Sterilization method of Kaixinsan raw medicinal material oral powder

Abstract

The invention relates to a sterilization method for a raw medicinal material oral powder of Kaixinsan. The method comprises the following steps: step 1, four medicinal pieces of ginseng, poria, calamus and polygala are weighed according to a formula respectively, are placed in a retort bag individually or after being mixed, and are placed in a high-temperature and high-pressure conditioning sterilizer, the temperature of which is controlled at 110-130 DEG C for 50-70 seconds; step 2, the four medicinal pieces of ginseng, poria, calamus and polygala obtained in step 1 are mixed, placed in a medicine pounding pot, crushed, passed through a No. 6 sieve, the particle size is controlled to be above 100 meshes, and mixed evenly to obtain Kaixinsan.

Description

Technical field:

[0001] The invention relates to a sterilization method for Chinese medicinal materials and Chinese medicinal preparations, and in particular to a sterilization method for Kaixinsan raw medicinal material oral powder. Background technology:

[0002] The classic prescription Kaixinsan is a traditional Chinese medicine dosage form, that is, an oral powder in the Chinese Pharmacopoeia. Common oral powders on the market are usually dry powders extracted, concentrated and dried from Chinese medicinal materials, while Kaixinsan is a fine powder of native Chinese medicine. As an ancient "powder", Kaixinsan is generally prepared as needed, and the microbial flora it contains usually does not cause harm to the human body; as an industrialized mass-produced oral powder of fine powder of native Chinese medicine, there is a risk of an increase in the number of microorganisms by tens of millions during long-term (6-12 months) storage.

[0003] In this case, some Chinese medicinal materials and preparations need to be sterilized to ensure their storage safety.

[0004] At present, the main methods for sterilizing traditional Chinese medicine include dry heat sterilization, radiation sterilization, gas sterilization, microwave drying sterilization, and moist heat sterilization. Due to the characteristics of traditional Chinese medicines such as a wide variety of species, complex properties, and large differences in microbial content, when choosing a sterilization method, it is necessary to flexibly select and comprehensively utilize different sterilization methods based on their advantages and disadvantages.

[0005] The present invention has been found in the research that Kaixin Powder is composed of four medicinal materials, namely ginseng, Poria cocos, Acorus calamus and Polygala tenuifolia. Its main components include ginsenosides and polysaccharides in ginseng; pachymaran and pachymic acid contained in Poria cocos; volatile oil components contained in Acorus calamus and polygala tenuifolia saponins and oligosaccharides contained in Polygala tenuifolia, including easily hydrolyzed components and easily volatile components. It is necessary to screen the sterilization method according to the characteristics of these medicinal materials in Kaixin Powder to obtain the best effect. Summary of the invention:

[0006] During the development of the classic prescription Kaixinsan, the inventor investigated the sterilization method of Kaixinsan oral powder. The research results showed that the use of supersaturated steam sterilization method, which sterilizes the medicinal materials from the beginning to the preparation after it is formed, can completely sterilize and retain the active ingredients to the greatest extent.

[0007] To this end, the present invention provides a method for preparing Kaixin powder, the method comprising the following steps:

[0008] Step 1,

[0009] The four decoction pieces of ginseng, Poria, Acorus calamus and Polygala are weighed according to the formula, placed in a cooking bag separately or mixed, and placed in a high temperature and high pressure conditioning sterilizer, the temperature is controlled at 110-130°C for 50-70 seconds; step 2,

[0010] The four pieces of decoction of ginseng, Poria cocos, Acorus calamus and Polygala tenuifolia obtained in step 1 are mixed and crushed in a medicine pounding pot, passed through a No. 6 sieve, the particle size is controlled to be above 100 mesh, and mixed evenly to obtain Kaixin Powder.

