New preparation process of refreshing reconstituted capsule

Abstract

The invention relates to the technical field of pharmacy, and particularly discloses a novel preparation process of a refreshing reconstituted capsule. The preparation process comprises the following steps: mixing the borneol subjected to low-temperature refrigeration treatment with the medicinal powder according to the mass ratio of 1: 1, crushing at the temperature of-15 DEG C to-20 DEG C, uniformly mixing the obtained borneol-containing mixed powder with the remaining medicinal powder and the pearl powder according to the prescription dosage, and encapsulating to obtain the product. The prepared product meets the standard process requirements, the problems that in an actual original production process, borneol is not prone to being smashed independently, smashed fine powder is prone to being mutually adsorbed and agglomerated and cannot be mixed evenly, and the huge risk of fire disasters is caused by flammable static electricity is solved, and the loss of the borneol is reduced.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and particularly to a new preparation process for Xingnao Zaizao Capsules. Background Art

[0002] Xingnao Zaizao Capsules, a product of Guizhou Yuancheng Pharmaceutical Co., Ltd., are included in the Chinese Pharmacopoeia (2020 Edition) and are national medical insurance varieties. Its [Prescription] includes Astragali Radix 162.2 g, Epimedii Folium 94.6 g, Acori Tatarinowii Rhizoma 40.5 g, Ginseng Rubra Pulvis 33.8 g, Notoginseng Radix et Rhizoma 27 g, Pheretima 27 g, Angelicae Sinensis Radix 33.8 g, Carthami Flos 27 g, Stephaniae Tetrandrae Radix 27 g, Paeoniae Radix Rubra 27 g, Persicae Semen Praeparatum 27 g, Haliotidis Concha 27 g, Gastrodiae Rhizoma 27 g, Agrimoniae Herba 27 g, Sophorae Flos Praeparatus 27 g, Atractylodis Macrocephalae Rhizoma Praeparatum 27 g, Arisaematis Rhizoma Cum Bile 27 g, Puerariae Lobatae Radix 27 g, Scrophulariae Radix 27 g, Coptidis Rhizoma Pulvis 27 g, Forsythiae Fructus 27 g, Alismatis Rhizoma 27 g, Chuanxiong Rhizoma 27 g, Lycii Fructus 27 g, Scorpio (without hooks) 6.8 g, Polygoni Multiflori Radix Praeparata 40.5, Cassiae Semen 27 g, Aquilariae Lignum Resinatum Pulvis 13.5 g, Typhonii Rhizoma Praeparatum 13.5 g, Asari Radix et Rhizoma 13.5 g, Aucklandiae Radix 13.5 g, Bombyx Batryticatus Praeparatus 6.8 g, Gleditsiae Sinensis Spina 13.5 g, Borneolum Syntheticum 13.5 g, Margarita (processed with bean curd) 20.3 g, Rhei Radix et Rhizoma 13.5 g; [Preparation Method] The above thirty-six flavors are processed as follows: Margarita and Borneolum Syntheticum are separately ground into fine powders, Gleditsiae Sinensis Spina, Bombyx Batryticatus Praeparatus, Asari Radix et Rhizoma, Aquilariae Lignum Resinatum Pulvis, Scorpio (without hooks), Coptidis Rhizoma Pulvis, Gastrodiae Rhizoma, Notoginseng Radix et Rhizoma, and Ginseng Rubra Pulvis are pulverized into fine powders. The remaining twenty-five flavors including Astragali Radix are decocted twice with water, for 3 hours for the first time and 2 hours for the second time. The decoction liquids are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.20 - 1.25 (80 °C). The fine powders such as Gleditsiae Sinensis Spina are added, mixed evenly, dried, pulverized, granulated, and then the powders of Margarita and Borneolum Syntheticum are added, mixed evenly, filled into capsules to make 1000 capsules, thus obtaining the product. In the [Preparation Method] recorded in the included quality standard, Margarita and Borneolum Syntheticum are separately ground into fine powders, that is, they are separately pulverized and then mixed with other drug components to make the product.

[0003] Borneolum Syntheticum is included in the Chinese Pharmacopoeia (2020 Edition). Properties: This product is a colorless transparent or white semi-transparent flaky and brittle crystal; it has a delicate fragrance, a pungent and cool taste; it is volatile, and when ignited, it emits thick smoke and has a flame with light. This product is easily soluble in ethanol, chloroform, or ether and is almost insoluble in water. It is one of the raw materials for our company's Xingnao Zaizao Capsules.

[0004] In the actual production of our company, Borneolum Syntheticum is not easily pulverized alone. During pulverization, Borneolum Syntheticum adheres to the inner cavity of the pulverizer and the blades, resulting in an excessive load on the pulverizer motor and inability to pulverize normally. Moreover, the pulverized fine powders are prone to adsorbing and aggregating into lumps, making it impossible to mix evenly, and there is a great risk of electrostatic ignition and fire, as well as actual cases. Therefore, it is necessary to improve the original production process of Xingnao Zaizao Capsules.

[0005] Based on the problems of the existing technology, in the present invention, the original traditional process of separately pulverizing borneol is changed to mixed pulverization. On the basis of the preliminary research and exploration, relevant research and investigation on the mass ratio of borneol to medicinal powder, etc. will be carried out to solve the compliance problems and form a new production process for Xingnao Zaizao Capsules. Summary of the Invention

[0006] The object of the present invention is to provide a new preparation process for Xingnao Zaizao Capsules. Borneol treated by low-temperature refrigeration is mixed with the medicinal powder of Xingnao Zaizao Capsules obtained by preparation according to a mass ratio of 1:1, and pulverized under the conditions of -15°C to -20°C to obtain Xingnao Zaizao Capsules, so as to solve the problems that borneol is not easily pulverized separately in actual production, the fine powder after pulverization is easy to adsorb and agglomerate with each other, cannot be evenly mixed, and there is a great risk of generating static electricity and causing fire.

[0007] In order to achieve the above object, the present invention is realized through the following technical solutions:

[0008] A new preparation process for Xingnao Zaizao Capsules according to the present invention specifically includes the following steps:

[0009] Step 1, low-temperature refrigeration treatment of borneol:

[0010] Take borneol according to the prescription amount and store it at -15°C to -20°C for 10 - 15 h;

[0011] Step 2, mixed pulverization:

[0012] Take the medicinal powder of Xingnao Zaizao Capsules according to the prescription amount, mix the borneol treated in the above step with the medicinal powder of Xingnao Zaizao Capsules according to a certain mass ratio, and pulverize it at -15°C to -20°C for 5 - 15 min to obtain a mixed powder;

[0013] Step 3, preparation of the preparation: Mix the mixed powder evenly with the remaining medicinal powder of Xingnao Zaizao Capsules and the pearl powder according to the prescription amount, and fill them into capsules to obtain the product.

