CN107625863B - Compound traditional Chinese medicine soft capsule for treating rheumatism bone disease and preparation method thereof - Google Patents

Abstract

The invention provides a compound traditional Chinese medicine soft capsule for treating rheumatoid bone diseases, which comprises a soft capsule body and soft capsule body contents, wherein the soft capsule body contents comprise the following traditional Chinese medicine raw materials: rhizoma Acori Graminei, carapax et Plastrum Testudinis, rhizoma Drynariae, Notopterygii rhizoma, radix Angelicae Pubescentis, caulis Spatholobi, rhizoma Dioscoreae, fructus Lycii, radix astragali, Mel, brown sugar, vitamin D, and grape seed oil. In addition, the invention also provides a preparation method of the compound traditional Chinese medicine soft capsule. The traditional Chinese medicine raw materials selected by the compound traditional Chinese medicine soft capsule are tonifying both liver and kidney, have the effects of dispelling wind and removing dampness, relaxing tendons and activating collaterals, promoting blood circulation by removing blood stasis, and relieving swelling and pain, have an obvious treatment effect on the rheumatoid bone diseases, and have the advantages of high cure rate, safety, convenience and no toxic or side effect, and the current situations of long treatment course and low cure rate in the prior art for treating the rheumatoid bone diseases are changed.

Description

Compound traditional Chinese medicine soft capsule for treating rheumatism bone disease and preparation method thereof

Technical Field

The invention belongs to the technical field of medicine and health care, and particularly relates to a compound traditional Chinese medicine soft capsule for treating rheumatoid bone diseases and a preparation method thereof.

Background

The rheumatism bone disease is mainly caused by that wind-cold-dampness pathogen invades the human body and enters the channels of the human body through skin pores to cause unsmooth blood circulation, the channels of the human body are smooth by qi and blood and are not communicated, wind-cold-dampness pathogen is blocked and silted on each large acupuncture point of the human body, the blockage of the whole acupuncture points can shake seriously, hands and feet are inflexible, the blockage of the channels is silted and blocked for a long time, pain is difficult for light people, action of heavy people is inconvenient, and paralysis and disability of the human body can be finally caused. The traditional Chinese medicine considers that the rheumatism bone disease belongs to the range of 'arthralgia syndrome', and the factors inducing the rheumatism bone disease are caused by insufficient essence and blood of liver, spleen and kidney of a human body, malnutrition of muscles and bones, invasion of pathogenic factors of wind, cold, dampness and heat in the nature into the human body, entering joints, qi and blood obstruction, unsmooth circulation of qi and blood, blockage of channels and collaterals or turbid phlegm and blood stasis, or stagnation of blood stasis and obstruction of channels and collaterals caused by overstrain and trauma, arthralgia, numbness of limbs, stiff joints, unfavorable bending of the body and the like.

At present, the treatment methods of the rheumatoid bone diseases comprise two methods of traditional Chinese medicine treatment and western medicine treatment. The western medicine treatment method for the diseases comprises drug treatment, physical treatment, surgical treatment, rehabilitation treatment, special treatment and the like, and the western medicine treatment has the defects of operation pain and easy relapse, and the health of the patient is influenced by long-term use of antibiotics; therefore, the traditional Chinese medicine method is generally adopted for treating the rheumatic bone disease, and the traditional Chinese medicine method for treating the rheumatic bone disease has various methods, generally comprises two categories of strengthening body resistance and eliminating pathogenic factors, such as dispelling wind, dispelling cold, removing dampness, moistening dryness, clearing heat, purging fire and the like; the body resistance strengthening method is mainly to regulate the physiological functions of yin and yang, qi and blood and viscera in vivo, enhance the self-resistance of the organism and the like; the pathogenic factors expelling method is mainly based on the excessive pathogenic factors and the difference of symptoms caused by wind-cold-dampness, and adopts symptomatic treatment methods such as clearing away heat and toxic materials, or dispelling wind, removing dampness and dispelling cold. However, clinical verification shows that the traditional Chinese medicine treatment method for the rheumatoid bone disease in the prior art can cure only a few patients, and most patients can only relieve symptoms but cannot effectively control the development of the disease.

