A Chinese medicine composition for treating breast nodules and a preparation method of its solubilized preparation

Abstract

The invention provides a Chinese medicine composition, including Prunella vulgaris, Pinellia tuber, frankincense, bergamot, Cyperus rotundus, Forsythia suspensa, ginger, liquorice, Radix Rehmanniae, and Angelica sinensis. The Chinese medicine composition is used together to regulate qi and blood, take both the symptoms and the root into consideration, and play the effects of soothing the liver and regulating qi, promoting blood circulation and resolving phlegm, softening and dispersing nodules, nourishing blood and calming the mind. It has the advantages of attacking evil without hurting the body, and solves the problem that breast nodules cannot be completely cured. After the Chinese medicine solubilizing preparation of the invention meets water, it can disperse the medicine, increase its solubility, promote the release of the medicine, and enhance the efficacy.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical preparation, and in particular to a method for preparing a traditional Chinese medicine composition and a solubilized preparation thereof. Background Art

[0002] Breast nodules are structural degenerative lesions of breast tissue ducts and lobules and the growth of progressive connective tissue, which are common in breast hyperplasia (mammary cysts can be formed) and breast tumor diseases, including benign breast tumors (such as breast fibroids, phyllodes tumors, etc.) and malignant breast tumors (breast cancer). Traditional Chinese medicine believes that: if the emotions are not smooth, the liver qi cannot be properly discharged, and the qi stagnation and blood stasis are condensed, and the Chong and Ren meridians are not adjusted, there will often be menstrual disorders and facial spots. Modern medicine believes that: marriage, childbirth, diet, the external environment of human survival and genetic factors are the main causes of breast disease. Modern Western medicine believes that: marriage, childbirth, diet, the external environment of human survival and genetic factors are the main causes of breast disease. Because patients lack a correct understanding of this disease, bad psychological factors, excessive tension, anxiety and sadness cause neurasthenia, greatly aggravate endocrine disorders, and promote the aggravation of the disease. At present, surgical methods are mostly used to treat breast nodules. The existing Chinese medicine preparations have a general therapeutic effect on the already formed nodules, which can only inhibit the growth and expansion of the nodules, and cannot achieve the elimination of the nodules.

[0003] In addition, in the current production process of traditional Chinese medicine, the traditional Chinese medicine preparations prepared using traditional Chinese medicine powder as raw material have the defect of low solubility. Summary of the invention

[0004] The object of the present invention is to provide a method for preparing a traditional Chinese medicine composition for treating breast nodules and a solubilized preparation thereof.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The invention provides a traditional Chinese medicine composition, comprising the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of selfheal, 5-10 parts of pinellia, 12-18 parts of frankincense, 8-13 parts of citron, 5-10 parts of cyperus, 3-8 parts of forsythia, 6-9 parts of ginger, 3-6 parts of liquorice, 6-12 parts of rehmannia and 7-15 parts of angelica.

[0007] Preferably, the Chinese medicine composition includes the following components in parts by weight: 18-25 parts of Prunella Vulgaris, 6-8 parts of Pinellia, 15-17 parts of frankincense, 9-11 parts of Citron, 7-9 parts of Cyperus rotundus, 5-7 parts of Forsythia suspensa, 7-8 parts of ginger, 4-5 parts of Licorice, 8-10 parts of Rehmannia glutinosa, and 9-13 parts of Angelica sinensis.

[0008] The present invention also provides a solubilized preparation of the traditional Chinese medicine composition, comprising the traditional Chinese medicine extract powder and pharmaceutical excipients, wherein the pharmaceutical excipients include a nonionic surfactant, a glidant, a lubricant and an adhesive; the weight ratio of the traditional Chinese medicine extract powder to the pharmaceutical excipients is 78-90:10-22.

[0009] Preferably, the nonionic surfactant is a nonionic surfactant with polyethylene glycol as a hydrophilic group.

[0010] Preferably, the nonionic surfactant is selected from Tween, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil or vitamin E polyethylene glycol succinate.

[0011] Preferably, the weight ratio of the nonionic surfactant, the glidant, the lubricant and the adhesive is: 10-20: 0.4-0.8: 0.5-1.2: 0.03-0.06.