[0011] Preferably, the preparation method of Kaixin powder of the present invention comprises the following steps:

[0012] Step 1,

[0013] Four medicinal materials, namely, ginseng, poria, calamus and polygala, are weighed according to the formula, placed in a cooking bag individually or mixed, and placed in a high temperature and high pressure conditioning sterilizer at a temperature of 110-130°C for 60 seconds;

[0014] Step 2,

[0015] The four decoction pieces of ginseng, Poria cocos, Acorus calamus and Polygala tenuifolia obtained in step 1 are placed in a multifunctional grinder and crushed into fine powder separately or mixed, passed through a No. 6 sieve, the particle size is controlled to be above 100 mesh, and mixed evenly to obtain Kaixin powder.

[0016] Wherein, the formula of the happy powder is:

[0017] The weight ratio of the four medicinal materials, ginseng, polygala, poria and calamus, is 1:1:2:1.

[0018] Wherein, the high temperature and high pressure conditioning sterilizer has a pressure set at 1-6 atmospheres and a rotation speed of 1-35 revolutions per minute.

[0019] Wherein, the high temperature and high pressure conditioning and sterilization machine is introduced with high temperature saturated steam.

[0020] The Kaixin powder obtained by the method of the present invention can be completely sterilized and retain the effective ingredients to the greatest extent. This method is more commonly used than dry heat sterilization, radiation sterilization, gas sterilization, microwave drying sterilization and moist heat sterilization, and a sterilization method in which one or more methods are combined. It has absolute advantages in sterilizing native Chinese medicines, such as good sterilization effect, short time, simple and easy operation, little impact on effective ingredients, and is suitable for industrial production.

[0021] By adopting the method of the present invention, the test sample can be heated to the sterilization temperature evenly and quickly, so as to achieve the purpose of rapid sterilization (60s), and the herbal medicinal properties of the test sample can be retained to the greatest extent; due to the physical isolation of the cooking bag, the test sample does not directly contact the steam, the water content of the test sample is little affected, the powdered test sample will not stick together due to moisture absorption, and there is no need to perform secondary drying and crushing operations.

[0022] The method of the present invention is obtained through screening, and the screening process is as follows:

[0023] 1.1 Dry heat sterilization

[0024] Dry heat sterilization can use dry hot air as a heat transfer medium to act on raw Chinese medicine powder, destroying microorganisms by destroying their DNA, and achieving the purpose of sterilization. Since the heat transfer medium is air, it can avoid the problems of moisture absorption and hardening of raw Chinese medicine powder caused by wet heat sterilization, as well as secondary contamination during drying and crushing. It is suitable for raw Chinese medicine powder that is resistant to high temperatures and is very easy to absorb moisture. However, the specific heat capacity of air is low, its penetration is weak, and the small gap between the powders may lead to unsatisfactory sterilization effects. Dry heat sterilization has high temperatures, long times, large amounts of floating dust, and is prone to contamination, which can easily lead to a loss rate of active ingredients of 25% to 40%. Therefore, raw Chinese medicine powder containing different types of heat-sensitive components such as volatile oils, alkaloids, quinones, flavonoids, and high requirements for appearance and color are not suitable for dry heat sterilization. The powder color becomes darker, the appearance changes, and the raw Chinese medicine powder volatilizes [1].

[0025] The Acorus calamus in Kaixin Powder contains a large amount of volatile oil, which is one of the main active ingredients of Kaixin Powder. In order to ensure that the active ingredients are not lost in large quantities, this method is not selected.

[0026] 1.2 Radiation sterilization

[0027] Radiation sterilization uses radiation to destroy microbial DNA to kill microorganisms in order to achieve the purpose of sterilization. The most commonly used method is 60Co-γ ray radiation sterilization [2]. The radiation sterilization dose is generally

[0028] 25000Gy (1Gy=1J / kg).

[0029] The characteristics of radiation sterilization are that it does not increase the temperature of the product and has strong penetrating power. As long as the irradiated objects are controlled at a certain radiation amount according to the standards set by the World Health Organization, all microorganisms can be killed.

[0030] This method is not selected because it is expensive, has a high risk of operating the equipment, is difficult to obtain, may induce various cancers, and is harmful to the human body. It is not suitable for conventional industrial sterilization.

[0031] 1.3 Gas sterilization

[0032] Gas sterilization refers to the method of killing microorganisms with gas or steam formed by chemical disinfectants. It is also called cold sterilization. Commonly used chemical disinfectants are ethylene oxide, gaseous hydrogen peroxide, formaldehyde ozone (O3), propylene glycol, 8-propiolactone, etc.

