Angelica-based traditional Chinese medicine preparation and preparation method thereof

Abstract

The application relates to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine preparation based on angelica and a preparation method thereof. The traditional Chinese medicine preparation contains the following raw materials in parts by weight: angelica, astragalus root, rhizoma discontinuorum, gordon euryale seed, gold cherry, radix astragali complanati, radix bupleuri, corn silk, sea algae and emulsifying aids. The emulsifying aids are innovatively added in the traditional Chinese medicine compound, the emulsifying aids are mixed with the volatile oil extracted from the traditional Chinese medicine components to be emulsified, and then the traditional Chinese medicine preparation is prepared by mixing the concentrated extract from the traditional Chinese medicine components. The obtained traditional Chinese medicine preparation not only improves the liver stagnation and blood deficiency caused by diabetic renal anemia through the synergistic effect of multiple pathways such as liver and kidney tonification, qi and blood regulation, water reduction and swelling reduction and antioxidation, reduces the burden of the kidney, but also enhances the tonifying effect of angelica, so that the purposes of treating diabetic renal anemia and reducing complications are achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, more particularly, to a traditional Chinese medicine preparation based on angelica and a preparation method thereof. BACKGROUND

[0002] Diabetic nephropathy is the main cause of chronic kidney disease, with high morbidity and mortality. Diabetic nephropathy patients often have renal anemia, which is mainly caused by erythropoietin deficiency, absolute or functional iron deficiency, nutritional deficiency, uremic toxins and inflammation. Studies have shown that anemia is an important risk factor for the progression of diabetic nephropathy. With the development of the disease, the incidence of anemia increases, which leads to an increase in the morbidity and mortality of patients with kidney disease, induces cardiovascular and other systemic diseases, and has a significant impact on the quality of life and clinical prognosis of patients with diabetic nephropathy.

[0003] In the prior art, for diabetic renal anemia patients, Western medicine mainly uses erythropoietin, iron agents, HIF-PHI and other drugs and blood transfusion therapy. The above treatments require patients to adhere to regular monitoring of blood routine, iron metabolism indicators, kidney function and electrolytes, which poses a challenge to the compliance of patients; in addition, even if the blood sugar is controlled, diabetic renal anemia still faces the risk of chronic complications such as hypertension, thrombosis and hyperkalemia; some hypoglycemic drugs may even have side effects.

[0004] There is no record of the name of diabetic renal anemia in medical books of past dynasties. Modern medical doctors treat renal anemia from the perspective of five-organ integration according to its etiology, pathogenesis and symptom characteristics. However, existing traditional Chinese medicine is not widely used in diabetic renal anemia, mainly due to unclear mechanism of action and slow effect. Based on the above statements, the present application provides a traditional Chinese medicine preparation based on angelica and a preparation method thereof. SUMMARY

[0005] In order to solve the problems of unclear mechanism of action and slow effect of existing traditional Chinese medicine preparations in the treatment of diabetic renal anemia, the present application provides a traditional Chinese medicine preparation based on angelica and a preparation method thereof.

[0006] The present application provides a traditional Chinese medicine preparation based on angelica and a preparation method thereof, which adopts the following technical scheme:

[0007] In a first aspect, the present application provides a traditional Chinese medicine preparation based on angelica, which comprises the following raw materials by weight: angelica 20-24 parts, radix astragali 10-14 parts, rhizoma dipsaci 6-8 parts, gordon euryale seed 4-6 parts, rosa davurica 2-3 parts, radix lactiferae 5-7 parts, radix bupleuri 0.6-1 part, corn silk 0.2-0.4 part, sea algae 3-5 parts and emulsifying aid 1.2-2.6 parts.

[0008] Further, the Chinese medicine preparation based on angelica contains the following raw materials by weight: angelica 21-23 parts, astragalus 11-13 parts, continue to break 6.5-7.5 parts, gordon euryale 4.5-5.5 parts, cherry 2.4-2.6 parts, cow knee 5.5-6.5 parts, bupleurum 0.7-0.9 parts, corn silk 0.24-0.36 parts, seaweed 3.5-4.5 parts and emulsifying aid 1.6-2.2 parts.

[0009] Further, the Chinese medicine preparation based on angelica contains the following raw materials by weight: angelica 21-23 parts, astragalus 11-13 parts, continue to break 6.5-7.5 parts, gordon euryale 4.5-5.5 parts, cherry 2.4-2.6 parts, cow knee 5.5-6.5 parts, bupleurum 0.7-0.9 parts, corn silk 0.24-0.36 parts, seaweed 3.5-4.5 parts and emulsifying aid 1.6-2.2 parts.

[0010] Further, the emulsifying aid is composed of olive oil and beeswax in a mass ratio of 1:2-4.

[0011] In the second aspect, the application provides a preparation method of the Chinese medicine preparation based on angelica in the first aspect, which comprises the following steps:

[0012] Step S1, raw materials of angelica, astragalus, continue to break, gordon euryale, cherry, cow knee, bupleurum, corn silk, seaweed and emulsifying aid are weighed by weight parts for standby;

[0013] Step S2, angelica, astragalus, continue to break, gordon euryale, cherry, cow knee, bupleurum, corn silk and seaweed are mixed, sieved, and mixed medicine powder is obtained, and volatile oil and extract are extracted, and the extract is concentrated under reduced pressure to obtain thick paste;

[0014] Step S3, take the volatile oil and add the emulsifying aid, heat to 65-75℃, mix uniformly to form emulsified oil;

[0015] Step S4, after mixing the thick paste and the emulsified oil uniformly, sterilize and pack to obtain the Chinese medicine preparation based on angelica.

