Preparation method of capsule for dispelling wind and eliminating dampness

Abstract

The invention relates to the technical field of preparation of wind-dispelling and dampness-eliminating capsules, and discloses a preparation method of a wind-dispelling and dampness-eliminating capsule, which comprises the following steps: step 1, carrying out moist heat sterilization treatment on medicinal raw materials; step 2, drying the sterilized medicinal materials for 4-6 hours by adopting a temperature control box type dryer; step 3, grinding the dried medicinal materials into 80-mesh fine powder through an ultrafine grinder; step 4, sieving the crushed fine powder to obtain powder with uniform particle size; and step 5, uniformly mixing the powder, and filling into empty capsules to prepare 1000 finished products. Through reasonable matching of various traditional Chinese medicinal materials, the synergistic effect of all the medicines is fully exerted, and the traditional Chinese medicine composition has the remarkable effects of dispelling wind and eliminating dampness, warming and activating meridians and tonifying the liver and kidney and has important clinical application value and social benefits. By adopting the technologies of moist heat sterilization, superfine grinding and temperature-controlled drying, the quality stability and the drug effect release performance of the preparation are improved.

Description

Technical Field

[0001] The invention relates to the technical field of preparation of wind-dispelling and dampness-removing capsules, in particular to a preparation method of wind-dispelling and dampness-removing capsules. Background Art

[0002] Dispelling wind and dampness is a treatment method in Traditional Chinese Medicine (TCM) primarily used to treat illnesses caused by the invasion of wind or dampness. In TCM theory, wind and dampness are considered external pathogens that can disrupt the smooth flow of Qi and blood, leading to a variety of illnesses. The key to dispelling wind and dampness is to dispel these pathogens through medication or other means, restoring the balance of yin and yang.

[0003] With the advancement of science and technology and the promotion of the modernization of traditional Chinese medicine, in order to achieve greater breakthroughs in the preparation process, quality control and clinical efficacy of traditional Chinese medicine preparations for dispelling wind and dampness, and provide more efficient and safe solutions for the treatment of rheumatic diseases, a preparation method of Qufengchushi capsules is proposed. Summary of the Invention

[0004] The object of the present invention is to provide a method for preparing a Qufengchushi capsule to solve the problems raised in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical solution: a method for preparing a Qufengchushi capsule, comprising the following steps:

[0006] Step 1: sterilize the medicinal materials with moist heat;

[0007] Step 2: After sterilization, the medicinal materials are dried in a temperature-controlled box dryer for 4-6 hours;

[0008] Step 3: The dried medicinal materials are crushed into 80 mesh fine powder by ultrafine grinding machine;

[0009] Step 4: Sieve the crushed fine powder to select powder with uniform particle size;

[0010] Step 5: After the powder is evenly mixed, it is filled into hollow capsules to make 1,000 finished capsules.

[0011] Preferably, in step 1, the composition ratio by mass of the medicinal materials is as follows: 6-15g of processed Chuanwu; 10-15g of whole scorpion; 10-15g of clematis root; 10-15g of processed Strychnos nux vomica; 6-15g of Notopterygium wilfordii; 10-15g of myrrh; 15-20g of earthworm; 10-15g of Gentiana macrophylla; 10-15g of Corydalis yanhusuo; 10-15g of Saposhnikovia divaricata; 10-15g of Astragalus membranaceus; 6-15g of processed aconite root; 10-15g of Acanthopanax acanthopanax; 6-15g of Chuanxiong vine; 20-25g of white peony root; 6-15g of Linderae strychnos; 10-15g of processed rhubarb; 6-15g of Coptis chinensis; 6-15g of Bombyx batryticatus. 5g; processed ephedra 6-15g; liquorice 6-15g; processed aconite 6-15g; earthworm 10-15g; rat worm 10-15g; angelica dahurica 10-15g; frankincense 10-15g; safflower 6-15g; papaya 10-15g; redbud bark 10-15g; angelica dahurica 10-15g; ginseng 10-15g; eucommia ulmoides 6-15g; white cardamom 6-15g; mistletoe 10-15g; salvia miltiorrhiza 10-15g; angelica sinensis 10-15g; ligusticum chuanxiong 6-15g; scutellaria baicalensis 10-15g; white moss bark 10-15g; kudzu root 15-20g; cassia twig 6-15g.

