Preparation method of solid preparation of ancient and classical famous prescription pinellia ternate heart-fire purging decoction

Abstract

The invention discloses a preparation method of an ancient classical famous prescription pinellia ternate heart-fire purging decoction solid preparation, and relates to the technical field of traditional Chinese medicine preparation preparation.The preparation method comprises the steps that 8-10 times of water is added for soaking for 30-40 min, first extraction is conducted after boiling is conducted for 1-1.5 h, 6-8 times of water is added into medicine residues, second extraction is conducted after boiling is conducted for 0.5-1 h, and the extracting solution is filtered with a 350-450-mesh sieve while being hot for use, so that the dry paste rate of the extracting solution is increased; after loss, the dry extract rate of the pinellia ternata heart-fire purging decoction spray powder can still meet the dry extract rate range of a reference sample of the pinellia ternata heart-fire purging decoction, and the similarity between the pinellia ternata heart-fire purging decoction spray powder as an active ingredient of a preparation and the active ingredient of the reference sample through fingerprint detection reaches 0.9 or above. The quality of the sample is basically consistent with that of a reference sample, and the safety is qualified through toxicological evaluation.

Description

Technical Field

[0001] The invention relates to the technical field of preparation of traditional Chinese medicine preparations, and in particular to a preparation method of a solid preparation of a classic prescription Banxia Xiexin Decoction. Background Art

[0002] In the Treatise on Febrile Diseases, it is mentioned that the Banxia Xiexin Decoction is prepared as follows: 0.5 liter of Banxia (washed), 3 liang each of Huangqin, Ganjiang, Renshen, Gancao (roasted), 1 liang of Huanglian, 12 jujubes (split). The preparation method is: boil the above seven ingredients with 1 dou of water to obtain 6 liters, remove the dregs, and boil again to obtain 3 liters, take 1 liter warm three times a day.

[0003] Ancient classic prescriptions are prescriptions recorded in medical books from the Qing Dynasty and before that are still widely used, have definite efficacy, and have obvious characteristics and advantages. Classic Chinese medicine prescriptions are the product of thousands of years of refinement of traditional Chinese medicine theory and are the treasures of the traditional Chinese medicine treasure house. In order to protect and support the research and innovative development of classic prescriptions, the national level has issued a number of relevant policies on the innovative development of compound preparations of classic Chinese medicine prescriptions, which has far-reaching significance for the inheritance of traditional Chinese medicine. Banxia Xiexin Decoction is one of the classic prescriptions in the "Catalogue of Ancient Classic Prescriptions (First Batch)" published by the State Administration of Traditional Chinese Medicine in 2018. The State Administration of Traditional Chinese Medicine and the State Drug Administration jointly issued the "Key Information Table of Ancient Classic Prescriptions (25 Prescriptions)" in September 2022, of which the third prescription is "Banxia Xiexin Decoction".

[0004] During the production process of Banxia Xiexin Decoction, there are inherent / systematic losses in the production equipment from extraction and concentration to the formation of spray powder, which makes it difficult for the dry paste rate of Banxia Xiexin Decoction spray powder to reach the benchmark quality range of the benchmark sample during large-scale production. How to control the dry paste rate of the ancient classic prescription Banxia Xiexin Decoction within the benchmark quality range during the production process, and at the same time achieve the goal of basic consistency in quality with the benchmark sample, is a technical problem faced by this field. Summary of the invention

[0005] The main purpose of the present invention is to propose a preparation method of a solid preparation of the ancient classic prescription Banxia Xiexin Decoction, so as to overcome the technical problem that the dry paste rate of Banxia Xiexin Decoction spray powder decreases during large-scale production and is difficult to reach the benchmark quality range of the benchmark sample, while achieving the goal of basic consistency in quality with the benchmark sample.

