Traditional Chinese medicine composition for treating xerostomia and preparation method and application thereof

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating xerostomia, which comprises the following raw material medicines: adenophora tetraphylla, radix pseudostellariae, rehmannia, astragalus membranaceus, dendrobe, radix ophiopogonis, medlar, stiff silkworm (stir-fried with bran), selfheal, Huai wheat, Chinese date and liquorice. The traditional Chinese medicine composition has the effects of nourishing yin and moistening dryness, nourishing yin and clearing heat, replenishing qi and strengthening the spleen, and moistening the lung and promoting salivation, can promote salivary secretion of patients and relieve the dry mouth symptom of the patients, and is mainly used for treating the dry mouth symptom caused by various factors. The preparation process is simple and convenient, the toxic and side effects are small, the administration is convenient, the effects of regulating and balancing the body immunity, relieving the dry mouth symptom, relieving the oral gland injury and the like are achieved in the treatment of the dry mouth symptom, and the life quality of a patient with the dry mouth symptom can be obviously improved.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating xerostomia, and a preparation method and application thereof. Background Art

[0002] The salivary glands play an extremely important role in the health of the body. The oral microenvironment of the human body is composed of a variety of factors in the oral cavity, saliva and its components, and the unique structure of the oral cavity. Among them, the nature and amount of saliva secretion are the core of the oral microenvironment. Insufficient saliva secretion caused by salivary gland hypofunction is the main cause of xerostomia. It is a multifactorial oral symptom rather than an independent disease. Clinically, xerostomia is mainly caused by diabetes, Sjögren's syndrome, radiotherapy, drugs or anxiety. About 30% to 50% of middle-aged and elderly people suffer from varying degrees of dry mouth symptoms, which brings a huge burden to patients' physical, mental and economic health.

[0003] There is no ideal therapeutic drug for xerostomia at present. The pilocarpine tablets used for xerostomia on the market have poor selectivity and can only improve the symptoms of xerostomia, but are prone to cause systemic adverse reactions. In addition, long-term use of drugs such as immunosuppressants and hormones can also cause a series of side effects. Therefore, it has become an urgent need for clinical treatment to find and develop drugs that can effectively treat xerostomia caused by head and neck tumor radiotherapy and Sjögren's syndrome. TCM syndrome differentiation treatment has unique advantages in the treatment of xerostomia, with good efficacy and few side effects. Therefore, it has good development potential and important therapeutic value to find and develop a Chinese medicine composition for treating xerostomia caused by various reasons from traditional Chinese medicine. Summary of the invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating xerostomia and a preparation method and application thereof.

[0005] The first aspect of the present invention provides a Chinese medicine composition for treating dry mouth, wherein the raw materials include Adenophora australis, Radix Pseudostellariae, Radix Rehmanniae, Radix Astragali, Dendrobium officinale, Radix Ophiopogonis, Fructus Lycii, Bombyx Batryticatus (fried with bran), Herba Prunellae, Triticum truncatum, Jujube, and Licorice;

[0006] Among them, the weight portions of each raw material are respectively: 5-10 parts of Adenophora australis, 10-25 parts of Pseudostellaria pseudoginseng, 5-10 parts of Rehmannia glutinosa, 5-10 parts of Astragalus membranaceus, 2-8 parts of Dendrobium officinale, 2-8 parts of Ophiopogon japonicus, 2-8 parts of Lycium barbarum, 2-8 parts of Bombyx batryticatus (fried with bran), 5-15 parts of Prunella vulgaris, 10-25 parts of Huai wheat, 2-8 parts of jujube, and 1-5 parts of licorice.