[0014] Preferably, the low-temperature refrigeration treatment of borneol in the present invention is: storing at -20°C for 10 h.

[0015] Preferably, the mass ratio in the present invention is: borneol: medicinal powder of Xingnao Zaizao Capsules = 1:0.8 - 1.5

[0016] Preferably, the mass ratio in the present invention is: borneol: medicinal powder of Xingnao Zaizao Capsules = 1:1.

[0017] Preferably, the pulverization time in the present invention is: 15 min.

[0018] The preparation method of the Xingnao Zaizao Capsule powder of the present invention is as follows: the prescribed amounts of red ginseng powder, coptis powder and agarwood powder are mixed evenly to obtain a first mixed powder; the prescribed amounts of Panax notoginseng powder, asarum powder, scorpion powder, fried silkworm powder, sophora flavescens powder and gastrodia powder are mixed evenly to obtain a second mixed powder; the first mixed powder, the second mixed powder and the Xingnao Zaizao Capsule Chinese medicine extract are mixed, granulated, dried and crushed to obtain the Xingnao Zaizao Capsule powder.

[0019] The Chinese medicine extract of the Xingnao Zaizao Capsule of the present invention: according to the [Preparation Method] included in the 2020 edition of the "Chinese Pharmacopoeia", specifically: according to the prescription amount of Xingnao Zaizao Capsule, take 25 medicinal materials including astragalus, epimedium, calamus, earthworm, angelica, safflower, stephania tetrandra, red peony root, fried peach kernel, semen cassiae, agrimony, fried Sophora japonica flower, fried Atractylodes macrocephala, Arisaema consanguineum, Pueraria root, Scrophularia ningpoensis, Forsythia suspensa, Alisma orientalis, Ligusticum chuanxiong, wolfberry, processed Polygonum multiflorum, Cassia seed, processed White aconite, costus root, and rhubarb, add water and boil twice, the first time for 3 hours and the second time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.20-1.25 (80°C), add water and boil twice, the first time for 3 hours and the second time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.20-1.25 (80°C).

[0020] Preferably, the mixed granulation drying of the present invention is specifically as follows: the material temperature of the dryer is set to 100°C, the fan frequency is set to 30-50Hz, and when the material temperature reaches 45-55°C, the first mixed powder and the second mixed powder are pumped into the dryer for boiling drying; when the material temperature reaches 70-80°C, the extract is sprayed, and the drying is stopped when the particles are dispersed and non-sticky; after the material is cooled to a temperature below 45-55°C, the material is discharged.

[0021] Preferably, the mixed granulation drying of the present invention is specifically as follows: the material temperature of the dryer is set to 100°C, the fan frequency is 40-50Hz, and when the material temperature reaches 50°C, the first mixed powder and the second mixed powder are pumped into the dryer for boiling drying; when the material temperature reaches 80°C, the extract is sprayed in, and the drying is stopped when the particles are dispersed and non-sticky; after the material is cooled to a temperature below 50°C, the material is discharged.

[0022] Preferably, the pulverizing of the present invention is: pulverizing through a 50-80 mesh sieve.

[0023] Preferably, the pulverizing of the present invention is: pulverizing through a 60-mesh sieve.

[0024] Compared with the prior art, the present invention has the following advantages:

[0025] 1. Using the technical solution of the present invention, borneol treated by low-temperature refrigeration (-20°C storage for 10 h) is mixed with medicinal powder at a mass ratio of 1:1 and pulverized at -15°C to -20°C. The borneol can be smoothly pulverized, and the pulverized mixed powder is evenly dispersed and does not agglomerate. This solves the problems that borneol is not easily pulverized alone, and the pulverized fine powder is easily adsorbed and aggregated with each other and cannot be evenly mixed. At the same time, it can also avoid the huge risk of fire caused by static electricity generated during the separate pulverization of borneol.

[0026] 2. Using the mixed pulverization technical solution of the present invention not only solves the compliance problem of mixing and pulverizing borneol with other medicinal powders, but also reduces the loss of borneol. Description of the Drawings

[0027] Figure 1 : Sample diagram of mixing and pulverizing borneol and medicinal powder at a mass ratio of 1:1

[0028] Figure 2 : Sample diagram of mixing and pulverizing borneol and medicinal powder at a mass ratio of 1:0.5

[0029] Figure 3 : Chromatogram of content determination of Xingnao Zaizao Capsule - Borneol reference substance 1

[0030] Figure 4 : Chromatogram of content determination of Xingnao Zaizao Capsule - Borneol reference substance 2

[0031] Figure 5 : Chromatogram of content determination of Xingnao Zaizao Capsule - Borneol reference substance 3

[0032] Figure 6 : Chromatogram of content determination of Xingnao Zaizao Capsule - Borneol reference substance 4

[0033] Figure 7 : Chromatogram of content determination of Xingnao Zaizao Capsule - Borneol reference substance 5

[0034] Figure 8 : Chromatogram of content determination of Xingnao Zaizao Capsule - Sample 1 (mixed)

[0035] Figure 9 : Chromatogram of content determination of Xingnao Zaizao Capsule - Sample 2 (mixed)

[0036] Figure 10 : Chromatogram of content determination of Xingnao Zaizao Capsule - Sample 3 (mixed)

[0037] Figure 11 : Chromatogram of content determination of Xingnao Zaizao Capsule - Sample 4 (separately pulverized)

[0038] Figure 12 : Chromatogram of content determination of Xingnao Zaizao Capsule - Sample 5 (separately pulverized)

[0039] Figure 13 : Chromatogram of Determination of Content of Xingnao Zaizao Capsules - Sample 6 (Individually Ground)

[0040] Figure 14 : Test Report of Mixed - Ground Borneol Sample on April 6, 2023 - 1

[0041] Figure 15 : Test Report of Mixed - Ground Borneol Sample on April 6, 2023 - 2

[0042] Figure 16 : Test Report of Mixed - Ground Borneol Sample on April 7, 2023 - 1

[0043] Figure 17 : Test Report of Individually - Ground Borneol Sample on April 7, 2023 - 2