[0006] To achieve the above object, the present invention discloses a method for preparing a solid preparation of the ancient classic Banxia Xiexin Decoction, comprising the following steps:

[0007] S1. Add 8-10 times water to the seven herbs of Pinellia ternata, Scutellaria baicalensis, Dried ginger, Ginseng, Licorice, Coptis chinensis and Jujube in a weight ratio of 34.5:41.4:41.4:41.4:41.4:13.8:36, soak for 30-40 minutes, boil for 1 hour to 1.5 hours and extract, add 6-8 times water to the residue, boil for 0.5-1 hour and extract, filter the extract through a 350-450 mesh sieve while hot for later use;

[0008] S2, concentrating the extract in S1 under reduced pressure;

[0009] S3, spray-drying the concentrated solution in S2 to obtain Banxia Xiexin Decoction spray powder;

[0010] S4, adding or not adding auxiliary materials to the Banxia Xiexin Decoction spray powder in S3, and mixing evenly to obtain a powder to be prepared;

[0011] S5. Prepare the Banxia Xiexin Decoction solid preparation from the powder to be prepared in S4.

[0012] In accordance with relevant national requirements, by referring to the preparation method of the ancient classic prescription Banxia Xiexin Decoction in the "Key Information Table of Ancient Classic Prescriptions (25 Prescriptions)" published in 2022, multiple batches of benchmark samples and benchmark quality measurement results were prepared to obtain a reasonable indicator range. The dry paste rate of Banxia Xiexin Decoction powder (Bananxia Xiexin Decoction dry paste powder / input medicine piece weight × 100%) ranges from 22.0% to 26.9%. However, in the process of preparing Banxia Xiexin Decoction spray powder by concentrating and spray drying the extract prepared by the existing extraction process, the dry paste rate of Banxia Xiexin Decoction spray powder is usually 64% to 73% of the dry paste rate of the remaining extract after system loss. After testing, it does not reach the dry paste rate range of Banxia Xiexin Decoction powder of the benchmark sample. The present invention limits the addition of 8 to 10 times of water for soaking for 30 to 40 minutes, boiling for 1 hour to 1.5 hours for the first extraction, and then adding 6 to 8 times of water to the residue, boiling for 0.5 to 1 hour for the second extraction, and filtering the extract with a 350-450 mesh sieve while hot to increase the dry paste rate of the extract, so that the dry paste rate of the Banxia Xiexin Decoction spray powder can still meet the dry paste rate range of the benchmark sample Banxia Xiexin Decoction powder after loss, and the Banxia Xiexin Decoction spray powder prepared by the present invention is tested as an effective ingredient of the preparation. The similarity between the effective ingredient of the benchmark sample through fingerprint detection reaches more than 0.9, which is basically consistent with the quality of the benchmark sample, and the safety is qualified through toxicological evaluation.

[0013] Furthermore, in step S2, the vacuum degree is 0.04-0.09Mpa, the concentration temperature is ≤80°C, and the relative density is 1.08-1.16 at a detection temperature of 60°C. When the concentration temperature is greater than 80°C, the concentration efficiency is greatly affected, and when the relative density is greater than 1.16, the viscosity is too high and is not conducive to production.

[0014] Further, the reduced pressure concentration condition is: the concentration temperature is 60° C. to 80° C. Preferably, the reduced pressure concentration condition is: the concentration temperature is 66° C. to 75° C. The quality of the substance is relatively stable within the concentration temperature range of 60° C. to 80° C., and further preferably, the concentration efficiency is higher within the temperature range of 66° C. to 75° C.

[0015] Furthermore, in step S2, the concentrated solution is stirred and heated to 85°C ± 5°C, and kept warm and mixed for 1 to 1.5 hours. Stirring and heating at an appropriate temperature can achieve sterilization while improving fluidity and uniformity.

[0016] Further, in step S3, the spray drying conditions are: the air inlet temperature is 165°C ± 10°C, and the air outlet temperature is 95°C ± 10°C. Specifically, the nozzle motor frequency is 40Hz ± 5Hz. The above spray drying process parameters are helpful to efficiently dry the Banxia Xiexin Decoction spray powder and improve the quality and stability of the product.

[0017] Furthermore, in step S5, the powder to be prepared is granulated by a dry method and mixed evenly to obtain Banxia Xiexin Decoction granules.

[0018] Further, in step S4, the Banxia Xiexin Decoction spray powder is added with auxiliary material dextrin, the auxiliary material addition amount is 13.8% to 29.4% of the preparation amount, and mixed evenly after passing through a 20-mesh sieve to obtain the powder to be prepared. The advantages of adding dextrin in this preferred ratio are high yield, not easy to be crushed, and good granulation effect.

[0019] Preferably, the powder or granules to be prepared are mixed by a two-dimensional motion mixer at a rotation speed of 8 to 10 times / min and a shaking speed of 5 to 7 times / min to achieve uniform quality of the powder or granules. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying any creative work.