[0007] Furthermore, the traditional Chinese medicine composition for treating dry mouth is composed of the following raw materials in parts by weight: 5-6 parts of Adenophora australis, 10-15 parts of Pseudostellaria heterophylla, 5-6 parts of Rehmannia glutinosa, 5-6 parts of Astragalus membranaceus, 4-5 parts of Dendrobium officinale, 4-5 parts of Ophiopogon japonicus, 4-5 parts of Lycium barbarum, 4-5 parts of Bombyx batryticatus (fried with bran), 5-8 parts of Prunella vulgaris, 10-15 parts of Huai wheat, 4-5 parts of jujube, and 1-2 parts of licorice.

[0008] Furthermore, the Chinese medicine composition for treating dry mouth is composed of the following raw materials in parts by weight: 6 parts of Adenophora australis, 15 parts of Radix Pseudostellariae, 6 parts of Rehmannia glutinosa, 6 parts of Astragalus membranaceus, 5 parts of Dendrobium officinale, 5 parts of Ophiopogon japonicus, 5 parts of Lycium barbarum, 5 parts of Bombyx batryticatus (fried with bran), 8 parts of Prunella vulgaris, 15 parts of Huai wheat, 5 parts of jujube, and 2 parts of licorice.

[0009] The second aspect of the present invention provides a pharmaceutical preparation having the above-mentioned Chinese medicine composition for treating dry mouth as an active ingredient, wherein the pharmaceutical preparation is prepared into a commonly used dosage form in pharmacy by conventional preparation methods in the art.

[0010] Furthermore, the dosage form of the pharmaceutical preparation is decoction, tablet, capsule, granule, oral liquid or syrup.

[0011] Furthermore, the pharmaceutical preparation also includes pharmaceutically acceptable excipients.

[0012] Furthermore, the preparation method of the pharmaceutical preparation is as follows: take the above 12 raw materials by weight, add 8 times and 6 times the amount of water respectively, decoct twice, the first time for 1-2 hours, the second time for 0.5-1.5 hours, filter them separately, combine the filtrate and let it stand for more than 12 hours, take the supernatant and concentrate it 15-30 times, add preservatives and sweeteners while hot, stir well, and package them.

[0013] Furthermore, the preservative is one or a combination of preservatives including benzoic acid or sodium benzoate, sorbic acid or potassium sorbate, and parabens, with a weight ratio of 0.05-0.25 parts.

[0014] Furthermore, the sweetener is one or two of sucrose, aspartame, xylitol and saccharin, and the weight ratio is 10-15 parts.

[0015] The third aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating xerostomia.

[0016] A fourth aspect of the present invention provides a use of the pharmaceutical preparation as described above in the preparation of a drug for treating xerostomia.

[0017] Furthermore, the xerostomia is caused by factors such as diabetes, Sjögren's syndrome, radiotherapy, drugs or anxiety.

[0018] The advantages and beneficial effects of the present invention are:

[0019] 1. The Chinese medicine composition of the present invention is a medicine prescription selected under the guidance of traditional Chinese medicine theory and clinical experience, which treats both the symptoms and the root causes. In the Chinese medicine composition of the present invention, the main medicine Adenophora australis nourishes yin and promotes body fluid, and Radix Pseudostellariae Pseudostellariae nourishes qi and nourishes yin. The assistant medicines Radix Rehmanniae, Radix Astragali, Herba Dendrobii, and Radix Ophiopogonis clear away heat and nourish yin, promote body fluid and quench thirst. The adjuvant medicines Fructus Lycii, Bombyx Batryticatus, Herba Prunellae, Triticum truncatum, and Jujube can resolve phlegm and disperse nodules. The auxiliary medicine Licorice nourishes the heart and calms the mind, relieves urgency and moisturizes dryness, and harmonizes the medicines. The medicines are used together, coordinated with each other, and work together to play the effects of nourishing yin and moisturizing dryness, clearing heat and cooling blood, and invigorating qi and strengthening the spleen.

[0020] 2. The compositions of the present invention all use natural Chinese medicinal raw materials, which are simple to prepare, have a wide source of medicine, and the cost of the Chinese medicinal raw materials used is low.