[0012] The present invention also provides a method for preparing the solubilized preparation of the traditional Chinese medicine composition, comprising the following steps:

[0013] S1. Freeze the raw material segments of Chinese medicine in liquid nitrogen for 15 to 25 minutes;

[0014] S2. Grind the raw material segments of Chinese medicine frozen with liquid nitrogen, re-add liquid nitrogen every 4 to 7 minutes, grind to 80 to 100 mesh, dry to obtain Chinese medicine powder, decoct the Chinese medicine powder, concentrate, spray-dry, and obtain extract powder;

[0015] S3. The extract powder is mixed with a nonionic surfactant, a glidant and a binder to obtain a mixture 1;

[0016] S4. Mix the mixture 1 with a lubricant, and compress the mixture into tablets to obtain the solubilized preparation of the traditional Chinese medicine composition.

[0017] Preferably, the length of the Chinese medicine segment is 0.3 to 0.5 cm.

[0018] Preferably, the grinding time in step S2 is 50-55 min; and the drying temperature is 40-50°C.

[0019] Preferably, the volume ratio of the Chinese medicine segment in S1 to liquid nitrogen is 1 to 2:10.

[0020] By adopting the above technical scheme, the present invention has the following beneficial effects: the Chinese medicine for treating breast nodules of the present invention has reasonable compatibility and excellent prescription. Among them, Prunella vulgaris dispersing stagnation and reducing swelling is the main medicine; Cyperus rotundus soothes the liver and relieves depression, regulates qi and relieves the middle, regulates menstruation and relieves pain, Pinellia tuber removes dampness and resolves phlegm, eliminates lumps and dissipates stagnation, Frankincense promotes blood circulation, promotes qi and relieves pain, activates collaterals, Citrus hand regulates qi and resolves phlegm, soothes the liver and relieves depression, Forsythia clears away heat and detoxifies, dissipates stagnation and reduces swelling, and they are all ministerial medicines; Rehmannia root nourishes yin and blood, nourishes yin and produces body fluid, Angelica sinensis nourishes blood and moisturizes dryness, and together helps Rehmannia root nourish yin and blood, and nourishes the heart and calms the mind, ginger not only helps Pinellia tuber and dried orange peel resolve phlegm and harmonize the middle, but also can restrain the toxicity of Pinellia tuber, and they are all adjuvants; Licorice invigorates qi, strengthens the spleen and harmonizes the middle, and harmonizes all medicines, and is the guiding medicine. The Chinese medicine composition uses various drugs together to regulate qi and blood, take both the symptoms and the root causes into consideration, and has the effects of soothing the liver and regulating qi, promoting blood circulation and resolving phlegm, softening and dispersing nodules, nourishing blood and calming the mind, and has the advantage of attacking evil without harming the body.

[0021] The Chinese medicine solubilization preparation of the present invention has good compatibility between the auxiliary materials and the extract powder, and is evenly dispersed to form a dispersible tablet with solid dispersion characteristics. The present invention utilizes the rapid dissolution characteristics of non-ionic surfactants, and the prepared tablets can disperse the drug after contacting water, increase its solubility, promote drug release, and enhance drug efficacy. DETAILED DESCRIPTION

[0022] The invention provides a traditional Chinese medicine composition, comprising the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of selfheal, 5-10 parts of pinellia, 12-18 parts of frankincense, 8-13 parts of citron, 5-10 parts of cyperus, 3-8 parts of forsythia, 6-9 parts of ginger, 3-6 parts of liquorice, 6-12 parts of rehmannia and 7-15 parts of angelica.

[0023] In the present invention, the weight proportion of Prunella vulgaris is preferably 15 to 30 parts, more preferably 18 to 25 parts, and even more preferably 22 parts.

[0024] In the present invention, the weight proportion of Pinellia ternata is preferably 5 to 10 parts, more preferably 6 to 8 parts, and even more preferably 7 parts.

[0025] In the present invention, the weight percentage of frankincense is preferably 12 to 18 parts, more preferably 15 to 17 parts, and even more preferably 16 parts.

[0026] In the present invention, the weight proportion of bergamot is preferably 8 to 13 parts, more preferably 9 to 11 parts, and even more preferably 10 parts.

[0027] In the present invention, the weight proportion of Cyperus rotundus is preferably 5 to 10 parts, more preferably 7 to 9 parts, and even more preferably 8 parts.

[0028] In the present invention, the weight proportion of Forsythia suspensa is preferably 3 to 8 parts, more preferably 5 to 7 parts, and even more preferably 6 parts.

[0029] In the present invention, the weight proportion of ginger is preferably 6 to 9 parts, more preferably 7 to 8 parts.