[0012] Preferably, in step 1, the moist heat sterilization treatment uses a steam sterilizer with a sterilization pressure of 0.1 MPa-0.2 MPa.

[0013] Preferably, in step 1, the sterilization temperature is 100° C.-120° C. and maintained for 30 min-60 min.

[0014] Preferably, in step 1, the medicinal materials need to be cleaned and sliced ​​before the moist heat sterilization treatment, and the thickness of the slices is 2 mm to 4 mm.

[0015] Preferably, in step 2, the drying temperature is 50°C-70°C.

[0016] Preferably, in step 2, the air flow rate in the drying box is 1 m / s-2 m / s.

[0017] Preferably, in step 3, the operating frequency of the ultrafine grinder is 25kHz-35kHz.

[0018] Preferably, in step 5, the uniform mixing process uses a three-dimensional motion mixer, and the mixing time is 15 minutes to 25 minutes.

[0019] Compared with the prior art, the present invention employs the above technical solution and has the following technical effects: By rationally combining multiple Chinese medicinal materials, the present invention fully utilizes the synergistic effects of the various medicinal ingredients, exhibiting significant efficacy in dispelling wind and dampness, warming the meridians and unblocking the collaterals, and tonifying the liver and kidneys, thereby possessing important clinical application value and social benefits. By employing moist heat sterilization, ultrafine grinding, and temperature-controlled drying techniques, the quality stability and drug release performance of the preparation are improved, and by setting process parameters, process repeatability and product quality consistency are ensured. 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0021] Figure 1 Schematic diagram of the preparation method of the present invention. DETAILED DESCRIPTION

[0022] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0023] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions under which this application can be implemented. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical content disclosed in this application without affecting the efficacy and purpose that can be achieved by this application.

[0024] Example

[0025] See also Figure 1 The present invention provides a technical solution: a method for preparing a Qufengchushi capsule, comprising the following steps:

[0026] Step 1: The medicinal materials are sterilized with wet heat. The wet heat sterilization process uses a steam autoclave to effectively kill microorganisms in the medicinal materials and ensure the safety of the preparation. The sterilization pressure is 0.2 MPa and the sterilization temperature is 120°C for 30 minutes. The medicinal materials need to be cleaned and sliced ​​before wet heat sterilization. The thickness of the slices is 2mm-4mm, which can ensure the uniformity of subsequent sterilization and extraction.

[0027] Step 2: After sterilization, the medicinal materials are dried in a temperature-controlled box dryer with a drying time of 6 hours, a drying temperature of 50°C, and an air flow rate of 1m / s-2m / s in the drying box. The moisture content of the medicinal materials after drying shall not exceed 3% to ensure smooth subsequent crushing and mixing.

[0028] Step 3: The dried medicinal materials are crushed into 80-mesh fine powder by an ultrafine grinder, and the operating frequency of the ultrafine grinder is 25kHz-35kHz; the dissolution rate and bioavailability of the drug can be significantly improved by the micro-crushing technology;

[0029] Step 4: Sieve the crushed fine powder to obtain powder with uniform particle size; sieve through an 80-mesh sieve to remove impurities and incompletely crushed particles;

[0030] Step 5: After the powder is mixed evenly, it is filled into hollow capsules. The evenly mixed powder is filled into hollow capsules through a capsule filling machine to make 1,000 finished products. The mixing process uses a three-dimensional motion mixer with a mixing time of 25 minutes to ensure that the powder is evenly distributed.

[0031] By adopting the technologies of moist heat sterilization, ultrafine grinding and temperature-controlled drying, the quality stability and drug release performance of the preparation are improved, and by setting the process parameters, the repeatability of the process and the consistency of product quality are ensured.