Disclosure of Invention

The invention aims to provide a compound traditional Chinese medicine soft capsule for treating rheumatoid bone diseases, which performs systemic adjuvant therapy on the rheumatoid bone diseases by using compatibility of traditional Chinese medicine raw materials and tonifying liver and kidney, and has obvious treatment effect.

The technical scheme of the invention provides a compound traditional Chinese medicine soft capsule for treating rheumatoid bone diseases, which comprises a soft capsule body and soft capsule body contents, wherein the soft capsule body contents comprise the following traditional Chinese medicine raw materials: rhizoma Acori Graminei, carapax et Plastrum Testudinis, rhizoma Drynariae, Notopterygii rhizoma, radix Angelicae Pubescentis, caulis Spatholobi, rhizoma Dioscoreae, fructus Lycii, radix astragali, Mel, brown sugar, vitamin D, and grape seed oil.

Further, the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease comprises the following traditional Chinese medicine raw materials in parts by weight: 20-30 parts of calamus, 5-10 parts of tortoise shell, 15-20 parts of drynaria rhizome, 15-20 parts of notopterygium root, 15-20 parts of radix angelicae pubescentis, 5-10 parts of caulis spatholobi, 10-20 parts of Chinese yam, 10-20 parts of medlar, 15-20 parts of astragalus membranaceus, 5-10 parts of honey, 5-10 parts of brown sugar, 5-8 parts of vitamin D and 80-100 parts of grape seed oil.

According to an optimized implementation scheme, the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease comprises the following traditional Chinese medicine raw materials in parts by weight: 20 parts of acorus gramineus, 10 parts of tortoise shell, 15 parts of rhizoma drynariae, 20 parts of notopterygium root, 20 parts of radix angelicae pubescentis, 10 parts of caulis spatholobi, 20 parts of Chinese yam, 15 parts of medlar, 15 parts of astragalus membranaceus, 5 parts of honey, 10 parts of brown sugar, 5 parts of vitamin D and 80 parts of grape seed oil.

The traditional Chinese medicine raw materials of the invention are as follows:

rhizoma Acori Graminei has effects of regulating qi-flowing, promoting blood circulation, dispelling pathogenic wind, removing dampness, and relieving pain, and can be used for treating rheumatism, superficial infection, toxic swelling, arthralgia, and traumatic injury.

The carapax et Plastrum Testudinis is abdomen and dorsal scale of animals of the family Testudinis, has mild nature and salty and sweet taste, and can enter liver and kidney channels, and has effects of nourishing yin, suppressing yang, invigorating kidney, strengthening bone, nourishing blood, and nourishing heart; can be used for treating kidney yang deficiency, yin deficiency, internal heat, deficiency wind, kidney deficiency, bone atrophy, asthenia of viscera, deficiency of yin and blood, palpitation, insomnia, and amnesia.

The rhizoma Drynariae is dry rhizome of Drynariae orthopedics plant Drynariae, has warm and bitter taste, enters kidney and liver channels, has effects of invigorating kidney, strengthening bone, and relieving pain, and can be used for treating kidney essence deficiency, lumbago, tinnitus, deafness, odontoseisis, traumatic injury, contusion, and fracture of bones and muscles.

Notopterygium root: the traditional Chinese medicine composition is pungent and bitter in taste and warm in nature, enters bladder, liver and kidney channels, has the effects of relieving exterior syndrome, dispelling cold, dispelling wind, eliminating dampness, relieving pain and benefiting joints, and is used for treating cold, wind-cold, headache, anhidrosis, wind-cold-dampness arthralgia, neck rigidity, spasm, aching pain of bone joints, edema due to wind-cold, carbuncle, sore, cold pain of waist and knees, asthma due to kidney deficiency and diarrhea before dawn.

Radix Angelicae Pubescentis is dry root of Angelica gigas nakai of Umbelliferae, has pungent and bitter taste and mild nature, enters kidney and bladder channels, has effects of dispelling pathogenic wind, eliminating dampness, dispelling cold and relieving pain, and can be used for treating anemofrigid-damp arthralgia, soreness of waist and knees, and spasm and pain of hands and feet.