[0016] Further, the emulsifying aid in step S1 is composed of olive oil and beeswax in a mass ratio of 1:2-4.

[0017] Further, the particle size of the mixed medicine powder in step S2 is 60-80 meshes.

[0018] Further, the step S2 in the extract refers to: the mixed medicine powder is extracted by water vapor distillation method for 4-5h to obtain volatile oil and dregs.

[0019] Further, the extract in step S2 is obtained by refluxing the dregs with ethanol solution for 2-3h.

[0020] Further, the mass fraction of the ethanol solution is 50-70%, and the material-liquid ratio of the residue and the ethanol solution is 1:8-10.

[0021] Further, in the step S2, the temperature for the reduced-pressure concentration is 50-60 DEG C, and the vacuum degree is -0.08 MPa to -0.06 MPa.

[0022] Further, in the step S2, the volume of the concentrated paste is 0.20-0.25 times the volume of the extraction liquid.

[0023] In summary, the present application has the following beneficial effects:

[0024] The present application has scientific formula and strict proportion, and the selection of raw materials focuses on regulating the overall yin-yang balance of patients with diabetic renal anemia, fundamentally improving the patient's constitution and immune function, and further reducing the occurrence of diabetes and its complications; wherein, angelica and astragalus are used as monarch drugs, angelica is sweet, pungent and warm, and returns to liver, heart and spleen channels; it has the effects of tonifying blood, activating blood, regulating menstruation and relieving pain; astragalus is sweet and warm, and returns to spleen and lung channels, and has the effects of tonifying spleen and lung qi and assisting blood production; the combination of the two is in line with the traditional Chinese medicine theory that "the blood of form is born from the qi of formlessness", and directly targets the core pathogenesis of anemia; the discontinuation, gordon euryale seed and cherokee rose are used as ministerial drugs, the discontinuation is bitter, pungent and slightly warm, and returns to liver and kidney channels, and has the effects of tonifying liver and kidney; gordon euryale seed is sweet, astringent and flat, and returns to spleen and kidney channels, and has the effects of benefiting kidney, astringing essence, invigorating spleen and stopping diarrhea; cherokee rose is sour, sweet, astringent and flat, and returns to kidney, bladder and large intestine channels, and has the effects of astringing essence and reducing urine; through the synergistic effect of the three, the effects of tonifying liver and kidney, astringing essence, activating blood and removing blood stasis and assisting the monarch drug to strengthen the treatment are achieved; not only it is helpful for benefiting qi and blood, filling essence and marrow, and astringing essence, can enhance the physical quality of patients, qi and blood, promote the recovery of the body, but also it has the auxiliary treatment effect on the symptoms of insufficient qi and blood production, exhausted blood production and excessive loss of essence caused by diabetic renal anemia, and can reduce the occurrence of complications; the ox knee, bupleurum and seaweed are used as auxiliary drugs, wherein, the ox knee is bitter, sweet, sour and flat, and returns to liver and kidney channels, and has the effects of tonifying liver and kidney, strengthening tendons and bones, activating blood and dredging channels, and leading blood downward; bupleurum is pungent, bitter and slightly cold, and returns to liver, gallbladder and lung channels, and has the effects of soothing liver and relieving depression, and lifting yang qi; seaweed is salty and cold, and returns to liver and kidney channels, and has the effects of softening and resolving, eliminating phlegm and water, and clearing heat and detoxifying; through soothing liver and relieving depression, eliminating water and reducing swelling, the secondary symptoms are treated; the corn silk is used as a service drug, and the corn silk is flat, sweet and bland, and returns to kidney, bladder, liver and gallbladder channels, and has the effects of reducing sugar and regulating lipid, and resisting hemolysis; while tonifying, the ox knee can lead blood downward and activate blood, seaweed can eliminate phlegm and resolve, and corn silk can benefit dampness and guide turbidity, which together promote the discharge of pathological products such as stasis and dampness in the body, and the ascending effect of bupleurum and the descending effect of ox knee form a clever ascending and descending relationship, which is helpful for the normal circulation of the body qi, through the synergistic effect of tonifying liver and kidney, regulating qi and blood, eliminating water and reducing swelling, and resisting oxidation, the liver depression and blood deficiency caused by diabetic renal anemia are improved, and the burden on the kidney is reduced.

[0025] The present application creatively combines the tonifying drugs such as astragalus, angelica, discontinuation, cherokee rose and gordon euryale seed with the draining drugs such as ox knee, seaweed and corn silk, which embodies the strategy of attacking and tonifying at the same time.

