Application and preparation method of traditional Chinese medicine composition for treating stroke caused by phlegm-damp stasis

Abstract

The invention provides a traditional Chinese medicine composition which is named as a summer hemp turbidity-dissolving granule. Comprising the following components in parts by mass: 7-11 parts of rhizoma pinelliae preparata, 13-17 parts of rhizoma gastrodiae, 13-17 parts of radix salviae miltiorrhizae, 8-12 parts of rhizoma atractylodis macrocephalae fried with bran, 28-32 parts of trichosanthes kirilowii maxim, 8-12 parts of arisaema cum bile, 8-12 parts of bamboo shavings, 8-12 parts of radix scrophulariae, 8-12 parts of rhizoma coptidis slices, 8-12 parts of radix paeoniae rubra, 8-12 parts of cooked rhubarb, 8-12 parts of scorched hawthorn fruit, 8-12 parts of scorched medicated leaven, 8-12 parts of scorched malt, 8-12 parts of fructus aurantii fried with bran, 8-12 parts of ginger processed cortex magnoliae officinalis and 8-12 parts of liquorice slices. According to the treatment principle of promoting blood circulation to remove meridian obstruction, removing phlegm and dissolving turbidity, medicines are carefully selected, and the compatibility is precise and appropriate. The traditional Chinese medicine prescription is remarkable in curative effect on phlegm-dampness stasis type stroke, small in side effect, high in safety and reliability and suitable for application and popularization.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to the application and preparation method of a traditional Chinese medicine composition for stroke with phlegm-dampness stagnation. Background Technology

[0002] Stroke is a common and frequently occurring clinical disease, characterized by high incidence, high disability rate, and high recurrence rate. Especially in recent years, due to factors such as the accelerated pace of life, increased work pressure, and changes in lifestyle habits, the incidence of stroke has been on the rise, and there is a trend towards younger patients. Currently, the habit of high-salt diets is contributing to the increasing incidence of stroke year by year.

[0003] The pathogenesis of stroke is complex. Medical experts generally believe that blood stasis affects the movement of qi, causing dysfunction in the ascending and descending functions of qi, and affecting the normal distribution of body fluids. The resulting loss of body fluid distribution and stagnation of body fluids leads to the formation of phlegm and fluid retention, hence the saying "phlegm due to blood stasis." The mutual binding of phlegm and blood stasis can also generate wind, and internal wind often combines with blood stasis and phlegm, ultimately leading to the syndrome of wind-phlegm-blood stasis obstruction. Both phlegm and blood stasis are pathogenic factors resulting from abnormal metabolism in the human body, belonging to the same yin evil, and jointly causing disease. In short, phlegm-dampness stagnation is the fundamental pathogenesis of this disease. Currently, traditional Chinese medicine research on stroke treatment mainly focuses on promoting blood circulation and removing blood stasis, but there are no products that simultaneously treat dampness and turbidity. Although some clinical efficacy has been achieved, the treatment effect is not ideal, and the applicable population is relatively narrow. Developing a traditional Chinese medicine preparation that primarily promotes blood circulation, removes blood stasis, and eliminates dampness and turbidity to treat common types of stroke is urgently needed. Summary of the Invention

[0004] The purpose of this invention is to overcome the technical deficiency in the existing technology that "there are no products that promote blood circulation and remove blood stasis while also treating dampness and turbidity", and to provide a traditional Chinese medicine that promotes blood circulation, removes blood stasis, removes dampness and turbidity as the main treatment for common types of stroke.

[0005] This invention provides a traditional Chinese medicine composition called Xiama Huazhuo Granules. Xiama Huazhuo Granules are based on a base formula with blood-activating and stasis-removing effects, combined with the main formula "Banxia Baizhu Tianma Tang" which has the effect of "clearing phlegm and removing turbidity," and finally prepared into granules to form "Xiama Huazhuo Granules." This formula treats blood stasis and phlegm turbidity as the basic pathogenic factors, addressing both simultaneously. It has the characteristics of definite efficacy, convenient portability, and good taste. Through long-term clinical efficacy observation, the clinical efficacy has been summarized to show that Xiama Huazhuo Granules have a good therapeutic effect on stroke of the phlegm-dampness stagnation type. Currently, "Xiama Huazhuo Granules" are not yet used in the market for the treatment of stroke.

[0006] To achieve the above objectives, the present invention provides a traditional Chinese medicine composition, called Xiama Huazhuo Granules, comprising the following ingredients in the indicated mass ratios: 7-11 parts of Pinellia ternata, 13-17 parts of Gastrodia elata, 13-17 parts of Salvia miltiorrhiza, 8-12 parts of stir-fried Atractylodes macrocephala, 28-32 parts of Trichosanthes kirilowii, 8-12 parts of Arisaema cum Bile, 8-12 parts of Bambusa textilis, 8-12 parts of Scrophularia ningpoensis, 8-12 parts of Coptis chinensis, 8-12 parts of Paeonia lactiflora, 8-12 parts of processed rhubarb, 8-12 parts of charred hawthorn, 8-12 parts of charred Shenqu (medicated leaven), 8-12 parts of charred malt, 8-12 parts of stir-fried Citrus aurantium, 8-12 parts of Magnolia officinalis, and 8-12 parts of Glycyrrhiza uralensis.

[0007] Preferably, the traditional Chinese medicine composition comprises the following ingredients in the indicated mass ratios: 9 parts Pinellia ternata, 15 parts Gastrodia elata, 15 parts Salvia miltiorrhiza, 10 parts stir-fried Atractylodes macrocephala, 30 parts Trichosanthes kirilowii, 10 parts Arisaema cum Bile, 10 parts Bambusa textilis, 10 parts Scrophularia ningpoensis, 10 parts Coptis chinensis, 10 parts Paeonia lactiflora, 10 parts processed Rheum palmatum, 10 parts charred Crataegus pinnatifida, 10 parts charred Shenqu (medicated leaven), 10 parts charred Hordeum vulgare, 10 parts stir-fried Citrus aurantium, 10 parts Magnolia officinalis, and 10 parts Glycyrrhiza uralensis.

[0008] Preferably, the traditional Chinese medicine composition described in any of the above-mentioned embodiments is decocted in water and taken orally.

[0009] Preferably, the traditional Chinese medicine composition described in any of the above embodiments is formed into granules. Preferably, the traditional Chinese medicine composition further includes dextrin.

[0010] In a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises: 9 parts of Pinellia ternata, 15 parts of Gastrodia elata, 15 parts of Salvia miltiorrhiza, 10 parts of Atractylodes macrocephala stir-fried with wheat bran, 30 parts of Trichosanthes kirilowii, 10 parts of Arisaema cum Bile, 10 parts of Bambusa textilis, 10 parts of Scrophularia ningpoensis, 10 parts of Coptis chinensis, 10 parts of Paeonia lactiflora, 10 parts of Rheum palmatum, 10 parts of Crataegus pinnatifida, 10 parts of Massa fermentata, 10 parts of Hordeum vulgare, 10 parts of Citrus aurantium stir-fried with wheat bran, 10 parts of Magnolia officinalis, and 10 parts of Glycyrrhiza uralensis. Preferably, the above-mentioned traditional Chinese medicine composition is decocted in water and taken orally, with the dosage being a one-day dose.