[0044] Figure 18 : Test Report of Mixed - Ground Borneol Sample on April 8, 2023 - 1

[0045] Figure 19 : Test Report of Individually - Ground Borneol Sample on April 8, 2023 - 2

[0046] Figure 20 : Test Report of Individually - Ground Borneol Sample on December 1, 2023 - 1

[0047] Figure 21 : Test Report of Individually - Ground Borneol Sample on December 1, 2023 - 2

[0048] Figure 22 : Test Report of Individually - Ground Borneol Sample on December 2, 2023 - 1

[0049] Figure 23 : Test Report of Individually - Ground Borneol Sample on December 2, 2023 - 2

[0050] Figure 24 : Test Report of Individually - Ground Borneol Sample on December 3, 2023 - 1

[0051] Figure 25 : Test Report of Individually - Ground Borneol Sample on December 3, 2023 - 1 Detailed Implementation Manner

[0052] The present invention will be described in detail below in conjunction with specific embodiments.

[0053] Embodiment 1 Preparation Process

[0054] (1) Preparation of Chinese Medicine Extract of Xingnao Zaizao Capsules

[0055] According to the prescription amount of Xingnao Zaizao Capsules, take 162.2 g of Astragalus membranaceus, 94.6 g of Epimedium brevicornu, 40.5 g of Acorus tatarinowii, 27 g of Pheretima aspergillum, 33.8 g of Angelica sinensis, 27 g of Carthamus tinctorius, 27 g of Stephania tetrandra, 27 g of Paeonia lactiflora, 27 g of stir-fried Prunus persica, 27 g of Haliotis diversicolor, 27 g of Agrimonia pilosa, 27 g of stir-fried Sophora japonica, 27 g of stir-fried Atractylodes macrocephala, 27 g of Arisaema cum Bile, 27 g of Pueraria lobata, 27 g of Scrophularia ningpoensis, 27 g of Forsythia suspensa, 27 g of Alisma orientale, 27 g of Ligusticum chuanxiong, 27 g of Lycium barbarum, 40.5 g of processed Polygonum multiflorum, 27 g of Cassia obtusifolia, 13.5 g of processed Typhonium giganteum, 13.5 g of Aucklandia lappa, 13.5 g of Rheum palmatum, add water and decoct for extraction twice, 2 hours each time, and concentrate to a relative density of 1.23 (80 °C) to obtain a clear extract;

[0056] (2) Preparation of the medicinal powder of Xingnao Zaizao Capsules

[0057] Mix 33.8 g of red ginseng powder, 27 g of Coptis chinensis powder, and 13.5 g of Aquilaria sinensis powder in the prescription amount to obtain the first mixed powder; mix 27 g of Panax notoginseng powder, 13.5 g of Asarum sieboldii powder, 6.8 g of Scorpio powder, 6.8 g of stir-fried Bombyx batryticatus powder, 13.5 g of Gleditsia sinensis powder, and 27 g of Gastrodia elata in the prescription amount to obtain the second mixed powder; mix the first mixed powder, the second mixed powder with the clear extract obtained in the above step, granulate and dry, sieve through a 60-mesh sieve and crush to obtain the medicinal powder of Xingnao Zaizao Capsules;

[0058] The specific process of the above-mentioned mixing, granulating and drying is as follows: set the material temperature of the dryer at 100 °C and the fan frequency at 40 - 50 Hz. After the material temperature reaches 50 °C, pump the first mixed powder and the second mixed powder into the dryer for fluidized drying; after the material temperature reaches 80 °C, spray the extract. When the particles are dispersed and non-sticky, stop drying; after the material cools to a temperature below 50 °C, discharge the material.

[0059] (3) Low-temperature refrigeration treatment of borneol

[0060] Take 13.5 g of borneol according to the prescription amount and store it at -15 °C to -20 °C for 10 h;

[0061] (4) Mixing and crushing

[0062] Mix the borneol after the refrigeration treatment in the above step with the medicinal powder of Xingnao Zaizao Capsules at a mass ratio of 1:1 and crush at -15 °C to -20 °C for 15 min to obtain the third mixed powder;

[0063] (5) Forming of the preparation

[0064] Mix the third mixed powder evenly with the remaining medicinal powder of Xingnao Zaizao Capsules and 20.3 g of pearl powder in the prescription amount, and fill into capsules to obtain the product.

[0065] Preparation process of Example 2

[0066] (1) Preparation of the traditional Chinese medicine extract of Xingnao Zaizao Capsules: the same as in Example 1;

[0067] (2) Preparation of the powder of Xingnao Zaizao Capsules: same as Example 1;

[0068] (3) Low-temperature refrigeration treatment of borneol: same as Example 1;

[0069] (4) Mixing and grinding

[0070] Mix the borneol after the refrigeration treatment in the above step with the powder of Xingnao Zaizao Capsules at a mass ratio of 1:1, and grind at -15°C to -20°C for 10 minutes to obtain the third mixed powder;

[0071] (5) Forming the preparation

[0072] Mix the third mixed powder evenly with the remaining powder of Xingnao Zaizao Capsules and 20.3 g of pearl powder in the prescription amount, and fill into capsules to obtain the product.

[0073] Preparation process of Example 3

[0074] (1) Preparation of the Chinese medicine extract of Xingnao Zaizao Capsules: same as Example 1;

[0075] (2) Preparation of the powder of Xingnao Zaizao Capsules: same as Example 1;

[0076] (3) Low-temperature refrigeration treatment of borneol: same as Example 1;

[0077] (4) Mixing and grinding

[0078] Mix the borneol after the refrigeration treatment in the above step with the powder of Xingnao Zaizao Capsules at a mass ratio of 1:0.8, and grind at -15°C to -20°C for 5 minutes to obtain the third mixed powder;

[0079] (5) Forming the preparation

[0080] Mix the third mixed powder evenly with the remaining powder of Xingnao Zaizao Capsules and 20.3 g of pearl powder in the prescription amount, and fill into capsules to obtain the product.