Caulis spatholobi: is bitter and sweet in taste and warm in nature, enters liver and kidney channels, and has the effects of promoting blood circulation, tonifying blood, regulating menstruation, relieving pain, relaxing muscles and tendons and activating collaterals.

The rhizoma Dioscoreae is dry rhizome of Dioscoreaceae plant, has sweet taste and neutral nature, and has effects of invigorating spleen, tonifying lung, invigorating kidney, replenishing essence, and treating spleen deficiency diarrhea, chronic dysentery, cough due to asthenia, diabetes, nocturnal emission, leukorrhagia, and frequent micturition.

Medlar: neutral in nature and sweet in taste, enters liver and kidney meridians, has the effects of nourishing liver and kidney, replenishing vital essence and improving eyesight, and is used for consumptive disease and essence deficiency, soreness and pain of waist and knees, dizziness and tinnitus, internal heat and thirst, blood deficiency and sallow complexion, and blurred vision.

Astragalus root: sweet in taste and slightly warm in nature, enters lung, spleen, liver and kidney meridians, has the effects of tonifying qi, consolidating superficial resistance, promoting urination, expelling toxin, discharging pus, healing sore and promoting granulation, and is used for treating qi deficiency, hypodynamia, anorexia, loose stool, sinking of middle-jiao energy, chronic diarrhea, rectocele, hematochezia, metrorrhagia and metrostaxis, superficial deficiency, spontaneous perspiration, carbuncle, cellulitis, ulceration difficulty, ulceration failure, blood deficiency, sallow complexion, internal heat, and diabetes; pharmacological research proves that astragalus polysaccharide is one of the main active ingredients of astragalus, can be used as an immune promoter or a regulator, and has the effects of enhancing the body resistance, promoting antibody synthesis, bidirectionally regulating blood sugar, protecting a cardiovascular system and the like.

Brown sugar: the wine is warm in nature and sweet in taste, enters liver and spleen channels, and has the effects of tonifying qi and enriching blood, tonifying spleen and warming stomach, relieving pain, and activating blood circulation to dissipate blood stasis; brown sugar contains malic acid, riboflavin, carotene, nicotinic acid and trace elements such as manganese, zinc and chromium which are indispensable to human growth and development, and is easy to be digested and absorbed by human body.

Vitamin D can promote calcium absorption.

The grape seed oil contains mineral substances such as potassium, sodium, calcium and the like and various fat-soluble and water-soluble vitamins which are necessary for human bodies, and meanwhile, the grape seed oil is rich in vitamin E, has stronger inoxidizability and can effectively prolong the shelf life of the product.

Shichang Pu is thin and fragrant in qi, pungent and warm in flavor, pungent and fragrant in flavor, warm in nature and capable of dispelling dampness and cold in nature, and has the functions of inducing resuscitation and eliminating phlegm, regulating qi and activating blood circulation, and dispelling wind and eliminating dampness. The acorus gramineus is good at dispelling wind and eliminating dampness, the rhizoma drynariae is good at tonifying the kidney and removing blood stasis, the astragalus membranaceus is good at tonifying qi and strengthening exterior, the three medicines are combined, the deficiency and the excess are taken into consideration, the advantages are complementary, and the three medicines complement each other; the radix angelicae pubescentis is pungent, bitter, dry and warm in nature, mild in nature, good for promoting blood circulation, good for dispelling wind-damp, capable of promoting qi and blood circulation, dredging waist and knee joints, descending leg and foot, good for treating shaoyin wind-cold headache, waist, leg, knee and foot rheumatism pain and the like, and treating the lower part; qiang Huo is pungent, bitter and warm in flavor, strongly divergent in nature, good at moving qi system, and clear and light in weight, so it can be used to treat wind pathogen at upper part, especially pain in shoulder, back and limbs. The two medicines are compatible, one is used for treating wind-cold-wind-proneness of foot-yin, the other is used for treating wind-cold-wind-proneness of foot-sun, the two medicines are mutually reinforced, the upper and lower parts are treated, the effects of dispelling wind-damp, dredging arthralgia and relieving pain are enhanced, the upper and lower disease positions of the exterior and interior are taken care of, and the tortoise shell, the caulis spatholobi, the Chinese yam and the medlar are combined, so that the effects of promoting blood circulation and removing blood stasis are mainly taken as the main, the kidney is tonifying and qi is supplemented, the pathogenesis is.