[0011] The present invention also provides a method for preparing granules of the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0012] Step 1: Extraction: Take the prescribed amount of Pinellia ternata, Gastrodia elata, Salvia miltiorrhiza, stir-fried Atractylodes macrocephala, Trichosanthes kirilowii, Arisaema cum bile, Bambusa textilis, Scrophularia ningpoensis, Coptis chinensis, Paeonia lactiflora, prepared rhubarb, charred hawthorn, charred Shenqu, charred malt, stir-fried Citrus aurantium, Magnolia officinalis, and Glycyrrhiza uralensis, add water and decoct, filter to obtain the extract;

[0013] Step 2: Concentrate the filtered extract under reduced pressure to obtain an extract with a relative density of 1.28 to 1.32, wherein the relative density is the relative density at 65°C;

[0014] Step 3: Dry, pulverize, and sieve the extract obtained in Step 2 to obtain dry extract powder;

[0015] Step 4: Mix the dry extract powder obtained in Step 3 with dextrin;

[0016] Step 5: Obtain granules, preferably by dry method.

[0017] In any of the above preferred embodiments, the specific steps of adding water for decoction in step 1 are as follows: take the prescribed amount of medicinal materials, add 10 times the mass of water to the medicinal materials, heat until the water boils and record the time for 1 hour, and obtain the filtrate; repeat the water decoction step three times, each time for 1 hour, combine the filtrates, and filter through 100 mesh to obtain the extract.

[0018] In any of the above-mentioned preferred embodiments, in step 2, the filtered extract is concentrated under reduced pressure at a temperature below 70°C to an extract with a relative density of 1.28-1.32, wherein the relative density is the relative density at 65°C.

[0019] In any of the above preferred embodiments, in step 3, the extract obtained in step 2 is vacuum dried at 65°C, pulverized under a vacuum of -0.08 MPa, and passed through an 80-mesh sieve to obtain dry extract powder.

[0020] In any of the above preferred embodiments, in step 4, the dry extract powder and dextrin in a mass ratio of 7:2 are added to a triple eccentric mixer, the speed is 20 rpm, and the mixture is mixed for 30 minutes.

[0021] In any of the above preferred embodiments, in step 5, a dry granulator is used, with the main pressure of the pressure roller set to 2~28 MPa, the extrusion speed to 2~7 rpm, the feeding speed to 2~14 rpm, and the cooling zone water temperature to 10°C, to dry granulate the premixed material.

[0022] In any of the above preferred embodiments, the preparation method further includes step 6, in which the particles obtained in step 5 are sized by passing them through 12-mesh and 60-mesh sieves, and the material on the sieves is collected as qualified particles, while the material under the sieves is recycled and pressed.

[0023] This invention also provides the traditional Chinese medicine composition described in any one of the above claims, and the preparation method described in any one of the above claims, for use in preparing a medicine for treating stroke that simultaneously possesses the functions of promoting blood circulation, removing blood stasis, and eliminating dampness and turbidity. In particular, it is used in preparing a medicine for treating stroke of the phlegm-dampness stagnation type.

[0024] The Xiama Huazhuo granules are brownish-yellow to brownish-brown granules; they have a slightly fragrant odor and a slightly bitter taste.

[0025] The main functions of Xiama Huazhuo Granules are to strengthen the spleen, resolve phlegm, invigorate blood circulation, and unblock the meridians. They are used in the clinical treatment of stroke with phlegm-dampness stagnation, characterized by hemiplegia, dysarthria, dizziness, sticky phlegm in the mouth, hoarse voice, abdominal distension, and constipation.

[0026] In a preferred embodiment of the present invention, granules are prepared according to the following mass ratio: 9 parts Pinellia ternata, 15 parts Gastrodia elata, 15 parts Salvia miltiorrhiza, 10 parts stir-fried Atractylodes macrocephala, 30 parts Trichosanthes kirilowii, 10 parts Arisaema cum Bile, 10 parts Bambusa textilis, 10 parts Scrophularia ningpoensis, 10 parts Coptis chinensis, 10 parts Paeonia lactiflora, 10 parts Rheum palmatum, 10 parts Crataegus pinnatifida, 10 parts Massa fermentata, 10 parts Hordeum vulgare, 10 parts stir-fried Citrus aurantium, 10 parts Magnolia officinalis, and 10 parts Glycyrrhiza uralensis. Granules are prepared according to the method for preparing granules of the aforementioned traditional Chinese medicine composition. During the preparation process, dextrin is added at a mass ratio of 7:2 (dry extract powder: dextrin). Preferably, the dosage and administration are as follows: the granules prepared above are packaged in 6g bags, one bag each time, three times a day, or taken under the guidance of a physician.

[0027] The specifications of Xiama Huazhuo Granules prepared according to the above method and prescription ratio are: 6g per bag. The medicinal slices are a traditional Chinese medicine composition composed of the following ingredients: 9g of Pinellia ternata, 15g of Gastrodia elata, 15g of Salvia miltiorrhiza, 10g of Atractylodes macrocephala stir-fried with wheat bran, 30g of Trichosanthes kirilowii, 10g of Arisaema cum bile, 10g of Bambusa textilis, 10g of Scrophularia ningpoensis, 10g of Coptis chinensis slices, 10g of Paeonia lactiflora, 10g of Rheum palmatum, 10g of Crataegus pinnatifida, 10g of Massa fermentata, 10g of Hordeum vulgare, 10g of Citrus aurantium stir-fried with wheat bran, 10g of Magnolia officinalis, and 10g of Glycyrrhiza uralensis slices.

[0028] The traditional Chinese medicine composition provided by this invention has the following functions and indications: strengthening the spleen and resolving phlegm, promoting blood circulation and unblocking collaterals. It is used in the clinical treatment of stroke with phlegm-dampness stagnation, characterized by hemiplegia, dysarthria, dizziness, sticky phlegm in the mouth, hoarse voice, abdominal distension, and constipation. The dosage and administration of the Xiama Huazhuo granules are as follows: oral administration, one sachet each time, three times a day, or under the guidance of a physician.

[0029] This invention studies the extraction process of Xiama Huazhuo granules. The extraction process, as a key step in the preparation of compound traditional Chinese medicine, directly affects the quality of the preparation. The optimized efficacy and safety of new compound drug preparations require compliance with industrial production standards and the achievement of quality stability and uniformity. The research on the process route of new compound drugs determines the material basis for their therapeutic effects. An inappropriate process route design can directly lead to insufficient safety and efficacy of the drug; in severe cases, it may even render an already verified prescription ineffective. Therefore, the scientific rationality of the process route is the foundation and core of process research and is extremely important.

[0030] The content determination indicators for traditional Chinese medicine preparations are usually specific and active ingredients, often selecting the effective and specific components of the principal or chief herb. The active ingredient in Gastrodia elata is generally considered to be gastrodin, which is frequently used as a key indicator for quality control of the raw materials or preparations. Gastrodin is an excellent calcium channel blocker, widely used in reducing cardiovascular resistance, dilating cerebral blood vessels, and treating diseases of the nervous system, such as stroke, dementia, hemiplegia, and hypertension. Therefore, this invention selects gastrodin as the content determination indicator. During the research process, it was found that the yield and content of the dried extract were not significantly different between soaked and unsoaked herbs, and no significant difference was found in the effect of powdering degree on extraction. Therefore, this invention ultimately selected the amount of water added, extraction time, and number of extractions as the main factors to be investigated.