[0033] It has the advantages of being carried out at room temperature, not heating the sterilized items, strong penetration, and rapid sterilization. Since commonly used chemical disinfectants are flammable and explosive, teratogenic, and have residual toxicity, they are not suitable for the sterilization of oral powders, so this method is not selected.

[0034] 1.4 Microwave drying sterilization method

[0035] The microwave drying sterilization method is based on the principle that raw medicinal powder is heated in a high-frequency electromagnetic field. The friction between microwaves and medicinal materials generates high heat, which inactivates proteins, ribonucleic acids and enzymes to achieve the purpose of sterilization. Microwaves usually refer to electromagnetic waves with a frequency between 3.0×102 and 3.0×105 MHz. The active ingredients of raw medicinal powder treated with microwaves are basically not destroyed, and the general sterilization time is 3 to 6 minutes. Microwave sterilization has little effect on the efficacy of the drug, but it has certain requirements for the thickness, moisture content and thermal stability of the active ingredients of the material. When the moisture content and sterilization time are within a certain range, the higher the moisture content, the longer the microwave sterilization time, and the better the sterilization effect. Its disadvantage is that it is not suitable for medicinal powder with low moisture content [3].

[0036] Since the Chinese Pharmacopoeia Volume 4 stipulates that the moisture content of powders shall not exceed 9.0%, the moisture content is relatively low, so this method is not selected.

[0037] 1.5 Moist heat sterilization

[0038] Moist heat sterilization is a method of sterilizing items by placing them in a sterilization cabinet and using high-pressure saturated steam, superheated water spray, etc. to denature the proteins and nucleic acids in the microorganisms and kill the microorganisms [4]. Moist heat sterilization has a strong sterilization capacity and is simple and easy to use. Currently, companies generally use moist heat sterilization. However, sterilization requires high temperature and high pressure, and the sterilization time is long, which can easily lead to the change of the medicinal properties of traditional Chinese medicine, turning raw drug powder into cooked drug powder, which does not conform to the principle of using raw and cooked Chinese medicine differently. Moist heat sterilization conditions usually use a procedure of 121℃×15min, 121℃×30min or 116℃×40min. However, the active ingredients in Kaixin Powder are mainly water-soluble and easily hydrolyzed. Under the current conditions, it is not suitable for the sterilization of Kaixin Powder.

[0039] 1.6 Supersaturated steam sterilization method

[0040] The supersaturated steam sterilization method is based on the moist heat sterilization method, adding a strong stirring operation to make the liquid and steam mix instantly, enhance the contact rate between steam and liquid, achieve rapid sterilization, and solve the shortcoming of the moist heat sterilization method that takes too long.

[0041] The supersaturated steam sterilization method is currently mainly used for liquid sterilization. The inventors conducted an investigation on the sterilization of Kaixin Powder by the supersaturated steam moist heat sterilization method and confirmed that the supersaturated steam sterilization method can sterilize Kaixin Powder and plan to use it for industrial production.

[0042] 2. Investigation of supersaturated steam sterilization method

[0043] Experimental method: Wrap the test sample in a cooking bag, flatten it, and put it into a high-temperature and high-pressure sterilization device. Set the pressure at 1-6 atmospheres and the speed at 1-35 revolutions per minute. Pass high-temperature steam to perform sterilization operations.

[0044] Through experimental verification, the supersaturated steam sterilization method can be used not only for liquid sterilization, but also for the sterilization of powders and medicinal pieces. The corresponding sterilization conditions can be obtained by analyzing the data before and after sterilization.

[0045] 2.1 Investigation of Sterilization Effectiveness

[0046] From the experimental data, it can be seen that under the sterilization conditions of 111-131℃, 60sec, after sterilization using saturated steam method, the powder and slices of Kaixin Powder can meet the microbial limit standards under the 0115 powder of the Chinese Pharmacopoeia. [5] The saturated steam sterilization method can be used for the sterilization of Kaixin powder and herbal pieces. The results of the bacterial examination of Kaixin powder and herbal pieces are shown in Table 1.

