阅读说明：本技术 一种治疗骨质疏松症的中药复方及制备方法 (Traditional Chinese medicine compound for treating osteoporosis and preparation method thereof ) 是由 仇湘中 张信成 仇杰 蒋盛昶 唐皓 张旭桥 许辉 于 2021-03-12 设计创作，主要内容包括：本申请提供一种治疗骨质疏松症的中药复方及制备方法,本中药复方包括生黄芪、补骨脂、白术、龟甲、丹参、白芍、白芷、甘草等中药。该方中黄芪益气固表、行血通痹,补骨脂补肾壮阳、补脾健胃,共为君药；白芍养血柔肝,缓急止痛,龟甲滋阴潜阳、益肾强骨,白术健脾、益气、燥湿利水,共为臣药；丹参活血祛瘀,通经止痛,白芷散风除湿、通窍止痛,共为佐药；甘草为使,调和诸药。纵观全方具有补益肝肾、养血柔筋、通络止痛之效。临床适应于西医诊断为骨质疏松症,中医辨证为骨痿病之腰腿痛、压缩性骨折等病症。(The application provides a traditional Chinese medicine compound for treating osteoporosis and a preparation method thereof, and the traditional Chinese medicine compound comprises raw astragalus mongholicus, fructus psoraleae, bighead atractylodes rhizome, tortoise shell, salvia miltiorrhiza, radix paeoniae alba, radix angelicae, liquorice and the like. In the formula, astragalus root, radix astragali has the effects of benefiting qi, strengthening exterior, promoting blood circulation, removing obstruction of qi-flowing, tonifying kidney, strengthening yang, invigorating spleen and stomach, and is used as a monarch drug; white paeony root has the effects of nourishing blood and liver, relieving spasm and pain, nourishing yin and suppressing yang, tonifying kidney and strengthening bone, and the largehead atractylodes rhizome has the effects of tonifying spleen, tonifying qi, eliminating dampness and inducing diuresis and is used as a ministerial drug; the radix salviae miltiorrhizae activates blood circulation and removes blood stasis, and can dredge meridians and relieve pain, and the radix angelicae dahuricae can dispel wind and remove dampness, and dredge orifices and relieve pain, which are used as adjuvant drugs; the liquorice is used for guiding and harmonizing the effects of the drugs in the recipe. The whole formula has the effects of tonifying liver and kidney, nourishing blood, softening tendons, dredging collaterals and relieving pain. The traditional Chinese medicine composition is clinically applicable to osteoporosis diagnosed in western medicine and diseases such as lumbocrural pain and compression fracture caused by flaccidity of bones and the like differentiated by traditional Chinese medicine.)

1. A traditional Chinese medicine compound for treating osteoporosis is characterized by comprising the following raw materials: astragalus root, psoralea fruit, white atractylodes rhizome, tortoise shell, root of red rooted saliva, root of herbaceous peony, dahurian angelica root and licorice root.

2. The traditional Chinese medicine compound for treating osteoporosis of claim 1, wherein the traditional Chinese medicine compound comprises the following raw materials in parts by weight:

4-6 parts of astragalus membranaceus, 4-6 parts of fructus psoraleae, 2-5 parts of bighead atractylodes rhizome, 1-2 parts of tortoise shell, 2-5 parts of salvia miltiorrhiza, 2-5 parts of radix paeoniae alba, 1-3 parts of radix angelicae and 1-3 parts of liquorice.

3. The traditional Chinese medicine compound for treating osteoporosis of claim 2, wherein the traditional Chinese medicine compound comprises the following raw materials in parts by weight:

5 parts of astragalus, 5 parts of fructus psoraleae, 3 parts of bighead atractylodes rhizome, 1.5 parts of tortoise shell, 3 parts of salvia miltiorrhiza, 3 parts of white paeony root, 2 parts of angelica dahurica and 1 part of liquorice.

4. A preparation method of a traditional Chinese medicine compound for treating osteoporosis is characterized by comprising the following steps:

cutting radix astragali, fructus Psoraleae, Saviae Miltiorrhizae radix, radix Paeoniae alba, and Glycyrrhrizae radix;

distilling Atractylodis rhizoma and radix Angelicae Dahuricae with water to obtain volatile oil, and separately collecting the water solution and residue;

crushing tortoise shell into medium powder, adding water, decocting for 1 hour, adding the crushed astragalus, fructus psoraleae, salvia miltiorrhiza, radix paeoniae alba and liquorice, and the decoction dregs of the bighead atractylodes rhizome and the angelica dahurica, and decocting for two times with water, wherein each time lasts for 1.5 hours;

mixing the two decoctions, filtering, mixing the obtained filtrate with the water solution of Atractylodis rhizoma and radix Angelicae Dahuricae after distillation to obtain mixed solution, and concentrating the mixed solution to obtain extract with relative density of 1.20-1.40;

drying the extract, and pulverizing to obtain the final product.

