if herbal mixture soft capsule is basic, normal, high Dosage is respectively that 0.225g/kgbw, 0.450g/kgbw, 1.350g/kgbw (are respectively equivalent to human body recommended dose 5th, 10,30 times), during sample preparation, herbal mixture soft capsule content 4.50g in basic, normal, high dosage difference Example 1, 9.00g, 27.00g add deionized water to 200ml, sham-operation group and ovary excision+solvent group to give isometric deionized water, Ovary excision+calcium carbonate control group orally administration 0.479g/kgbw calcium carbonate (equivalent to sample high dose group calcium content), Animal subject gavage is given respectively, and once, gavage volume is 1.0ml/100gbw to daily gavage;It is big from on-test, each group The raising of mouse equal single cage, the feed of more than feeding formula, gavage are given respective by test solution, drink deionized water, totally 90 days.
1.4.3 animal growth index:Weigh weekly body weight.
1.4.4 femoral bmd determines:At the end of experiment, cervical dislocation puts to death rat, peels off right femur, is baked to perseverance Weight, measure femur midpoint and the bone density (BMD) of distal end.
1.4.5 the measure of calcium content of bone:After the gross weight for weighing femur, with chemical determination calcium content of bone.
1.5 experimental datas count:Variance analysis is carried out with the softwares of SPSS 11.0, is as a result represented with mean+SD
2nd, result
Influence of the 2.1 herbal mixture soft capsules to rat body weight, the results are shown in Table 1.The latter stage body weight of rats in sham-operated group and Weight gain is less than solvent control group, and difference has conspicuousness (P > 0.01).
Influence of the sample of table 1 to rat body weight
Influence of the sample of continued 1 to rat body weight
Influence of the 2.2 herbal mixture soft capsules to rat femur length and bone density, the results are shown in Table 2.The stock of each group rat Bone length no significant difference (P > 0.05);Sham-operation group, high dose group rat femur center bone density compare higher than molten Ji Group, difference have conspicuousness (P < 0.05);Sham-operation group, middle and high dosage group rat femur distal end bone density are higher than solvent control Group, difference have conspicuousness (P < 0.01 or P < 0.05).
Influence of the sample of table 2 to rat femur length and bone density
Influence of the 2.3 herbal mixture soft capsules to rat femur weight and calcium content, the results are shown in Table 3.The stock of each group rat Bone weight no significant difference (P > 0.05);Sham-operation group, middle and high dosage group calcium content of bone are higher than solvent control group, and difference has Conspicuousness (P < 0.01 or P < 0.05).
The sample of table 3 is to rat femur weight, the influence of calcium content of bone
3rd, result
Under this experiment condition, with the compound of 0.225g/kgbw, 0.450g/kgbw, 1.350g/kgbw dosage Medicine soft capsule content gives female castration SD rat oral gavages 90 days, and the latter stage body weight and weight gain of rats in sham-operated group are less than molten Agent control group, difference have conspicuousness (P < 0.01);Rats in sham-operated group femur center bone density and distal end bone density, bone calcium Content is significantly higher than solvent control group (P < 0.01 or P < 0.05), shows the low model modeling success of rat bone density; The femur distal end bone density of 0.450g/kgbw dosage group rats, calcium content of bone are significantly higher than solvent control group (P < 0.05), the femur center bone density of 1.350g/kgbw dosage groups rat and distal end bone density, calcium content of bone are significantly higher than Solvent control group (P < 0.01 or P < 0.05), represent that the submitted sample has increase rat bone density effect.
Clinical trial example:
1.1 case selection:100 rheumatism bone diseases accepted for medical treatment Hubei Provincial Hospital of TCM's in March, 2014 in January, 2015 are chosen to face Bed case, wherein man 47, female 53,32~71 years old age, average age 46 ± 3.7 years old, all person patients meet disease Sick inclusive criteria;Patient is divided into treatment group and control group, every group each 50, the clinical data pair such as two groups of patient ages, sexes It is more different in nature (P > 0.05) than without significance difference, it can carry out comparing between group.
1.2 treatment method:For two groups of patients all using conventional treatment method during treatment, 15 days are an experiment week Phase, treatment group daily herbal mixture soft capsule of the present invention sooner or later twice, three every time;Control group is removed and routinely controlled using hospital Outside treating, normal diet, herbal mixture soft capsule is not taken, the therapeutic effect of two groups of patients is contrasted after terminating an experimental period, Observe whether two groups of patients have adverse reaction appearance during treatment.
1.3 result:After 15 days treat (conventional therapy containing hospital), significantly effective 31 in treatment group patient, effective 15, Invalid 4, total effective rate 92%;Significantly effective 23 in control group patient, effective 9, invalid 18, total effective rate is 64%, P < 0.05, two groups of patient outcomes' contrasts are statistically significant.During treatment, two groups of patients have no adverse reaction out It is existing, hepatic and renal function check, none exception are carried out after treatment end.
It is exemplified as above be only to the present invention for example, do not form the limitation to protection scope of the present invention, it is all It is to be belonged to the same or analogous design of the present invention within protection scope of the present invention.