[0021] Figure 1 This is the reference fingerprint of Banxia Xiexin Decoction spray powder;

[0022] The realization of the purpose, functional features and advantages of this application will be further explained in conjunction with embodiments and with reference to the accompanying drawings. DETAILED DESCRIPTION

[0023] The technical solutions in the embodiments of the present invention will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in this field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0024] Characterization methods:

[0025] In the specific embodiments and comparative examples, the dry extract rate of the Banxia Xiexin Decoction extract was compared based on the extraction process (weight of dry solids / weight of input pieces × 100%). The method for detecting the similarity of fingerprint spectra mentioned in the content of the invention is specifically determined by referring to the high performance liquid chromatography method (General Rules 0512 of the 2020 edition of the Chinese Pharmacopoeia).

[0026] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; acetonitrile was used as mobile phase A, 0.07% formic acid solution was used as mobile phase B, and gradient elution was performed according to the provisions in the following table; the flow rate was 0.3 ml per minute; the column temperature was 30°C; the detection wavelength was 265 nm. The theoretical plate number calculated based on the berberine peak should not be less than 20,000.

[0027]

[0028] Preparation of reference solution: Take appropriate amounts of liquiritin reference substance, ammonium glycyrrhizinate reference substance, and berberine hydrochloride reference substance, accurately weigh them, and add methanol to prepare a mixed solution containing 15 μg of liquiritin, 30 μg of glycyrrhizic acid, and 25 μg of berberine hydrochloride per 1 ml, namely (weight of glycyrrhizic acid = weight of ammonium glycyrrhizinate / 1.0207).

[0029] Preparation of test solution: Take an appropriate amount of the product, mix well, weigh accurately, place in a stoppered conical flask, accurately add 20 ml of 70% methanol, stopper, weigh, ultrasonically treat (power 400 W, frequency 40 kHz) for 15 minutes, cool, weigh again, make up the lost weight with 70% methanol, shake well, filter, and take the filtrate to obtain.

[0030] The determination method is to accurately pipette 1 μl of the reference solution and the test solution respectively, inject them into the liquid chromatograph, record the chromatogram for 60 minutes, and calculate the similarity.

[0031] The fingerprint of the test sample should show 17 characteristic peaks corresponding to the fingerprint of the control sample. The similarity between the fingerprint of the test sample and the fingerprint of the control sample shall not be less than 0.90. Figure 1 , where the chromatographic column is CSH TM C18 (100mm×2.1mm, 1.7μm); control fingerprint peak 1: magnolamine; peak 2: coptisine; peak 3: epiberberine; peak 4: tertrenol; peak 5: jatrorrhizine; peak 6: liquiritin; peak 8(S): berberine; peak 10: palmatine; peak 11: baicalin; peak 14: wogonin; peak 15: baicalein; peak 16: wogonin; peak 17: glycyrrhizic acid.

[0032] The main sources of decoction pieces involved in the specific embodiments and comparative examples (the medicinal materials involved are from the same batch) and production instruments are as follows:

[0033] Main medicinal pieces

[0034]

[0035] Main instruments

[0036]

[0037]

[0038] Example 1

[0039] Extraction: Add 1 times the prescription amount into the extraction tank, add water to extract twice, the first time add 9 times the drinking water to soak for 0.5 hours, boil for 1 hour and then extract, add 7 times the drinking water to the residue, boil for 0.5 hours and then extract for the second time, filter the extract with a 400-mesh sieve while it is hot, and obtain the combined extract for use.

[0040] Example 2

[0041] Extraction: Add 1 times the prescription amount into the extraction tank, add water to extract twice, the first time add 10 times the drinking water to soak for 0.5h, boil for 1 hour and then extract, add 8 times the drinking water to the residue, boil for 0.5 hours and then extract for the second time, filter the extract with a 400-mesh sieve while it is hot, and obtain the combined extract for use.

[0042] Example 3

[0043] Extraction: Add 1 times the prescription amount into the extraction tank, add water to extract twice, the first time add 8 times the drinking water to soak for 0.5h, boil for 1 hour and then extract, add 6 times the drinking water to the residue, boil for 0.5 hours and then extract for the second time, filter the extract with a 400-mesh sieve while it is hot, and obtain the combined extract for use.