[0081] Preparation process of Example 4

[0082] (1) Preparation of the Chinese medicine extract of Xingnao Zaizao Capsules: same as Example 1;

[0083] (2) Preparation of the powder of Xingnao Zaizao Capsules

[0084] Mix 33.8 g of red ginseng powder, 27 g of coptis powder, and 13.5 g of agarwood powder in the prescribed amounts evenly to obtain the first mixed powder; mix 27 g of notoginseng powder, 13.5 g of asarum powder, 6.8 g of scorpion powder, 6.8 g of stir-fried bombyx batryticatus powder, 13.5 g of gleditsia sinensis powder, and 27 g of gastrodia elata in the prescribed amounts evenly to obtain the second mixed powder; mix the first mixed powder, the second mixed powder with the clear extract obtained in the above step, granulate, dry, crush through a 50-mesh sieve to obtain the powder of Xingnao Zaizao Capsules;

[0085] The mixing, granulating, and drying are specifically as follows: Set the material temperature of the dryer to 100 °C and the fan frequency to 40 - 50 Hz. After the material temperature reaches 45 °C, pump the first mixed powder and the second mixed powder into the dryer for fluidized drying; after the material temperature reaches 70 °C, spray in the extract, and stop drying when the particles are dispersed and non-sticky; after the material cools to a temperature below 45 °C, discharge the material.

[0086] (3) Low-temperature refrigeration treatment of borneol

[0087] Take 13.5 g of borneol in the prescribed amount and store it at -15 °C to -20 °C for 15 h;

[0088] (4) Mixing and crushing

[0089] Mix the borneol after the refrigeration treatment in the above step with the powder of Xingnao Zaizao Capsules at a mass ratio of 1:0.8 and crush at -15 °C to -20 °C for 15 min to obtain the third mixed powder;

[0090] (5) Preparation of the finished product

[0091] Mix the third mixed powder evenly with the remaining powder of Xingnao Zaizao Capsules and 20.3 g of pearl powder in the prescribed amount, and fill into capsules to obtain the product.

[0092] Preparation process of Example 5

[0093] (1) Preparation of the Chinese medicine extract of Xingnao Zaizao Capsules: The same as in Example 1;

[0094] (2) Preparation of the powder of Xingnao Zaizao Capsules:

[0095] Mix 33.8 g of red ginseng powder, 27 g of coptis powder, and 13.5 g of agarwood powder in the prescribed amounts evenly to obtain the first mixed powder; mix 27 g of notoginseng powder, 13.5 g of asarum powder, 6.8 g of scorpion powder, 6.8 g of stir-fried bombyx batryticatus powder, 13.5 g of gleditsia sinensis powder, and 27 g of gastrodia elata in the prescribed amounts evenly to obtain the second mixed powder; mix the first mixed powder, the second mixed powder with the clear extract obtained in the above step, granulate, dry, crush through an 80-mesh sieve to obtain the powder of Xingnao Zaizao Capsules;

[0096] The mixing, granulation, and drying are specifically as follows: Set the material temperature of the dryer to 100°C and the fan frequency to 30 Hz. After the material temperature reaches 55°C, pump the first mixed powder and the second mixed powder into the dryer for fluidized drying. After the material temperature reaches 80°C, spray in the extract. Stop drying when the particles are dispersed and non-sticky. After the material cools to a temperature below 55°C, discharge the material.

[0097] (3) Low-temperature refrigeration treatment of borneol:

[0098] Take 13.5 g of borneol according to the prescription amount and store it at -15°C to -20°C for 10 h;

[0099] (4) Mixing and grinding

[0100] Mix the borneol after the refrigeration treatment in the above step with the powder of Xingnao Zaizao Capsules in a mass ratio of 1:1.5 and grind at -15°C to -20°C for 10 min to obtain the third mixed powder;

[0101] (5) Preparation forming

[0102] Mix the third mixed powder evenly with the remaining powder of Xingnao Zaizao Capsules and 20.3 g of pearl powder according to the prescription amount, and fill them into capsules to obtain the product.

[0103] To further verify the feasibility of the present invention, the inventors conducted a series of tests, which are specifically as follows:

[0104] I. Process research

[0105] In order to solve the problems that borneol in the product Xingnao Zaizao Capsules of our company is not easy to be ground alone in actual production, borneol adheres to the inner cavity and blades of the grinder during grinding, resulting in excessive load on the grinder motor and inability to grind normally, and the fine powder after grinding is easy to adsorb and agglomerate with each other, making it impossible to be mixed evenly, and there are huge risks and actual cases of electrostatic ignition and fire, etc., the present invention adopts the method of mixing and grinding borneol with the powder, intends to carry out quality comparison of borneol stored at a cool place and at -20°C for different times, conduct research on grinding equipment, carry out experimental research on low-temperature grinding of borneol, conduct experimental research on mixing and grinding of borneol in Xingnao Zaizao Capsules, etc., determine the quality consistency of grinding borneol alone and by mixing, and form a new production process for Xingnao Zaizao Capsules.

[0106] 1. Quality comparison investigation of borneol stored at a cool place and at -20°C for different times

[0107] The investigation indexes are based on the character, identification, inspection, and content determination of borneol in the Chinese Pharmacopoeia (2020 Edition). Three batches of borneol are used for the test, and the batch numbers are: 221255, 230532, and 230610.

[0108] 1.1 Sampling

[0109] Take 4 portions of borneol stored in a cool place with different batch numbers. The first portion is 50 g, and the other 3 portions are each 100 g. Seal them and number them as ①②③④ respectively. Among them, No. ① is the quality inspection sample of borneol stored in a cool place; No. ② is the quality inspection sample of borneol after storage at -20 °C for 12 hours; No. ③ is the quality inspection sample of borneol after storage at -20 °C for 24 hours; No. ④ is the quality inspection sample of borneol after storage at -20 °C for 48 hours.

[0110] 1.2 Experimental procedures

[0111] (1) Take 50 g of sample ① and test it according to the item of borneol in the Chinese Pharmacopoeia (2020 Edition).

[0112] (2) Quality inspection of borneol with different storage times at -20 °C: Take 50 g of sample ② and test it according to the item of borneol in the Chinese Pharmacopoeia (2020 Edition); take 50 g of sample ③ and test it according to the item of borneol in the Chinese Pharmacopoeia (2020 Edition); take 50 g of sample ④ and test it according to the item of borneol in the Chinese Pharmacopoeia (2020 Edition).

[0113] (3) Quality inspection of ground powder of borneol with different storage times at -20 °C: Take 50 g of sample ② and grind it into fine powder, then test it according to the item of borneol in the Chinese Pharmacopoeia (2020 Edition); take 50 g of sample ③ and grind it into fine powder, then test it according to the item of borneol in the Chinese Pharmacopoeia (2020 Edition); take 50 g of sample ④ and grind it into fine powder, then test it according to the item of borneol in the Chinese Pharmacopoeia (2020 Edition).