[0032] In step 1, the composition ratio by mass of the medicinal materials is as follows: 9g of processed Chuanwu; 15g of whole scorpion; 15g of clematis root; 15g of processed Strychnos nux vomica; 12g of Notopterygium wilfordii; 15g of myrrh; 20g of earthworm; 15g of Gentiana macrophylla; 15g of Corydalis yanhusuo; 15g of Saposhnikovia divaricata; 15g of Astragalus membranaceus; 10g of processed aconite root; 15g of Acanthopanax acanthopanax; 12g of Chuanxiong vine; 25g of white peony root; 10g of Linderae striata; 15g of processed rhubarb; 10g of Coptis chinensis; 10g of Bombyx batryticatus; 12g of processed ephedra; 10g of liquorice; 9g of processed Kusnezoffii; 15g of Eupolyphaga sinensis; 15g of Rhizoma Cyperi; 12g of processed ephedra; 10g of liquorice; 15g of processed Aconitum kusnezoffii; 15g of Eupolyphaga sinensis; 15g of Rhizoma Cyperi; 15g of Rhizoma Cyperi; 15g of Radix Aconiti Lateralis Preparata; 15g of Eupolyphaga sinensis; 15g of Rhizoma Cyperi; 15g of Radix Aconiti Lateralis Preparata; 15g of Radix Aconiti Lateralis Preparata. 5g; Angelica dahurica 15g; Frankincense 15g; Carthamus tinctorius 9g; Papaya 15g; Bauhinia bark 15g; Angelica dahurica 15g; Ginseng 15g; Eucommia ulmoides 10g; White cardamom 10g; Viscum album 15g; Salvia miltiorrhiza 15g; Angelica sinensis 15g; Chuanxiong 13g; Scutellaria baicalensis 15g; Dictamni bark 15g; Pueraria lobata 20g; Cinnamon twig 12g; Through the rational combination of multiple Chinese medicinal materials, the synergistic effect of each medicine is fully exerted, and it has significant effects of dispelling wind and dampness, warming the meridians and unblocking the collaterals, and nourishing the liver and kidneys. It has important clinical application value and social benefits.

[0033] The ginseng in the prescription is described in the Dongyi Baojian as being slightly bitter and slightly warm, and entering the spleen, lung, and liver meridians. It greatly replenishes vital energy, tonifies the spleen and lungs, and is good at replenishing the liver and kidney qi, making it an essential medicine for the four-element body constitution. The Xiangyao Jicheng Fang describes astragalus as being sweet, warm, and entering the spleen and lung meridians. It replenishes qi and raises yang, strengthens qi, consolidates the exterior, promotes diuresis, and reduces swelling, and should be the main ingredient. White cardamom, acanthopanax bark, and mistletoe dispel rheumatism and promote diuresis, benefit the liver and kidneys, strengthen the tendons and bones, and assist the main ingredient in replenishing qi and raising yang, removing dampness and promoting diuresis, and reducing swelling. Chuanxiong is used because the patient has been ill for a long time and has a weak constitution and blood deficiency. It promotes qi and warms the blood vessels, activates blood circulation and eliminates phlegm, and relieves pain. Combined with white peony root, salvia miltiorrhiza, and angelica, it replenishes qi and nourishes blood, activates blood circulation, removes blood stasis, and dredges the meridians, assisting the main ingredient in activating blood circulation, removing phlegm and blood stasis, warming the meridians and dredges the meridians, and replenishing qi and nourishing blood. For patients with Shaoyang and Shaoyin meridians who suffer from chronic kidney deficiency, processed aconite root is used. According to the "Medical Prescription Collection," processed aconite root replenishes fire and yang, dispels cold and relieves pain, and is commonly used for arthralgia caused by cold and dampness. Combined with Eucommia bark, it nourishes the liver and kidneys and strengthens tendons and bones. Over time, phlegm and blood stasis in the spine can block the meridians, leading to arthralgia. Therefore, frankincense, myrrh, processed Chuanwu (Aconite), processed Caowu (Aconite), processed Strychnos nux vomica, rat worm, and scorpion are used to dispel wind and dampness, warm the meridians, dispel cold and relieve pain, and dissipate phlegm, swelling, and pain. Chuanniu Teng (Chuan Niu Teng), Baizhi (Angelica dahurica), earthworm, and Corydalis yanhusuo (Rhizoma Corydalis) promote blood circulation, dissipate phlegm, and relieve swelling and pain. Because chronic illness damages the spleen and stomach, causing dysfunctional transport and transformation, dampness accumulates and generates phlegm that blocks the meridians. Therefore, a combination of Clematidis, Duhuo (Pupil) Angelica dahurica, Notopterygium wilfordii, and Morus alba is used to dispel wind and dampness, dredge the meridians, relax tendons and bones, and relieve pain. Because the disease has lasted for a long time and phlegm and dampness have accumulated to form stubborn phlegm and blood stasis, we use processed rhubarb, white moss bark, white silkworm, and redbud bark to clear away heat and detoxify, dry dampness, promote diuresis and dampness, eliminate rheumatism, reduce swelling and relieve pain. Licorice harmonizes the effects of the various medicines to strengthen the spleen and replenish qi.

