A Chinese medicine preparation containing Cassia truncatum and preparation method thereof

Abstract

The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine preparation containing cassia bark and a preparation method thereof. The traditional Chinese medicine composition containing cassia bark comprises: cassia bark, cassia seed, schizonepeta, chrysanthemum and liquorice. The traditional Chinese medicine composition provided by the present invention has a high content of luteolin, a fast release rate, a complete release rate, is convenient to take, has a suitable taste and a long shelf life. The preparation process is simple, the paste yield is high, the main component extraction rate is high, and it is suitable for industrial production. It has broad scientific and market significance in terms of unifying drug quality, reducing drug costs and the diversity of clinical drugs.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine preparation containing Cassia truncatum and a preparation method thereof. Background Art

[0002] "Puji Fang" records that "Shijueming Powder is used to treat wind poison gas attacking the head, causing dark eyes and headaches." Shijueming, Qianghuo (without the reed head), Caocassia, chrysanthemum, and licorice (roasted and crushed). The above is a powder. Take 2 qian each time with a cup of water. Boil for 6 minutes, mix and dissolve, and take warm after meals and before going to bed. Boil and powder. This prescription is widely used in ophthalmology, and is mostly used for liver heat and cataract eye diseases.

[0003] In actual application, the above-mentioned prescription has the disadvantage of being insufficient in anti-inflammatory and treating dry eyes. Summary of the invention

[0004] In view of this, the technical problem to be solved by the present invention is to provide a Chinese medicine preparation containing Semen Cassiae and a preparation method thereof, which has a high solubility.

[0005] To achieve the above object, the present invention provides a Chinese medicine composition containing Semen Cassiae, comprising Semen Cassiae, Semen Cassiae, Schizonepeta, Chrysanthemum and Licorice.

[0006] Preferably, the mass ratio of the semen cassiae, cassia seed, schizonepeta, chrysanthemum and liquorice is 2:2:1-3:2:0.5-1.

[0007] Preferably, the mass ratio of Semen Cassiae, Semen Cassiae, Schizonepeta, Chrysanthemum and Licorice is 2:2:2:2:1.

[0008] Lithospermum officinale is a commonly used shellfish medicinal material. It tastes salty and is cold in nature. It belongs to the liver meridian. It has the effects of calming the liver and clearing heat, improving eyesight and removing cataracts. It is used to treat headaches, dizziness, red eyes, blurred vision, and amblyopia. Lithospermum officinale is the main drug of Lithospermum officinale powder in the "Catalogue of Ancient Classic Prescriptions (First Batch)". There are 6 sources of Lithospermum officinale in the 2020 edition of the "Chinese Pharmacopoeia", which are Haliotis animals of the Haliolidae family, namely H. diversicolor, H. discushannai, H. ovina, H. ruber, H. asinina and H. laevigata.

[0009] Cassia seed is the dried mature seed of Cassia obtusifolia L. or Cassia tora L. of the leguminous plant. It has the effects of clearing away heat, improving eyesight, moistening the intestines and relieving constipation. Cassia seed is the main drug in the traditional Chinese medicine composition provided by the present invention, and its main component is cassia bark extract.

[0010] Chrysanthemum is the dried inflorescence of Chrysanthemum morifolium Ramat., a plant of the Asteraceae family. It has the effects of dispersing wind and heat, calming the liver and improving eyesight, and clearing away heat and detoxifying.

[0011] Schizonepetatenuifolia Briq. is listed in the 2020 edition of the Chinese Pharmacopoeia. It is the dried aerial part of the Lamiaceae plant. It is harvested in summer and autumn when the flowers are in full bloom and the spikes are green, and then removed from impurities and dried in the sun. It is pungent and slightly warm. It enters the lung and liver meridians. It has the effects of dispelling wind, clearing rashes, and eliminating sores.

[0012] The invention uses schizonepeta as the adjuvant drug, one of the main components of which is luteolin.

[0013] Licorice is included in the 2020 edition of the Chinese Pharmacopoeia. It is the dried root and rhizome of Glycyrrhiza uralensis, G. glabra, and G. inflata of the Leguminosae family. It is a common Chinese herbal medicine in my country and is often used as an adjuvant in Chinese medicine prescriptions. It tastes sweet and is neutral in nature. It has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving urgency and relieving pain, and harmonizing various medicines.