[0114] 1.3 Experimental results

[0115] The quality inspection results are shown in Tables 1 to 3.

[0116] Table 1 Comparison of the quality of borneol and its ground powder with batch number 221255

[0117]

[0118] Table 2 Comparison of the quality of borneol and its ground powder with batch number 230532

[0119]

[0120] Table 3 Comparison of the quality of borneol and its ground powder with batch number 230610

[0121]

[0122] As can be seen from Tables 1 to 3, borneol stored at -20°C for 12 hours, 24 hours, and 48 hours respectively, and the ground borneol powder after storage at the above temperature and time and then ground, compared with borneol stored in a cool place as specified in the Chinese Pharmacopoeia (2020 Edition), showed no change in properties, no change in melting point, identification, inspection all met the requirements, content determination met the requirements and was stable. The results showed that storage at -20°C for 48 hours had no effect on the quality of borneol.

[0123] 2. Experimental study on low-temperature comminution of borneol

[0124] In order to understand the comminution of borneol at different temperatures and times after storage at low temperature for 5 hours and 10 hours, observe the comminution situation of borneol and the particle size distribution of borneol powder, preliminarily determine the storage time of borneol at -20°C, comminution temperature and comminution time, observe the comminution situation, and conduct particle size partial tests on the comminuted samples.

[0125] 2.1 Experimental content

[0126] In order to determine whether the comminution of borneol can proceed smoothly and whether the comminuted borneol powder aggregates, the present invention designs 6 schemes, which are specifically as follows:

[0127] 2.1.1 Borneol stored at -20°C for 5 hours, comminuted at 5°C to -10°C for 5 minutes

[0128] Experimental design: Place borneol in a freezer, store it at -20°C for 5 hours, take 0.5 kg of borneol and add it to the comminution hopper, turn on the comminutor, set the temperature to 5°C to -10°C, and start comminution when the equipment temperature reaches -10°C, with a comminution time of 5 minutes.

[0129] 2.1.2 Borneol stored at -20°C for 5 hours, comminuted at -10°C to -15°C for 5 minutes

[0130] Experimental design: Place borneol in a freezer, store it at -20°C for 5 hours, take 0.5 kg of borneol and add it to the comminution hopper, turn on the comminutor, set the temperature to -10°C to -15°C, and start comminution when the equipment temperature reaches -15°C, with a comminution time of 5 minutes.

[0131] 2.1.3 Borneol stored at -20°C for 5 hours, comminuted at -15°C to -20°C for 5 minutes

[0132] Experimental design: Place borneol in a freezer, store it at -20°C for 5 hours, take 0.5 kg of borneol and add it to the comminution hopper, turn on the comminutor, set the temperature to -15°C to -20°C, and start comminution when the equipment temperature reaches -20°C, with a comminution time of 5 minutes.

[0133] 2.1.4 Borneol stored at -20°C for 10 hours, comminuted at -15°C to -20°C for 5 minutes

[0134] Experimental design: Place borneol in a freezer and store it at -20°C for 10 hours. Take 0.5 kg of borneol and add it to the crushing hopper. Start the crusher and set the temperature to -15°C to -20°C. After the equipment temperature reaches -20°C, start crushing for 5 minutes.

[0135] 2.1.5 Borneol is stored at -20°C for 10 hours and crushed at -15°C to -20°C for 10 minutes

[0136] Experimental design: Place borneol in a freezer and store it at -20°C for 10 hours. Take 1 kg of borneol and add it to the crushing hopper. Start the crusher and set the temperature to -15°C to -20°C. After the equipment temperature reaches -20°C, start crushing for 10 minutes.

[0137] 2.1.6 Borneol is stored at -20°C for 10 hours and crushed at -15°C to -20°C for 15 minutes

[0138] Experimental design: Place borneol in a freezer and store it at -20°C for 10 hours. Take 1 kg of borneol and add it to the crushing hopper. Start the crusher and set the temperature to -15°C to -20°C. After the equipment temperature reaches -20°C, start crushing for 15 minutes.

[0139] 2.2 Experimental results

[0140] According to the experiments of "2.1.1", "2.1.2", and "2.1.3", the borneol adhered to the grinding rod and the storage time was insufficient; according to the experiments of "2.1.4", "2.15", and "2.1.6", the borneol did not adhere to the grinding rod. Through particle size distribution detection, according to the experiment of "2.1.6", the particle size met the requirements. Therefore, crush borneol according to the experiment of "2.1.6": Borneol is stored at -20°C for 10 hours and crushed at -15°C to -20°C for 15 minutes.

[0141] 3. Research on the mixed crushing test of borneol in Xingnao Zaizao Capsules

[0142] Due to the special properties of borneol, borneol adheres to the crusher cavity and blades during crushing, resulting in an excessive load on the crusher motor and inability to crush normally. The powder-carrying crushing method can enable normal crushing of borneol. It is intended to compare the yields of separate crushing of medicinal powder and mixed crushing of borneol and medicinal powder through experimental research.

[0143] 3.1 Experimental content

[0144] 3.1.1 Take 90 times the amount of medicinal materials in the prescription of the quality standard of Xingnao Zaizao Capsules and extract to obtain an extract according to the [Manufacturing Method] (temperature 80°C, relative density 1.23);

[0145] 3.1.2 Divide the extracted extract evenly into 3 parts, and mix them with the mixed powder of red ginseng, coptis, aloeswood, notoginseng powder, asarum powder, scorpion powder, stir-fried bombyx batryticatus powder, and gleditsia sinensis powder in 30 times the prescription amount respectively. After granulation, dry them at a drying temperature of 100°C to prepare 3 batches of Xingnao Zaizao Capsule powder (RD20231001, RD20231002, RD20231003);

[0146] 3.1.3 Take the powder of the 3 batches of Xingnao Zaizao Capsules after granulation and drying, and use the pulverizing equipment used in production to pass through a 60-mesh sieve for pulverization respectively. Weigh the amount of the pulverized powder and calculate the recovery rate. The powder pulverization recovery rate = the amount of the pulverized powder / the amount of the powder before pulverization × 100%.

[0147] 3.1.4 Take the powder of the 3 batches of Xingnao Zaizao Capsules after pulverization respectively, mix them with an equal amount of borneol, and then use the same pulverizing equipment to pass through a 60-mesh sieve for pulverization. Weigh the pulverized mixed powder and calculate the recovery rate. The mixed pulverization recovery rate = the total amount of the pulverized powder / the total amount of the powder before pulverization × 100%.