[0047] Table 1: Microbial limit test results (unit: cfu)

[0048]

[0049]

[0050] 2.2 Sterilization parameter screening

[0051] 2.2.1 Investigation of medicinal material pieces

[0052] 2.2.1.1 Polygala tenuifolia

[0053] After the Polygala slices are sterilized, the color turns slightly red. The comparison results of the properties of the Polygala slices before and after sterilization are shown in Table 2. Figure 3 shown.

[0054] When the sterilization condition was "131°C, 60 sec", the moisture content increased significantly, with an increase rate of 0.37%.

[0055] When the sterilization conditions are "111-121℃, 60sec", the moisture content increases slightly, with the maximum increase rate being 0.18%. The moisture content of Polygala tenuifolia slices should be controlled below 10.17% before sterilization.

[0056] When the sterilization condition is "111-121℃, 60sec", the effective ingredients are slightly lost, the maximum loss rate of polygala ketone is 0.18%, the maximum loss rate of 3,6' dierucyl sucrose is 0.33%, and the maximum loss rate of 3,6' dierucyl sucrose is 0.19%. The index components of Polygala slices before sterilization should be controlled to be no less than 0.12% of polygala ketone, no less than 0.45% of 3,6' dierucyl sucrose, and no less than 2.46% of Polygala tenuifolia saponin. The test results of Polygala slices before and after sterilization are shown in Table 3. Figure 1 and Figure 2 shown.

[0057] Table 2: Comparison of properties of Polygala tenuifolia slices before and after sterilization

[0058]

[0059]

[0060] Table 3: Test results of Polygala root slices before and after sterilization

[0061]

[0062] 2.2.1.2 Ginseng

[0063] The surface color of ginseng slices deepens after sterilization. The comparison results of the properties of ginseng slices before and after sterilization are shown in Table 4. Figure 6 shown.

[0064] When the sterilization condition was "131°C, 60 sec", the moisture content increased significantly, with an increase rate of 0.23%.

[0065] When the sterilization condition is "111-1121℃, 60sec", the moisture content is slightly changed and slightly lost, the effective ingredients are slightly lost, the maximum loss rate of the total amount of ginsenosides Rg1 and Re is 0.03%, and the maximum loss rate of ginsenoside Rb1 is 0.06%. The index components of ginseng slices before sterilization should be controlled to ginsenosides Rg1 and Re not less than 0.28%, and ginsenoside Rb1 not less than 0.21%. The test results of ginseng slices before and after sterilization are shown in Table 5. Figure 4 and Figure 5 shown.

[0066] Table 4: Comparison of properties of ginseng slices before and after sterilization

[0067]

[0068]

[0069]

[0070] Table 5: Test results of ginseng slices before and after sterilization

[0071] 2.2.1.3 Poria

[0072] There is no significant change in the properties of the Poria cocos slices after sterilization. The results of the comparison of the properties of the Poria cocos slices before and after sterilization are shown in Table 6. Figure 7 shown.

[0073] When the sterilization condition is "131°C, 60 sec", the moisture content increases by 0.03%.

[0074] When the sterilization condition is "111-121℃, 60sec", the moisture content is slightly changed and slightly lost, and the maximum loss rate of the extract is 0.05%. The index component of the Poria cocos slices before sterilization should be controlled to be no less than 2.62%. The test results of the Poria cocos slices before and after sterilization are shown in Table 7.

[0075] Table 6: Comparison of properties of Poria cocos slices before and after sterilization

[0076]

[0077] Table 7: Test results of Poria cocos slices before and after sterilization

[0078]

[0079]

[0080] 2.2.1.4 Acorus calamus

[0081] The color of Acorus calamus slices deepens after sterilization. The comparison results of the properties of Acorus calamus slices before and after sterilization are shown in Table 8. Figure 8 shown.

[0082] When the sterilization condition was "131°C, 60 sec", the moisture content increased significantly, with an increase rate of 0.37%.