[0014] The present invention adopts Schizonepeta to replace Notopterygium wilfordii in the original prescription, thereby increasing the content of luteolin in the medicine, thereby increasing the anti-inflammatory activity thereof, and having a higher efficacy in treating eye diseases such as dry eye.

[0015] The dosage forms of the above-mentioned Chinese medicine composition provided by the present invention include but are not limited to capsules, granules or tablets.

[0016] Optionally, the components of the traditional Chinese medicine composition also include auxiliary materials.

[0017] The present invention does not limit the specific types of the excipients, which can be selected according to the specific dosage form.

[0018] Optionally, the auxiliary materials include one or more of fillers and sweeteners.

[0019] The filler may be any suitable filler known to those skilled in the art, including but not limited to one or more of lactose, sucrose, dextrin, microcrystalline cellulose, and the like.

[0020] The mass content of the filler is preferably 15% to 65%.

[0021] The sweetener may be any suitable sweetener known to those skilled in the art, including but not limited to one or more of sucralose, aspartame, sorbitol, sucrose, and the like.

[0022] The mass content of the sweetener is preferably 0-65%.

[0023] After the dosage form of the traditional Chinese medicine composition is adjusted to granules, tablets or capsules, the release efficiency and release rate of the active ingredients of the medicine can be improved.

[0024] The present invention provides a method for preparing the above-mentioned Chinese medicine composition containing Semen Cassiae, comprising the following steps:

[0025] Mixing Cassiae Semen, Cassia Seed, Nepeta Tenuifolia, Chrysanthemum and Licorice, extracting with water, and filtering to obtain a water extract;

[0026] The water extract was concentrated under reduced pressure to a density of 1.3-1.4 g / mL to obtain a clear paste.

[0027] Preferably, the water extraction is repeated twice, including a first water extraction and a second water extraction.

[0028] The extraction time of the first water extraction is preferably 1.5 to 2.5 hours, more preferably 2 hours.

[0029] In the first water extraction, the amount of water used is preferably 10 to 14 times the total amount of the raw materials, and more preferably 12 times.

[0030] The extraction time of the second water extraction is preferably 1 to 2 hours, more preferably 1.5 hours.

[0031] In the second water extraction, the amount of water used is preferably 8 to 12 times the total amount of the raw materials, and more preferably 10 times.

[0032] During the extraction process, the present invention optimizes the extraction process through orthogonal experiments, and scales up production based on small-scale tests. By optimizing process parameters, samples produced on an industrial scale are kept consistent with small-scale test samples, and scientific accelerated experiments verify that the quality of the preparation of the present invention does not change over a long period of time.

[0033] Preferably, the present invention further comprises a granulation process after obtaining the above-mentioned clear paste.

[0034] Preferably, the auxiliary agent and the clear paste are mixed and granulated.

[0035] After granulation, the process can also include packaging, tableting, filling and other processes.

[0036] If it is a tablet, it can be mixed with 1% magnesium stearate and then pressed into tablets. If it is a capsule, it can be mixed with 1% magnesium stearate and then filled into capsules. If it is a granule, it can be directly packaged.

[0037] The main component content obtained by the method is stable, the paste yield is stable, and the dissolution rate and solubility of cassia bark extract are improved, so that the release is faster and more complete.

[0038] Traditional Chinese medicine decoctions have many disadvantages, such as complex preparation, inconvenient decoction, short shelf life after decoction, poor taste, and incomplete extraction of active ingredients due to uncertain water volume and time during decoction.

[0039] The method provided by the invention has simple process, high paste yield and high main component extraction rate, and is suitable for industrial production.

[0040] The test results show that the traditional Chinese medicine composition provided by the present invention has a moisture content of less than 5%, and has no significant changes in the content of main components, moisture content and properties after being placed under accelerated stability conditions for 6 months.

[0041] The Chinese medicine composition provided by the present invention can be used to prepare medicines for treating eye diseases.

[0042] Preferably, the granules for daily adult dosage are prepared by extracting and concentrating 6.25 g of Semen Cassiae, 6.25 g of Semen Cassiae, 3.125-9.375 g of Schizonepeta, 6.25 g of Chrysanthemum, and 1.5625-3.125 g of Licorice, and adding appropriate amounts of auxiliary materials.

[0043] Compared with the prior art, the present invention provides a Chinese medicine composition containing cassia bark, including cassia bark, cassia seed, schizonepeta, chrysanthemum and liquorice. The Chinese medicine composition provided by the present invention has a high content of luteolin, a fast release rate, a complete release rate, is easy to take, has a suitable taste and a long shelf life.