[0030] In the present invention, the weight proportion of licorice is preferably 3 to 6 parts, more preferably 4 to 5 parts.

[0031] In the present invention, the weight percentage of the raw rehmannia is preferably 6 to 12 parts, more preferably 8 to 10 parts, and even more preferably 9 parts.

[0032] In the present invention, the weight proportion of angelica sinensis is preferably 7 to 15 parts, more preferably 9 to 13 parts, and even more preferably 11 parts.

[0033] The present invention also provides a solubilized preparation of the traditional Chinese medicine composition, comprising the traditional Chinese medicine extract powder and pharmaceutical excipients, wherein the pharmaceutical excipients include non-ionic surfactants, glidants, lubricants or adhesives; the weight ratio of the traditional Chinese medicine extract powder to the pharmaceutical excipients is 78-90:10-22.

[0034] In the present invention, the nonionic surfactant is a nonionic surfactant with polyethylene glycol as a hydrophilic group.

[0035] In the present invention, the nonionic surfactant is selected from Tween, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil or vitamin E polyethylene glycol succinate.

[0036] In the present invention, the glidant is preferably talcum powder or micro-powdered silica gel.

[0037] In the present invention, the lubricant is preferably stearate or hydrogenated vegetable oil, more preferably calcium stearate or magnesium stearate.

[0038] In the present invention, the binder is preferably starch, methyl cellulose, or sodium carboxymethyl cellulose.

[0039] In the present invention, the weight ratio of the nonionic surfactant, glidant, lubricant and adhesive is preferably: 10-20: 0.4-0.8: 0.5-1.2: 0.03-0.06; more preferably 13-18: 0.5-0.7: 0.8-1.0: 0.04-0.05, and more preferably 15: 0.6: 0.9: 0.05.

[0040] The present invention also provides a method for preparing the solubilized preparation of the traditional Chinese medicine composition, comprising the following steps:

[0041] S1. Freeze the raw material segments of Chinese medicine in liquid nitrogen for 15 to 25 minutes;

[0042] S2. Grind the raw material segments of Chinese medicine after freezing with liquid nitrogen, re-add liquid nitrogen every 4 to 7 minutes, grind to 80 to 100 mesh, dry to obtain Chinese medicine powder, decoct the Chinese medicine powder, concentrate, spray dry to obtain extract powder;

[0043] S3. The extract powder is mixed with a nonionic surfactant, a glidant and a binder to obtain a mixture 1;

[0044] S4. Mix the mixture 1 with a lubricant, and compress the mixture into tablets to obtain the solubilized preparation of the traditional Chinese medicine composition.

[0045] In the present invention, it is preferred to remove impurities and moldy products in the Chinese medicine raw materials, wash them with clean water, and dry them. In the present invention, after washing and drying the Chinese medicine raw materials, they are cut into sections, and the length of the cut sections is preferably 0.3 to 0.5 cm.

[0046] The present invention preferably freezes and grinds the cut Chinese medicine in liquid nitrogen; the freezing time is preferably 15 to 25 minutes, more preferably 17 to 22 minutes, and more preferably 20 minutes; liquid nitrogen is preferably added again every 4 to 7 minutes during the grinding process, so as to avoid the high temperature generated by the grinding from destroying the efficacy of the medicine or to avoid the Chinese medicine raw materials from becoming sticky and soft when heated, resulting in insufficient crushing fineness; the grinding fineness is preferably 80 to 100 meshes, and the grinding is preferably performed in a fully automatic freezing grinder.

[0047] After obtaining the fine powder of traditional Chinese medicine, the traditional Chinese medicine powder is decocted, concentrated and spray-dried to obtain the extract powder; the number of decoctions is preferably 2 times, and the time of each decoction is preferably 50 to 60 minutes, and more preferably 55 minutes; the concentration is preferably rotary evaporation concentration, the rotation speed of the rotary evaporation concentration is preferably 150 to 180 rpm, and more preferably 160 rpm, the temperature of the rotary evaporation concentration is 80 to 95°C, and more preferably 85°C; the temperature of the spray drying is preferably 100 to 120°C, and preferably 110°C.

[0048] The extract powder is mixed with a nonionic surfactant, a flow aid and a binder to obtain a mixture 1; the mixture 1 is mixed with a lubricant, and tabletted to obtain the solubilized preparation of the traditional Chinese medicine composition.