[0034] The identification method of Qufengchushi capsule is as follows:

[0035] 1. Take 10g of the contents of this product, add 50ml of methanol, ultrasonically treat for 30min, filter, evaporate the filtrate to dryness, and dissolve the residue in 2ml of methanol to use as the test solution. Take 1g of the control medicinal material of Eupolyphaga sinensis, add 10ml of methanol, and prepare the control medicinal material solution in the same way. According to the thin layer chromatography method (0502 of the fourth general rule of the 2020 edition of the Chinese Pharmacopoeia), 10μl of the test solution and 5μl of the control medicinal material solution were taken and spotted on the same silica gel G thin layer plate, respectively, with toluene-dichloromethane-acetone (5:5:0.5) as the developing agent, develop, take out, dry, and inspect under ultraviolet light (365nm). In the test chromatogram, fluorescent spots of the same color appear at the corresponding position of the control medicinal material chromatogram.

[0036] 2. Take 10g of this product, add 50ml of methanol, sonicate for 30min, filter, evaporate the filtrate to dryness, and add 2ml of methanol to the residue as the test solution. Separately, take 0.1g of frankincense and 0.5g of myrrh control medicinal materials, add 2ml of methanol, and prepare frankincense and myrrh control medicinal material solutions in the same manner. According to the thin layer chromatography method (General Rules 0502 of Part IV of the 2020 edition of the Chinese Pharmacopoeia), take 10μl of the test solution and 5μl of the control medicinal material solution, and spot them on the same silica gel G thin layer plate. Use petroleum ether (60-90°C)-ethyl acetate (95:5) as the developing solvent. Develop, remove, dry, spray with 5% vanillin sulfuric acid solution, and heat at 105°C until the spots are clearly colored. In the chromatogram of the test sample, spots of the same color appear at the corresponding positions in the chromatogram of the control medicinal material.

[0037] 3. Take 10g of the contents of this product, add 50ml of chloroform, ultrasonicate for 30min, filter, evaporate the filtrate to dryness, and dissolve the residue in 2ml of chloroform to prepare the test solution. Separately, take 1g of the control medicinal material of earthworm, add 20ml of chloroform to ultrasonicate, filter, evaporate the filtrate to dryness, and dissolve the residue in 1ml of chloroform to prepare the control medicinal material solution. According to the thin layer chromatography method (0502 of the fourth general rule of the 2020 edition of the Chinese Pharmacopoeia), 10μl of the test solution and 5μl of the control medicinal material solution were taken and spotted on the same silica gel G thin layer plate, using toluene-acetone (9:1) as the developing solvent, developing, removing, drying, and examining under ultraviolet light (365nm). In the chromatogram of the test sample, fluorescent spots of the same color appeared at the corresponding positions of the chromatogram of the control medicinal material.

[0038] 4. Take 15g of this product, add 50ml of 70% ethanol, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 20ml of water, adjust the pH to 11 with concentrated ammonia test solution, extract twice with ethyl acetate, shake, and combine the ethyl acetate extracts, evaporate to dryness, and dissolve the residue in 0.5ml of ethyl acetate to prepare the test solution. Separately, take a tetrahydropalmatine reference standard and add methanol to prepare a solution containing 0.1mg per 1ml. This will serve as the reference solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2020 Edition, Part IV, General Rules 0502), spot 10μl of the test solution and 5μl of the reference solution onto the same silica gel G thin layer plate prepared with 1% sodium hydroxide solution. Develop with toluene-acetone (9:2), remove, and air dry. Place in an iodine flask for 3 minutes, remove, and evaporate any iodine adsorbed on the plate. Inspect under ultraviolet light (365nm). In the test sample chromatogram, fluorescent spots of the same color appear at the corresponding positions in the reference sample chromatogram.