[0021] 3. The Chinese medicine composition provided by the present invention is used to treat xerostomia caused by various reasons, which can effectively promote the patient's saliva secretion, relieve the patient's xerostomia symptoms, and reduce oral gland damage. The present invention has a simple production process, small toxic and side effects, and convenient administration. In the treatment of xerostomia, it plays a role in regulating and balancing the body's immunity, relieving xerostomia symptoms, and reducing oral gland damage, and can significantly improve the quality of life of patients with xerostomia. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 These are the results of saliva secretion in rats with xerostomia induced by M-cholinergic blocker.

[0023] Figure 2 These are the results of AQP5 immunohistochemistry in rats with xerostomia induced by M-cholinergic blockers.

[0024] Figure 3 These are the results of ALT, AST, BUN, and CREA serum levels in each treatment group of rats with xerostomia induced by M cholinergic blockers.

[0025] Figure 4 The statistical results of saliva secretion measured in each drug-dosing group of the mouse Sjögren's syndrome model at the 1st, 2nd, 3rd, 4th, 5th and 6th week (* indicates comparison with the normal control group (control), # indicates comparison with the model control group (model), pilocarpine indicates the positive control group (pilocarpine), low-dose group indicates the low-dose group, medium-dose group indicates the medium-dose group, high-dose group indicates the high-dose group, week one, week two: n=10, week three, week four: n=7, week five, week six: n=4, the same below).

[0026] Figure 5 These are the weights of heart and submandibular gland of mice in each group at 2, 4, and 6 weeks after Sjögren's syndrome modeling.

[0027] Figure 6 Masson staining results of the submandibular gland of mice at 2, 4, and 6 weeks after Sjögren's syndrome modeling (400×).

[0028] Figure 7 The results of immunofluorescence staining of B220, CD4 / CD8, and CD4 / FoxP3 in the submandibular gland of mice at the 6th week of Sjögren's syndrome modeling (400×).

[0029] Figure 8 The immunohistochemistry results of AQP5 in the submandibular gland of mice at the 6th week of Sjögren's syndrome modeling (400×).

[0030] Fig. 9 These are the results of IKKβ / p-IKKβ, p65 / p-p65, p38 / p-p38, and IKBα / p-IKBα protein expression in the submandibular gland of mice at the 6th week of Sjögren's syndrome modeling. DETAILED DESCRIPTION

[0031] The specific implementation methods provided by the present invention are described in detail below in conjunction with examples.

[0032] Embodiment 1: Chinese medicine composition of the present invention

[0033] 5 parts of Adenophora australis, 10-25 parts of Pseudostellariae Radix, 5-10 parts of Rehmannia glutinosa, 5 parts of Astragalus, 2 parts of Dendrobium, 2 parts of Ophiopogon japonicus, 2 parts of Lycium barbarum, 2 parts of Bombyx batryticatus (fried with bran), 5 parts of Prunella vulgaris, 10 parts of Huai wheat, 2 parts of jujube, and 1 part of Licorice.

[0034] Embodiment 2: Chinese medicine composition of the present invention

[0035] 6 parts of Adenophora australis, 15 parts of Radix Pseudostellariae, 6 parts of Rehmannia glutinosa, 6 parts of Radix Astragali, 5 parts of Dendrobium, 5 parts of Ophiopogon japonicus, 5 parts of Fructus Lycii, 5 parts of Bombyx Batryticatus (fried with bran), 8 parts of Spica Prunellae, 15 parts of Triticum aestivum, 5 parts of Jujube, and 2 parts of Licorice.

[0036] Embodiment 3: Chinese medicine composition of the present invention

[0037] 8 parts of Adenophora australis, 20 parts of Radix Pseudostellariae, 8 parts of Rehmanniae, 8 parts of Radix Astragali, 6 parts of Herba Dendrobii, 6 parts of Radix Ophiopogonis, 6 parts of Fructus Lycii, 6 parts of Bombyx Batryticatus (fried with bran), 10 parts of Spica Prunellae, 20 parts of Triticum vulgare, 6 parts of Jujube, and 3 parts of Radix Glycyrrhizae.