[0083] When the sterilization condition is "111-121℃, 60sec", the moisture content increases slightly, with the maximum increase rate being 0.18%. The moisture content of Polygala tenuifolia slices before sterilization should be controlled to not exceed 11.02%.

[0084] When the sterilization condition is "111-121℃, 60sec", the volatile oil content is slightly lost, and the maximum loss rate of volatile oil content is 0.32%. The index components of Acorus calamus slices before sterilization should be controlled to a volatile oil content of not less than 1.03%. The test results of Acorus calamus slices before and after sterilization are shown in Table 9.

[0085] Table 8: Comparison of properties of Acorus calamus slices before and after sterilization

[0086]

[0087] Table 9: Test results of Acorus calamus slices before and after sterilization

[0088]

[0089]

[0090] 2.2.2 Investigation of Kaixinsan Powder

[0091] After sterilization, Kaixinsan powder becomes lighter in color, has stronger hygroscopicity, and forms a clumping shape. The shape comparison results of Kaixinsan powder before and after sterilization are shown in Table 10. Fig. 9 shown.

[0092] When the sterilization condition was "121-131°C, 60 sec", the moisture content increased significantly, with the maximum increase rate being 0.28%.

[0093] When the sterilization condition is "111℃, 60sec", the moisture content increases slightly, with the maximum increase rate of 0.14%. The moisture content of Kaixinsan powder should be controlled to not exceed 7.89% before sterilization. The bulk density and moisture content of Kaixinsan powder under different sterilization methods are shown in Table 11.

[0094] Table 10: Comparison of the shape of Kaixinsan powder before and after sterilization

[0095]

[0096] Table 11: Bulk density and moisture content of Kaixinsan powders determined by different sterilization methods

[0097]

[0098]

[0099] 3. Comparative study of different sterilization methods for Kaixinsan

[0100]

[0101] The experimental results show that the supersaturated steam sterilization method of the present invention can be used to control the sterilization parameters at "111-130°C, 60sec", which can effectively kill the microorganisms in the four-flavor decoction pieces of Polygala tenuifolia, ginseng, Acorus calamus, and Poria cocos and the Kaixinsan oral powder, while ensuring that the effective ingredient volatile oil is not lost and retaining the characteristics of the crude drug.

[0102] When the sterilization parameters are at "110-130℃, 60sec", the impact on the moisture and active ingredients in the sample is small, and the quality of unsterilized medicinal materials or powders can be controlled through the company's internal control standards.

[0103] By comparing the moisture loss rates of medicinal slices and powders before and after sterilization, it was found that the sterilization method has less impact on the moisture content of medicinal slices than on powders, so the sterilization of Kaixinsan oral powder was carried out at the medicinal slice end.

[0104] In summary, under the conditions of "110-130℃, 60sec", the supersaturated steam sterilization method can effectively kill the microorganisms in the four medicinal pieces of Polygala tenuifolia, Ginseng, Acorus calamus, and Poria cocos in the Kaixinsan prescription, and can ensure that all indicators meet the requirements of the pharmacopoeia and are stable and controllable. Description of the drawings:

[0105] Figure 1 :Testing of Polygala root slices before sterilization

[0106] Figure 2 :Testing of sterilized samples of Polygala root slices

[0107] Figure 3 :Comparison of properties of Polygala root slices before and after sterilization

[0108] Figure 4 :Testing of ginseng samples before sterilization

[0109] Figure 5 :Testing of ginseng samples after sterilization

[0110] Figure 6 :Comparison of properties of ginseng before and after sterilization

[0111] Figure 7 :Comparison of properties of Poria cocos slices before and after sterilization

[0112] Figure 8 :Comparison of properties of Acorus calamus slices before and after sterilization

[0113] Fig. 9 :Comparison of properties of powder before and after sterilization Specific implementation method:

[0114] The present invention is further illustrated by the following examples, but are not intended to limit the present invention.

[0115] Example 1 Sterilization of Kaixinsan (sterilization at the decoction piece stage)

[0116] 1.1 Preparation of medicinal materials

[0117] 1.1.1 Ginseng: Take 500g of the original medicinal material, crush it and pass it through a No. 1 sieve to obtain pieces with a size of not less than 10 mesh.