[0044] Comparative Example 1

[0045] Extraction: Add 1 times the prescribed amount into the extraction tank, add water to extract once, add 10 times the drinking water to soak for 0.5h, boil for 2 hours and then extract for later use.

[0046] The extraction processes in Examples 1 to 3 and Comparative Example 1 were investigated, and the dry extract ratios of the extracts were as follows:

[0047]

[0048] According to the above data, the present invention adds 8 to 10 times of water to soak for 30 to 40 minutes, boils for 1 hour to 1.5 hours, extracts for the first time, adds 6 to 8 times of water to the residue, boils for 0.5 to 1 hour for the second extraction, and filters the extract while hot with 350 to 450 mesh. The extraction method significantly improves the dry cream rate of the extract. The dry cream rate of the extract prepared by the existing extraction process in Comparative Example 1 is lost, and the dry cream rate of the Banxia Xiexin Decoction spray powder prepared is 64% to 73% of the dry cream rate of the extract. , the dry extract rate range of Banxia Xiexin Decoction powder of the benchmark sample cannot reach 22.0% to 26.9%. Compared with Comparative Example 1, Examples 1 to 3 can effectively improve the dry extract rate range of the extract, so that the dry extract rate of the Banxia Xiexin Decoction spray powder after loss in this preparation process can meet the dry extract rate range of the Banxia Xiexin Decoction powder of the benchmark sample, and after measurement, compared with the benchmark sample, the similarity of the active ingredient fingerprint spectra of Examples 1 to 3 all reached more than 0.9, which is basically consistent with the quality of the benchmark sample.

[0049] Similar experiments have found that if the extraction times exceed 2 times, impurities in the drug residue will also be extracted, affecting the efficacy and possibly the safety of the drug.

[0050] The Banxia Xiexin Decoction spray powder was prepared by extraction, low-pressure concentration and spray drying, and the pharmacological and toxicological tests were carried out according to the following prescription and preparation steps:

[0051] Prescription: Pinellia ternata 5750g, Scutellaria baicalensis 6900g, Dried ginger 6900g, Ginseng 6900g

[0052] Stir-fried licorice root 6900g, coptis root 2300g, jujube 6000g

[0053] The preparation steps are as follows:

[0054] Prepare ingredients according to the prescribed amount, put into the extraction tank, add water to extract twice, the first time add 9 times drinking water to soak for 0.5 hours, boil and extract for 1 hour, the second time add 7 times drinking water, boil and extract for 0.5 hours, filter the extract with a 400-mesh sieve while it is hot and set aside.

[0055] The extract enters the vacuum concentrator for concentration. The vacuum degree in the pot is controlled at 0.04-0.09 (-MPa), the concentration temperature is controlled below 85°C, and the extract is concentrated under vacuum to a relative density of 1.08-1.16 (10-20°Bé) (60°C), and then passed through a 400-mesh sieve.

[0056] Heat the concentrate to 85°C ± 5°C while stirring, and keep mixing for 1 hour.

[0057] In a spray dryer, spray drying is performed under the conditions of an inlet air temperature of 165°C±10°C, an outlet air temperature of 95°C±10°C, and a nozzle motor frequency of 40Hz±5Hz to obtain Banxia Xiexin Decoction spray powder.

[0058] The Banxia Xiexin Decoction spray powder prepared above was subjected to toxicological experiments as follows:

[0059] According to the requirements of the "Technical Guidelines for Toxicological Studies of Traditional Chinese Medicine Compound Preparations of Ancient Classic Prescriptions (Draft for Comments)", toxicological studies of traditional Chinese medicine compound preparations of ancient classic prescriptions generally include single-dose toxicity tests and repeated-dose toxicity test data. According to the above requirements, single-dose toxicity tests and repeated-dose toxicity tests were carried out on Banxia Xiexin Decoction Granules. Among them, the single-dose toxicity test studied the SD rats given the test substance three times by gavage within 24 hours, observed the toxic reactions produced within a certain period of time, and understood the acute toxic dose. The repeated-dose toxicity test studied the SD rats given the test substance by gavage for 26 weeks and stopped the drug for 28 days to observe its toxic reactions to rats and its dose-response relationship; whether delayed toxic reactions occurred after drug withdrawal and the reversibility of toxic reactions; determined the safe dose range to provide a reference for clinical safe drug use.