[0049] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0050] Example 1

[0051] Take 15kg of Prunella vulgaris, 5kg of Pinellia, 12kg of Frankincense, 8kg of Citron, 5kg of Cyperus, 3kg of Forsythia, 6kg of Ginger, 3kg of Licorice, 6kg of Rehmannia, and 7kg of Angelica, remove impurities and wash with clean water, dry and cut into small pieces of 0.3-0.5cm, freeze with liquid nitrogen for 15min and grind, add liquid nitrogen every 4min during the grinding process to avoid high temperature generated by grinding, grind to 80 mesh to obtain Chinese medicine powder. Liquid nitrogen grinding is carried out in a fully automatic liquid nitrogen freezing grinder JXFSTPRP-II-01 (Tuohe Electromechanical Technology Shanghai Co., Ltd.). The Chinese medicine powder is decocted twice, each time for 50min; the decoction is concentrated by rotary evaporation at 150rpm, and spray dried at 100℃ to obtain extract dry powder. 78g of the extract powder was mixed with 10g of Tween 80, 0.4g of talc and 0.03g of starch, and after mixing evenly, 0.5g of magnesium stearate was added and mixed, and tablets were pressed, each tablet weighing 0.5g, to obtain the solubilized preparation of the traditional Chinese medicine composition.

[0052] Example 2

[0053] Take 30kg of Prunella vulgaris, 10kg of Pinellia, 18kg of Frankincense, 8kg of Citron, 10kg of Cyperus, 8kg of Forsythia, 9kg of Ginger, 6kg of Licorice, 12kg of Rehmannia, and 15kg of Angelica, remove impurities and wash with clean water, dry and cut into small segments of 0.3-0.5cm, freeze with liquid nitrogen for 25min and grind, add liquid nitrogen every 7min during the grinding process to avoid high temperature generated by grinding, grind to 100 mesh to obtain Chinese medicine powder. Liquid nitrogen grinding is carried out in a fully automatic liquid nitrogen freezing grinder JXFSTPRP-II-01 (Tuohe Electromechanical Technology Shanghai Co., Ltd.). The Chinese medicine powder is decocted twice, each time for 60min, the decoction liquid is concentrated by rotary evaporation at 180rpm, and spray dried at 120℃ to obtain extract dry powder. 90g of the extract powder was mixed with 20g of polyoxyethylene castor oil, 0.8g of micro-powder silica gel and 0.06g of methyl cellulose. After mixing evenly, 1.2g of calcium stearate was added and mixed. The mixture was pressed into tablets, with each tablet weighing 0.5g, to obtain the solubilized preparation of the traditional Chinese medicine composition.

[0054] Example 3

[0055] Take 20kg of Prunella vulgaris, 7kg of Pinellia, 15kg of Frankincense, 10kg of Citron, 8kg of Cyperus, 5kg of Forsythia, 6kg of Ginger, 5kg of Licorice, 9kg of Rehmannia, and 11kg of Angelica sinensis, wash with clean water after removing impurities, cut into small pieces of 0.3-0.5cm after drying, freeze with liquid nitrogen for 20min and grind, add liquid nitrogen again every 5min during the grinding process to avoid the high temperature generated by grinding, grind to 100 mesh to obtain Chinese medicine powder. Liquid nitrogen grinding is carried out in a fully automatic liquid nitrogen freezing grinder JXFSTPRP-II-01 (Tuohe Electromechanical Technology Shanghai Co., Ltd.). The Chinese medicine powder is decocted twice, each time for 55min, the decoction liquid is concentrated by rotary evaporation at 160rpm, and spray dried at 110℃ to obtain extract dry powder. Take 85g of the extract powder and mix it with 15g of vitamin E polyethylene glycol succinate, 0.6g of talc, and 0.04g of sodium carboxymethyl cellulose. After mixing evenly, add 0.9g of hydrogenated vegetable oil and mix, and press into tablets, each tablet weighing 0.5g, to obtain the solubilized preparation of the traditional Chinese medicine composition.

[0056] Comparative Example 1

[0057] Compared with Example 1, Comparative Example 1 does not add frankincense, and the remaining components and preparation method are the same as those of Example 1.

[0058] Comparative Example 2

[0059] Compared with Example 1, Comparative Example 2 does not add bergamot, and the remaining components and preparation method are the same as those of Example 1.

[0060] Comparative Example 3

[0061] Compared with Example 1, Comparative Example 3 did not add Cyperus rotundus, and the remaining components and preparation method were the same as those of Example 1.