[0118] 1.1.2 Polygala: Take 500g of raw medicinal materials, select by hand to remove impurities, wash, pile the washed Polygala into a pile, spread moist gauze under the materials and cover them with moist gauze, spray 10ml of clean water on the medicinal materials every 30 minutes to keep them moist. After the pile is moistened to a soft state, use a small medicine cutter to cut it into 10-15mm Polygala segments, dry it at 50℃ for 8 hours, and cool it to room temperature.

[0119] 1.1.3 Poria cocos: Take fresh Poria cocos from the place of origin and process it into 500g of Poria cocos blocks, and select by hand to remove impurities.

[0120] 1.1.4 Acorus calamus: Take 500g of the original medicinal material, select by hand to remove impurities, wash it, pile the washed Acorus calamus into a pile, spread moist gauze under the material and cover it with moist gauze, spray 10ml of clean water on the medicinal material every 30 minutes to keep it moist. After the pile is moistened to a soft state, use a small medicine cutting machine to cut it into 2-4mm thick slices, dry it at 60℃ for 3 hours, and cool it to room temperature.

[0121] 1.2 Sterilization of decoction pieces

[0122] The four medicinal materials obtained were placed in cooking bags, respectively, and placed in a high-temperature and high-pressure conditioning sterilizer. The temperature was maintained at 121°C for 60 seconds, the pressure was set at 1-6 atmospheres, the speed was 1-35 revolutions per minute, and high-temperature saturated steam was introduced to obtain solid oral decoction pieces that met the requirements of the "Chinese Pharmacopoeia (2015 Edition)".

[0123] 1.3 Crushing, sieving and mixing of medicinal pieces

[0124] The following operations must be performed in a clean area.

[0125] Take 50g of sterilized ginseng, 50g of Polygala tenuifolia, 100g of Poria cocos, and 50g of Acorus calamus, mix them, put them in a medicine pounding pot and crush them, pass through a No. 6 sieve to obtain a powder of not less than 100 mesh, and then mix all the powders until the texture is uniform and there is no color difference, and you will get Kaixin Powder.

[0126] Example 2 Sterilization of Kaixin Powder (Powder Stage Sterilization)

[0127] 2.1 Preparation of medicinal materials

[0128] 2.1.1 Ginseng: Take 500g of the original medicinal material, crush it and pass it through a No. 1 sieve to obtain pieces with a size of not less than 10 mesh.

[0129] 2.1.2 Polygala: Take 500g of the original medicinal material, select by hand to remove impurities, wash it, pile the washed Polygala into a pile, spread moist gauze under the material and cover it with moist gauze, spray 10ml of clean water on the medicinal material every 30 minutes to keep it moist. After the pile is moistened to a soft state, use a small medicine cutter to cut it into 10-15mm Polygala segments, dry it at 50℃ for 8 hours, and cool it to room temperature.

[0130] 2.1.3 Poria cocos: Take fresh Poria cocos from the place of origin and process it into 500g of Poria cocos blocks, and select by hand to remove impurities.

[0131] 2.1.4 Acorus calamus: Take 500g of the original medicinal material, select by hand to remove impurities, wash it, pile the washed Acorus calamus into a pile, spread moist gauze under the material and cover it with moist gauze, spray 10ml of clean water on the medicinal material every 30 minutes to keep it moist. After the pile is moistened to a soft state, use a small medicine cutting machine to cut it into 2-4mm thick slices, dry it at 60℃ for 3 hours, and cool it to room temperature.

[0132] 2.2 Crushing, sieving and mixing of medicinal pieces

[0133] Take 50g of ginseng, 50g of polygala, 100g of poria, and 50g of calamus, mix them, put them in a medicine pounding pot and crush them, pass through a No. 6 sieve to obtain medicine powder of not less than 100 mesh, and then mix all the medicine powder until the texture is uniform and there is no color difference.

[0134] 2.3 Sterilization

[0135] The obtained Kaixin powder is placed in a cooking bag, and placed in a high-temperature and high-pressure conditioning sterilizer. The temperature is controlled at 121°C for 60 seconds, the pressure is set at 1-6 atmospheres, the speed is 1-35 revolutions per minute, and high-temperature saturated steam is introduced to obtain Kaixin powder.