[0026] The application adds emulsifying aids innovatively in traditional Chinese medicine compound, and then mixes and emulsifies the volatile oil extracted from the traditional Chinese medicine composition, and then mixes the concentrated extract of the traditional Chinese medicine composition to prepare a traditional Chinese medicine preparation; the emulsifying aids are composed of olive oil and beeswax in a specific ratio, wherein the beeswax is warm and moist, has the effects of warming meridians, activating blood circulation, removing blood stasis, and regulating immunity; the olive oil is lubricating and rich in oleic acid, as an oil phase, can promote the dissolution of the fat-soluble components in the traditional Chinese medicine composition, is beneficial to the absorption of the active ingredients of the medicine, enhances the tonifying effect of angelica, and further achieves the purposes of treating diabetic renal anemia and reducing complications. DETAILED DESCRIPTION

[0027] In order to make the embodiments of the application easier to understand, the application will be described in detail below in combination with specific examples, which are only illustrative and do not limit the application.

[0028] If a specific technology or condition is not specified in the examples, the technology or condition described in the literature in the field or according to the product manual is used. If the manufacturer of the reagent or instrument is not specified, it is a conventional product that can be purchased through a regular channel.

[0029] Angelica was purchased from Bozhou Hengyi Traditional Chinese Medicine Technology Co., Ltd.; Astragalus was purchased from Bozhou Bolintang Pharmaceutical Co., Ltd.; Dipsacus was purchased from Yunnan Xilaoculture Communication Co., Ltd.; Euryale was purchased from Bozhou Fuyongtang Pharmaceutical Co., Ltd.; Rosa was purchased from Jilin Yelutang Commerce and Trade Co., Ltd.; Radix Achyranthis was purchased from Bozhou Jinghuitang Pharmaceutical Co., Ltd.; Bupleurum was purchased from Bozhou Deng Dawei Pharmaceutical Co., Ltd.; Corn Silk was purchased from Bozhou Ximutang Pharmaceutical Co., Ltd.; Sea Algae was purchased from Bozhou Wu Xianbin Traditional Chinese Medicine Planting Co., Ltd.; Olive oil was purchased from Xi'an Hongyao Pharmaceutical Auxiliary Co., Ltd., with CAS number 8001-25-0; Beeswax was purchased from Xi'an Tianzheng Pharmaceutical Auxiliary Co., Ltd.

[0030] The application will be further described below in combination with examples.

[0031] Examples 1-3 provide a traditional Chinese medicine preparation based on angelica.

[0032] Example 1

[0033] The example provides a traditional Chinese medicine preparation based on angelica, which is made from the following raw materials by weight: 20 parts of angelica, 10 parts of astragalus, 6 parts of dipsacus, 4 parts of euryale, 2 parts of rosa, 5 parts of radix achyranthis, 0.6 parts of bupleurum, 0.2 parts of corn silk, 3 parts of sea algae, and 1.2 parts of emulsifying aids, wherein the emulsifying aids are composed of olive oil and beeswax in a mass ratio of 1:2.

[0034] A preparation method of a traditional Chinese medicine preparation based on angelica, comprising the following steps:

[0035] Step S1, take the raw materials angelica, astragalus, rhizoma discontinu, semen euryales, cherokee rose, moxa, bupleurum, corn silk, seaweed and emulsifying aid by weight parts for standby;

[0036] Step S2, mix angelica, astragalus, rhizoma discontinu, semen euryales, cherokee rose, moxa, bupleurum, corn silk and seaweed, crush and pass through a 60 mesh sieve to obtain mixed medicinal powder; volatile oil in the mixed medicinal powder is extracted by water vapor distillation method for 4 hours to obtain volatile oil and dregs;

[0037] According to the solid-liquid ratio of 1:8, the dregs are added into an ethanol solution with a mass fraction of 50% to reflux extract for 2 hours to obtain an extract liquid; the temperature is controlled at 50°C, the vacuum degree is-0.06 MPa, and the extract liquid is concentrated under reduced pressure to 0.20 times the original volume to obtain a thick paste;

[0038] Step S3, take the volatile oil obtained in step S2 and add the emulsifying aid, heat to 65°C, control the rotation speed at 900 rpm, mix for 14 minutes until uniform, and form an emulsified oil;

[0039] Step S4, mix the thick paste obtained in step S2 and the emulsified oil obtained in step S3 at a rotation speed of 800 rpm for 16 minutes until uniform, heat to 121°C, sterilize for 16 minutes, and then distribute to obtain the angelica-based traditional Chinese medicine preparation.

[0040] Example 2

[0041] The present embodiment provides an angelica-based traditional Chinese medicine preparation, which is made from the following raw materials by weight parts: angelica 22 parts, astragalus 12 parts, rhizoma discontinu 7 parts, semen euryales 5 parts, cherokee rose 2.5 parts, moxa 6 parts, bupleurum 0.8 parts, corn silk 0.3 parts, seaweed 4 parts, and emulsifying aid 1.9 parts;

[0042] A preparation method of an angelica-based traditional Chinese medicine preparation, comprising the following steps:

[0043] Step S1, take the raw materials angelica, astragalus, rhizoma discontinu, semen euryales, cherokee rose, moxa, bupleurum, corn silk, seaweed and emulsifying aid by weight parts for standby, wherein the emulsifying aid is composed of olive oil and beeswax in a mass ratio of 1:3;