[0062] Comparative Example 4

[0063] Compared with Example 1, Comparative Example 4 did not add Forsythia suspensa, and the remaining components and preparation method were the same as those in Example 1.

[0064] Comparative Example 5

[0065] Compared with Example 1, Comparative Example 5 did not add ginger, and the remaining components and preparation method were the same as those of Example 1.

[0066] Comparative Example 6

[0067] Compared with Example 1, Comparative Example 6 did not add licorice, and the remaining components and preparation method were the same as those of Example 1.

[0068] Comparative Example 7

[0069] Compared with Example 1, Comparative Example 7 does not add raw rehmannia, and the remaining components and preparation method are the same as those of Example 1.

[0070] Comparative Example 8

[0071] Compared with Example 1, Comparative Example 8 does not add Angelica sinensis, and the remaining components and preparation method are the same as those of Example 1.

[0072] Comparative Example 9

[0073] Compared with Example 1, Comparative Example 9 did not add Tween 80, and the remaining components and preparation method were the same as those of Example 1.

[0074] Experimental Example 1: Treatment Effect Experiment

[0075] (1) Basic data: A total of 270 female patients aged 20 to 65 years were used for clinical observation. Based on the differences in treatment methods among the patients, the cases were divided into 9 groups, with 30 patients in each group.

[0076] (2) Inclusion criteria: breast pain during normal times or before menstruation, and nodules or lumps shown by breast ultrasound.

[0077] (3) Dosage and Administration: Groups 1 to 9 orally take the pharmaceutical preparations prepared in Example 1 and Comparative Examples 1 to 9, 3 to 5 tablets each time, twice a day, for 3 consecutive months.

[0078] (4) Efficacy criteria:

[0079] Cure: Breast nodules, lumps, pain and discomfort symptoms completely disappear, and color Doppler ultrasound examination shows that breast nodules or lumps completely disappear;

[0080] Significantly effective: The symptoms of breast nodules, lumps, pain and discomfort are significantly relieved, and color Doppler ultrasound examination shows that breast nodules or lumps partially disappear or shrink;

[0081] Effective: Breast nodules, swelling, pain and discomfort are partially relieved, and color Doppler ultrasound examination shows that breast nodules or lumps are reduced;

[0082] Ineffective: There is no relief of breast nodules, swelling, pain and discomfort, and color Doppler ultrasound shows no change or enlargement of breast nodules or lumps.

[0083] (5) Therapeutic effect: After taking the solubilized Chinese medicine composition preparations in Example 1 and Comparative Examples 1 to 8 for 3 months, the specific therapeutic effects of each group are shown in Table 1:

[0084] Table 1 Therapeutic effects of each group of Chinese medicine composition solubilization preparations

[0085]

[0086]

[0087] Clinical Case 1

[0088] The patient is a 30-year-old female who has suffered from breast nodules for two years. She complained of dry mouth, bitter taste, irritability, insomnia, repeated breast pain or tingling, and aggravated menstruation. Ultrasound showed that there was no abnormality in the acoustic structure of the skin and fascia muscle layer of both breasts. There was a round, slightly hypoechoic area in the lower outer quadrant of the right glandular tissue, about 1.0×1.2CM in size, with smooth edges. The left breast had a capsule with high echoes, and another hypoechoic area of ​​about 0.3×0.2CM in size was seen. The border was clear, and CDFI: blood flow signals were visible in the above-mentioned round, slightly hypoechoic area.

[0089] Western medicine diagnosis: bilateral breast nodules

[0090] TCM diagnosis: breast disease, qi stagnation and blood stasis, phlegm and blood stasis

[0091] Treatment principle: Soothe the liver and activate blood circulation, dry dampness and resolve phlegm, disperse stagnation and reduce swelling

[0092] The solubilized preparation of the Chinese medicine composition of the present invention is taken twice a day, 3 to 5 tablets each time, for 3 consecutive months.

[0093] Efficacy: One month later, the patient was re-examined, and the symptoms of dry mouth, bitter taste, irritability, and insomnia were significantly improved. After taking the medicine for 2 months, the symptoms of breast pain and tingling were significantly alleviated. Color Doppler ultrasound showed that there was a round, slightly low-echo in the outer lower quadrant of the right glandular tissue, about 0.5×0.4CM in size, and no abnormality was found in the left breast; after taking the medicine for 3 months, the symptoms of breast pain and tingling disappeared, and the color Doppler ultrasound re-examination showed that there was no abnormality in both breasts.