[0044] The preparation process is simple, the paste yield is high, the main component extraction rate is high, and it is suitable for industrial production. It has broad scientific and market significance in unifying drug quality, reducing drug costs, and diversifying clinical drug use. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 This is a comparative dissolution curve of cassia bark extract in the traditional Chinese medicine composition prepared by Prescription 5 of the present invention and Comparative Example 1. DETAILED DESCRIPTION

[0046] In order to further illustrate the present invention, the Chinese medicine preparation containing Semen Cassiae and the preparation method thereof provided by the present invention are described in detail below in conjunction with examples.

[0047] Example 1

[0048] Nine batches of clear paste were prepared by different extraction processes, and the paste yield and the content of cassia bark extract were measured.

[0049] Table 1 Extract prescription

[0050] prescription Dosage Lithospermum officinale 625g Cassia seed 625g Nepeta 625g chrysanthemum 625g Licorice 312.5g

[0051] Preparation process: Weigh the pieces of Semen Cassiae, Semen Cassiae, Herba Nepetae, Flos Chrysanthemi, and Radix Glycyrrhizae according to the prescription amount into an extraction tank, add purified water, decoct, repeat twice, filter out the decoction, and combine the two decoctions for later use. The extraction time and water addition multiple are shown in Table 2 below:

[0052] Table 2 Water addition times and decoction time

[0053]

[0054]

[0055] The above 9 batches of decoctions were concentrated to about 1000 ml respectively, transferred to a tray, dried, and the paste rate was calculated. The dried product was dissolved in 1000 ml of ethanol, and the content of cassia bark extract was measured.

[0056] Ointment yield (%) = dry matter / total amount of medicinal materials*100%

[0057] Table 3 Comparison of the yield of ointment and the content of cassia bark

[0058]

[0059] From the research results, it can be seen that the paste yield is related to the water addition multiple. The more water is added, the greater the paste yield is. It has little to do with the extraction time. The content of cassia bark is related to both the extraction time and the water addition multiple. When the water addition multiple is 12 times for the first time and 10 times for the second time, continuing to increase the water addition multiple has little effect on the content of cassia bark. The extraction time is 2 hours for the first time and 1.5 hours for the second time.

[0060] Example 2

[0061] Preparation of clear paste: Weigh 625g of Semen Cassiae, 625g of Semen Cassiae, 625g of Schizonepeta, 625g of Chrysanthemum, and 312.5g of Licorice into an extraction tank, add purified water, decoct, repeat twice, filter out the decoction, combine the two decoctions, concentrate to a density of 1.3-1.4g / ml, and prepare a prescription amount of clear paste.

[0062] prescription:

[0063] Table 4 Tablet prescription

[0064] prescription Dosage Clear Cream A prescription amount Microcrystalline Cellulose 65.2g dextrin 60g Magnesium Stearate 4.8g Made 1200 pieces

[0065] Preparation process: weigh microcrystalline cellulose and dextrin according to the above prescription, add them into the hopper of a one-step granulator and preheat to 70-80°C, spray the clear paste, dry until the moisture is less than 5%, add 4.8g of magnesium stearate after discharging, and mix in a three-dimensional mixer for 3min; take the mixed powder and press it into tablets, control the average tablet weight to 0.4g / tablet, and the tablet hardness to 70-120N.

[0066] Example 3

[0067] Preparation of clear paste: Weigh 625g of Semen Cassiae, 625g of Semen Cassiae, 625g of Schizonepeta, 625g of Chrysanthemum, and 312.5g of Licorice into an extraction tank, add purified water, decoct, repeat twice, filter out the decoction, combine the two decoctions, concentrate to a density of 1.3-1.4g / ml, and prepare a prescription amount of clear paste.

[0068] prescription:

[0069] Table 5 Capsule prescription

[0070] prescription Dosage Clear Cream A prescription amount lactose 35.8g dextrin 30g Magnesium Stearate 4.2g Made 1200 pieces

[0071] Preparation process: Weigh lactose and dextrin according to the above prescription, add them into the hopper of a one-step granulator and preheat them to 70-80°C, spray the clear paste, dry until the moisture is less than 5%, add 4.2g of magnesium stearate after discharging, and mix in a three-dimensional mixer for 3min; take the mixed powder and fill it into 1# capsules, controlling the average filling amount to 0.35g / capsule.