In addition, the invention also provides a preparation method of the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease, which comprises the following steps:

1) taking calamus, tortoise shell, rhizoma drynariae, notopterygium root, radix angelicae pubescentis, caulis spatholobi, Chinese yam, medlar and astragalus mongholicus in parts by weight, crushing and sieving to obtain mixed traditional Chinese medicine powder.

2) Adding water with the weight 8-12 times that of the mixed traditional Chinese medicine powder obtained in the step 1), decocting for 1.5-2 hours, and filtering with gauze to obtain a first extracting solution; and adding 5-8 times of water into the residues, decocting for 1-1.5 hours, filtering to obtain a second extracting solution, combining the two extracting solutions, and placing the mixture in a ceramic jar for cooling for later use.

3) Adding honey and brown sugar in parts by weight into the cooled extracting solution in the step 2), and uniformly stirring to obtain the traditional Chinese medicine extracting solution.

4) Inoculating mixed bacteria liquid of bifidobacterium, lactobacillus and saccharomycetes into the traditional Chinese medicine extracting solution obtained in the step 3), uniformly stirring, sealing with red cloth, shading, storing at normal temperature, and fermenting for 7-10 days.

5) Taking the fermentation liquor fermented in the step 4), boiling for sterilization, and concentrating under reduced pressure until the relative density is 1.20-1.25 (measured at 50 ℃), so as to obtain thick paste;

6) spray drying the above soft extract in a spray drying machine, pulverizing with a universal mill, and sieving to obtain dry extract powder;

7) adding gelatin, glycerol and purified water in certain parts by weight into a gelatin melting tank, stirring and heating, after the gelatin is completely melted, continuously heating to 75-80 ℃, preserving heat and stirring, and vacuumizing until the viscosity is 2.5-3.5 ten thousand mpa · s to obtain a gelatin solution; and sieving the glue solution with a 60-80-mesh sieve, transferring the glue solution into a glue storage tank, preserving heat at 55-65 ℃, and standing for 4-6 hours for later use.

8) Uniformly mixing the dry extract powder obtained in the step 6) with vitamin D, dissolving the mixture in grape seed oil, and preparing the content of the soft capsule.

9) Using a soft capsule machine, preparing the glue solution prepared in the step 7) and the content of the soft capsule prepared in the step 8) into soft capsules with the specification of 0.6 g/capsule, and drying to obtain the compound traditional Chinese medicine soft capsules.

Further, crushing and sieving with a sieve of 10-20 meshes in the step 1).

Further, in the step 4), the mass ratio of the bifidobacteria to the lactic acid bacteria to the yeasts is 1:1:1.5, and the inoculation amount of the mixed bacterial liquid is 1-2.5%.

Further, the spray drying conditions in the step 6) are as follows: the temperature of the liquid inlet material is 70-80 ℃, the liquid inlet speed is 55-65 mL/min, the air inlet temperature is 128-150 ℃, and the air outlet temperature is 65-75 ℃.

Further, the glue solution in the step 7) comprises 20-25 parts of gelatin, 8-10 parts of glycerol and 20-25 parts of purified water.

In the compound prescription, a plurality of traditional Chinese medicinal materials are all from roots and stems of plants, effective components of the traditional Chinese medicinal materials are extracted by a water extraction process, and plant cells remained in an extracting solution are subjected to wall breaking treatment by utilizing microorganism submerged fermentation, so that the extraction efficiency of the effective components is improved, and the toxic and side effects of the traditional Chinese medicinal materials on human bodies are reduced; the water extract is added with brown sugar to be beneficial to the growth of microorganisms, and secondary metabolites generated by fermentation can be deeply fused with effective components and are not easy to volatilize; the liquid grape seed oil in the soft capsule can dissolve the effective components of the traditional Chinese medicinal materials in the soft capsule, isolate oxygen, resist oxidation and be beneficial to long-time storage, meanwhile, fat-soluble vitamin D is added to promote the absorption of calcium, and the soft capsule can promote blood circulation to remove blood stasis, disperse wind and eliminate dampness, increase the calcium and bone density in vivo, repair damaged joints, regulate and supplement in all aspects and cooperate with each other.