[0148] Calculate the recovery rates of the powder pulverized alone and mixed with borneol through the experimental data.

[0149] 3.2 Experimental results

[0150] See Tables 4 to 5.

[0151] Table 4 Experimental results of borneol loss during single pulverization

[0152]

[0153]

[0154] Table 5 Experimental results of borneol loss during mixed pulverization

[0155]

[0156] As can be seen from Tables 4 and 5, the average recovery rate of single pulverization is 98.21%, and the average recovery rate of mixed pulverization is 98.29%. The loss amount during 6 times of single pulverization or mixed pulverization is 0.1 - 0.2 kg, and the average value is 0.14 kg. It is necessary to further increase the pulverization amount and investigate the loss amount during pulverization with different amounts.

[0157] Pulverize 16 kg of the mixed powder of borneol and powder of Xingnao Zaizao Capsule to investigate the pulverization loss amount. See Table 6:

[0158] Table 6 Experimental results of the effect of increasing pulverization amount on borneol loss amount

[0159]

[0160]

[0161] In summary, regardless of the amount of crushing, the loss amount of one-time crushing is between 0.1 - 0.2 kg.

[0162] To simulate the production volume, 32.4 kg of the above-mentioned mixed powder of borneol and medicinal powder was collected and crushed, and the crushing loss amount was investigated. See Table 7:

[0163] Table 7 Experimental results of the effect of simulated production volume on borneol loss

[0164]

[0165] In summary, the average recovery rate of the three-batch samples after mixed crushing is 98.29%. The loss amounts of mixed crushing are 0.16 kg, 0.13 kg, and 0.12 kg respectively; 16 kg of the mixed powder of borneol and medicinal powder of Xingnao Zaizao Capsules was taken for crushing, and the loss amount was 0.14 kg, and the mixed crushing recovery rate was 99.12%; then, when simulating the crushing amount during the mixed crushing of borneol in production, 32.4 kg of the mixed powder of medicinal powder and borneol with a ratio of 1:1 in Xingnao Zaizao Capsules was taken for crushing, and the loss amount was 0.15 kg, and the mixed crushing recovery rate was 99.54%. It can be seen from the experiment that regardless of the amount of materials, the loss amount is basically within a certain range. When using this production equipment to crush materials, the loss amount range is: 0.12 kg - 0.16 kg, indicating that the greater the crushing weight, the higher the mixed crushing recovery rate.

[0166] 4. Experimental study on the mixed crushing of borneol and medicinal powder in different ratios of Xingnao Zaizao Capsules

[0167] In order to ensure the smooth crushing of borneol and the uniform dispersion of the crushed mixture without agglomeration, this experiment intends to conduct experiments on the mixed crushing of medicinal powder and borneol in different ratios to determine the ratio during the mixed crushing of medicinal powder and borneol.

[0168] 4.1 Source of medicinal powder

[0169] Take the medicinal powder of Xingnao Zaizao Capsules prepared under item "3" above, batch number: RD20231001.

[0170] 4.2 Experimental procedure

[0171] Weigh the medicinal powder and borneol of Xingnao Zaizao Capsules in the ratios of 1:1, 1:0.5, and 1:0.3 respectively; add the medicinal powder and borneol into the crusher, turn on the equipment for crushing, observe the crushing situation, and collect the crushed mixed powder.

[0172] 4.3 Experimental results

[0173] The experimental records are shown in Tables 8 to 9.

[0174] Table 8 Experimental record of the mixed crushing of borneol and medicinal powder in a ratio of 1:1

[0175]

[0176]

[0177] Table 9 Experimental Record of Mixing and Pulverizing Borneol and Medicinal Powder in a Ratio of 1:0.5

[0178]

[0179] According to the experiment of mixing and pulverizing borneol and medicinal powder in different ratios for Xingnao Zaizao Capsules, when borneol and medicinal powder are mixed and pulverized in a ratio of 1:1, the borneol can be smoothly pulverized, and the pulverized mixed powder is evenly dispersed and does not agglomerate into lumps (see Figure 1 ); when borneol and medicinal powder are mixed and pulverized in a ratio of 1:0.5, the borneol can be pulverized, but the pulverized mixed powder agglomerates into lumps and is not evenly dispersed (see Figure 2 ); due to the unsatisfactory pulverization effect of the 1:0.5 ratio, the experiment with a ratio of 1:0.3 in the plan is no longer carried out, so the ratio of mixing and pulverizing borneol and medicinal powder is determined to be 1:1.

[0180] 5. Determination Test of Borneol Content under Different Pulverization Methods

[0181] In the "Manufacturing Method" of the quality standard of Xingnao Zaizao Capsules, 1000 capsules are prepared according to the prescription amount, and each capsule contains 0.35 g. Calculating the theoretical amount of medicinal powder for preparing 1000 capsules is 1000 capsules × 0.35 g / capsule = 350 g. The amount of borneol in the prescription is 13.5 g. Therefore, the amount of medicinal powder without borneol is 350 g - 13.5 g = 336.5 g, and 1 / 2 of this amount is taken for the experiment.

[0182] 5.1 Sample Preparation

[0183] Take the medicinal powder of Xingnao Zaizao Capsules prepared above, batch numbers: RD20231001, RD20231002, RD20231003, and prepare samples according to the prescription amount of Xingnao Zaizao Capsules.

[0184] Prepare samples according to different pulverization methods:

[0185] (1) Respectively take the above-mentioned medicinal powder of Xingnao Zaizao Capsules, add separately pulverized borneol according to the prescription ratio, mix evenly, and prepare Samples 1, 2, and 3. The amounts of medicinal powder of Xingnao Zaizao Capsules and borneol are shown in Table 10.

[0186] Table 10 Information on Preparing Samples by Separately Pulverizing Borneol and Medicinal Powder According to the Prescription Ratio

[0187]

[0188]

[0189] (2) Take the above-mentioned Xingnao Zaizao Capsule powder respectively, mix and pulverize it with borneol according to the prescription ratio, mix evenly, and prepare Samples 4, 5, and 6. The amounts of Xingnao Zaizao Capsule powder and borneol are shown in Table 11.