[0044] Step S2, mix angelica, astragalus, rhizoma discontinu, semen euryales, cherokee rose, moxa, bupleurum, corn silk and seaweed, crush and pass through a 70 mesh sieve to obtain mixed medicinal powder; volatile oil in the mixed medicinal powder is extracted by water vapor distillation method for 4.5 hours to obtain volatile oil and dregs;

[0045] According to the solid-liquid ratio of 1:8.5, the dregs are added into an ethanol solution with a mass fraction of 55% to reflux extract for 2.5 hours to obtain an extract liquid; the temperature is controlled at 55°C, the vacuum degree is-0.07 MPa, and the extract liquid is concentrated under reduced pressure to 0.22 times the original volume to obtain a thick paste;

[0046] Step S3: Take the volatile oil obtained in step S2, add emulsifying agent, heat to 70°C, control the speed to 950 rpm and mix for 12 minutes until uniform to form emulsified oil;

[0047] Step S4: Mix the concentrated extract obtained in step S2 with the emulsified oil obtained in step S3 at a speed of 850 rpm for 14 min until homogeneous, heat to 121℃, sterilize for 18 min, and dispense to obtain a traditional Chinese medicine preparation based on Angelica sinensis.

[0048] Example 3

[0049] This embodiment provides a traditional Chinese medicine preparation based on Angelica sinensis, which is made from the following raw materials in parts by weight: 24 parts Angelica sinensis, 14 parts Astragalus membranaceus, 8 parts Dipsacus asper, 6 parts Euryale ferox, 3 parts Rosa laevigata, 7 parts Achyranthes bidentata, 1 part Bupleurum chinense, 0.4 parts corn silk, 5 parts Sargassum fusiforme, and 2.6 parts emulsifying agent, wherein the emulsifying agent is composed of olive oil and beeswax in a mass ratio of 1:4;

[0050] A method for preparing a traditional Chinese medicine preparation based on Angelica sinensis includes the following steps:

[0051] Step S1: Weigh out the raw materials Angelica sinensis, Astragalus membranaceus, Dipsacus asper, Euryale ferox, Rosa laevigata, Achyranthes bidentata, Bupleurum chinense, corn silk, seaweed, and emulsifying agent by weight and set aside.

[0052] Step S2: Mix Angelica sinensis, Astragalus membranaceus, Dipsacus asper, Euryale ferox, Rosa laevigata, Achyranthes bidentata, Bupleurum chinense, corn silk and seaweed, pulverize and pass through an 80-mesh sieve to obtain mixed medicinal powder; extract the volatile oil from the mixed medicinal powder by steam distillation for 5 hours to obtain volatile oil and medicinal residue;

[0053] Add the dregs to a 60% ethanol solution at a material-to-liquid ratio of 1:9, reflux for 3 hours to obtain the extract, control the temperature at 60℃ and the vacuum degree at -0.08MPa, and concentrate under reduced pressure to 0.25 times the original volume to obtain a concentrated extract.

[0054] Step S3: Take the volatile oil obtained in step S2, add emulsifying agent, heat to 75°C, control the speed at 1000 rpm and mix for 10 minutes until uniform to form emulsified oil;

[0055] Step S4: Mix the concentrated extract obtained in step S2 with the emulsified oil obtained in step S3 at a speed of 900 rpm for 12 minutes until homogeneous, heat to 121℃, sterilize for 20 minutes, and dispense to obtain a traditional Chinese medicine preparation based on Angelica sinensis.

[0056] To verify the comprehensive efficacy of the Angelica sinensis-based traditional Chinese medicine preparations prepared in Examples 1-3 of this invention, comparative examples 1-4 were set up, as follows:

[0057] Comparative Example 1

[0058] The present comparative example provides a Chinese medicine preparation based on angelica, which is made of the following raw materials by weight: angelica 20 parts, astragalus 10 parts, rhizoma discontinuorum 6 parts, gordon euryale seed 4 parts, gold cherry 2 parts, radix astragali 5 parts, radix bupleuri 0.6 parts, corn silk 0.2 parts, sea algae 3 parts and emulsifying aid 1.2 parts, wherein the emulsifying aid is composed of olive oil and beeswax in a mass ratio of 1:2;

[0059] A preparation method of a Chinese medicine preparation based on angelica, comprising the following steps:

[0060] Step S1, by weight, the raw materials of angelica, astragalus, rhizoma discontinuorum, gordon euryale seed, gold cherry, radix astragali, radix bupleuri, corn silk, sea algae and emulsifying aid are weighed and prepared for use;

[0061] Step S2, mix angelica, astragalus, rhizoma discontinuorum, gordon euryale seed, gold cherry, radix astragali, radix bupleuri, corn silk and sea algae, crush and pass through a 60-mesh sieve to obtain mixed medicinal powder; take the mixed medicinal powder and add 50% ethanol solution to reflux extraction for 2h to obtain an extract, control the temperature at 50℃, and under the vacuum degree of-0.06MPa, reduce the pressure to concentrate to 0.20 times the original volume to obtain a thick paste;

[0062] Step S3, take the emulsifying aid, heat to 65℃, control the rotation speed at 900rpm and mix for 14min until uniform to form emulsified oil;

[0063] Step S4, take the emulsified oil obtained in step S3 and the thick paste obtained in step S2, mix at a rotation speed of 800rpm for 16min until uniform, heat to 121℃, sterilize for 16min, and then distribute to obtain the Chinese medicine preparation based on angelica.