The invention has the beneficial effects that:

(1) the traditional Chinese medicine raw materials selected by the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease provided by the invention are liver and kidney tonifying, have the effects of dispelling wind and removing dampness, relaxing tendons and activating collaterals, promoting blood circulation to remove blood stasis, and relieving swelling and pain, have an obvious treatment effect on the rheumatoid bone disease, are high in cure rate, safe and convenient, have no toxic or side effect, and change the current situations of long course of treatment and low cure rate for treating the rheumatoid bone disease in the prior art.

(2) According to the preparation method of the compound traditional Chinese medicine soft capsule for treating the rheumatic bone disease, provided by the invention, the microbial fermentation characteristic is utilized, the liquid of the traditional Chinese medicine raw material extract of the content in the soft capsule is deeply fermented to synthesize a secondary metabolite, the functional characteristic of the extract is enhanced, meanwhile, the Chinese yam and the medlar can stimulate the growth of bifidobacterium, the astragalus can promote the growth of lactic acid bacteria, brown sugar and honey are carbon sources of a culture medium, and the growth of mixed bacteria can synthesize effective components in the traditional Chinese medicine extract, so that the concentration and the content of the effective components are obviously improved.

Detailed Description

The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1:

the embodiment provides a compound traditional Chinese medicine soft capsule for treating rheumatoid bone diseases, which is prepared by the following steps:

firstly, weighing 200g of calamus, 100g of tortoise shell, 150g of rhizoma drynariae, 200g of notopterygium root, 200g of radix angelicae pubescentis, 100g of caulis spatholobi, 200g of Chinese yam, 150g of medlar and 150g of astragalus mongholicus, crushing, sieving with a 10-mesh sieve, adding 10 times of water, decocting for 1 hour, and filtering with gauze to obtain a first extracting solution; adding 6 times of water into the residue, decocting for 1 hour, filtering to obtain a second extractive solution, mixing the two extractive solutions, and cooling in a ceramic jar; adding 50g of honey and 100g of brown sugar into the cooled extracting solution, and uniformly stirring to obtain the traditional Chinese medicine extracting solution.

Then inoculating mixed bacteria liquid of bifidobacterium, lactobacillus and saccharomycetes into the traditional Chinese medicine extracting solution, uniformly stirring, sealing by red cloth, shading, storing at normal temperature and fermenting for 7-10 days, wherein the mass ratio of the bifidobacterium, the lactobacillus and the saccharomycetes is 1:1:1.5, and the inoculation amount of the mixed bacteria liquid is 1%; taking fermented broth, boiling for sterilization, concentrating under reduced pressure until the relative density is 1.20-1.25 (measured at 50 ℃) to obtain an extract, and placing the extract in a spray drying machine set for spray drying to obtain medicinal powder, wherein in the spray drying process, the temperature of liquid inlet materials is 70-80 ℃, the liquid inlet speed is 55-65 mL/min, the air inlet temperature is 128-150 ℃, and the air outlet temperature is 65-75 ℃.

Secondly, adding 250g of gelatin, 100ml of glycerol and 200ml of purified water into a gelatin melting tank, stirring and heating, continuously heating to 78 ℃ after the gelatin is completely melted, preserving heat and stirring, and vacuumizing until the viscosity is 2.5-3.5 ten thousand mpa · s to obtain a gelatin solution; and (3) sieving the glue solution with a 80-mesh sieve, transferring the glue solution into a glue storage tank, preserving heat at 60 ℃, and standing for 6 hours for later use.

Finally, uniformly mixing the obtained medicinal powder with 50g of vitamin D, and dissolving the mixture in 800g of grape seed oil to prepare the content of the soft capsule; and (3) preparing the obtained glue solution and the prepared soft capsule content into soft capsules with the specification of 0.6 g/capsule by using a soft capsule machine, and drying to obtain the soft capsule.

The compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease has the usage and dosage as follows: the recommended dose for oral administration to human body is 2 times daily, 3 capsules each time, and the adult weight is calculated according to 60kg, and the equivalent dose is 0.045g/kg · bw.