[0031] Because the volatile oils and polysaccharides in traditional Chinese medicinal materials are easily decomposed during high-temperature drying, choosing a suitable concentration and drying method is crucial for maximizing their medicinal value. Concentration and drying of granules can concentrate the active ingredients in solutions or suspensions to a certain level, reducing moisture content and thus improving stability and extending shelf life. Lower moisture content helps slow down chemical reactions, reduce microbial growth, and prevent physical changes. Furthermore, concentrated and dried granules are usually in solid granule form, which is easier to store and transport than liquid form, less susceptible to external environmental influences, and facilitates dosage control, allowing for more accurate measurement and dispensing to ensure patients receive the correct dosage. Moreover, improving solubility is particularly important for oral medications, as it determines the rate of absorption and efficacy in the body. Therefore, determining the optimal concentration and drying process for granules can improve stability, shelf life, dosage control, and solubility, thereby enhancing the quality and efficacy of the granules. This invention repeatedly explored the concentration and drying process of the Xiama Huazhuo granules and finally determined its concentration and drying conditions, which effectively avoided the decomposition of volatile oils and polysaccharide components during the high-temperature drying process, and ensured the effective concentration of active ingredients in the drug after drying, especially gastrodin, thus ensuring the efficacy of the drug.

[0032] The Xiama Huazhuo Granules provided by this invention target the pathogenesis of phlegm-dampness stagnation in stroke, using the principles of promoting blood circulation, clearing the meridians, and eliminating phlegm and turbidity. The formula is made from carefully selected and appropriately combined herbs. The principal herb is Pinellia ternata, which is pungent and warm, and enters the spleen, stomach, and lung meridians. Combined with Gastrodia elata, it dries dampness, resolves phlegm, dispels wind, and clears the meridians. The assistant herbs are Salvia miltiorrhiza, which is bitter and slightly cold, and enters the heart, pericardium, and liver meridians, promoting blood circulation and removing blood stasis; and Atractylodes macrocephala (stir-fried with wheat bran), which is sweet, bitter, and warm, and enters the spleen and stomach meridians, strengthening the spleen and eliminating dampness. The adjuvant herbs are Trichosanthes kirilowii, which is sweet, slightly bitter, and cold, and enters the lung and stomach meridians. Combined with Arisaema cum Bile, Bambusa textilis, Scrophularia ningpoensis, and Coptis chinensis, it clears heat and resolves phlegm. Paeonia lactiflora and Rheum palmatum (processed) promote blood circulation and clear the meridians. Crataegus pinnatifida (stir-fried with wheat bran), Massa fermentata (stir-fried with wheat bran), Hordeum vulgare (stir-fried with wheat bran), Magnolia officinalis (stir-fried with ginger), and Glycyrrhiza uralensis (stir-fried with licorice root) harmonize the effects of the other herbs. The combined effects of these herbs work synergistically to clear phlegm, eliminate turbidity, invigorate blood circulation, and unblock the meridians, fully leveraging the therapeutic properties of each herb and enhancing the overall treatment efficacy. The palatability of the various herbs in the formula improves patient compliance. The preparation process is simple, facilitating industrial production and reducing costs. Clinical trials have demonstrated that this herbal formula is significantly effective in treating stroke caused by phlegm-dampness stagnation, with minimal side effects, exhibiting high safety and reliability, making it suitable for widespread application. Attached Figure Description

[0033] Figure 1 This is a flowchart of the preparation process of Xiama Huazhuo granules provided in Embodiment 3 of the present invention.

[0034] Figure 2 Thin-layer chromatography for the identification of Salvia miltiorrhiza in Example 12 of this invention.

[0035] Figure 3 This is for the identification of stir-fried Atractylodes macrocephala in Example 12 of the present invention.

[0036] Figure 4 This is for the identification of Coptis chinensis slices in Example 12 of the present invention.

[0037] Figure 5 This is for the identification of Paeonia lactiflora in Example 12 of the present invention.

[0038] Figure 6 This is for the identification of processed rhubarb in Example 12 of the present invention.

[0039] Figure 7 This is for the identification of the stir-fried bitter orange peel in Example 12 of the present invention.

[0040] Figure 8 This is the standard curve for the determination of gastrodin content in Example 12 of the present invention. Detailed Implementation

[0041] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0042] Example 1

[0043] Example 1 provides the traditional Chinese medicine mixture of the present invention, which has the following components by mass:

[0044] The prescription for Xiama Huazhuo Granules contains the following ingredients: Pinellia ternata 7-11g, Gastrodia elata 13-17g, Salvia miltiorrhiza 13-17g, Atractylodes macrocephala stir-fried with wheat bran 8-12g, Trichosanthes kirilowii 28-32g, Arisaema cum bile 8-12g, Bambusa textilis 8-12g, Scrophularia ningpoensis 8-12g, Coptis chinensis slices 8-12g, Paeonia lactiflora 8-12g, Rheum palmatum 8-12g, Crataegus pinnatifida 8-12g, Massa fermentata 8-12g, Malt 8-12g, Citrus aurantium stir-fried with wheat bran 8-12g, Magnolia officinalis 8-12g, and Glycyrrhiza uralensis slices 8-12g.

[0045] The dosage of Xiama Huazhuo Granules prepared according to the above quality specifications is one dose of decoction, i.e., one-day decoction dosage; preferably, it is decocted once and taken twice a day, morning and evening.

[0046] Example 2

[0047] The prescription for Xiama Huazhuo Granules in Example 2 consists of the following ingredients: 9g of Pinellia ternata, 15g of Gastrodia elata, 15g of Salvia miltiorrhiza, 10g of stir-fried Atractylodes macrocephala, 30g of Trichosanthes kirilowii, 10g of Arisaema cum bile, 10g of Bambusa textilis, 10g of Scrophularia ningpoensis, 10g of Coptis chinensis, 10g of Paeonia lactiflora, 10g of processed rhubarb, 10g of charred hawthorn, 10g of charred Shenqu (medicated leaven), 10g of charred malt, 10g of stir-fried Citrus aurantium, 10g of Magnolia officinalis, and 10g of Glycyrrhiza uralensis.

[0048] The dosage of Xiama Huazhuo Granules prepared according to the above quality specifications is one dose of decoction, i.e., one-day decoction dosage; preferably, it is decocted once and taken twice a day, morning and evening.

[0049] Example 3

[0050] Example 3 provides a method for preparing the aforementioned Xiama Huazhuo granules, such as... Figure 1 As shown.

[0051] Prescription dosage: Pinellia ternata 7-11 parts, Gastrodia elata 13-17 parts, Salvia miltiorrhiza 13-17 parts, Atractylodes macrocephala stir-fried with wheat bran 8-12 parts, Trichosanthes kirilowii 28-32 parts, Arisaema cum bile 8-12 parts, Bambusa textilis 8-12 parts, Scrophularia ningpoensis 8-12 parts, Coptis chinensis slices 8-12 parts, Paeonia lactiflora 8-12 parts, Rheum palmatum 8-12 parts, Crataegus pinnatifida 8-12 parts, Massa fermentata 8-12 parts, Malt 8-12 parts, Citrus aurantium stir-fried with wheat bran 8-12 parts, Magnolia officinalis 8-12 parts, Glycyrrhiza uralensis slices 8-12 parts.