[0190] Table 11 Information on the preparation of samples by mixing and pulverizing borneol and powder according to the prescription ratio

[0191] Sample Powder batch number Amount of Xingnao Zaizao Capsule powder (g) Amount of borneol (g) Sample 4 RD20231001 168.25 6.75 Sample 5 RD20231002 168.25 6.75 Sample 6 RD20231003 168.25 6.75

[0192] 5.2 Determination of samples

[0193] According to the "Determination Method of Borneol Content in Xingnao Zaizao Capsule", the content of borneol in each sample of the above-mentioned Xingnao Zaizao Capsule was determined by gas chromatography.

[0194] Chromatographic conditions Chromatographic column: WEL-PEG20M (30m×0.32mm×0.5um); Column temperature: 140°C; Injection port temperature: 250°C; Detector temperature: 280°C; Carrier gas: Nitrogen; Flow rate: 107.5 mL / min; Split ratio: 50:1; Injection volume: 1 μL.

[0195] Preparation of reference solution Weigh an appropriate amount of borneol reference substance accurately, dissolve it in ethyl acetate to make a solution containing 0.5 mg per 1 ml, and you will get it.

[0196] Preparation of test solution Grind this product finely, take about 0.5 g, weigh it accurately, place it in a 25 ml volumetric flask, add an appropriate amount of ethyl acetate, ultrasonically treat it (power 500 W, frequency 40 kHz) for 30 minutes, let it cool, dilute it to the mark with ethyl acetate, shake well, centrifuge (10000 r / min; 5 min), and take the supernatant, and you will get it.

[0197] Determination method Precisely pipette 1 μl of the reference solution and the test solution respectively, inject them into the gas chromatograph, and determine, and you will get it.

[0198] Calculation formula:

[0199] Content = (A 样 ×C 对 ×25) / (W×A×1000) × 100%

[0200] The chromatogram for content determination is shown in Figures 3 to 13 ; The experimental results of content calculation are shown in Table 12.

[0201] Table 12 Borneol content determined by two different pulverization methods

[0202]

[0203] It can be known from the experimental determination of the sample contents of two different borneol comminution methods that there is no significant difference in the borneol content between the sample of borneol comminuted alone and then mixed with the medicinal powder and the sample of borneol comminuted together with the drug.

[0204] 6. Investigation on the Yield of Borneol in Xingnao Zaizao Capsules with Different Comminution Methods

[0205] 6.1 Investigation on the Experiment of Borneol Comminuted Alone at Low Temperature

[0206] 6.1.1 Investigation Contents

[0207] (1) Investigate that borneol is stored at -20°C for 5 hours, comminuted at different temperatures for 5 minutes respectively, and the borneol powder after comminution is collected respectively to calculate the yield.

[0208] (2) Investigate that borneol is stored at -20°C for 10 hours, comminuted at -15°C to -20°C for different times, and the borneol powder after comminution is collected respectively to calculate the yield.

[0209] (3) Investigate that borneol is stored at -20°C for different times, and comminution experiments are carried out at different temperatures for different times. According to the experimental data, comprehensively analyze to clarify the temperature and comminution time for comminuting borneol.

[0210] 6.1.2 Experimental Results

[0211] The experimental results are shown in Table 13.

[0212] Table 13 Experimental Results of Borneol Comminuted Alone at Low Temperature

[0213] Storage time (h) Crushing temperature (°C) Crushing time (min) Yield (%) Experiment 1 5 5～-10 5 72 Experiment 2 5 -10～-15 5 76 Experiment 3 5 -15～-20 5 78 Experiment 4 10 -15～-20 5 98 Experiment 5 10 -15～-20 10 99 Experiment 6 10 -15～-20 15 99

[0214] It can be seen from Table 13 that when the storage time is 5 hours and it is comminuted at different comminution temperatures of 5 to -10, -10 to -15, and -15 to -20 for 5 minutes, the borneol yields are 72%, 76%, and 78% respectively, indicating that the borneol yield is relatively good under the comminution temperature condition of -15 to -20; when the storage time is 10 hours and the comminution temperature is -15 to -20°C, and it is comminuted for 5 minutes, 10 minutes, and 15 minutes respectively, the borneol yields are 98%, 99%, and 99% in sequence, indicating that the borneol yield is the best under this condition; therefore, it is okay to choose to store at -20°C for 10 hours, with a comminution temperature of -15 to -20°C and a comminution time of 5 - 15 minutes.

[0215] 6.2 Investigation on the Yield Experiment of Borneol Comminuted Together

[0216] 6.2.1 Preparation of Medicinal Powder

[0217] Prepare 3 batches of Xingnao Zaizao Capsule medicinal powder without borneol according to the prescription and preparation method of the quality standard of Xingnao Zaizao Capsules.

[0218] 6.2.2 Sample Preparation

[0219] Respectively take the powder of Xingnao Zaizao Capsules without borneol and an equal amount of borneol, mix and pulverize them using the pulverizer used in production, and collect the powder after mixing and pulverizing. Calculate the yield.

[0220] 6.2.3 Experimental Results

[0221] The experimental results are shown in Table 14.

[0222] Table 14 Experimental Results of Mixing and Pulverizing Borneol

[0223]

[0224]

[0225] The average yield of mixing and pulverizing the above three batches of samples is 98.29%, and the losses of mixing and pulverizing are 0.16 kg, 0.13 kg, and 0.12 kg respectively.

[0226] Take 16 kg of the mixed powder of borneol and powder of Xingnao Zaizao Capsules for pulverizing, with a loss of 0.14 kg and a mixing and pulverizing yield of 99.12%. Then simulate the pulverizing amount of 32.4 kg when mixing and pulverizing borneol in production, take 32.4 kg of the mixed powder with a ratio of 1:1 of the powder of Xingnao Zaizao Capsules to borneol for pulverizing, with a loss of 0.15 kg and a mixing and pulverizing yield of 99.54%. It can be seen from the experiment that regardless of the amount of materials, the loss is basically within a certain range. When using this production equipment to pulverize materials, the loss range is 0.12 kg - 0.16 kg, indicating that the greater the pulverizing weight, the higher the mixing and pulverizing yield.