Example 2:

the embodiment provides a compound traditional Chinese medicine soft capsule for treating rheumatoid bone diseases, which comprises the following traditional Chinese medicine raw materials in mass: 300g of rhizoma acori graminei, 50g of tortoise shell, 200g of rhizoma drynariae, 150g of notopterygium root, 150g of radix angelicae pubescentis, 50g of caulis spatholobi, 100g of Chinese yam, 100g of medlar, 200g of astragalus membranaceus, 100g of honey, 50g of brown sugar, 80g of vitamin D and 1000g of grape seed oil.

The preparation method of the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease is the same as that of the example 1.

Examples of the experiments

1. Materials and methods

1.1 Experimental animals and Environment: SPF grade female SD rats 60, weighing about 300 g; the experimental conditions are a barrier environment, the temperature of the experimental environment is 22-24 ℃ and the humidity is 52-58% during the experiment.

1.2 feed formulation (%): 23.0 parts of low-calcium casein, 0.3 part of DL-methionine, 32.0 parts of corn starch, 30.0 parts of cane sugar, 5.0 parts of fiber, 5.0 parts of corn oil, 3.5 parts of mixed mineral salt, 1.0 part of mixed vitamin and 0.2 part of choline bitartrate.

1.3 Main instruments: SD-1000C bone mineral substance measuring instrument.

1.4 Experimental methods

1.4.1 oophorectomy: injecting a sodium pentobarbital solution into the abdominal cavity of a rat at the dose of 30mg/kg · bw, performing bilateral oophorectomy after anesthesia, and injecting 2 ten thousand units of penicillin into the muscle after operation for 3 days continuously; the sham operation group only cuts about 0.5g of fat after opening the abdominal cavity, and the ovaries at both sides are reserved; 5 days after ovariectomy of the rats, vaginal smear examination was performed to eliminate the ovariectomized rats.

1.4.2 dose group selection and subject administration: the experimental animals were randomly divided into six groups by weight: sham surgery, ovariectomy + solvent control, ovariectomy + calcium carbonate control, ovariectomy + sample low dose, ovariectomy + sample medium dose, and ovariectomy + sample high dose. According to the recommended oral dose of a human body, the low, medium and high doses of the compound traditional Chinese medicine soft capsule are respectively 0.225g/kg · bw, 0.450g/kg · bw and 1.350g/kg · bw (respectively equivalent to 5, 10 and 30 times of the recommended oral dose of the human body), when samples are prepared, 4.50g, 9.00g and 27.00g of contents of the compound traditional Chinese medicine soft capsule in example 1 are respectively taken as the low, medium and high doses, deionized water is added to 200ml, isovolumetric deionized water is given to a sham operation group and an oophorectomy + solvent group, calcium carbonate (equivalent to the calcium content of the sample high dose group) of 0.479g/kg · bw is given to an oophorectomy + calcium carbonate control group through the mouth, the test animals are respectively given to the gavage once a day, and the gavage volume is 1.0ml/100g · bw; from the start of the experiment, rats in each group were raised in a single cage, fed with the above formula, gavaged with the respective test solution, and given deionized water for 90 days.

1.4.3 animal growth and development indexes: weigh the body weight weekly.

1.4.4 femoral bone Density determination: at the end of the experiment, the rats were sacrificed by dislocation of the cervical vertebrae, the right femur was peeled off, baked to constant weight, and the bone density (BMD) at the midpoint of the femur was measured.

1.4.5 determination of bone calcium content: after weighing the total weight of the femur, the bone calcium content was determined chemically.

1.5 statistics of experimental data: analysis of variance was performed using SPSS 11.0 software, and the results are expressed as mean. + -. standard deviation

2. Results

2.1 the effect of the compound Chinese medicinal soft capsule on the weight of rats, the results are shown in Table 1. The terminal weight and weight gain of the sham-operated rats are lower than those of the solvent control group, and the difference is significant (P is more than 0.01).

TABLE 1 Effect of samples on rat body weight

TABLE 1 Effect of samples on rat body weight

2.2 the effect of the compound Chinese medicinal soft capsule on the length and bone density of rat femur, the results are shown in Table 2. The difference of the length of the thighbone of each group of rats is not significant (P is more than 0.05); the bone density of the femoral center of the rats in the sham operation group and the high dose group is higher than that of the relief control group, and the difference is significant (P is less than 0.05).