[0038] Embodiment 4: Chinese medicine composition of the present invention

[0039] 10 parts of Adenophora australis, 25 parts of Radix Pseudostellariae, 10 parts of Rehmannia glutinosa, 10 parts of Radix Astragali, 8 parts of Herba Dendrobii, 8 parts of Radix Ophiopogonis, 8 parts of Fructus Lycii, 8 parts of Bombyx Batryticatus (fried with bran), 15 parts of Spica Prunellae, 25 parts of Triticum aestivum, 8 parts of Jujube, and 5 parts of Radix Glycyrrhizae.

[0040] Example 5: Preparation of the Chinese medicine composition decoction of the present invention

[0041] Weigh each Chinese medicine raw material according to the weight ratio, add water and boil into a decoction in a conventional manner.

[0042] Example 6: Preparation of Chinese medicine composition tablets / capsules of the present invention

[0043] Weigh each Chinese medicine raw material according to weight proportion, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract, dry and crush the extract into granules, add pharmaceutical excipients, and press it into tablets or fill it into capsules.

[0044] Example 7: Preparation of the Chinese medicine composition granules of the present invention

[0045] Weigh each Chinese medicine raw material according to weight proportion, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract, which is then dried and crushed to prepare granules.

[0046] Example 8: Preparation of oral liquid / syrup of the Chinese medicine composition of the present invention

[0047] Weigh each Chinese medicine raw material according to the weight ratio, grind it into powder, decoct it, take the supernatant, and concentrate it into a thick extract; add appropriate pharmaceutical excipients (such as sugar, honey, benzopropionic acid or ethylparaben) to prepare an oral liquid or syrup.

[0048] Embodiment 9:

[0049] Add 8 times and 6 times the amount of water to 12g of Adenophora australis, 30g of Pseudostellaria heterophylla, 12g of Rehmannia glutinosa, 12g of Astragalus membranaceus, 9g of Dendrobium officinale, 9g of Ophiopogon japonicus, 9g of Lycium barbarum, 9g of Bombyx batryticatus (fried with bran), 15g of Spica prunellae, 30g of Triticum truncatum, 9g of Jujube and 3g of Licorice, and boil twice, the first time for 1.5h and the second time for 1h. Filter them separately, let the combined filtrate stand for more than 12h, take the supernatant and concentrate it to 100ml. Add 0.3g of sodium benzoate and 20g of sucrose while hot, stir well, make up to 100ml, and divide into portions.

[0050] Saliva secretion test:

[0051] 60 SD rats were randomly divided into a blank group, a model group, a positive drug control group, and a high, medium, and low dose group of the Chinese medicine composition prepared above, with 10 rats in each group. Except for the blank control group, the remaining rats were given atropine (1 mg / kg) through the tail vein to prepare a dry mouth model. After 20 minutes of successful modeling, the administration group was divided into high, medium, and low dose groups of the Chinese medicine composition according to the clinical common dose of the Chinese medicine composition and the body surface area of ​​SD rats. The positive drug selected pilocarpine, and the blank control group and the model control group used normal saline as a negative control. The high, medium, and low dose groups were gavaged with 1.5 mL, 1 mL, and 0.5 mL of the Chinese medicine composition, respectively, the positive control group was injected with 0.4 mg / mL pilocarpine solution 0.5 mL through the tail vein, and the blank control group and the model control group were gavaged with 1 mL of normal saline. The daily water intake of rats in each group after the end of the administration was recorded, and the mass of the drinking bottle of rats in each group was recorded. The daily water intake = the mass of the drinking bottle on the previous day - the mass of the drinking bottle on the day. The next day, rats in each group were fasted for 1 hour, but not water. After administration, 30 mg dry cotton balls were placed under the tongue of all animals to measure the saliva secretion of the rats. The cotton balls were replaced every 30 minutes and the measurement was continued for 150 minutes. Saliva secretion (mg) = wet cotton ball mass - initial dry cotton ball mass.