[0039] 5. Take 10g of the contents of this product, add 50ml of ether, soak for 1h, shake from time to time, filter, evaporate the filtrate, and dissolve the residue in 1ml of ethyl acetate to use as the test solution. Take the imperatorin reference substance and add ethyl acetate to make a solution containing 1mg per 1ml as the reference solution. According to the thin layer chromatography method (0502 of the fourth general rule of the 2020 edition of the Chinese Pharmacopoeia), 10μl of the test solution and 2μl of the reference solution were taken and spotted on the same silica gel G thin layer plate, respectively, with petroleum ether (30-60℃)-ether (3:2) as the developing agent, take out, dry, and examine under ultraviolet light (365nm). In the test chromatogram, fluorescent spots of the same color appear at the corresponding positions of the reference chromatogram.

[0040] 6. Take 16g of the contents of this product, add 100ml of ether, reflux for 1h, cool, evaporate the ether from the residue, then reflux with 50ml of methanol for 1h, cool, filter, evaporate the filtrate to dryness, dissolve the residue in 30ml of water, extract with water-saturated n-butanol by shaking three times, 20ml each time, combine the n-butanol extracts, wash with ammonia test solution three times, 30ml each time, discard the washings, evaporate the n-butanol solution to dryness, dissolve the residue in 10ml of 40% methanol, apply it to a neutral alumina column (80 mesh, 5g, inner diameter 1.5cm), elute with 150ml of 40% methanol, collect the eluate, evaporate to dryness, dissolve the residue in 1ml of methanol, and use this as the test solution. Separately, take the astragaloside IV reference standard and add methanol to make a solution containing 1mg per 1ml. This is used as the reference solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2020 edition, Part IV, General Chapter 0502), 10 μl of the test solution and 2 μl of the reference solution were spotted on the same silica gel G thin layer plate. The plate was developed with a lower layer of chloroform-methanol-water (13:7:2) as the developing solvent. The plate was removed, air-dried, sprayed with 10% ethanolic sulfuric acid solution, heated at 105°C for several minutes, and examined under ultraviolet light (365 nm). Fluorescent spots of the same color appeared in the chromatogram of the test sample at the corresponding position in the chromatogram of the reference sample.

[0041] 7. Take 12g of this product, add 50ml of methanol, sonicate for 30min, filter, and evaporate the filtrate to dryness. Dissolve the residue in 20ml of water and extract twice with ether (20ml each time). Discard the ether solution. Extract the aqueous solution three times with 20ml of n-butanol saturated with water by shaking. Combine the n-butanol extracts and evaporate to dryness. Dissolve the residue in 1ml of methanol to prepare the test solution. Separately, take a paeoniflorin reference substance and add methanol to prepare a solution containing 1mg per 1ml. This is the reference solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2020 Edition, Part IV, General Rules 0502), 10μl of the test solution and 5μl of the reference solution were spotted on the same silica gel G thin layer plate. Develop with chloroform-ethyl acetate-methanol-formic acid (40:5:10:0.2) as the developing solvent. Remove the plate, let it air dry, and spray with 5% vanillin in ethanolic sulfuric acid. Heat at 105°C until the spots are clearly colored. In the chromatogram of the test sample, spots of the same color appear at the corresponding positions in the chromatogram of the reference sample.

[0042] 8. Take 20g of the contents of this product, add 100ml of petroleum ether (60-90℃), ultrasonicate for 20min, filter, and concentrate the filtrate to 1ml to use as the test solution. Separately, take 1g of Angelica sinensis control medicinal material and 0.5g of Chuanxiong control medicinal material and add 10ml of petroleum ether (60-90℃) to prepare Angelica sinensis and Chuanxiong control medicinal material solutions, respectively. According to the thin layer chromatography method (General Rules 0502 of Part IV of the 2020 edition of the Chinese Pharmacopoeia), take 10μl of the test solution and 5μl of the control medicinal material solution, respectively, and spot them on the same silica gel G thin layer plate. Use n-hexane-ethyl acetate (7:1) as the developing solvent, develop, remove, dry, and examine under ultraviolet light (365nm). In the chromatogram of the test sample, at the corresponding position in the chromatogram of the control medicinal material, a fluorescent spot of the same color appears.