TABLE 2 Effect of samples on rat femur length and bone Density

2.3 the effect of the compound Chinese medicinal soft capsule on the weight and calcium content of rat femur, the results are shown in Table 3. The femur weight difference of each group of rats is not significant (P is more than 0.05); the bone calcium content of the sham operation group, the medium-dose group and the high-dose group is higher than that of the solvent control group, and the difference is significant (P is less than 0.01 or P is less than 0.05).

TABLE 3 Effect of samples on rat femur weight and bone calcium content

3. Results

Under the experimental condition, the contents of the compound traditional Chinese medicine soft capsule with the doses of 0.225 g/kg-bw, 0.450 g/kg-bw and 1.350 g/kg-bw are used for gastric perfusion of female castrated SD rats for 90 days, the terminal weight and the weight gain of the rats in the sham operation group are lower than those of a solvent control group, and the difference is significant (P is less than 0.01); the bone density and bone calcium content of the femoral center of a rat in the sham operation group are obviously higher than those of a solvent control group (P is less than 0.01 or P is less than 0.05), which indicates that the model of the rat with low bone density is successfully molded; the bone calcium content of the rats in the 0.450 g/kg-bw dosage group is obviously higher than that of the solvent control group (P < 0.05), and the bone density and the bone calcium content of the femoral center of the rats in the 1.350 g/kg-bw dosage group are obviously higher than those of the solvent control group (P < 0.01 or P < 0.05), which indicates that the test sample has the effect of increasing the bone density of the rats.

Clinical experimental examples:

1.1 case selection: selecting 100 clinical cases of the rheumatic bone disease collected from 3 months 2014 to 1 month 2015 in traditional Chinese medicine institute of Hubei province, wherein 47 cases of men and 53 cases of women are aged 32-71 years and the average age is 46 +/-3.7 years, and all the selected patients meet the disease inclusion standard; the patients are divided into a treatment group and a control group, 50 patients in each group have no significant difference (P is more than 0.05) in comparison of clinical data such as age, sex and the like of the patients in the two groups, and comparison among the groups can be carried out.

1.2 methods of treatment: the two groups of patients adopt a conventional treatment method in the treatment period, fifteen days are an experimental period, and the treatment group takes the compound traditional Chinese medicine soft capsule twice in the morning and at night every day, three capsules each time; the control group adopts the hospital routine treatment, and normal diet, does not take the compound traditional Chinese medicine soft capsule, compares the treatment effect of the two groups of patients after one experiment period is finished, and observes whether the two groups of patients have adverse reaction during the treatment period.

1.3 results: after 15 days of treatment (including hospital conventional treatment), 31 cases of patients in a treatment group are remarkably effective, 15 cases of patients are effective, 4 cases of patients are ineffective, and the total effective rate is 92%; 23 patients in the control group are obviously effective, 9 patients are effective, 18 patients are ineffective, the total effective rate is 64 percent, P is less than 0.05, and the comparison of the treatment effects of the two groups of patients has statistical significance. During the treatment period, no adverse reaction appears in two groups of patients, and after the treatment is finished, the functions of the liver and the kidney are rechecked, so that no abnormal condition exists.

The above examples are merely illustrative of the present invention and should not be construed as limiting the scope of the invention, which is intended to be covered by the claims and any design similar or equivalent to the scope of the invention.

Claims (7)

1. The compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease comprises a soft capsule body and contents of the soft capsule body, and is characterized in that: the contents of the soft capsule are prepared from the following raw materials: 20-30 parts of calamus, 5-10 parts of tortoise shell, 15-20 parts of drynaria rhizome, 15-20 parts of notopterygium root, 15-20 parts of radix angelicae pubescentis, 5-10 parts of caulis spatholobi, 10-20 parts of Chinese yam, 10-20 parts of medlar, 15-20 parts of astragalus membranaceus, 5-10 parts of honey, 5-10 parts of brown sugar, 5-8 parts of vitamin D and 80-100 parts of grape seed oil; wherein the rhizoma Acori Graminei, carapax et Plastrum Testudinis, rhizoma Drynariae, Notopterygii rhizoma, radix Angelicae Pubescentis, caulis Spatholobi, rhizoma Dioscoreae, fructus Lycii and radix astragali are water extracts.