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine compound for treating osteoporosis and a preparation method thereof.

Background

Osteoporosis (OP) is a systemic disease characterized by low bone mass and microstructural destruction of bone tissue, leading to increased bone fragility and susceptibility to fracture. With the aging of social population, the incidence of osteoporosis is higher and higher, and postmenopausal women are mainly used, so that the osteoporosis becomes a common general bone metabolic disease of the old women at present and is also an important reason for the fracture of the old women. Postmenopausal osteoporosis is a common disease and frequently encountered disease of middle-aged and old women, the incidence rate of the postmenopausal osteoporosis is far higher than that of men, women can obviously accelerate the bone loss after the age of 50, the total incidence rate of osteoporosis of over 40 years is 15.70 percent for women, and the incidence rate of osteoporosis of 50-79 years old people is 67.30 percent for women. The disease is the seventh most common disease in the world at present, the number of the affected people is more than 2 hundred million at present, 7500 million people in the United states, Western Europe and Japan are treated every year, and the hospitalization cost is as high as 250 hundred million dollars. The Chinese population accounts for 22 percent of the world population, the peak of the aged after half a century comes, and the national research, diagnosis and treatment of the epidemic disease of osteoporosis are the key subjects for overcoming the senile diseases.

Kidneys are the innate root, and they are used for storing essence and bone marrow, so the relationship between bone growth, development, strength, weakness and kidney essence is closely related. When kidney essence is sufficient, bone marrow has biochemical and active sources, and bones are strongly nourished; the deficiency of kidney essence can lead to bone marrow biochemical depletion, bone malnutrition and bone depletion, i.e. bone mineral content is reduced, bone density is reduced, and osteoporosis occurs. Therefore, the deficiency of the kidney and marrow is the core traditional Chinese medicine pathological essence of the onset of postmenopausal osteoporosis. The Chinese patent medicine for treating osteoporosis is developed, so that the pain of a patient is relieved, huge economic loss can be recovered for the country, huge social and economic benefits are generated, and the modernization of the traditional Chinese medicine is promoted.

Disclosure of Invention

Aiming at the defects of the prior art, the invention provides a traditional Chinese medicine compound for treating osteoporosis and a preparation method thereof.

In a first aspect, the present application provides a compound Chinese medicine for treating osteoporosis, wherein the raw materials of the compound Chinese medicine comprise: astragalus root, psoralea fruit, white atractylodes rhizome, tortoise shell, root of red rooted saliva, root of herbaceous peony, dahurian angelica root and licorice root.

Preferably, the traditional Chinese medicine compound comprises the following raw materials in parts by weight: 4-6 parts of astragalus membranaceus, 4-6 parts of fructus psoraleae, 2-5 parts of bighead atractylodes rhizome, 1-2 parts of tortoise shell, 2-5 parts of salvia miltiorrhiza, 2-5 parts of radix paeoniae alba, 1-3 parts of radix angelicae and 1-3 parts of liquorice.

Preferably, the traditional Chinese medicine compound comprises the following raw materials in parts by weight: 5 parts of astragalus, 5 parts of fructus psoraleae, 3 parts of bighead atractylodes rhizome, 1.5 parts of tortoise shell, 3 parts of salvia miltiorrhiza, 3 parts of white paeony root, 2 parts of angelica dahurica and 1 part of liquorice.

In a second aspect, the present application provides a method for preparing a Chinese herbal compound for treating osteoporosis, comprising the following steps:

cutting radix astragali, fructus Psoraleae, Saviae Miltiorrhizae radix, radix Paeoniae alba, and Glycyrrhrizae radix;

distilling Atractylodis rhizoma and radix Angelicae Dahuricae with water to obtain volatile oil, and separately collecting the water solution and residue;

crushing tortoise shell into medium powder, adding water, decocting for 1 hour, adding the crushed astragalus, fructus psoraleae, salvia miltiorrhiza, radix paeoniae alba and liquorice, and the decoction dregs of the bighead atractylodes rhizome and the angelica dahurica, and decocting for two times with water, wherein each time lasts for 1.5 hours;

mixing the two decoctions, filtering, mixing the obtained filtrate with the water solution of Atractylodis rhizoma and radix Angelicae Dahuricae after distillation to obtain mixed solution, and concentrating the mixed solution to obtain extract with relative density of 1.20-1.40;

drying the extract, and pulverizing to obtain the final product.