[0043] 9. Take 10g of the contents of this product, add 50ml of methanol, sonicate for 15min, filter, evaporate the filtrate to dryness, dissolve the residue in 20ml of water, add 1ml of hydrochloric acid, heat on a water bath for 30min, cool immediately, extract with ether twice, 20ml each time, combine the ether solutions, evaporate to dryness, and dissolve the residue in 0.5ml of chloroform to prepare the test solution. Separately, take the emodin reference substance and add chloroform to prepare a solution containing 1mg per 1ml as the reference solution. According to the thin layer chromatography method (0502 of the fourth part of the 2020 edition of the Chinese Pharmacopoeia), take 10μl of the test solution and 5μl of the reference solution and spot them on the same silica gel H thin layer plate. Use the upper layer solution of petroleum ether (60-90℃)-ethyl acetate-formic acid (15:5:1) as the developing solvent, develop, remove, dry, and examine under ultraviolet light (365nm). In the test sample chromatogram, fluorescent spots of the same color appear at the corresponding positions in the reference sample chromatogram.

[0044] 10. Take 10g of the contents of this product, add 50ml of ethanol, ultrasonically treat for 20min, filter, evaporate the filtrate to dryness, and add 0.5ml of methanol to the residue to dissolve it as the test solution. Take another baicalin reference substance and add methanol to make a solution containing 1mg per 1ml as the reference solution. According to the thin layer chromatography method (0502 of the fourth general rule of the 2020 edition of the Chinese Pharmacopoeia), 10μl of the test solution and 5μl of the reference solution were taken and spotted on the same silica gel G thin layer plate, respectively, with the upper layer solution of ethyl acetate-butanone-acetic acid-water (10:7:5:3) as the developing agent, develop, take out, and dry. Spray with 2% ferric chloride ethanol solution. In the test sample chromatogram, spots of the same color appear at the corresponding position of the reference chromatogram.

[0045] 11. Take 8g of the contents of this product, add 50ml of methanol, sonicate for 30min, filter, and pass the filtrate through a neutral alumina column (100-200 mesh, 3g, inner diameter 1cm). Collect the effluent and concentrate to 2ml to use as the test solution. Separately, take 0.5g of the reference medicinal material Coptis chinensis, add 10ml of methanol, sonicate for 30min, filter, and take the filtrate as the reference medicinal material solution. According to the thin layer chromatography method (0502 of the fourth general rule of the 2020 edition of the Chinese Pharmacopoeia), take 10μl of the test solution and 2μl of the reference solution and spot them on the same silica gel G thin layer plate. Use cyclohexane-ethyl acetate-isopropanol-methanol-water-triethylamine (3:3.5:1:1.5:0.5:1) as the developing solvent. Place it in a developing cylinder pre-saturated with ammonia vapor for 20min. Develop, remove, dry, and inspect under ultraviolet light (365nm). In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions in the chromatogram of the control medicinal material.

[0046] 12. Take 13g of the contents of this product, add 50ml of methanol, ultrasonically treat for 30min, filter, evaporate the filtrate to dryness, add 5ml of water to the residue to dissolve it, pass it through a polyamide column (60-90 mesh, 3g, inner diameter 1.5cm, pre-washed with water), elute with 80ml of dilute ethanol, collect the eluate, evaporate to dryness, and dissolve the residue in 2ml of methanol as the test solution. Take the puerarin reference substance and add methanol to make a solution containing 1mg per 1ml as the reference solution. According to the thin layer chromatography method (General Rules 0502 of Part Four of the 2020 Edition of the Chinese Pharmacopoeia), 10μl of the test solution and 2μl of the reference solution were taken and spotted on the same silica gel G thin layer plate, using dichloromethane-methanol-water (7:2.5:0.25) as the developing agent, develop, take out, dry, and inspect under ultraviolet light (365nm). In the test sample chromatogram, fluorescent spots of the same color appear at the corresponding positions in the reference sample chromatogram.

[0047] Inspection: Diester alkaloids Take 60g of the contents of this product, add 30ml of ammonia test solution, mix well, let it stand for 2h, add 150ml of ether, shake for 1h, let it stand for 24h, filter, evaporate the filtrate, and dissolve the residue in anhydrous ethanol to make 0.5ml as the test solution. Separately take aconitine reference substance, mesaconitine reference substance, and neoaconitine reference substance, add anhydrous ethanol to make a solution containing 1.0mg per 1ml as the reference solution. According to the thin layer chromatography method (General Rules 0502 of Part Four of the 2020 Edition of the Chinese Pharmacopoeia), 10μl of the test solution and 5μl of the reference solution were taken and spotted on the same silica gel G thin layer plate, using dichloromethane (dehydrated with anhydrous sodium sulfate)-acetone-methanol (6:1:1.5) as the developing solvent, develop, take out, dry, and spray with dilute potassium bismuth iodide test solution. In the chromatogram of the test sample, the spot that appears at the corresponding position in the chromatogram of the reference sample should be smaller than the spot of the reference sample, or no spot should appear. Other requirements should comply with the relevant provisions under capsules (General Rules 0103 of Part IV of the 2020 edition of the Chinese Pharmacopoeia).