[0136] Example 3 Kaixinsan Sterilization (Sterilization at the Piece Stage)

[0137] 3.1 Preparation of medicinal materials

[0138] 3.1.1 Ginseng: Take 500g of the original medicinal material, crush it and pass it through a No. 1 sieve to obtain pieces with a size of not less than 10 mesh.

[0139] 3.1.2 Polygala: Take 500g of raw medicinal materials, select by hand to remove impurities, wash, pile the washed Polygala into a pile, spread moist gauze under the materials and cover them with moist gauze, spray 10ml of clean water on the medicinal materials every 30 minutes to keep them moist. After the pile is moistened to a soft state, use a small medicine cutter to cut it into 10-15mm Polygala segments, dry it at 50℃ for 8 hours, and cool it to room temperature.

[0140] 3.1.3 Poria cocos: Take fresh Poria cocos from the place of origin and process it into 500g blocks, and select by hand to remove impurities.

[0141] 3.1.4 Acorus calamus: Take 500g of the original medicinal material, select by hand to remove impurities, wash it, pile the washed Acorus calamus into a pile, spread moist gauze under the material and cover it with moist gauze, spray 10ml of clean water on the medicinal material every 30 minutes to keep it moist. After the pile is moistened to a soft state, use a small medicine cutting machine to cut it into 2-4mm thick slices, dry it at 60℃ for 3 hours, and cool it to room temperature.

[0142] 3.2 Sterilization of decoction pieces

[0143] The four medicinal materials obtained were placed in cooking bags, respectively, and placed in a high-temperature and high-pressure conditioning sterilizer. The temperature was maintained at 130°C for 50 seconds, the pressure was set at 1-6 atmospheres, the rotation speed was 1-35 revolutions per minute, and high-temperature saturated steam was introduced to obtain solid oral decoction pieces that met the requirements of the "Chinese Pharmacopoeia (2015 Edition)".

[0144] 3.3 Crushing, sieving and mixing of medicinal pieces

[0145] The following operations must be performed in a clean area.

Claims

1. A method for sterilizing Kaixinsan raw medicinal material oral powder, characterized in that: The method comprises the following steps: Step 1, four decoction pieces of ginseng, Poria cocos, Acorus calamus and Polygala tenuifolia are weighed according to the formula, placed in a cooking bag separately or mixed, and placed in a high temperature and high pressure conditioning sterilizer, the temperature is controlled at 110-130° C., and the duration is 50-70 seconds; Step 2, the four medicinal pieces of ginseng, Poria, Acorus calamus and Polygala obtained in step 1 are mixed and placed in a medicine pounding pot, crushed, passed through a No. 6 sieve, the particle size is controlled to be above 100 mesh, and mixed evenly to obtain Kaixin powder; The high temperature and high pressure conditioning sterilizer has a pressure set at 1-6 atmospheres and a rotation speed of 1-35 revolutions per minute.

2. The sterilization method according to claim 1, characterized in that: The method comprises the following steps: Step 1, four medicinal materials, ginseng, poria, calamus and polygala, are weighed according to the formula, placed in a cooking bag separately or mixed, and placed in a high temperature and high pressure conditioning sterilizer, the temperature is controlled at 110-130°C for 60 seconds; Step 2, the four medicinal pieces of ginseng, Poria cocos, Acorus calamus and Polygala tenuifolia obtained in step 1 are placed in a multifunctional grinder and crushed into fine powder separately or mixed, passed through a No. 6 sieve, the particle size is controlled to be above 100 mesh, and mixed evenly to obtain Kaixin powder.

3. The sterilization method according to claim 1, characterized in that: in, The Kaixin powder has a formula of: the weight ratio of four raw medicinal materials, ginseng, polygala, poria and calamus, is 1:1:2:

1.

4. The sterilization method according to claim 1, characterized in that: The high temperature and high pressure conditioning and sterilizing machine is introduced with high temperature saturated steam.

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