[0052] The results of water intake are shown in Table 1. The results show that the water intake after administration of the Chinese medicine combination is shown in Table 1. Compared with the blank group, the water intake of the model group was significantly increased (P < 0.05). Compared with the model group, the water intake of the pilocarpine group and the Chinese medicine complex administration group (high, medium, and low dose groups) was significantly reduced (P < 0.05).

[0053] Table 1 Comparison of water intake in each group of rats ( n=10,g / d)

[0054]

[0055]

[0056] Note: Compared with the blank group 1) P<0.05; compared with the model group, 2) P<0.05.

[0057] The results of saliva secretion are shown in Figure 1The results showed that compared with the blank group, the saliva secretion of the model group decreased (P < 0.05). Compared with the model group, the saliva secretion of the pilocarpine group and the Chinese medicine combination administration group (high, medium and low dose groups) increased significantly (P < 0.0001). Compared with the pilocarpine group, the saliva secretion of the high dose group was not statistically significant (P > 0.05). Compared with the saliva secretion of the high dose group of the Chinese medicine combination, the saliva secretion of the medium dose group was significantly reduced (P < 0.0001). Compared with the saliva secretion of the medium dose group, the saliva secretion of the low dose group was reduced (P < 0.01).

[0058] The results of immunohistochemistry for water channel protein AQP5 are shown in Figure 2 Compared with the blank group, the expression level of AQP5 in the model group was significantly decreased, while the expression levels of AQP5 in the low-, medium-, and high-dose groups and the positive control group increased to varying degrees compared with the model control group, and were similar to those in the blank group.

[0059] Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), and creatinine (CREA) levels are shown in the table below. Figure 3 The results showed that there was no significant difference in ALT, AST, BUN, and CREA levels among the medication groups, indicating that the Chinese medicine composition had no obvious toxicity to the liver and kidneys and had good safety.

[0060] Embodiment 10:

[0061] BALB / c mice were used as experimental animals to establish a BALB / c mouse Sjögren's syndrome model. The mice were randomly divided into 6 groups: normal control group; model control group; positive control group; high, medium and low dose groups of compound Shatai mixture, with 10 mice in each group. Except for the normal control group, the mice in the other groups were modeled.

[0062] Antigen preparation: Take the submandibular gland of BALB / c mice, remove the capsule and connective tissue, wash the blood with physiological saline containing 0.5g / L sodium azide, cut into pieces and put into physiological saline, beat the submandibular gland into homogenate with a high-speed grinder, keep at 4℃, crush it on an ultrasonic crusher for 1h, 3000rpm for 15min, take the supernatant, and determine the protein antigen content with a spectrophotometer. Dilute the supernatant with 0.1M PBS to 100μg / mL, and mix the submandibular gland antigen with an equal volume of Freund's complete adjuvant CFA.

[0063] Modeling: The above antigens were injected at multiple points into the submandibular gland, foot pad, and back subcutaneous tissue of each group of mice except the normal control group, with a total amount of 0.5 mL, and two equal booster injections were given on the 14th and 28th days respectively.

[0064] Administration: The high, medium and low dose groups of Compound Shatai Mixture were intragastrically administered with 0.5mL, 0.2mL and 0.1mL daily, and the positive control drug was intravenously injected with 1mg / kg pilocarpine daily; the mice in the normal control group and the model group were intragastrically administered with 0.2mL normal saline daily. The saliva secretion was measured once a week: After administration, a 30mg dry cotton ball was placed under the tongue of all animals, and each cotton ball was replaced every 30 minutes, and the measurement was continuously carried out for 150 minutes. The saliva secretion of the mice was calculated based on the change in the weight of the cotton ball. Three mice were killed at the 2nd, 4th and 6th week of modeling (all mice were killed at the 6th week), and the submandibular gland and heart were weighed, and the submandibular gland was taken for Masson staining to observe pathological changes. At the 6th week of modeling, the submandibular glands were obtained for B220, CD4 / CD8, and CD4 / FoxP3 immunofluorescence staining to observe the infiltration of immune cells. At the same time, protein was extracted from the submandibular and parotid glands, and Western Blot was used to determine the expression levels of the water channel protein AQP5 and inflammation-related proteins such as IKKβ / p-IKKβ, p65 / p-p65, p38 / p-p38, and IKBα / p-IKBα.