[0060] Among them, the single-dose toxicity test studies SD rats to be gavaged with the test substance three times within 24 hours, observes the toxic reactions produced within a certain period of time, and understands the acute toxic dose. The repeated-dose toxicity test studies SD rats to be gavaged for 26 weeks and then stopped for 28 days to observe the toxic reactions on rats.

[0061] 1. Single-dose toxicity test

[0062] Forty SD rats with qualified adaptability observation were selected for the experiment and randomly divided into two groups according to body weight balance, namely negative control group (group A) and Banxia Xiexin Decoction spray powder group (group B, 30.6g powder (106.79g crude drug) / kg), 20 rats / group, half male and half female. After the animals were grouped, they were all gavaged, 20mL / kg / time, three times a day, with at least 5 hours between each administration, and observed continuously for at least 4 hours after administration, and then observed 1-2 times a day for 2 weeks. The clinical observation of animals included appearance signs, behavioral activities, glandular secretion, respiration, excrement characteristics, diet, poisoning reactions and deaths. After administration, the death of all animals, poisoning symptoms and the starting time, severity, duration, reversibility of poisoning reactions, etc. were recorded in detail. The observation of poisoning symptoms refers to Appendix 1 of the Technical Guidelines for Single-dose Toxicity Studies of Drugs. At the same time, body weight and food intake were checked as planned. Gross anatomical examinations were performed on surviving animals as planned. Discussion and evaluation of the main results are as follows:

[0063] (1) Clinical observation results: During the trial, no obvious toxic reactions related to the test substance were observed in any animal.

[0064] (2) Results of the mortality of SD rats: During the experiment, no animals in the Banxia Xiexin Decoction spray powder group died.

[0065] (3) Food intake and body weight of SD rats: During the experimental period, no obvious abnormal changes were observed in the food intake, body weight and weight gain of the animals in the Banxia Xiexin Decoction spray powder group.

[0066] (4) Pathological examination results of SD rats: Under the experimental conditions, a single oral administration of Banxia Xiexin Decoction spray powder to SD rats resulted in no animal deaths during the 14-day observation period. Gross autopsy of 28 tissues and organs including the heart, liver, spleen, lung, and kidney showed no obvious abnormal changes.

[0067] Under the conditions of this experiment, after Banxia Xiexin Decoction spray powder was administered to SD rats by gavage three times a day at the maximum dosage (30.6g powder (106.79g crude drug) / kg, equivalent to 4.7 times the intended clinical dosage for humans based on body surface area and 30 times the intended clinical dosage for humans based on kilograms of body weight), no toxicological changes related to the test substance were observed in the animals. The maximum tolerated dose of Banxia Xiexin Decoction spray powder for a single oral administration to SD rats is >30.6g powder (106.79g crude drug) / kg.

[0068] 2. Repeated dose toxicity test

[0069] The experiment selected 160 SD rats that passed the adaptive observation and ophthalmological examination and met the requirements. They were randomly divided into 4 groups according to body weight, namely the negative control group, the Banxia Xiexin Decoction spray powder low (23.03g crude drug / kg), medium (45.02g crude drug / kg), and high (53.40g crude drug / kg) dose groups, 40 rats / group, half male and half female. Each group was given 15mL / kg / time oral administration, twice a day, at least 5 hours apart between each administration, and the dosage was adjusted according to the latest body weight. The administration was continued for 6 months. During the experiment, the appearance signs, behavioral activities, glandular secretions, respiration, fecal characteristics, and death of the animals were observed every day. The animals were weighed on the 3rd, 5th, 7th, and 11th days and every week, and the food intake of the animals was measured on the 2nd, 4th, 6th, 10th, and 13th days and every week. Some animals were killed in the middle (3 months) and the end (6 months) of the administration, and various examinations such as hematology, blood biochemistry, and pathology were performed. The remaining animals were observed for 4 weeks during the recovery period. Specific observations and examinations included the following: clinical observation, food intake, body weight, ophthalmology, hematology, coagulation function, blood biochemistry, bone marrow cell classification, urine routine, pathological histology, etc. The main results were discussed and evaluated as follows:

[0070] (1) Clinical observation, ophthalmological examination, body weight, food intake, hematology and coagulation function, blood biochemistry, urine routine, and bone marrow cell classification test results: No toxicologically significant changes related to the test substance were observed in any group.