2. The compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease as claimed in claim 1, which is characterized in that: the weight ratio of the raw materials is as follows: 20 parts of acorus gramineus, 10 parts of tortoise shell, 15 parts of rhizoma drynariae, 20 parts of notopterygium root, 20 parts of radix angelicae pubescentis, 10 parts of caulis spatholobi, 20 parts of Chinese yam, 15 parts of medlar, 15 parts of astragalus membranaceus, 5 parts of honey, 10 parts of brown sugar, 5 parts of vitamin D and 80 parts of grape seed oil.

3. The method for preparing the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease as claimed in claim 1 or 2, which is characterized in that: the method comprises the following steps:

1) taking calamus, tortoise shell, rhizoma drynariae, notopterygium root, radix angelicae pubescentis, caulis spatholobi, Chinese yam, medlar and astragalus mongholicus in parts by weight, crushing and sieving to obtain mixed traditional Chinese medicine powder;

2) adding water with the weight 8-12 times that of the mixed traditional Chinese medicine powder obtained in the step 1), decocting for 1.5-2 hours, and filtering with gauze to obtain a first extracting solution; adding 5-8 times of water into the residues, decocting for 1-1.5 hours, filtering to obtain a second extracting solution, combining the two extracting solutions, and placing the mixture in a ceramic cylinder for cooling for later use;

3) adding honey and brown sugar in parts by weight into the cooled extracting solution in the step 2), and uniformly stirring to obtain a traditional Chinese medicine extracting solution;

4) inoculating mixed bacteria liquid of bifidobacterium, lactobacillus and saccharomycetes into the traditional Chinese medicine extracting solution obtained in the step 3), uniformly stirring, sealing with red cloth, shading, storing at normal temperature and fermenting for 7-10 days;

5) taking the fermentation liquor fermented in the step 4), boiling for sterilization, and concentrating under reduced pressure until the relative density is 1.20-1.25 (measured at 50 ℃), so as to obtain thick paste;

6) spray drying the above soft extract in a spray drying machine, pulverizing with a universal mill, and sieving to obtain dry extract powder;

7) adding gelatin, glycerol and purified water in certain parts by weight into a gelatin melting tank, stirring and heating, after the gelatin is completely melted, continuously heating to 75-80 ℃, preserving heat and stirring, and vacuumizing until the viscosity is 2.5-3.5 ten thousand mpa · s to obtain a gelatin solution; sieving the glue solution with a 60-80-mesh sieve, transferring the glue solution into a glue storage tank, preserving heat at 55-65 ℃, and standing for 4-6 hours for later use;

8) uniformly mixing the dry extract powder obtained in the step 6) with vitamin D, and dissolving the mixture in grape seed oil to prepare the content of the soft capsule;

9) using a soft capsule machine, preparing the glue solution prepared in the step 7) and the content of the soft capsule prepared in the step 8) into soft capsules with the specification of 0.6 g/capsule, and drying to obtain the compound traditional Chinese medicine soft capsules.

4. The method for preparing the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease as claimed in claim 3, is characterized in that: and (2) crushing and sieving by using a sieve of 10-20 meshes in the step 1).

5. The method for preparing the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease as claimed in claim 3, is characterized in that: in the step 4), the mass ratio of the bifidobacteria to the lactic acid bacteria to the saccharomycetes is 1:1:1.5, and the inoculation amount of the mixed bacterial liquid is 1-2.5%.

6. The method for preparing the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease as claimed in claim 3, is characterized in that: the spray drying conditions in the step 6): the temperature of the liquid inlet material is 70-80 ℃, the liquid inlet speed is 55-65 mL/min, the air inlet temperature is 128-150 ℃, and the air outlet temperature is 65-75 ℃.

7. The method for preparing the compound traditional Chinese medicine soft capsule for treating the rheumatoid bone disease as claimed in claim 3, is characterized in that: the glue solution in the step 7) is prepared from 20-25 parts of gelatin, 8-10 parts of glycerol and 20-25 parts of purified water.