[0065] The results of saliva secretion are as follows Figure 4 As shown in the figure, starting from the first week after modeling, the saliva secretion of mice in the model control group decreased significantly compared with the normal control group, indicating that the secretion function of the salivary glands was severely impaired. The saliva secretion of the low, medium, high dose groups and the positive control group all improved to varying degrees compared with the model control group. The improvement trend was as follows: high dose group ≈ positive control group > medium dose group > low dose group, and there was no significant difference between the groups.

[0066] At the 2nd, 4th and 6th week of modeling, there was no significant difference in the heart weight among the mice groups. However, at the 6th week of modeling, the submandibular gland weight of the model control group was significantly lower than that of the positive control group (P<0.05), indicating that Sjögren's syndrome modeling has a significant damaging effect on the submandibular gland ( Figure 5 ).

[0067] At 2, 4, and 6 weeks after modeling, Masson staining Figure 6 It can be seen that the submandibular gland alveoli of the mice in the normal control group were of regular size and normal morphology, with almost no collagen deposition, while the submandibular gland alveoli of the mice in the model control group were of different sizes and irregular arrangement, with obvious duct dilatation, lymphocyte infiltration and a large amount of collagen deposition. The irregular morphology of the submandibular gland alveoli in the pilocarpine group and the Chinese medicine composition (high, medium and low dose) administration group was significantly improved, and the duct dilatation was alleviated. A small amount of collagen deposition began to occur in the low-dose group in the second week, and a small amount of collagen deposition began to occur in the medium-dose group in the fourth week, while no obvious collagen deposition was observed in the high-dose group and the positive control group during the modeling period.

[0068] After modeling, the submandibular glands of each group were taken for immunofluorescence staining. Figure 7It can be seen that compared with the normal control group, the submandibular gland of the model control group has a large amount of B220 + B cells and CD4 + / CD8 + T cell infiltration, while B220 + B cells and CD4 + / CD8 + Compared with the model control group, the infiltration of T cells was improved to varying degrees, and the improvement trend was as follows: high-dose group ≈ positive control group > medium-dose group > low-dose group. In addition, compared with the normal control group, the model control group had an increase in immunosuppressive cell CD4 + / FoxP3 + Treg cell infiltration was significantly reduced, while CD4 + / FoxP3 + Treg cell infiltration increased to varying degrees compared with the model control group, and the increasing trend was as follows: high-dose group ≈ positive control group > medium-dose group > low-dose group.

[0069] Immunohistochemistry Figure 8 As shown in the figure, compared with the normal control group, the expression of water channel protein AQP5 in the model control group was significantly reduced, while AQP5 in the low-, medium-, high-dose groups and the positive control group increased to varying degrees. The increasing trend was roughly as follows: high-dose group ≈ positive control group > medium-dose group > low-dose group.

[0070] Western Blot results Fig. 9 As shown, compared with the normal control group, the phosphorylation of inflammatory-related proteins IKKβ, p65, p38, and IKBα in the model control group was significantly increased, while the phosphorylation of IKKβ, p65, p38, and IKBα in the low, medium, and high dose groups decreased to varying degrees. The increasing trend was roughly as follows: high dose group > medium dose group > low dose group. The phosphorylation level of the high dose group was basically close to that of the normal control group, indicating that the Chinese medicine composition can improve inflammatory infiltration in a dose-dependent manner.