[0064] Comparative example 2

[0065] The present comparative example provides a Chinese medicine preparation based on angelica, which is made of the following raw materials by weight: angelica 20 parts, astragalus 10 parts, rhizoma discontinuorum 6 parts, gordon euryale seed 4 parts, gold cherry 2 parts, radix astragali 5 parts, radix bupleuri 0.6 parts, corn silk 0.2 parts, sea algae 3 parts and emulsifying aid 1.2 parts, wherein the emulsifying aid is composed of olive oil and beeswax in a mass ratio of 1:2;

[0066] A preparation method of a Chinese medicine preparation based on angelica, comprising the following steps:

[0067] Step S1, by weight, the raw materials of angelica, astragalus, rhizoma discontinuorum, gordon euryale seed, gold cherry, radix astragali, radix bupleuri, corn silk, sea algae and emulsifying aid are weighed and prepared for use;

[0068] Step S2, mix angelica, astragalus, rhizoma discontinu, euryale ferox, rosa davurica, radix astragali complanati, corn silk and seaweed, crush and pass through a 60-mesh sieve to obtain a mixed medicinal powder; extract volatile oil from the mixed medicinal powder by water vapor distillation for 4 hours to obtain volatile oil and dregs;

[0069] According to the solid-liquid ratio of 1:8, the dregs are added into an ethanol solution with a mass fraction of 50%, and reflux extraction is performed for 2 hours to obtain an extract. The temperature is controlled at 50°C, the vacuum degree is-0.06 MPa, and the extract is concentrated under reduced pressure to 0.20 times the original volume to obtain a thick paste.

[0070] Step S3, take the volatile oil obtained in step S2, add an emulsifying aid and the thick paste obtained in step S2, heat to 65°C, control the rotation speed to 900 rpm, mix for 14 minutes until uniform, heat to 121°C, sterilize for 16 minutes, and then distribute to obtain the angelica-based traditional Chinese medicine preparation, wherein the addition amount of the thick paste is 20 times the total mass of the volatile oil, olive oil, and beeswax.

[0071] Comparative Example 3

[0072] This comparative example provides an angelica-based traditional Chinese medicine preparation made from the following raw materials by weight: 20 parts of angelica, 10 parts of astragalus, 6 parts of rhizoma discontinu, 4 parts of euryale ferox, 2 parts of rosa davurica, 5 parts of radix astragali complanati, 0.6 parts of radix bupleuri, 0.2 parts of corn silk, 3 parts of seaweed, and 1.2 parts of an emulsifying aid, wherein the emulsifying aid is olive oil.

[0073] A preparation method of an angelica-based traditional Chinese medicine preparation, comprising the following steps:

[0074] Step S1, weigh the raw materials of angelica, astragalus, rhizoma discontinu, euryale ferox, rosa davurica, radix astragali complanati, corn silk, seaweed, and olive oil according to the weight parts;

[0075] Step S2, mix angelica, astragalus, rhizoma discontinu, euryale ferox, rosa davurica, radix astragali complanati, corn silk, and seaweed, crush and pass through a 60-mesh sieve to obtain a mixed medicinal powder; extract volatile oil from the mixed medicinal powder by water vapor distillation for 4 hours to obtain volatile oil and dregs;

[0076] According to the solid-liquid ratio of 1:8, the dregs are added into an ethanol solution with a mass fraction of 50%, and reflux extraction is performed for 2 hours to obtain an extract. The temperature is controlled at 50°C, the vacuum degree is-0.06 MPa, and the extract is concentrated under reduced pressure to 0.20 times the original volume to obtain a thick paste.

[0077] Step S3, take the volatile oil obtained in step S2, add an emulsifying aid and the thick paste obtained in step S2, heat to 65°C, control the rotation speed to 900 rpm, mix for 14 minutes until uniform, heat to 121°C, sterilize for 16 minutes, and then distribute to obtain the angelica-based traditional Chinese medicine preparation, wherein the addition amount of the thick paste is 20 times the total mass of the volatile oil, olive oil, and beeswax.

[0078] Step S4, the concentrated paste obtained in step S2 is mixed with the emulsified oil obtained in step S3 at a rotation speed of 800 rpm for 16 min until uniform, heated to 121℃, sterilized for 16 min, and then divided into portions to obtain the angelica-based traditional Chinese medicine preparation.