[0048] Those skilled in the art will appreciate that various combinations and / or combinations of features described in the various embodiments and / or claims of the present invention may be made, even if such combinations and / or combinations are not explicitly described in the present invention. In particular, various combinations and / or combinations of features described in the various embodiments and / or claims of the present invention may be made, without departing from the spirit and teachings of the present invention. All such combinations and / or combinations fall within the scope of the present invention.

Claims

1. A method for preparing a Qufengchushi capsule, characterized in that: The following steps are involved: Step 1, subjecting the medicinal material raw materials to wet heat sterilization treatment; Step 2: Dry the sterilized medicinal materials in a temperature-controlled box dryer for 4 to 6 hours; Step 3, the dried medicinal materials are crushed into 80 mesh fine powder by an ultrafine grinder; Step 4: Sieve the crushed fine powder to select powder with uniform particle size; Step 5: After the powder is mixed evenly, it is filled into hollow capsules to make 1000 finished capsules.

2. The method for preparing the Qufengchushi capsule according to claim 1, characterized in that: In step 1, the composition weight ratio of the medicinal materials is: 6-15g of processed Chuanwu; 10-15g of whole scorpion; 10-15g of clematis; 10-15g of processed Strychnos nux vomica; 6-15g of Notopterygium wilfordii; 10-15g of myrrh; 15-20g of earthworm; Gentiana macrophylla 10-15g; Corydalis 10-15g; Saposhnikovia divaricata 10-15g; Astragalus membranaceus 10-15g; Processed Aconite 6-15g; Acanthopanax cortex 10-15g; Chuanxiong vine 6-15g; White peony root 20-25g; Linderae 6-15g; Processed Rhubarb 10-15g; Coptis chinensis 6-15g; Bombyx batryticatus 6-15g; Processed Ephedra 6-15g; Licorice root 6-15g; Processed Aconitum kusnezoffii 6-15g; Eupolyphaga sinensis 10-15g; Rattus glomerulosa 1 0-15g; Angelica dahurica 10-15g; Frankincense 10-15g; Safflower 6-15g; Papaya 10-15g; Bauhinia bark 10-15g; Angelica dahurica 10-15g; Ginseng 10-15g; Eucommia ulmoides 6-15g; White cardamom 6-15g; Viscum album 10-15g; Salvia miltiorrhiza 10-15g; Angelica sinensis 10-15g; Chuanxiong 6-15g; Scutellaria baicalensis 10-15g; White moss bark 10-15g; Pueraria root 15-20g; 6-15g cinnamon twig.

3. The method for preparing the Qufengchushi capsule according to claim 1, characterized in that: In step 1, the moist heat sterilization treatment uses a steam sterilizer with a sterilization pressure of 0.1MPa-0.2MPa.

4. The method for preparing the Qufengchushi capsule according to claim 1, characterized in that: In step 1, the sterilization temperature is 100°C-120°C and maintained for 30min-60min.

5. The method for preparing the Qufengchushi capsule according to claim 1, characterized in that: In step 1, the medicinal materials need to be cleaned and sliced ​​before the wet heat sterilization treatment, and the thickness of the slices is 2mm-4mm.

6. The method for preparing the Qufengchushi capsule according to claim 1, characterized in that: In step 2, the drying temperature is 50°C-70°C.

7. The method for preparing the Qufengchushi capsule according to claim 1, characterized in that: In step 2, the air flow rate in the drying oven is 1m / s-2m / s.

8. The method for preparing the Qufengchushi capsule according to claim 1, characterized in that: In step 3, the operating frequency of the ultrafine pulverizer is 25kHz-35kHz.

9. The method for preparing the Qufengchushi capsule according to claim 1, characterized in that: In step 5, the uniform mixing process uses a three-dimensional motion mixer, and the mixing time is 15 minutes to 25 minutes.

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