[0052] The Xiama Huazhuo granules were prepared according to the following method:

[0053] 1. Extraction: Take the prescription amount of the medicine, add 10 times the weight of the medicine in water, heat until the water boils, boil for 1 hour, filter to obtain the filtrate, repeat 3 times, boil for 1 hour each time, combine the filtrates, filter (100 mesh) to obtain the extract.

[0054] 2. Concentration: The extract obtained in step 1 is concentrated under reduced pressure at a temperature below 70°C to a paste with a relative density of 1.28-1.32 (65°C).

[0055] 3. The extract obtained in step 2 is dried, pulverized, and sieved: vacuum dried (65℃), pulverized under vacuum (-0.08Mpa), and sieved (80 mesh) to obtain dry extract powder.

[0056] 4. Mixing: Add the dry extract powder and dextrin (mass ratio 7:2) to the triple eccentric mixer, and mix for 30 minutes at a speed of 20 rpm.

[0057] 5. Dry granulation: A dry granulator is used, with the main pressure of the pressure rollers set to 2~28 MPa, the extrusion speed to 2~7 rpm, the feeding speed to 2~14 rpm, and the cooling zone water temperature to 10℃. The premixed material is then dry granulated.

[0058] 6. Granulation: Granulate through 12-mesh and 60-mesh sieves. Collect the material on the sieve as qualified granules, and recycle and press the material under the sieve.

[0059] 7. Inner packaging: The granules are packaged in aluminum-plastic composite film using a granule packaging machine, with each bag containing 6.0g. The filling amount is controlled within the range of 6.0g±7% (6.42g~5.58g), and then heat-sealed.

[0060] 8. Outer packaging: 9 bags per box, labeled.

[0061] Example 4

[0062] Example 4 uses the same preparation method as Example 3 for the Xiama Huazhuo Granules, but the difference is in the formula composition. The formula mass ratio of Example 4 is as follows: 9 parts of Pinellia ternata, 15 parts of Gastrodia elata, 15 parts of Salvia miltiorrhiza, 10 parts of stir-fried Atractylodes macrocephala, 30 parts of Trichosanthes kirilowii, 10 parts of Arisaema cum Bile, 10 parts of Bambusa textilis, 10 parts of Scrophularia ningpoensis, 10 parts of Coptis chinensis, 10 parts of Paeonia lactiflora, 10 parts of processed rhubarb, 10 parts of charred hawthorn, 10 parts of charred Shenqu (medicated leaven), 10 parts of charred malt, 10 parts of stir-fried Citrus aurantium, 10 parts of Magnolia officinalis, and 10 parts of Glycyrrhiza uralensis.

[0063] Example 5

[0064] Example 5 is prepared using the same method as Example 3 for preparing the Xiama Huazhuo Granules, but the difference lies in the formulation. The formulation of Example 5 is as follows: 7 parts Pinellia ternata, 13 parts Gastrodia elata, 13 parts Salvia miltiorrhiza, 8 parts stir-fried Atractylodes macrocephala, 28 parts Trichosanthes kirilowii, 8 parts Arisaema cum bile, 8 parts Bambusa textilis, 8 parts Scrophularia ningpoensis, 8 parts Coptis chinensis, 8 parts Paeonia lactiflora, 8 parts prepared Rheum palmatum, 8 parts charred Crataegus pinnatifida, 8 parts charred Shenqu (medicated leaven), 8 parts charred malt, 8 parts stir-fried Citrus aurantium, 8 parts Magnolia officinalis, and 8 parts Glycyrrhiza uralensis.

[0065] Example 6

[0066] Example 6 uses the same preparation method as Example 3 for the Xiama Huazhuo Granules, but the difference is in the formula composition. The formula mass ratio of Example 6 is as follows: 11 parts of Pinellia ternata, 17 parts of Gastrodia elata, 17 parts of Salvia miltiorrhiza, 12 parts of stir-fried Atractylodes macrocephala, 32 parts of Trichosanthes kirilowii, 12 parts of Arisaema cum bile, 12 parts of Bambusa textilis, 12 parts of Scrophularia ningpoensis, 12 parts of Coptis chinensis, 12 parts of Paeonia lactiflora, 12 parts of processed rhubarb, 12 parts of charred hawthorn, 12 parts of charred Shenqu (medicated leaven), 12 parts of charred malt, 12 parts of stir-fried Citrus aurantium, 12 parts of Magnolia officinalis, and 12 parts of Glycyrrhiza uralensis.

[0067] Example 7

[0068] Example 7 provides evidence of the drug's therapeutic effects.

[0069] Clinical efficacy analysis was conducted on 90 inpatient medical records from April 2022 to June 2024. All patients were diagnosed with stroke upon discharge, including 30 cases of cerebral infarction and 60 cases in the recovery phase of cerebral infarction. All patients were diagnosed with phlegm-dampness stagnation syndrome. These 90 patients were randomly divided into a control group, treatment group 1, and treatment group 2. All three groups received routine antiplatelet aggregation drugs, drugs to improve brain metabolism, and drugs for underlying diseases. In addition, the control group received the classic formula Banxia Baizhu Tianma Tang; treatment group 1 received a self-prepared empirical formula; and treatment group 2 received the traditional Chinese medicine composition provided by this invention, namely Xiama Huazhuo Tang.

[0070] The control group's traditional Chinese medicine composition consisted of 9g Pinellia ternata, 3g Gastrodia elata, 3g Poria cocos, 3g Citrus reticulata peel, 15g Atractylodes macrocephala, 3g Glycyrrhiza uralensis, 5g Zingiber officinale, and 10g Ziziphus jujuba.

[0071] The Chinese herbal composition of treatment group 1 was as follows: Pinellia ternata 9g, Atractylodes macrocephala 10g, Gastrodia elata 15g, Trichosanthes kirilowii 30g, Poria cocos 10g, Citrus reticulata 10g, Bambusa textilis 10g, Citrus aurantium 10g, Ligusticum chuanxiong 15g, and Pheretima aspergillum 10g.

[0072] The Chinese medicine composition of treatment group 2 was as follows: Pinellia ternata 9g, Gastrodia elata 15g, Salvia miltiorrhiza 15g, Atractylodes macrocephala stir-fried with wheat bran 10g, Trichosanthes kirilowii 30g, Arisaema cum bile 10g, Bambusa textilis 10g, Scrophularia ningpoensis 10g, Coptis chinensis 10g, Paeonia lactiflora 10g, Rheum palmatum 10g, Crataegus pinnatifida 10g, Massa fermentata 10g, Hordeum vulgare 10g, Citrus aurantium stir-fried with wheat bran 10g, Magnolia officinalis 10g, Glycyrrhiza uralensis 10g.

[0073] Decoction method: Decocted in water to obtain 400ml of liquid, taken in two divided doses, 200ml in the morning and 200ml in the evening, one dose per day, for two consecutive weeks.