[0079] Comparative Example 4

[0080] The present comparative example provides an angelica-based traditional Chinese medicine preparation, which is made from the following raw materials by weight: angelica 20 parts, astragalus 10 parts, rhizoma discontinuorum 6 parts, gordon euryale seed 4 parts, rosa davurica 2 parts, radix astragali 5 parts, radix bupleuri 0.6 parts, corn silk 0.2 parts, sea algae 3 parts, and emulsifying aid 1.2 parts, wherein the emulsifying aid is beeswax;

[0081] A preparation method of an angelica-based traditional Chinese medicine preparation, comprising the following steps:

[0082] Step S1, raw materials of angelica, astragalus, rhizoma discontinuorum, gordon euryale seed, rosa davurica, radix astragali, radix bupleuri, corn silk, sea algae, and beeswax are weighed by weight parts for standby;

[0083] Step S2, the angelica, astragalus, rhizoma discontinuorum, gordon euryale seed, rosa davurica, radix astragali, radix bupleuri, corn silk, and sea algae are mixed, crushed, and then passed through a 60-mesh sieve to obtain a mixed medicinal powder; the volatile oil in the mixed medicinal powder is extracted by a steam distillation method for 4 h to obtain the volatile oil and medicinal residues;

[0084] The medicinal residues are added into an ethanol solution with a mass fraction of 50% according to a solid-liquid ratio of 1:8, heated to a reflux temperature, and extracted for 2 h to obtain an extract; the temperature is controlled at 50℃, and the vacuum degree is-0.06 MPa; the extract is concentrated under reduced pressure to 0.20 times the original volume to obtain a concentrated paste;

[0085] Step S3, the volatile oil obtained in step S2 is added with beeswax, heated to 65℃, and mixed at a rotation speed of 900 rpm for 14 min until uniform to form an emulsified oil;

[0086] Step S4, the concentrated paste obtained in step S2 is mixed with the emulsified oil obtained in step S3 at a rotation speed of 800 rpm for 16 min until uniform, heated to 121℃, sterilized for 16 min, and then divided into portions to obtain the angelica-based traditional Chinese medicine preparation.

[0087] Comparative Example 5

[0088] The present comparative example provides an angelica-based traditional Chinese medicine preparation, which is made from the following raw materials by weight: angelica 20 parts, astragalus 10 parts, rhizoma discontinuorum 6 parts, gordon euryale seed 6 parts, radix astragali 5 parts, radix bupleuri 0.6 parts, corn silk 0.2 parts, sea algae 3 parts, and emulsifying aid 1.2 parts, wherein the emulsifying aid is composed of olive oil and beeswax in a mass ratio of 1:2;

[0089] A preparation method of a traditional Chinese medicine preparation based on angelica, comprising the following steps:

[0090] Step S1, raw materials angelica, astragalus, rhizoma curculignis, euryale ferox, achyranthes bidentata, bupleurum, corn silk, seaweed and emulsifying aid are weighed with reference to weight parts;

[0091] Step S2, angelica, astragalus, rhizoma curculignis, euryale ferox, achyranthes bidentata, bupleurum, corn silk and seaweed are mixed, crushed and then passed through a 60-mesh sieve to obtain mixed medicinal powder; volatile oil in the mixed medicinal powder is extracted by a steam distillation method for 4 hours to obtain volatile oil and dregs;

[0092] The dregs are added into an ethanol solution with a mass fraction of 50% according to a solid-liquid ratio of 1:8, heated to a reflux temperature, and extracted for 2 hours to obtain an extract; the temperature is controlled at 50 DEG C, and the vacuum degree is-0.06 MPa; the extract is concentrated to 0.20 times the original volume under reduced pressure to obtain a thick paste;

[0093] Step S3, the volatile oil obtained in step S2 is taken and mixed with the emulsifying aid at a temperature of 65 DEG C and a rotating speed of 900 rpm for 14 minutes until uniform to form emulsified oil;

[0094] Step S4, the thick paste obtained in step S2 is mixed with the emulsified oil obtained in step S3 at a rotating speed of 800 rpm for 16 minutes until uniform, heated to 121 DEG C, sterilized for 16 minutes, and then distributed to obtain a traditional Chinese medicine preparation based on angelica.

[0095] Comparative example 6

[0096] The present comparative example provides a traditional Chinese medicine preparation based on angelica, which is made from the following raw materials with reference to weight parts: angelica 20 parts, astragalus 10 parts, rhizoma curculignis 6 parts, cherokee rose 6 parts, achyranthes bidentata 5 parts, bupleurum 0.6 parts, corn silk 0.2 parts, seaweed 3 parts and emulsifying aid 1.2 parts, wherein the emulsifying aid is composed of olive oil and beeswax according to a mass ratio of 1:2;

[0097] A preparation method of a traditional Chinese medicine preparation based on angelica, comprising the following steps:

[0098] Step S1, raw materials angelica, astragalus, rhizoma curculignis, euryale ferox, achyranthes bidentata, bupleurum, corn silk, seaweed and emulsifying aid are weighed with reference to weight parts;

[0099] Step S2, angelica, astragalus, rhizoma curculignis, euryale ferox, achyranthes bidentata, bupleurum, corn silk and seaweed are mixed, crushed and then passed through a 60-mesh sieve to obtain mixed medicinal powder; volatile oil in the mixed medicinal powder is extracted by a steam distillation method for 4 hours to obtain volatile oil and dregs;

[0100] The residue is added into 50% ethanol solution with a material-liquid ratio of 1:8, and heated to reflux temperature for 2 hours to obtain an extract. The temperature is controlled at 50°C, and the vacuum degree is controlled at -0.06 MPa. The extract is concentrated to 0.20 times the original volume under reduced pressure to obtain a concentrated extract;

[0101] Step S3: The volatile oil obtained in step S2 is mixed with an emulsifying aid at a temperature of 65°C and a rotating speed of 900 rpm for 14 minutes until uniform, to form an emulsified oil.