[0227] 6.3 Analysis

[0228] For producing a batch of Xingnao Zaizao Capsules, the feeding amount of borneol is 16.2 kg, and the production capacity of the low-temperature freezing pulverizing equipment is 3 kg / time. When using this equipment to pulverize borneol alone, calculated based on the maximum production capacity, for each production batch of Xingnao Zaizao Capsules products, borneol needs to be pulverized separately 6 times to meet the production demand. From the above low-temperature pulverizing experiment of borneol, the yield of a single pulverizing is 99%. After 6 times of pulverizing, the yield will decrease by 6 percentage points. While the mixing and pulverizing is completed in one time with a yield of 99.54%. If calculating the loss, half of it is the loss of the powder without borneol. Therefore, when mixing and pulverizing, the loss amount of borneol is less. So, mixing and pulverizing borneol and powder has unique advantages.

[0229] 7. Experimental Study on the Particle Size Distribution of the Powder of Xingnao Zaizao Capsules Prepared by Different Pulverizing Methods of Borneol

[0230] 7.1 Samples of Mixing and Pulverizing

[0231] Take three batches of finished Xingnao Zaizao Capsules produced by the method of mixing and pulverizing borneol, with batch numbers: 20230406 (Sample 1), 20230407 (Sample 2), 20230408 (Sample 3). Take about 50 g of each of their Chinese medicine powders as samples for the mixing and pulverizing experiment.

[0232] 7.2 Separately pulverized samples

[0233] Take three batches of Chinese medicine powders of Xingnao Zaizao Capsules produced by the method of separately pulverizing borneol, with batch numbers: 20231201 (Sample 4), 20231202 (Sample 5), 20231203 (Sample 6), each about 50 g, as samples for the separate pulverizing experiment.

[0234] 7.3 Sample testing

[0235] Send Samples 1 - 6 to a third - party testing agency with complete qualifications to test the particle size distribution of each sample.

[0236] 7.4 Experimental results

[0237] According to the third method (dry method) of the determination method for particle size and particle size distribution in the fourth part of the Chinese Pharmacopoeia 2020 edition, General Rule 0982, conduct particle size distribution detection on three batches of products with borneol mixed and pulverized (20230406, 20230407, 20230408) and three batches of products with borneol separately pulverized (20231201, 20231202, 20231203). The particle size distribution detection range is D10, D50, D90, and the detection results are shown in Table 15. The test report is shown in Figures 14 to 19 。

[0238] Table 15 Detection results of particle size distribution of Samples 1 - 6

[0239]

[0240]

[0241] Result comparison: The mean deviation RSD of D10 between mixed and separate pulverization is 0.45%, the mean deviation RSD of D50 between mixed and separate pulverization is 1.1%, and the mean deviation RSD of D90 between mixed and separate pulverization is 1.3%. The relative standard deviation RSD of the three distribution ranges is less than 2%. The result data shows that there is no significant difference in the particle size distribution between borneol mixed pulverization and separate pulverization.

[0242] The embodiments described in the present invention are only descriptions of the preferred embodiments of the present invention, and do not limit the concept and scope of the present invention. Without departing from the design concept of the present invention, various variations and improvements made by those skilled in the art to the technical solutions of the present invention should fall within the protection scope of the present invention.

Claims

1. A new preparation process for Xingnao Zaizao Capsules, characterized in that, It includes the following steps: Step 1, low-temperature refrigeration treatment of borneol: Take borneol according to the prescription amount and store it at -15°C to -20°C for 10 - 15 hours; Step 2, mixing and pulverizing: Take the powder of Xingnao Zaizao Capsule according to the prescription amount, mix the borneol processed in the above step with the powder of Xingnao Zaizao Capsule according to a certain mass ratio, and pulverize at -15°C to -20°C for 5 - 15 minutes to obtain a mixed powder; Step 3, preparation of the preparation into a form: Mix the mixed powder evenly with the remaining powder of Xingnao Zaizao Capsule and the pearl powder according to the prescription amount, and fill into capsules to obtain the product.

2. The new preparation process of the Xingnao Zaizao Capsule drug according to claim 1, characterized in that, The low-temperature refrigeration treatment of the borneol is: store it at -20°C for 10 hours.

3. The new preparation process of the Xingnao Zaizao Capsule drug according to claim 1, characterized in that, The mass ratio is: borneol: powder of Xingnao Zaizao Capsule = 1: 0.8 - 1.

5.

4. The new preparation process of the Xingnao Zaizao Capsule drug according to claim 3, characterized in that, The mass ratio is: borneol: powder of Xingnao Zaizao Capsule = 1:

1.

5. The new preparation process of the Xingnao Zaizao Capsule drug according to claim 1, characterized in that, The pulverizing time is: 15 minutes.

6. The new preparation process of the Xingnao Zaizao Capsule drug according to any one of claims 1-4, characterized in that, The preparation of the powder of Xingnao Zaizao Capsule is: Mix the red ginseng powder, coptis powder, and agarwood powder according to the prescription amount to obtain a first mixed powder; Mix the notoginseng powder, asarum powder, scorpion powder, stir-fried bombyx batryticatus powder, gleditsia sinensis powder, and gastrodia elata powder according to the prescription amount to obtain a second mixed powder; Mix the first mixed powder, the second mixed powder with the Chinese medicinal extract of Xingnao Zaizao Capsule, granulate and dry, and pulverize to obtain the powder of Xingnao Zaizao Capsule.

7. The new preparation process of the Xingnao Zaizao Capsule drug according to claim 6, characterized in that, The mixing, granulating and drying are specifically: Set the material temperature of the dryer to 100°C and the fan frequency to 30 - 50 Hz. After the material temperature reaches 45 - 55°C, pump the first mixed powder and the second mixed powder into the dryer for fluidized bed drying; After the material temperature reaches 70 - 80°C, spray the extract. When the particles are dispersed and non-sticky, stop drying; After the material cools to a temperature lower than 45 - 55°C, discharge the material.

8. The new preparation process of the Xingnao Zaizao Capsule drug according to claim 7, characterized in that, The mixing, granulating and drying are specifically: Set the material temperature of the dryer to 100°C and the fan frequency to 40 - 50 Hz. After the material temperature reaches 50°C, pump the first mixed powder and the second mixed powder into the dryer for fluidized bed drying; After the material temperature reaches 80°C, spray the extract. When the particles are dispersed and non-sticky, stop drying; After the material cools to a temperature lower than 50°C, discharge the material.

9. The new preparation process of the Xingnao Zaizao Capsule drug according to claim 6, characterized in that, The pulverizing is: pulverize through a 50 - 80 mesh sieve.

10. The new preparation process of the Xingnao Zaizao Capsule drug according to claim 9, characterized in that, The pulverizing is: pulverize through a 60 mesh sieve.

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