[0072] Example 4

[0073] Preparation of clear paste: Weigh 625g of Semen Cassiae, 625g of Semen Cassiae, 625g of Schizonepeta, 625g of Chrysanthemum, and 312.5g of Licorice into an extraction tank, add purified water, decoct, repeat twice, filter out the decoction, combine the two decoctions, concentrate to a density of 1.3-1.4g / ml, and prepare a prescription amount of clear paste.

[0074] prescription:

[0075] Table 6 Granules prescription

[0076] prescription Prescription 1 Prescription 2 Prescription 3 Prescription 4 Prescription 5 Clear Cream A prescription amount A prescription amount A prescription amount A prescription amount A prescription amount sucrose 650g / / / / dextrin / 648g 647g 200g 650g Sucralose / 2g / / / Sorbitol / / / 449g / Aspartame / / 3g 1g / Made 1000g 1000g 1000g 1000g 1000g

[0077] Preparation process: Weigh the auxiliary materials according to the above prescription, add them into the hopper of the one-step granulator and preheat them to 70-80°C, spray the clear paste, dry until the moisture content is less than 5%, discharge the materials, and bag them according to the average loading amount of 5g.

[0078] Comparative Example 1

[0079] prescription:

[0080] Table 7 Original prescription

[0081] prescription Dosage Lithospermum officinale 625g Cassia seed 625g Notopterygium wilfordii 625g chrysanthemum 625g Licorice 312.5g

[0082] Process: Weigh the prescribed amount of Shijueming, Cassia seed, Qianghuo, Chrysanthemum, and Licorice slices, grind them, add 26 times purified water, boil until about 16 times water remains, filter out the decoction, concentrate the decoction and dry it, dry the decoction and the residue separately until the moisture content is less than 3%, mix the dried decoction and the residue, grind them, and make 200 portions.

[0083] Determination of the content of luteolin and cassia bark: Determined by high performance liquid chromatography (General Rule 0512 of the 2020 edition of the Chinese Pharmacopoeia).

[0084] Chromatographic conditions and system suitability: Agilent Poroshell EC C18 (100 mm × 4.6 mm, 2.7 μm) chromatographic column was used; acetonitrile was used as mobile phase A, 0.1% phosphoric acid solution was used as mobile phase B, and gradient elution was performed as specified in the following table; the flow rate was 1.5 mL / min; the column temperature was 30°C; 348 nm (0-12 min), 284 nm (12-14.5 min), the theoretical plate number was calculated based on the cassia bark peak, and should not be less than 20,000.

[0085] Table 8 Gradient elution conditions

[0086] Time (minutes) Mobile phase A% Mobile phase B% 0～6 16 84 6～8 16→33 84→67 8～20 33→36 67→64 20～24 36→70 64→30 24～25 70→16 30→84 25～30 16 84

[0087] Preparation of reference solution: Take appropriate amount of luteolin reference substance and aurantium cassiae reference substance, weigh accurately, add 70% methanol solution to dissolve and dilute to prepare a solution containing 40 μg of luteolin and 20 μg of aurantium cassiae per 1 mL as the reference solution.

[0088] Preparation of reference solution: Take an appropriate amount of cassia bark reference substance, weigh it accurately, and add 70% methanol solution to prepare a solution containing 7 μg of cassia bark per 1 mL as the reference solution.

[0089] Preparation of test sample: Take an appropriate amount of this product, grind it into powder, take about 0.5g or 1 / 10 portion, accurately weigh it into a 25ml volumetric flask, add 15ml of 70% methanol solution, heat and reflux for 30 minutes, cool, add 70% methanol solution to the mark, shake well, filter, and take the filtrate.

[0090] Determination method: Accurately pipette 5 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0091] Comparison of the content of cassia bark and luteolin:

[0092] Table 9

[0093] Detection items Prescription 5 Comparative Example 1 Cassia tangerine (mg / bag) 1.703 1.762 Luteolin (mg / bag) 2.561 1.473

[0094] Determination of dissolution rate and dissolution

[0095] Cassia seed is the main drug of the preparation, and its main component is cassia bark. The present invention can improve the dissolution rate and dissolution degree of cassia bark by changing the dosage form, so that the release of cassia bark can be faster and more complete.

[0096] Dissolution method:

[0097] Chinese Pharmacopoeia 2020 Edition Part IV 0931 Dissolution and Release Test Method 3.