[0074] 1. Observation indicators and evaluation criteria: Clinical treatment effects were evaluated for all cases after admission and discharge, with the criteria referring to the efficacy evaluation criteria for stroke in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine".

[0075] ① Efficacy evaluation instructions: The percentage conversion method of pre-treatment score and post-treatment score is used: [(pre-treatment score - post-treatment score) ÷ pre-treatment score] x 100%, expressed as a percentage.

[0076] ②Efficacy evaluation criteria:

[0077] Basic recovery: The reduction rate of syndrome score is ≥81%;

[0078] Significant progress: the reduction rate of syndrome scores was 56%-80%;

[0079] Progress: The rate of reduction in syndrome scores was 36%-55%;

[0080] Slight improvement: The rate of reduction in syndrome scores was 11%-35%;

[0081] No change: The decrease rate of syndrome score is ≤10%;

[0082] Deterioration: (including death) negative value.

[0083] Overall effectiveness = Basic recovery + Significant improvement + Improvement + Slight improvement

[0084] Comparison of scores before and after treatment: The total effective rate in the treatment group was >80%, and the difference in improvement was statistically significant (see Table 1).

[0085] Table 1: Comparison of effectiveness rates among groups

[0086]

[0087] The above results indicate that the Xiama Huazhuo Decoction provided by this invention can improve the clinical symptoms of patients.

[0088] Table 2: Comparison of blood lipid changes before and after treatment in each group ( (mmol / L)

[0089]

[0090] Note: Compared with before treatment a P<0.05; compared with the control group, b P<0.05; compared with treatment group 1, c P<0.05.

[0091] The above research results indicate that the Xiama Huazhuo Decoction provided by this invention has a certain regulatory effect on blood lipids.

[0092] Example 8

[0093] Example 8 is an orthogonal experiment for the extraction of the Xiama Huazhuo granules described in this invention. The conditions for the water-decoction step in the preparation method provided by this invention were optimized.

[0094] The specific steps of the decoction in this invention are as follows: take the prescribed amount of medicinal materials, add 10 times the weight of the medicinal materials in water, heat until the water boils and record for 1 hour, filter to obtain the filtrate; repeat the decoction step three times, boiling for 1 hour each time, combine the filtrates, filter through 100 mesh to obtain the extract.

[0095] (I) Experimental Instruments and Reagents:

[0096] 1. Experimental instruments: Agilent 1220 HPLC heating mantle: Shanghai Yuhua Instrument Equipment Co., Ltd.; ZNHW-250ml 1 / 2 liter balance: Yongkang Wuxin Weighing Instrument Co., Ltd. MTS3000D.

[0097] 2. Standards and reagents: as shown in Table 3.

[0098] Table 3: Standards and Reagents.

[0099]

[0100] (II) Experiment and Results:

[0101] 1. Orthogonal experiment:

[0102] Orthogonal experimental design was used to screen the main influencing factors and levels of extraction, examining the number of extractions (A), extraction time (B), and water volume (C), as shown in Table 4. The number of extractions (A) refers to the number of repetitions of the decoction step; extraction time (B) refers to the boiling time each time; and water volume (C) refers to the amount of water added in multiples of the prescribed amount of medicinal materials.

[0103] Table 4. Orthogonal experimental factor level table for decoction extraction

[0104]

[0105] 2. Orthogonal Experiment Arrangement

[0106] Each experiment was arranged according to the orthogonal experimental table. Nine portions were taken, including Pinellia ternata, Gastrodia elata, Salvia miltiorrhiza, Atractylodes macrocephala stir-fried with wheat bran, Trichosanthes kirilowii, Arisaema cum bile, Bambusa textilis, Scrophularia ningpoensis, Coptis chinensis slices, Paeonia lactiflora, Rheum palmatum, Crataegus pinnatifida, Massa fermentata, Malt, Citrus aurantium stir-fried with wheat bran, Magnolia officinalis, and Glycyrrhiza uralensis slices. The experiments were conducted according to the four factor levels in Table 4.

[0107] 3. Determination of gastrodin content in decoction

[0108] Chromatographic conditions: Agilent C18 column (4.6 × 250 mm, 5 μm); mobile phase: acetonitrile-0.1% phosphoric acid aqueous solution (1:99); detection wavelength: 220 nm; column temperature: 40 °C; flow rate: 1.0 mL / min

[0109] Reference solution: Take gastrodin reference standard, add acetonitrile-water solution (1:99) to prepare a solution containing 0.0173 mg / ml gastrodin, and shake well.

[0110] Test solution: Take the above 9 test solutions, mix them separately and shake well.

[0111] Assay: Accurately pipette 20 μL each of the reference solution and the test solution and inject them into the liquid chromatograph.

[0112] 4. Results and Analysis of Orthogonal Experiments

[0113] The measurement results are shown in Table 5:

[0114] Table 5: Orthogonal arrangement test and results of water extraction process.

[0115]

[0116] 5. Analysis of orthogonal results:

[0117] 5.1. Intuitive Analysis: Based on the average values ​​of the three levels of each factor, and guided by gastrodin, select A3, B2, and C3.

[0118] 5.2 Analysis of Variance: Based on the analysis of variance results, using gastrodin as the indicator, the number of extractions and the amount of water added have a significant impact, while other factors are not significant. Therefore, A3 and C3 are selected. Factor B has no significant impact, and B2 and B3 are not significantly different. Considering energy saving, cost reduction, and emission reduction, B2 is selected. In summary, A3, B2, and C3 are selected, meaning the optimal extraction process for the orthogonal experiment of water extraction is: add 10 times the amount of water, extract 3 times, and boil for 1.0 h each time. Table 6 shows the analysis of variance results.

[0119] Table 6: Analysis of variance.

[0120]

[0121] Example 9

[0122] Example 9 provides three batches of pilot production data.

[0123] The preparation method in Example 9 is the same as that in Example 4.

[0124] Prescription: Pinellia ternata 216g, Gastrodia elata 360g, Salvia miltiorrhiza 360g, Atractylodes macrocephala (stir-fried with wheat bran) 240g, Trichosanthes kirilowii 720g, Arisaema cum bile 240g, Bambusa textilis 240g, Scrophularia ningpoensis 240g, Coptis chinensis 240g, Paeonia lactiflora 240g, Rheum palmatum (processed) 240g, Crataegus pinnatifida (roasted) 240g, Massa fermentata (roasted) 240g, Hordeum vulgare (roasted) 240g, Citrus aurantium (stir-fried with wheat bran) 240g, Magnolia officinalis (processed with ginger) 240g, Glycyrrhiza uralensis 240g.

[0125] Preparation: The above seventeen ingredients are extracted three times with water, each time boiling for 1 hour. The filtrates are combined and filtered to obtain the extract. The extract is concentrated under reduced pressure to a relative density of 1.28-1.32 (65℃) to obtain an extract. An appropriate amount of dextrin is added, and granules are made to produce a total of 1000g of granules. (The detailed preparation method is described in Example 2, where the mass ratio of extract powder to dextrin is 7:2.)

[0126] Three batches of pilot-scale samples were produced according to the above production process, with batch numbers 20230901, 20230902, and 20230903.