Claims (8)

1. treat rheumatism bone disease herbal mixture soft capsule, including in flexible glue utricule and soft capsule body it is tolerant, it is characterised in that:Institute State tolerant including following Chinese medicine material in soft capsule body:Grass leaf sweetflag rhizome, tortoise plastron, the rhizome of davallia, notopterygium root, levisticum, reticulate millettia, Chinese yam, Chinese holly Qi, the Radix Astragali, honey, brown sugar, vitamin D, grape-kernel oil.
2. the herbal mixture soft capsule for the treatment of rheumatism bone disease as claimed in claim 1, it is characterised in that:The Chinese medicine material Weight proportion is:20~30 parts of grass leaf sweetflag rhizome, 5~10 parts of tortoise plastron, 15~20 parts of the rhizome of davallia, 15~20 parts of notopterygium root, levisticum 15~20 Part, 5~10 parts of reticulate millettia, 10~20 parts of Chinese yam, 10~20 parts of matrimony vine, 15~20 parts of the Radix Astragali, 5~10 parts of honey, brown sugar 5~10 Part, Vitamin D5~8 part, 80~100 parts of grape-kernel oil.
3. the herbal mixture soft capsule for the treatment of rheumatism bone disease as claimed in claim 2, it is characterised in that:The Chinese medicine material Weight proportion is:20 parts of grass leaf sweetflag rhizome, 10 parts of tortoise plastron, 15 parts of the rhizome of davallia, 20 parts of notopterygium root, 20 parts of levisticum, 10 parts of reticulate millettia, Chinese yam 20 Part, 15 parts of matrimony vine, 15 parts of the Radix Astragali, 5 parts of honey, 10 parts of brown sugar, 5 parts of vitamin D, 80 parts of grape-kernel oil.
4. the preparation method of the herbal mixture soft capsule of the treatment rheumatism bone disease as described in any one of claims 1 to 3, its feature It is:Comprise the following steps:
1) grass leaf sweetflag rhizome, tortoise plastron, the rhizome of davallia, notopterygium root, levisticum, reticulate millettia, Chinese yam, matrimony vine and the Radix Astragali of parts by weight meter are taken, crushed Sieve, obtains mixing traditional Chinese medicine powder;
2) water of 8~12 times of its weight is added to the mixing traditional Chinese medicine powder obtained by step 1), is decocted 1.5~2 hours, husky cloth filters First time extract solution;Residue adds 5~8 times of amount decoctings to boil 1~1.5 hour again, filters to obtain second of extract solution, and merging is extracted twice Be placed in after liquid in ceramic cylinder cool down it is standby;
3) take the honey of parts by weight meter and brown sugar to be added in the extract solution cooled down in step 2), stir, obtain Chinese medicine and carry Take liquid;
4) into the Chinese medicine extract obtained by step 3) inoculating bifidobacterium, lactic acid bacteria and saccharomycete mixed bacteria liquid, stirring is equal After even shading normal temperature storage fermentation 7~10 days is sealed with red cloth;
5) zymotic fluid after step 4) fermentation is taken, boiling sterilization, it is 1.20~1.25 (50 DEG C of heat to be concentrated under reduced pressure into relative density Survey), obtain thick paste;
6) above-mentioned thick paste is taken, is placed in spray drying unit and is spray-dried, and is crushed with universal mill, sieves, obtains dry Extract powder;
7) by the gelatin of certain mass number, glycerine, purified water additionization glue tank, stirring heats up, after gelatin is completely melt, 75~80 DEG C are continuously heating to, insulated and stirred, it is 2.5~3.5 ten thousand mpas to be evacuated to viscosity, obtains glue;Again by glue mistake 60~80 mesh sieves, move into storage glue tank, 55~65 DEG C of insulations, stand 4~6 hours, it is standby;
8) gained dry extract and vitamin D in step 6) are well mixed and are dissolved in grape-kernel oil and be made in soft capsule body It is tolerant;
9) encapsulating machine is used, the soft capsule content that the glue prepared with step 7) is prepared with step 8) is prepared into specification and is The soft capsule of 0.6g/ grains, dry, produce herbal mixture soft capsule.
5. the preparation method of the herbal mixture soft capsule for the treatment of rheumatism bone disease as claimed in claim 4, it is characterised in that:It is described 10~20 mesh sieves are crushed in step 1).
6. the preparation method of the herbal mixture soft capsule for the treatment of rheumatism bone disease as claimed in claim 4, it is characterised in that:It is described The mass ratio of Bifidobacterium, lactic acid bacteria and saccharomycete is 1 in step 4):1:1.5, mixed bacteria liquid inoculum concentration is 1~2.5%.
7. the preparation method of the herbal mixture soft capsule for the treatment of rheumatism bone disease as claimed in claim 4, it is characterised in that:It is described Spray drying condition in step 6):Feed liquor temperature of charge is 70~80 DEG C, and feed speed is 55~65mL/min, and EAT is 128~150 DEG C, leaving air temp is 65~75 DEG C.
8. the preparation method of the herbal mixture soft capsule for the treatment of rheumatism bone disease as claimed in claim 4, it is characterised in that:It is described Glue raw material proportioning is 20~25 parts of gelatin in step 7), 8~10 parts of glycerine, 20~25 parts of purified water.
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