The Chinese herbal compound for treating osteoporosis comprises raw astragalus, fructus psoraleae, bighead atractylodes rhizome, tortoise shell, salvia miltiorrhiza, white paeony root, angelica dahurica, liquorice and the like. In the formula, astragalus root, radix astragali has the effects of benefiting qi, strengthening exterior, promoting blood circulation, removing obstruction of qi-flowing, tonifying kidney, strengthening yang, invigorating spleen and stomach, and is used as a monarch drug; white paeony root has the effects of nourishing blood and liver, relieving spasm and pain, nourishing yin and suppressing yang, tonifying kidney and strengthening bone, and the largehead atractylodes rhizome has the effects of tonifying spleen, tonifying qi, eliminating dampness and inducing diuresis and is used as a ministerial drug; the radix salviae miltiorrhizae activates blood circulation and removes blood stasis, and can dredge meridians and relieve pain, and the radix angelicae dahuricae can dispel wind and remove dampness, and dredge orifices and relieve pain, which are used as adjuvant drugs; the liquorice is used for guiding and harmonizing the effects of the drugs in the recipe. The whole formula has the effects of tonifying liver and kidney, nourishing blood, softening tendons, dredging collaterals and relieving pain. The traditional Chinese medicine composition is clinically applicable to osteoporosis diagnosed in western medicine and diseases such as lumbocrural pain and compression fracture caused by flaccidity of bones and the like differentiated by traditional Chinese medicine.

Drawings

For a clearer explanation of the embodiments or technical solutions in the prior art of the present invention, the drawings used in the description of the embodiments or prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained based on these drawings without creative efforts.

Fig. 1 is a flowchart of a method for preparing a Chinese herbal compound for treating osteoporosis provided by the embodiment of the invention.

Detailed Description

In order to make those skilled in the art better understand the technical solutions in the present invention, the technical solutions in the embodiments of the present invention will be 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 obtained by a person skilled in the art without making creative efforts based on the embodiments of the present invention, shall fall within the protection scope of the present invention.

Aiming at the defects of the prior art, the scheme provides a traditional Chinese medicine compound for treating osteoporosis and a preparation method thereof. The traditional Chinese medicine compound for treating osteoporosis in the scheme comprises the following raw materials: astragalus root, psoralea fruit, white atractylodes rhizome, tortoise shell, root of red rooted saliva, root of herbaceous peony, dahurian angelica root and licorice root.

The Chinese herbal compound for treating osteoporosis consists of raw astragalus, fructus psoraleae, bighead atractylodes rhizome, tortoise shell, salvia miltiorrhiza, white paeony root, angelica dahurica, liquorice and the like. In the formula, astragalus root, radix astragali has the effects of benefiting qi, strengthening exterior, promoting blood circulation, removing obstruction of qi-flowing, tonifying kidney, strengthening yang, invigorating spleen and stomach, and is used as a monarch drug; white paeony root has the effects of nourishing blood and liver, relieving spasm and pain, nourishing yin and suppressing yang, tonifying kidney and strengthening bone, and the largehead atractylodes rhizome has the effects of tonifying spleen, tonifying qi, eliminating dampness and inducing diuresis and is used as a ministerial drug; the radix salviae miltiorrhizae activates blood circulation and removes blood stasis, and can dredge meridians and relieve pain, and the radix angelicae dahuricae can dispel wind and remove dampness, and dredge orifices and relieve pain, which are used as adjuvant drugs; the liquorice is used for guiding and harmonizing the effects of the drugs in the recipe. The whole formula has the effects of tonifying liver and kidney, nourishing blood, softening tendons, dredging collaterals and relieving pain. The traditional Chinese medicine composition is clinically applicable to osteoporosis diagnosed in western medicine and diseases such as lumbocrural pain and compression fracture caused by flaccidity of bones and the like differentiated by traditional Chinese medicine. The traditional Chinese medicine compound is an effective medicine for treating osteoporosis patients, and has the advantages of definite curative effect, safety and no toxic or side effect.

Example 1

The embodiment provides a traditional Chinese medicine compound for treating osteoporosis, which comprises the following raw materials in parts by weight:

4 parts of astragalus root, 4 parts of psoralea fruit, 2 parts of white atractylodes rhizome, 1 part of tortoise shell, 2 parts of red sage root, 5 parts of white peony root, 3 parts of dahurian angelica root and 1 part of licorice root

Example 2

The embodiment provides a traditional Chinese medicine compound for treating osteoporosis, which comprises the following raw materials in parts by weight:

6 parts of astragalus, 6 parts of fructus psoraleae, 5 parts of bighead atractylodes rhizome, 2 parts of tortoise shell, 5 parts of salvia miltiorrhiza, 2 parts of white paeony root, 1 part of angelica dahurica and 3 parts of liquorice.