[0127] (I) Production Data

[0128] Three batches of pilot-scale samples were produced according to the production process, with batch numbers 20230901, 20230902, and 20230903. Relevant production data are shown in Table 7.

[0129] Table 7:

[0130]

[0131] (II) Conclusion:

[0132] According to the table above, the key data of three batches of Xiama Huazhuo Granules in pilot production are shown in Table 8. According to the data shown, the production process of Xiama Huazhuo Granules provided by the present invention is stable.

[0133] Table 8: Key data from three batches of pilot production.

[0134]

[0135] Example 10

[0136] Example 10 determined the types and proportions of excipients for the Xiama Huazhuo granules by evaluating the granule forming rate, moisture absorption rate, and solubility.

[0137] 1. Determination of granule forming rate: Take the prepared Xiama Huazhuo granules and weigh the total mass (m1). Pass the prepared Xiama Huazhuo granules through 24 mesh and 60 mesh sieves respectively. Collect the granules that can pass through 24 mesh but not 60 mesh sieves and weigh them as a fixed mass (m2). Calculate the granule forming rate in one step.

[0138] The one-time forming rate of granules = weight of granules that can pass through a 24-mesh sieve but not a 60-mesh sieve / total mass of granules × 100%, that is, the one-time forming rate of granules = m2 / m1 × 100%.

[0139] 2. Weigh an appropriate amount of the prepared Xiama Huazhuo granules and place them in a weighing bottle that has been dried to constant weight. Open the weighing bottle cap and place the weighing bottle containing the Xiama Huazhuo granule sample in a glass container with a supersaturated NaCl solution at the bottom. Maintain a temperature of (25±1)℃ and a relative humidity of (75±5)%. Take out the sample at 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, and 60 hours, weigh it accurately, and calculate the hygroscopic rate of the granules.

[0140] Moisture absorption rate = (m4-m3) / m3×100%, where m3 is the mass of Xiama Huazhuo granules before moisture absorption and m4 is the mass of Xiama Huazhuo granules after moisture absorption.

[0141] 3. Solubility: Weigh an appropriate amount of Xiama Huazhuo granules, place them in a 250ml beaker, add 200mL of hot water, stir for 5 minutes, and wait until the granules are completely dissolved or slightly turbid, with no foreign matter, then it is qualified. Referring to the Chinese Pharmacopoeia's standard for solubility, a dissolution rate greater than 70 w / v% is considered qualified.

[0142] Common excipients for traditional Chinese medicine granules include dextrin and soluble starch. Xiama Huazhuo granules extract powder has a certain degree of hygroscopicity and is present in large quantities. Dextrin and soluble starch have good moisture resistance and good granulation rate. Soluble starch and dextrin were selected and mixed with the extract powder in a 1:2 ratio. Dry granulation was performed (feeding speed 14 r / min, extrusion speed 7 r / min, roller pressure 28 bar). The one-time granulation rate, solubility, and moisture absorption rate of the granules were measured as indicators to screen excipient types. The results are shown in Table 9. It can be seen that the one-time granulation rate of dextrin is greater than that of soluble starch, and the moisture absorption rate of dextrin is less than that of soluble starch. Based on the screening results, dextrin was selected as the excipient.

[0143] Table 9: Results of the screening of auxiliary materials.

[0144]

[0145] Dextrin and extract powder were mixed evenly at mass ratios of 1:7, 2:7, and 3:7, respectively, and then dry-granulated (feeding speed 14 r / min, extrusion speed 7 r / min, roller pressure 28 bar) to prepare *Hemp Leaf Turbidity Granules. The amount of excipients was screened based on the granule's one-time molding rate, solubility, and moisture absorption rate. The results are shown in Table 10. It can be seen that the solubility was satisfactory in all cases. When the mass ratio of extract powder to dextrin was 7:2, the one-time molding rate was higher, the moisture absorption rate was lower, and the production cost was lower. Therefore, the selected excipient ratio was 7:2.

[0146] Table 10: Screening results of auxiliary material usage.

[0147]

[0148] Example 11

[0149] Example 11: Daily dose conversion standard for the Xiama Huazhuo granules.

[0150] The Xiama Huazhuo Granules provided by this invention are preferably taken as medicinal slices or granules prepared according to the method provided by this invention.

[0151] The Xiama Huazhuo granules, prepared according to the prescription ratios and preparation methods provided in any one of Examples 2-5, are packaged in 6g / bags. The dosage is 1 bag (6g per bag) three times a day, for a total daily intake of 18g of granules.

[0152] Example 1 or 2 provides a daily dose of one dose of herbal medicine. The herbal medicine provided in Example 2 and the granules provided in Example 4 have the same prescription mass ratio. The dosage ratio of the granules prepared according to the method provided in Example 4 to the herbal medicine prepared in Example 2 is: 1g granules = 4.7g herbal medicine. That is to say, the daily dose of granules (18g) prepared in Example 4 is equivalent to the daily dose of 84.6g herbal medicine.

[0153] Example 12

[0154] Example 12 studied the quality standards of the Xiama Huazhuo granules.

[0155] This invention uses Banxia Tianma Baizhu Decoction as the main formula, supplemented with other medicinal ingredients.

[0156] The formula consists of three main ingredients: Pinellia ternata (the principal ingredient) and Gastrodia elata (the secondary ingredient) to dry dampness, resolve phlegm, dispel wind, and unblock the meridians; Atractylodes macrocephala (the secondary ingredient) to strengthen the spleen and dispel dampness; Trichosanthes kirilowii (the secondary ingredient), Arisaema cum Bile (the secondary ingredient), Bambusa textilis (the secondary ingredient), Scrophularia ningpoensis (the secondary ingredient), and Coptis chinensis (the secondary ingredient) to clear heat and resolve phlegm; Salvia miltiorrhiza (the secondary ingredient), Paeonia lactiflora (the secondary ingredient), and Rheum palmatum (the secondary ingredient) to remove blood stasis and unblock the meridians; and Crataegus pinnatifida (the secondary ingredient), Massa fermentata (the secondary ingredient), Hordeum vulgare (the secondary ingredient), Citrus aurantium (the secondary ingredient), and Magnolia officinalis (the secondary ingredient) to regulate qi, strengthen the spleen, and resolve phlegm; and Glycyrrhiza uralensis (the secondary ingredient) to harmonize the other ingredients. The combined effects of these ingredients are to strengthen the spleen, resolve phlegm, invigorate blood, and unblock the meridians. Therefore, in the thin-layer chromatography identification of Xiama Huazhuo granules, three batches of pilot-scale Xiama Huazhuo granules (20230901, 20230902, and 20230903) were used. Based on the pharmacopoeia standards and references, and according to the roles of the principal, secondary, secondary, and secondary ingredients, quality standards were studied separately.

[0157] Example 12 shows the following internal quality control standard operation for Xiama Huazhuo Granules:

[0158] Prescription: Pinellia ternata 216g, Gastrodia elata 360g, Salvia miltiorrhiza 360g, Atractylodes macrocephala (stir-fried with wheat bran) 240g, Trichosanthes kirilowii 720g, Arisaema cum bile 240g, Scrophularia ningpoensis 240g, Paeonia lactiflora 240g, Bambusa textilis 240g, Citrus aurantium (stir-fried with wheat bran) 240g, Rheum palmatum (processed) 240g, Glycyrrhiza uralensis 240g, Coptis chinensis 240g, Magnolia officinalis (processed with ginger) 240g, Crataegus pinnatifida (processed with charred hawthorn) 240g, Hordeum vulgare (processed with charred malt) 240g, Massa fermentata (processed with charred medicated leaven) 240g.