[0102] Step S4: The concentrated extract obtained in step S2 is mixed with the emulsified oil obtained in step S3 at a rotating speed of 800 rpm for 16 minutes until uniform, heated to 121°C, sterilized for 16 minutes, and then divided into portions to obtain the angelica-based traditional Chinese medicine preparation.

[0103] Performance detection

[0104] The angelica-based traditional Chinese medicine preparations prepared in Examples 1-3 and Comparative Examples 1-6 above are used as drug samples, and Roxadustat is used as a control sample. The following experimental methods are used to carry out the research.

[0105] 1. Model establishment

[0106] 120 male SD rats (purchased from Hainan Pharmaceutical Research Co., Ltd.) were randomly selected, license number: SCXK(Jiang)2020-0007. After adaptive feeding for 1 week, 10 rats were randomly selected as a blank group and fed with ordinary feed (ordinary mouse maintenance feed (ordinary grade), purchased from Jilin Jintaimedi Biotechnology Co., Ltd.). The remaining 110 rats were fed with high-fat feed (high-fat feed was composed of 6% egg yolk powder, 10% lard, 8% sucrose, 1% sodium cholate, 1% cholesterol, and 74% ordinary feed).

[0107] After 6 weeks of feeding, all rats were fasted for 12 hours without water. The blank group rats were injected with normal saline, and the 110 high-fat feed rats were induced to develop type 2 diabetes by a single intraperitoneal injection of streptozotocin (STZ) at a dose of 100 mg / kg. STZ was dissolved in a sodium citrate buffer (pH=4.5). After 1 week of induction, the rats were fasted for 12 hours without water. Blood was collected from the rats via the tail vein, and the fasting blood glucose of the rats was determined. The fasting blood glucose concentration (FBG) was measured at the same time for 3 consecutive days. A value greater than 11.1 mmol / L was considered to indicate the successful establishment of a T2DM model.

[0108] 2. Grouping

[0109] The 110 high-fat feed rats were randomly divided into 11 groups according to blood glucose, including a model group, Example 1-3 groups, Comparative Example 1-6 groups, and a control group (Roxadustat), with 10 rats in each group.

[0110] 3. Drug administration

[0111] The drug sample dosing amount of each control group of Examples 1-3 and Comparative Examples 1-6 was 27 mg / kg / d, which was dissolved in an appropriate amount of normal saline and then administered by gavage; the dosing amount of the positive control group of Rosaglitazone was 27 mg / kg / d, which was dissolved in the same volume of normal saline and then administered by gavage; the blank group and the model group were administered by gavage with the same volume of normal saline every day, and the drug was administered once a day at the same time every day, and the intervention was continued for 8 weeks. The rats in each corresponding group were normally fed with basic feed and high-fat feed, and the feeding was maintained until the end of the experiment.

[0112] 4. Index detection

[0113] After the administration of the drug to the rats was completed, 3 ml of blood was collected from the brachial artery after anesthesia, centrifuged to separate the supernatant, and the blood biochemical instrument was used to detect the blood creatinine (Scr) and urea nitrogen (BUN); the 24h urine of the rats was collected, and the biuret method was used to detect the 24h urine protein (24h Upro); the blood cell analyzer was used to detect the hemoglobin (Hb), hematocrit (HCT) and red blood cells (RBC), and the detection results are shown in Table 1.

[0114] 5. Statistical analysis

[0115] The data is expressed as mean ± standard deviation, ANOVA single factor variance analysis is used for comparison between multiple groups, LSD is used for post-hoc comparison, and P<0.05 represents a statistically significant difference.

[0116] Table 1. Detection results of kidney function and blood routine index

[0117]

[0118] Note: In Table 1, a and the model group P<0.05; b and the positive control group P<0.05.

[0119] Scr is a nitrogen-containing organic matter, and BUN is the end product of protein, which can reflect the damage degree of glomerular filtration function to a certain extent; 24h Upro can reflect the function of the kidney; RBC, Hb and HCT are important indicators for measuring anemia; among them, iron deficiency is a common cause of anemia in patients with chronic kidney disease, and iron is an important component of Hb, myoglobin, FER, etc.