Example 3

The embodiment provides a traditional Chinese medicine compound for treating osteoporosis, which comprises the following raw materials in parts by weight:

5 parts of astragalus, 5 parts of fructus psoraleae, 3 parts of bighead atractylodes rhizome, 1.5 parts of tortoise shell, 3 parts of salvia miltiorrhiza, 3 parts of white paeony root, 2 parts of angelica dahurica and 1 part of liquorice.

Example 4

The embodiment provides a preparation method of a traditional Chinese medicine compound for treating osteoporosis. Referring to fig. 1, a flowchart of a method for preparing a compound Chinese medicine for treating osteoporosis according to an embodiment of the present invention is shown. As can be seen from fig. 1, the method comprises the following steps:

step S100: cutting radix astragali, fructus Psoraleae, Saviae Miltiorrhizae radix, radix Paeoniae alba, and Glycyrrhrizae radix;

step S200: distilling Atractylodis rhizoma and radix Angelicae Dahuricae with water to obtain volatile oil, and separately collecting the water solution and residue;

step S300: crushing tortoise shell into medium powder, adding water, decocting for 1 hour, adding the crushed astragalus, fructus psoraleae, salvia miltiorrhiza, radix paeoniae alba and liquorice, and the decoction dregs of the bighead atractylodes rhizome and the angelica dahurica, and decocting for two times with water, wherein each time lasts for 1.5 hours;

step S400: mixing the two decoctions, filtering, mixing the obtained filtrate with the water solution of Atractylodis rhizoma and radix Angelicae Dahuricae after distillation to obtain mixed solution, and concentrating the mixed solution to obtain extract with relative density of 1.30(60 deg.C);

step S500: drying the extract, and pulverizing to obtain the final product.

In order to verify the beneficial effects of the present invention, the following experiments in pharmacodynamics were performed.

1. The traditional Chinese medicine compound has the influence on the expression of OPG and RANKL in tibial tissues of osteoporotic rats

Experimental animals: the body mass (345. + -.15) g of 10-month-old female rats was 36 in total.

Grouping: the experimental rats were divided into 6 groups by a completely randomized block grouping method, namely a control group, a sham operation group, a model group, an experimental group, a Gushukang granule group and a nilestriol group, and each group had 6 rats.

The administration method comprises the following steps: after molding for 1d, the cut was dried and administered. The experimental group, the bone Shunkang granule group and the nilestriol tablet group are respectively perfused with the traditional Chinese medicine compound granules, the bone Shunkang granules and the nilestriol tablet for treating the osteoporosis, and the other groups are perfused with 0.9 percent sodium chloride injection. 2 times daily.

Index collection and detection: at 3 and 6 weeks after treatment, 6 rats were randomly selected and tested as follows. 1) And centrifuging after tail vein blood drawing, and detecting the content of serum OPG and RANKL by adopting an ELISA method. 2) After the rats are killed by taking off the neck, the proximal end of the left tibia is taken out, the expression conditions of tibial OPG and RANKL are detected by an immunohistochemical detection method, and the average IOD (the ratio of the accumulated optical density of a positive expression part in a visual field to the area of a sample in the visual field) and the positive rate (the ratio of the number of positively expressed cell nuclei in the visual field to the total number of cell nuclei in the visual field) in 400-fold visual field are compared by using image analysis software as IPP.

The statistical method comprises the following steps: statistical analysis is carried out by adopting SPSS 19.0, the measured data is expressed by mean +/-standard deviation (x +/-s), the difference between groups is compared by adopting one-factor variance analysis, and the difference with P less than 0.05 has statistical significance.

Compared with the control group, the tibial OPG expression of the rats in each group is reduced, and the difference has statistical significance; after treatment, the tibial OPG expression of the experimental group, the osteopathy granule group and the nilestriol tablet group is increased compared with that of the model group, and the difference has statistical significance; the tibial OPG of each treatment group was increased at week 6 of treatment compared to that of the treatment group at week 3 of treatment, and the differences were statistically significant, as shown in Table 1.

Table 1: comparison of tibial OPG expression in rats of each group (x. + -. s, ng/L)

Compared with a control group, the shin bone RANKL expression of rats in each group is increased, and the difference has statistical significance; after treatment, the RANKL expression of the tibia in the experimental group, the bone Shunkang granule group and the nilestriol group is reduced compared with that in the model group, and the difference has statistical significance; tibial RANKL was decreased at week 6 of treatment in each treatment group compared to treatment at week 3 of this group, with statistical significance for the differences, detailed in table 2.