[0098] Speed: 50rpm

[0099] Medium: 250ml, water medium

[0100] Sampling time: 5min, 10min, 15min, 30min.

[0101] Detection method: Same as the determination of cassia bark content

[0102] Determination method: Accurately pipette 5-10 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0103] Take 6 portions of Comparative Example 1 and Prescription 5, test them according to the above method, and calculate the average content of cassia bark at each time point:

[0104] Table 10

[0105]

[0106]

[0107] From the above experiments, it can be seen that the content of citrus glabra in Comparative Example 1 is relatively close to that of Prescription 5, while the content of luteolin in Prescription 5 is higher than that in Comparative Example 1. The present invention increases the content of luteolin.

[0108] Figure 1 The comparative dissolution curves of cassia bark from the Chinese medicine compositions prepared by Prescription 5 of the present invention and Comparative Example 1 show that, when the content of cassia bark (1.6 mg / bag) is similar, the dissolution rate of Prescription 5 is faster than that of Comparative Example 1, and the 60-min solubility of Prescription 5 is close to the content value, which is basically completely dissolved, and is nearly 30% higher than that of Comparative Example 1.

[0109] Example 5

[0110] Scale up to industrial scale production of 3 batches

[0111] Table 11 Prescriptions for three batches of industrial-scale production

[0112] prescription Prescription 6 (kg) Prescription 7 (kg) Prescription 8 (kg) Lithospermum officinale 37.5 37.5 37.5 Cassia seed 37.5 37.5 37.5 Nepeta 37.5 37.5 37.5 chrysanthemum 37.5 37.5 37.5 Licorice 18.75 18.75 18.75 dextrin 39 39 39 Made 12,000 bags 12,000 bags 12,000 bags

[0113] Preparation process:

[0114] 1) Extraction:

[0115] Weigh the medicinal materials according to the prescription, add them into a 3000L extraction tank, add 2025kg (12 times) of purified water, boil for 2h, release the decoction for later use; add another 1687.5kg (10 times) of purified water, boil for 1.5h, release the filtrate, combine it with the first decoction, and set aside.

[0116] 2) Concentration:

[0117] Add the combined decoction to the concentration tank and concentrate under reduced pressure at -0.08 MPa and 50-60°C. Concentrate to a density of 1.3-1.4 g / ml, and discharge the mixture for later use.

[0118] 3) Granulation:

[0119] Weigh dextrin according to the prescription amount, add it into a one-step granulator, preheat it to 70-80°C, spray the clear paste into it, dry it until the moisture content is less than 5%, and discharge the material to obtain granules.

[0120] 4) Packaging: 5g / bag, aluminum-plastic composite film.

[0121] Quality comparison: The properties, moisture, particle size, solubility and citrus chrysanthemum content of the prescription 5 in Example 4 of the present invention and the prescriptions 6, 7 and 8 in Example 5 were compared.

[0122] Detection Methods

[0123] Properties: This product is a granule, which is light brown to brown in color; it tastes sweet and slightly bitter.

[0124] Moisture content: Determined according to the moisture determination method (Chinese Pharmacopoeia 2020 Edition, Part IV, General Rules 0832), unless otherwise specified, shall not exceed 6.0%.

[0125] Particle size: Determined according to the particle size and particle size distribution determination method (Chinese Pharmacopoeia 2020 Edition Part IV General Rules 0982 Second Method Double Screening Method), the sum of those that cannot pass through the No. 1 sieve and those that can pass through the No. 5 sieve shall not exceed 15%.

[0126] Solubility: Take 1 bag of test sample, add 200ml of hot water, stir for 5 minutes, and observe immediately. It should be completely dissolved or slightly turbid.

[0127] Determination of cassia bark content: Determined by high performance liquid chromatography (General Rule 0512 of the 2020 edition of the Chinese Pharmacopoeia).

[0128] Chromatographic Conditions and System Suitability: An Agilent Poroshell EC C18 (100 mm × 4.6 mm, 2.7 μm) chromatographic column was used; acetonitrile was used as mobile phase A, 0.1% phosphoric acid solution was used as mobile phase B, and gradient elution was performed as specified in the following table; the flow rate was 1.5 mL / min; the column temperature was 30°C; the detection wavelength was 284 nm, and the theoretical plate number was calculated based on the cassia bark peak and should not be less than 20,000.