[0120] As shown by the data in Table 1, compared with the groups of Examples 1-3, the groups of Examples 1-3 are significantly better than the groups of Comparative Examples 1-6 in improving the renal function and correcting the two core indicators of anemia, which indicates that the angelica-based traditional Chinese medicine preparation prepared by the present application has a significant therapeutic effect on diabetic renal anemia compared with the groups of Comparative Examples 1-6. The reasons for the above differences can be summarized as follows: the group of Comparative Example 1 does not extract volatile oil, and the volatile oil contains the fat-soluble active ingredients of angelica, chaste tree and other medicinal materials, and part of the medicinal material is completely missing, which leads to the fact that the angelica-based traditional Chinese medicine preparation prepared by the group of Comparative Example 1 is significantly inferior to the groups of Examples 1-3 in overall efficacy; the group of Comparative Example 2 mixes the volatile oil, emulsifying aid and concentrated paste at one time instead of forming a stable "emulsified oil" first, which leads to uneven dispersion and insufficient encapsulation of the oil phase (volatile oil), and the active ingredients are more likely to volatilize or be damaged in the subsequent mixing and sterilization process with the concentrated paste, thereby reducing the bioavailability and the final efficacy; the groups of Examples 1-3 use a specific ratio of olive oil and beeswax as emulsifiers, wherein the beeswax provides structural support to make the paste stable and can release the drug slowly, and the olive oil serves as an excellent oil dispersion medium to promote the dissolution and permeation absorption of fat-soluble ingredients. The present application forms a stable "oil-in-water" or composite cream base through the above-mentioned ratio, overcomes the "too hard" problem of single beeswax and the "too soft" problem of single olive oil, and makes the traditional Chinese medicine preparation have good stability and permeability. However, the group of Comparative Example 3 only uses olive oil as an emulsifier, and the olive oil is too soft to form a stable paste, which may lead to drug sedimentation, separation, affect the accuracy of the dose and the storage stability, and ultimately affect the overall efficacy of the angelica-based traditional Chinese medicine preparation prepared by the group of Comparative Example 3; the group of Comparative Example 4 only uses beeswax as an emulsifying base, and the base is too hard to be coated, which is not conducive to the dispersion of the active ingredients of the drug and affects the absorbability of the traditional Chinese medicine preparation, and ultimately leads to the fact that the overall efficacy of the angelica-based traditional Chinese medicine preparation prepared by the group of Comparative Example 4 is inferior to that of the groups of Examples 1-3; the group of Comparative Example 5 replaces the fructus rosae laevigatae in the traditional Chinese medicine preparation with euryale ferox, and the group of Comparative Example 6 replaces the euryale ferox in the traditional Chinese medicine preparation with fructus rosae laevigatae, which changes the raw material ratio of the traditional Chinese medicine preparation compared with the group of Example 1, destroys the "emperor, minister, assistant and messenger" compatibility balance of the traditional Chinese medicine, and ultimately leads to the fact that the overall efficacy of the angelica-based traditional Chinese medicine preparation prepared by the above two groups of comparative examples is inferior to that of the groups of Examples 1-3.

[0121] The specific embodiments are only an explanation of the present application, which is not a limitation of the present application. Those skilled in the art can make modifications to the embodiments without creative contribution after reading the specification, and the modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A traditional Chinese medicine preparation for diabetic nephropathy renal anemia, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials by weight: Angelica 20-24 parts, Astragalus 10-14 parts, Dipsacus 6-8 parts, Gorgon 4-6 parts, Gold cherry 2-3 parts, Radix Achyranthis 5-7 parts, Bupleurum 0.6-1 part, Corn silk 0.2-0.4 part, Sea silk 3-5 parts and emulsifying aid 1.2-2.6 parts; the emulsifying aid is composed of olive oil and beeswax in a mass ratio of 1:2-4.

2. The traditional Chinese medicine preparation according to claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials by weight: Angelica 22 parts, Astragalus 12 parts, Dipsacus 7 parts, Gorgon 5 parts, Gold cherry 2.5 parts, Radix Achyranthis 6 parts, Bupleurum 0.8 part, Corn silk 0.3 part, Sea silk 4 parts and emulsifying aid 1.9 parts.

3. The preparation method of the traditional Chinese medicine preparation for diabetic nephropathy anemia according to any one of claims 1-2, characterized in that, The method comprises the following steps: Step S1, raw materials of Angelica, Astragalus, Dipsacus, Gorgon, Gold cherry, Radix Achyranthis, Bupleurum, Corn silk, Sea silk and emulsifying aid are weighed by weight parts for standby; Step S2, Angelica, Astragalus, Dipsacus, Gorgon, Gold cherry, Radix Achyranthis, Bupleurum, Corn silk and Sea silk are mixed, crushed, sieved to obtain mixed powder, and then volatile oil and extract are extracted, and the extract is concentrated under reduced pressure to obtain thick paste; Step S3, the volatile oil is taken and mixed with the emulsifying aid, and the temperature is raised to 65-75℃ to form emulsified oil; Step S4, the thick paste is mixed with the emulsified oil, sterilized and packaged to obtain the product.

4. The production method according to claim 3, characterized by, The particle size of the mixed powder in step S2 is 60-80 mesh.

5. The preparation method according to claim 3, characterized in that, In step S2, the volatile oil is extracted by steam distillation method for 4-5h to obtain the volatile oil and residue.

6. The preparation method according to claim 3, characterized in that, In step S2, the temperature for concentration under reduced pressure is 50-60℃, and the vacuum degree is-0.08MPa to-0.06MPa.

7. The preparation method according to claim 3, characterized in that, In step S2, the extract is obtained by refluxing the residue with ethanol solution for 2-3h.

8. The preparation method according to claim 7, characterized in that, The mass fraction of the ethanol solution is 50-70%, and the solid-liquid ratio of the residue to the ethanol solution is 1:8-10.

9. The preparation method according to claim 3, characterized in that, In step S2, the volume of the thick paste is 0.20-0.25 times the volume of the extract.

10. The use of the traditional Chinese medicine preparation of any one of claims 1-2 in the preparation of a medicament for treating diabetic nephropathy anemia.

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