[0159] Preparation: The above seventeen ingredients are extracted three times with water, each time boiling for 1 hour. The filtrates are combined and filtered to obtain the extract. The extract is concentrated under reduced pressure to a relative density of 1.28-1.32 (65℃) to obtain an extract. An appropriate amount of dextrin is added, and granules are made to produce a total of 1000g of granules. (The detailed preparation method is described in Example 2, where the mass ratio of extract powder to dextrin is 7:2.)

[0160] Characteristics: This product is brownish-yellow to brownish-brown granules; it has a slightly fragrant odor and a slightly bitter taste.

[0161] Three batches of pilot-scale samples were produced according to the above production process, with batch numbers 20230901, 20230902, and 20230903 (i.e., the three batches of pilot-scale samples provided in Example 9).

[0162] Identification:

[0163] 1. Thin-layer chromatography experiments:

[0164] Referring to the 2020 edition of the Pharmacopoeia (Part IV: General Rule 0502 Thin-Layer Chromatography; Part I: Identification of Medicinal Materials and Processed Pieces), thin-layer chromatography was used to identify three batches of pilot-scale samples of Xiama Huazhuo Granules (20230901, 20230902, and 20230903). Experimental studies determined that the thin-layer identification items for Xiama Huazhuo Granules include Danshen (Salvia miltiorrhiza), stir-fried Atractylodes macrocephala (Bran-fried), Coptis chinensis (Coptis chinensis), Paeonia lactiflora (Red Peony Root), prepared Rheum palmatum (Rhubarb), and stir-fried Citrus aurantium (Bran-fried), which served as the basis for establishing the quality standard for Xiama Huazhuo Granules. The identification results are as follows:

[0165] (1) Identification results of Salvia miltiorrhiza: In the chromatogram of the test sample, spots of the same color appear at the corresponding positions as in the chromatograms of the reference standard and the reference medicinal material, as shown in the following results. Figure 2 As shown in the figure, from left to right, the sample consists of the standard, the control medicinal material, the sample from batch 20230901 (i.e., the drug granules obtained in Example 9), and the negative sample of Danshen.

[0166] (2) Identification results of stir-fried Atractylodes macrocephala: In the chromatogram of the test sample, fluorescent spots of the same color appeared at the corresponding positions as in the chromatogram of the reference medicinal material, as shown in the figure. Figure 3 As shown in the figure, from left to right, the control medicinal material, batch 20230901 sample (i.e., the drug granules obtained in Example 9), and negative sample of Atractylodes macrocephala are shown.

[0167] (3) Identification results of Coptis chinensis tablets: In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions as in the chromatogram of the reference sample. The results are as follows: Figure 4 As shown in the figure, from left to right, the sample consists of the standard, batch 20230901 (i.e., the drug granules obtained in Example 9), and a negative sample of Coptis chinensis.

[0168] (4) Identification results of Paeonia lactiflora: In the chromatogram of the test sample, spots of the same color appear at the corresponding positions as in the chromatogram of the reference sample, as shown in the figure. Figure 5 As shown in the figure, from left to right, the sample is batch 20230901 (i.e., the drug granules obtained in Example 9), the standard, and the negative control of Paeonia lactiflora.

[0169] (5) Identification results of processed rhubarb: In the chromatogram of the test sample, no bright blue fluorescent spot should appear at the same position as that of the reference sample, thus excluding impurities in the medicinal material. Results are as follows: Figure 6 As shown in the figure, from left to right, the standard product and batch 20230901 sample (i.e., the drug particles obtained in Example 9) are respectively.

[0170] (6) Identification results of stir-fried bitter orange peel: In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions as in the chromatogram of the reference sample. The results are as follows: Figure 7 As shown in the figure, from left to right are the standard, batch sample 20230901 (i.e., the drug granules obtained in Example 9), and negative sample of Citrus aurantium.

[0171] 2. Determination of Gastrodin Content

[0172] 2.1 Preparation of reference solution

[0173] Take an appropriate amount of gastrodin reference standard (refer to Table 3 for gastrodin standard), accurately weigh it, and add acetonitrile-water (1:99) mixed solution to prepare a solution containing 30 μg of gastrodin per 1 ml.

[0174] 2.2 Investigation of the preparation method of the test sample

[0175] Take the finely ground *Xia Ma Hua Zhuo* granules prepared in this example, accurately weigh 1.0 g, place them in a stoppered conical flask, accurately add 25 ml of dilute ethanol, weigh, sonicate (power 120 W, frequency 40 kHz) for 30 minutes, cool, weigh again, replenish the lost weight with dilute ethanol, filter, accurately measure 10 ml of the filtrate, concentrate until nearly dry and odorless, dissolve the residue in an acetonitrile-water (1:99) mixture, transfer to a 10 ml volumetric flask, dilute to the mark with an acetonitrile-water (1:99) mixture, shake well, filter, and collect the filtrate to obtain the final product.

[0176] 2.3 Chromatographic conditions

[0177] Chromatographic column: Agilent 5 TC-C18(2) (250 mm × 4.6 m, 5 μm); mobile phase: acetonitrile-0.1% phosphoric acid solution (1:99); detection wavelength: 220 nm; flow rate: 1.0 ml / min; injection volume: 20 μl; column temperature: 40 ℃.

[0178] 3. Methodological Experiments

[0179] 3.1 Specificity Experiment

[0180] Take Xiama Huazhuo Granules and negative samples without Tianma Xiama Huazhuo Granules, and prepare test solutions and negative sample solutions respectively according to the method of thin-layer chromatography study in Section 1 of this embodiment, and determine and record the chromatograms. Under these chromatographic conditions, the gastrodin chromatographic peak is well separated from other peaks, and the negative sample does not show an absorption peak at the corresponding position of the gastrodin reference standard.

[0181] 3.2 Examination of Linear Relationships

[0182] Accurately pipette the gastrodin reference solution and serially dilute it to obtain six solutions of different mass concentrations. Perform the determination according to the prescribed method. Record the corresponding peak areas. Plot a standard curve with peak area Y as the ordinate and reference concentration X (mg / ml) as the abscissa. Perform regression calculations. The linear regression equation for gastrodin is y = 37036x + 2.0496, r = 0.9997. The standard curve for gastrodin content determination is shown below. Figure 8 As shown, this method achieves good separation. Figure 8 In the figure, peak area Y is plotted on the ordinate and reference concentration X (mg / ml) on the abscissa. A standard curve was plotted and regression calculations were performed. The linear regression equation for gastrodin is y = 37036x + 2.0496, r = 0.9997. The results of the linear relationship investigation are shown in Table 11.

[0183] Table 11: Results of linear relationship examination.