[0071] In general, the Chinese medicine composition of the present invention can significantly improve the dry mouth symptoms of xerostomia modeling animals (such as xerostomia induced by M cholinergic receptor inhibitors and xerostomia induced by Sjögren's syndrome), promote saliva secretion, alleviate submandibular gland damage, and has good safety, and has great clinical transformation value and application prospects in the treatment of xerostomia.

[0072] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0073] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A Chinese medicine composition for treating xerostomia, characterized in that: The invention is composed of the following raw materials in parts by weight: 5-10 parts of Adenophora australis, 10-25 parts of Pseudostellaria pseudoginseng, 5-10 parts of Rehmannia glutinosa, 5-10 parts of Astragalus membranaceus, 2-8 parts of Dendrobium officinale, 2-8 parts of Ophiopogon japonicus, 2-8 parts of Lycium barbarum, 2-8 parts of Bombyx batryticatus (fried with bran), 5-15 parts of Prunella vulgaris, 10-25 parts of Huai wheat, 2-8 parts of jujube, and 1-5 parts of licorice.

2. The Chinese medicine composition for treating xerostomia according to claim 1, characterized in that: The drug is composed of the following raw materials in parts by weight: 5-6 parts of Adenophora australis, 10-15 parts of Pseudostellaria pseudoginseng, 5-6 parts of Rehmannia glutinosa, 5-6 parts of Astragalus membranaceus, 4-5 parts of Dendrobium officinale, 4-5 parts of Ophiopogon japonicus, 4-5 parts of Lycium barbarum, 4-5 parts of Bombyx batryticatus (fried with bran), 5-8 parts of Prunella vulgaris, 10-15 parts of Huai wheat, 4-5 parts of jujube, and 1-2 parts of licorice.

3. The Chinese medicine composition for treating xerostomia according to claim 1, characterized in that: The drug composition is composed of the following raw materials in parts by weight: 6 parts of Adenophora australis, 15 parts of Radix Pseudostellariae, 6 parts of Rehmannia glutinosa, 6 parts of Astragalus membranaceus, 5 parts of Dendrobium officinale, 5 parts of Ophiopogon japonicus, 5 parts of Lycium barbarum, 5 parts of Bombyx batryticatus (fried with bran), 8 parts of Prunella vulgaris, 15 parts of Triticum aestivum, 5 parts of Jujube, and 2 parts of Licorice.

4. A pharmaceutical preparation comprising the Chinese medicine composition for treating xerostomia as claimed in any one of claims 1 to 3 as an active ingredient, characterized in that: The pharmaceutical preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

5. The pharmaceutical preparation according to claim 4, characterized in that The dosage form of the pharmaceutical preparation is decoction, tablet, capsule, granule, oral liquid or syrup.

6. The pharmaceutical preparation according to claim 4, characterized in that The pharmaceutical preparation also includes pharmaceutically acceptable excipients.

7. The pharmaceutical preparation according to claim 4, characterized in that The preparation method of the pharmaceutical preparation is as follows: take the above 12 raw materials by weight, add 8 times and 6 times the amount of water respectively, decoct twice, the first time for 1-2 hours and the second time for 0.5-1.5 hours, filter them separately, combine the filtrates and let them stand for more than 12 hours, take the supernatant and concentrate it 15-30 times, add preservatives and sweeteners while hot, stir well, and package them.

8. The pharmaceutical preparation according to claim 7, characterized in that The preservative is one or a combination of preservatives including benzoic acid or sodium benzoate, sorbic acid or potassium sorbate, and parabens, with a weight ratio of 0.05-0.25 parts; the sweetener is one or two of sucrose, aspartame, xylitol, and saccharin, with a weight ratio of 10-15 parts.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating xerostomia.

10. Use of the pharmaceutical preparation according to any one of claims 4 to 8 in the preparation of a drug for treating xerostomia.

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