[0129] Table 12 Gradient elution conditions

[0130] Time (minutes) Mobile phase A% Mobile phase B% 0～6 16 84 6～8 16→33 84→67 8～20 33→36 67→64 20～24 36→70 64→30 24～25 70→16 30→84 25～30 16 84

[0131] Preparation of reference solution: Take an appropriate amount of cassia bark reference substance, weigh it accurately, and add 70% methanol solution to prepare a solution containing 7 μg of cassia bark per 1 mL as the reference solution.

[0132] Preparation of test sample: Take an appropriate amount of this product, grind it into powder, take about 0.5g, weigh it accurately, add 25mL of 70% methanol solution, weigh it, heat and reflux for 30 minutes, cool, weigh it again and make up the lost weight with solvent, shake well, filter, and take the filtrate to obtain it.

[0133] Determination method: Accurately pipette 5-10 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0134] Table 13 Comparison of quality of small test and large production samples

[0135]

[0136] It can be seen that the quality of samples from large-scale industrial production is consistent with that of small-scale test samples, and the content of cassia bark is slightly higher than that of small-scale test samples.

[0137] Stability comparison:

[0138] After accelerated placement, the properties, moisture content, and cassia bark content of Prescription 6, Prescription 7, and Prescription 8 in Example 5 of the present invention were compared:

[0139] Accelerated experiment: According to the guidelines for stability testing of raw materials and preparations (Guidelines 9001 of the Fourth Part of the 2020 Edition of the Chinese Pharmacopoeia), the test samples were placed at a temperature of 40℃±2℃ and a relative humidity of 75%±5% for 6 months, and samples were taken in January, February, March and June.

[0140] Table 14 Comparison of accelerated stability of three batches of samples from large production

[0141]

[0142] The results of the accelerated test showed that there was no significant difference in the appearance, moisture content and aurantium content of the three batches of samples compared with those in October.

[0143] In summary, the preparation process of the present invention can be industrially scaled up on the basis of a small test, and the scaled-up product is consistent with the small test product, and has good accelerated stability for 6 months.

[0144] The above embodiments are only used to help understand the method and core idea of ​​the present invention. It should be noted that, for those skilled in the art, several improvements and modifications can be made to the present invention without departing from the principles of the present invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicine composition containing Semen Cassiae, comprising: Cassia seed, cassia seed, schizonepeta, chrysanthemum and licorice.

2. The Chinese medicine composition containing Semen Cassiae according to claim 1, characterized in that: The mass ratio of the stone cassia seed, cassia seed, schizonepeta, chrysanthemum and liquorice is 2:2:1-3:2:0.5-1.

3. The Chinese medicine composition containing Semen Cassiae as claimed in claim 2, characterized in that: The mass ratio of the semen cassiae, cassia seed, schizonepeta, chrysanthemum and liquorice is 2:2:2:2:

1.

4. The Chinese medicine composition containing Semen Cassiae according to claim 1, characterized in that: The dosage form of the Chinese medicine composition is capsule, granule or tablet.

5. The Chinese medicine composition containing Semen Cassiae according to claim 1, characterized in that: Also includes auxiliary materials.

6. The Chinese medicine composition containing Semen Cassiae as claimed in claim 5, characterized in that: The auxiliary materials include one or more of fillers and sweeteners.

7. A method for preparing the Chinese medicine composition containing Semen Cassiae as claimed in any one of claims 1 to 6, comprising the following steps: Mixing Cassiae Semen, Cassia Seed, Nepeta Tenuifolia, Chrysanthemum and Licorice, extracting with water, and filtering to obtain a water extract; The water extract was concentrated under reduced pressure to a density of 1.3-1.4 g / mL to obtain a clear paste.

8. The preparation method according to claim 7, characterized in that: The water extraction includes a first water extraction and a second water extraction; The extraction time of the first water extraction is 1.5 to 2.5 hours; In the first water extraction, the amount of water used is 10 to 14 times the total amount of the raw materials; The extraction time of the second water extraction is 1 to 2 hours; In the second water extraction, the amount of water used is 8 to 12 times the total amount of raw materials.

9. The preparation method according to claim 8, characterized in that: The extraction time of the first water extraction is 2h; In the first water extraction, the amount of water used is 12 times the total amount of raw materials; The extraction time of the second water extraction is 1.5h; In the second water extraction, the amount of water used is 10 times the total amount of raw materials.

10. The preparation method according to claim 7, characterized in that: The method of obtaining the clear paste also includes granulation.

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