[0094] Experimental Example 2 Solubility Test of Chinese Medicine Composition Solubilization Preparation

[0095] Weigh 1.0 g of the samples of Example 1 and Comparative Example 9 respectively into a 100 ml volumetric flask, add water and shake to dissolve and fix the volume. Take a glass sand core funnel and dry it in an oven at 105°C for 30 minutes, then place it in a dryer to room temperature, take it out and weigh it together with the filter paper, record it as W1, filter the above solution with the weighed sand core funnel, put the sintered funnel after filtration in an oven with the filter paper and dry it at 105°C for 30 minutes, take it out and place it in a dryer to room temperature, take it out and weigh it, record it as W2.

[0096]

[0097] The solubility of the solubilizing agent of the Chinese medicine composition of Example 1 and Comparative Example 9 is shown in Table 2:

[0098] Table 2 Solubility of the solubilizing agent of the Chinese medicine composition of Example 1 and Comparative Example 9

[0099] W1(g) W2(g) Dissolution rate (%) Example 1 61.112 61.175 93.7％ Comparative Example 9 61.118 61.264 85.4％

[0100] It can be seen from Table 2 that the solubility of the solubilizing agent of the Chinese medicine composition in the present application is enhanced.

[0101] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A solubilized preparation of a Chinese medicine composition for treating breast nodules, characterized in that: It is composed of Chinese medicine extract dry powder and drug excipients; The Chinese medicine extract powder is composed of the following Chinese medicine raw materials in parts by weight: 15-30 parts of Prunella Vulgaris, 5-10 parts of Pinellia, 12-18 parts of Olibanum, 8-13 parts of Citron, 5-10 parts of Cyperus, 3-8 parts of Forsythia, 6-9 parts of Ginger, 3-6 parts of Licorice, 6-12 parts of Rehmannia glutinosa, and 7-15 parts of Angelica sinensis; The pharmaceutical excipients include nonionic surfactants, glidants, lubricants and adhesives; The weight ratio of the Chinese medicine extract dry powder to the drug excipient is 78-90:10-22; The preparation method of the solubilized preparation of the traditional Chinese medicine composition comprises the following steps: S1. Freeze the Chinese medicine raw materials in liquid nitrogen for 15 to 25 minutes; S2. Grind the raw materials of traditional Chinese medicine after freezing with liquid nitrogen, re-add liquid nitrogen every 4 to 7 minutes, grind to 80 to 100 mesh, dry to obtain traditional Chinese medicine powder, decoct the traditional Chinese medicine powder, concentrate, spray-dry to obtain dry powder of traditional Chinese medicine extract; S3. The Chinese medicine extract powder is mixed with a nonionic surfactant, a glidant and a binder to obtain a mixture 1; S4. Mix the mixture 1 with a lubricant, and compress the mixture into tablets to obtain a solubilized preparation of the Chinese medicine composition.

2. The solubilized preparation of the Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine extract powder is composed of the following components in parts by weight: 18-25 parts of Prunella Vulgaris, 6-8 parts of Pinellia, 15-17 parts of Olibanum, 9-11 parts of Citron, 7-9 parts of Cyperus rotundus, 5-7 parts of Forsythia suspensa, 7-8 parts of ginger, 4-5 parts of Licorice, 8-10 parts of Rehmannia glutinosa, and 9-13 parts of Angelica sinensis.

3. The solubilized preparation of the Chinese medicine composition according to claim 1, characterized in that: The nonionic surfactant is a nonionic surfactant with polyethylene glycol as a hydrophilic group.

4. The solubilized preparation of the Chinese medicine composition according to claim 3, characterized in that: The nonionic surfactant is selected from Tween, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil or vitamin E polyethylene glycol succinate.

5. The solubilized preparation of the Chinese medicine composition according to claim 4, characterized in that: The weight ratio of the nonionic surfactant, the flow aid, the lubricant and the adhesive is: 10-20: 0.4-0.8: 0.5-1.2: 0.03-0.

06.

6. The solubilized preparation of the Chinese medicine composition according to claim 5, characterized in that: The length of the Chinese medicinal material in step S1 is 0.3-0.5 cm.

7. The solubilized preparation of the Chinese medicine composition according to claim 6, characterized in that: The grinding time in step S2 is 50-55 minutes; the drying temperature is 40-50°C.

8. The solubilized preparation of the Chinese medicine composition according to claim 7, characterized in that: The volume ratio of the Chinese medicine raw material to liquid nitrogen in step S1 is 1 to 2:10.

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