[0071] (2) Results of organ weights and organ coefficients of SD rats: No toxicologically significant changes were observed in any dose group.

[0072] (3) Pathological examination results of SD rats: No toxicologically significant changes were observed in any dose group.

[0073] In summary, when Banxia Xiexin Decoction spray powder was repeatedly administered orally (twice a day) to SD rats at doses of 23.03 g crude drug / kg, 45.02 g crude drug / kg, and 53.40 g crude drug / kg (maximum dose) for 6 consecutive months, no toxicologically significant changes related to the test substance were observed in each dose group, that is, the no observed adverse effect level (NOAEL) was 53.40 crude drug / kg (maximum dose), which is 2.37 times the intended clinical dose for humans based on body surface area and 15 times the intended clinical dose for humans based on kilograms of body weight.

[0074] The above description is only a preferred embodiment of the present invention, and does not limit the patent scope of the present invention. All equivalent structural changes made by using the contents of the present invention specification under the inventive concept of the present invention, or directly / indirectly applied in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. A method for preparing a solid preparation of the ancient classic Banxia Xiexin Decoction, characterized in that: The following steps are involved: S1. Add 8-10 times water to the seven herbs of Pinellia ternata, Scutellaria baicalensis, dried ginger, ginseng, fried liquorice, Coptis chinensis and jujube in a weight ratio of 34.5:41.4:41.4:41.4:41.4:13.8:36, soak for 30-40 minutes, boil for 1h-1.5h and extract, add 6-8 times water to the residue, boil for 0.5-1h and extract, filter the extract through a 350-450 mesh sieve while hot for later use; S2, concentrating the extract in S1 under reduced pressure; S3, spray-drying the concentrated solution in S2 to obtain Banxia Xiexin Decoction spray powder; S4, adding or not adding auxiliary materials to the Banxia Xiexin Decoction spray powder in S3, and mixing evenly to obtain a powder to be prepared; S5. Prepare the Banxia Xiexin Decoction solid preparation from the powder to be prepared in S4.

2. The method for preparing the solid preparation of the ancient classic Banxia Xiexin Decoction according to claim 1, characterized in that: In step S2, the vacuum degree is 0.04-0.09 MPa, the concentration temperature is ≤80°C, and the relative density is 1.08-1.16 at a detection temperature of 60°C.

3. The method for preparing the solid preparation of the ancient classic Banxia Xiexin Decoction as claimed in claim 2, characterized in that: The reduced pressure concentration condition is: the concentration temperature is 60°C to 80°C.

4. The method for preparing the solid preparation of the ancient classic Banxia Xiexin Decoction as claimed in claim 3, characterized in that: The reduced pressure concentration condition is as follows: the concentration temperature is 66°C to 75°C.

5. The method for preparing the solid preparation of the ancient classic Banxia Xiexin Decoction according to any one of claims 2 to 4, characterized in that: In step S2, the concentrated solution is heated to 85°C±5°C with stirring, and the mixture is kept warm and mixed for 1 to 1.5 hours.

6. The method for preparing the solid preparation of the ancient classic Banxia Xiexin Decoction according to claim 1, characterized in that: In step S3, the spray drying conditions are: the air inlet temperature is 165°C±10°C, and the air outlet temperature is 95°C±10°C.

7. The method for preparing the solid preparation of the ancient classic Banxia Xiexin Decoction according to claim 1, characterized in that: In step S5, the powder to be prepared is granulated by a dry method and mixed evenly to obtain Banxia Xiexin Decoction granules.

8. The method for preparing the solid preparation of the ancient classic Banxia Xiexin Decoction according to claim 7, characterized in that: In step S4, the Banxia Xiexin Decoction spray powder is added with auxiliary material dextrin, the amount of the auxiliary material added is 13.8% to 29.4% of the preparation amount, and the mixture is evenly mixed after passing through a 20-mesh sieve to obtain the powder to be prepared.

9. The method for preparing the solid preparation of the ancient classic Banxia Xiexin Decoction according to claim 8, characterized in that: The powder or granules to be prepared are mixed by a two-dimensional motion mixer at a rotation speed of 8 to 10 times / min and a shaking speed of 5 to 7 times / min.

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