Table 2: comparison of tibial RANKL expression (x. + -. s, ng/L) in rats of each group

The pharmacodynamics experiment establishes an osteoporosis rat model, which is randomly divided into a control group, a pseudo-operation group, a model group, an experimental group, a Gushukang granule group and a nilestriol group, wherein each group comprises 6 animals, corresponding medicines are used for intragastric administration, and the control group, the pseudo-operation group and the model group are used for intragastric administration by sodium chloride injection with the equal dosage of 0.9%. Randomly extracting 2 animals for killing in each group at 3 and 6 weeks after administration, collecting affected tissue specimen, determining the content of OPG and RANKL in rat bone tissue by using the ratio of the accumulated optical density of positive expression part in visual field after staining and the sample area in visual field, and performing statistical analysis on the obtained data. The results show that the expression of OPG and RANKL in bone tissue specimens of affected parts of rats at the end of 3 and 6 weeks in the experimental group is higher than that in other groups (P is less than 0.05). Therefore, the compound preparation can promote the expression of OPG and RANKL in osteoporotic bone tissues and improve osteoporosis.

2. The traditional Chinese medicine compound has the influence on the expression of MTL and GAS in the serum of osteoporosis rat

Experimental animals: the body mass (345. + -.15) g of 10-month-old female rats was 36 in total.

Grouping: the experimental rats were divided into 6 groups by a completely randomized block grouping method, namely a control group, a sham operation group, a model group, an experimental group, a Gushukang granule group and a nilestriol group, and each group had 6 rats.

The administration method comprises the following steps: on the 1 st day after successful model building of experimental rats, the compound preparation provided by the application is subjected to intragastric administration for 2 times according to the standard of 75mg/kg every day. The control group, the sham operation group and the model group are respectively administered with 0.9% sodium chloride injection with equal dosage and are perfused with stomach 2 times per day. 1.12g of the gushukang granules and 0.21mg of the nilestriol tablets are respectively dissolved in 0.9 percent sodium chloride injection with corresponding volume, and the gavage is performed 2 times a day, and the gavage dosage is converted according to a human and animal dosage conversion formula. The gavage time was 13 weeks.

Observation indexes are as follows: on the 1 st day after the administration, 1ml of blood was collected by a femoral artery blood sampling method after anesthesia, the whole blood was left to stand for 1 hour, centrifuged at 2000rmp for 10min, and then serum was collected and subjected to detection of MTL and GAS by ELISA method for comparison.

And (3) comparing the MTL and GAS contents of the rat serum of each group, namely comparing the MTL and GAS contents of the rat serum of the model group with those of the dummy operation group, wherein the MTL and GAS contents of the rat serum of the model group are reduced compared with those of the dummy operation group, and the difference has statistical significance, thereby indicating that the modeling is successful. After treatment, the MTL and GAS contents of the experimental group are higher than those of the model group, but still lower than those of the sham operation group. The difference between the Gushunkang granule group \ Nierjingtong tablet group and the model group has no statistical significance, and the details are shown in a table 3.

Table 3: comparison of MTL and GAS content in serum of rats in each group (x + -s, ng/L)

The pharmacodynamics experiment establishes 36 osteoporosis rat models, and the models are randomly divided into a control group, a pseudo-operation group, a model group, an experimental group, a Gushukang granule group and a nilestriol tablet group, wherein each group comprises 6 rats. Reinforcing bone particles are used for intragastric administration in the experimental group; the control group, the sham operation group and the model group are respectively administered with equal dosage of 0.9% sodium chloride injection for intragastric administration, and the bone Shunkang granule group and the nilestriol tablet group are respectively administered with equal dosage of bone Shunkang granules and nilestriol tablet for intragastric administration. After the gavage for 13 weeks, the MTL and GAS contents of the serum of each group of rats are detected by adopting an enzyme-linked immunosorbent assay. The results show that the differences of the MTL and GAS contents of the rats, the comparison of the model group and the sham operation group, and the comparison of the experimental group and the model group have statistical significance, but the differences of the Gushunkang granule group and the Nierkiniol tablet group have no statistical significance compared with the model group. Therefore, the bone strengthening particles can promote the expression of serum MTL and GAS of the rat with osteoporosis and improve the osteoporosis.

In order to make those skilled in the art better understand the technical solutions in the present invention, the technical solutions in the embodiments of the present invention will be 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 obtained by a person skilled in the art without making creative efforts based on the embodiments of the present invention, shall fall within the protection scope of the present invention.