[0184]

[0185] 3.3 Precision Test

[0186] Take Xiama Huazhuo granules and prepare a reference solution according to the method in the thin-layer chromatography test study in Section 1 of this example. Inject the solution and determine it continuously for 6 times. Record the peak area of ​​gastrodin and calculate the RSD (%) of each peak area and retention time. The peak area and retention time RSD are 0.07% and 0.07%, respectively, indicating that the precision of this assay method is good. Table 12 shows the results of the precision test.

[0187] Table 12: Precision test results.

[0188]

[0189] 3.4 Stability Test

[0190] Using Xiama Huazhuo granules, prepare reference and test solutions according to the method in the thin-layer chromatography study in Section 1 of this embodiment. Seal the solutions and inject them once after standing at room temperature for 0, 1, 2, 3, 6, and 12 hours. Record the peak area of ​​gastrodin and calculate the RSD (%) of each peak area and retention time. The RSD of the peak area of ​​the reference solution was 0.41%, and the RSD of the retention time was 0.64%. The RSD of the peak area of ​​the test solution was 2.55%, and the RSD of the retention time was 0.20%. This method has good stability. The results are shown in Tables 13 and 14.

[0191] Table 13 Results of stability tests on reference solutions:

[0192]

[0193] Table 14: Results of the stability test of the test sample solution:

[0194]

[0195] 3.5 Repeatability Test

[0196] Six portions of Xiama Huazhuo granules were weighed in parallel, and test solutions were prepared according to the method described in the thin-layer chromatography study in Section 1 of this embodiment. The samples were injected sequentially, and the content of gastrodin was recorded, and the RSD (%) was calculated. The RSD value of the gastrodin content in the six test solutions was 2.62%, indicating good repeatability of the method. The results are shown in Table 15.

[0197] Table 15: Results of repeatability tests.

[0198]

[0199] 3.6. Recovery Test

[0200] Six portions of Xiama Huazhuo granules, each 0.5 g, were accurately weighed. Gastrodin reference standard was added to each portion sequentially according to 100% of the gastrodin content in the sample. The test solution was prepared according to the method described in Section 1 of this embodiment for thin-layer chromatography. 20 μL of each sample was injected for analysis, and the peak area of ​​gastrodin was recorded. The recovery rate and RSD of gastrodin in each sample were calculated. The average recovery rate of the six Xiama Huazhuo granules was 98.63%, and the RSD was 2.62%, indicating good accuracy of the method. The results are shown in Table 16.

[0201] Table 16: Results of the recovery test:

[0202]

[0203] Inspection: It should comply with all relevant regulations under the Granules section (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0104).

[0204] Content determination: determined by high performance liquid chromatography (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0512).

[0205] Chromatographic conditions and system suitability tests were conducted using octadecylsilane-bonded silica gel as the packing material; acetonitrile-0.1% phosphoric acid solution (1:99) as the mobile phase; detection wavelength of 220 nm; and theoretical plate number calculated based on the gastrodin peak of not less than 4000.

[0206] Preparation of the reference solution: Take an appropriate amount of gastrodin reference standard, accurately weigh it, and add acetonitrile-water (1:99) mixed solution to prepare a solution containing 30 μg of gastrodin per 1 ml.

[0207] Preparation of the test solution: Grind the product into a fine powder, take about 1g, accurately weigh it, place it in a stoppered conical flask, accurately add 25ml of dilute ethanol, weigh it, sonicate (power 120W, frequency 40kHz) for 30 minutes, cool it, weigh it again, replenish the lost weight with dilute ethanol, filter it, accurately measure 10ml of the filtrate, concentrate it to near dryness and remove the alcohol odor, dissolve the residue in an acetonitrile-water (1:99) mixture, transfer it to a 10ml volumetric flask, dilute it to the mark with an acetonitrile-water (1:99) mixture, shake well, filter it, and take the filtrate to obtain the test solution.

[0208] The assay involves accurately injecting 20 μL each of the reference solution and the test solution into the liquid chromatograph and determining the concentration. Each bag of this product contains gastrodin (Cgastrodin) from Gastrodia elata. 13 H 18 The dosage (O7) shall not be less than 2.5 mg.

[0209] The above embodiments are merely illustrative examples and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The formula consists of the following ingredients in the indicated weight proportions: 7-11 parts of Pinellia ternata, 13-17 parts of Gastrodia elata, 13-17 parts of Salvia miltiorrhiza, 8-12 parts of Atractylodes macrocephala stir-fried with wheat bran, 28-32 parts of Trichosanthes kirilowii, 8-12 parts of Arisaema cum Bile, 8-12 parts of Bambusa textilis, 8-12 parts of Scrophularia ningpoensis, 8-12 parts of Coptis chinensis slices, 8-12 parts of Paeonia lactiflora, 8-12 parts of Rheum palmatum (processed), 8-12 parts of Crataegus pinnatifida (roasted), 8-12 parts of Massa fermentata (roasted), 8-12 parts of Malt (roasted), 8-12 parts of Citrus aurantium (roasted with wheat bran), 8-12 parts of Magnolia officinalis (processed with ginger), and 8-12 parts of Glycyrrhiza uralensis slices.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The formula consists of the following ingredients in the indicated proportions: 9 parts Pinellia ternata, 15 parts Gastrodia elata, 15 parts Salvia miltiorrhiza, 10 parts stir-fried Atractylodes macrocephala, 30 parts Trichosanthes kirilowii, 10 parts Arisaema cum Bile, 10 parts Bambusa textilis, 10 parts Scrophularia ningpoensis, 10 parts Coptis chinensis, 10 parts Paeonia lactiflora, 10 parts prepared Rheum palmatum, 10 parts charred Crataegus pinnatifida, 10 parts charred Shenqu (medicated leaven), 10 parts charred Hordeum vulgare, 10 parts stir-fried Citrus aurantium, 10 parts Magnolia officinalis, and 10 parts Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, The traditional Chinese medicine composition also includes dextrin.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, wherein the traditional Chinese medicine composition is granules, characterized in that, Includes the following steps: Step 1: Extraction: Weigh out the prescribed amounts of Pinellia ternata, Gastrodia elata, Salvia miltiorrhiza, Atractylodes macrocephala (stir-fried with wheat bran), Trichosanthes kirilowii, Arisaema cum bile, Bambusa textilis, Scrophularia ningpoensis, Coptis chinensis, Paeonia lactiflora, Rheum palmatum (processed), Crataegus pinnatifida (roasted), Massa fermentata (roasted), Malt (roasted), Citrus aurantium (stir-fried with wheat bran), Magnolia officinalis (processed with ginger), and Glycyrrhiza uralensis. Add water and decoct to obtain the extract. Filter to obtain the extract. Step 2: Concentrate the filtered extract under reduced pressure to obtain an extract with a relative density of 1.28 to 1.32, wherein the relative density is the relative density at 65°C; Step 3: Dry, pulverize, and sieve the extract obtained in Step 2 to obtain dry extract powder; Step 4: Mix the dry extract powder obtained in Step 3 with dextrin; Step 5: Prepare granules from the mixture obtained in Step 4.

5. The preparation method according to claim 4, characterized in that, In step 1, the specific steps for decoction are as follows: take the prescribed amount of medicinal materials, add 10 times the weight of the medicinal materials in water, heat until the water boils and record the time for 1 hour, filter to obtain the filtrate; repeat the decoction step three times, each time for 1 hour, combine the filtrates, filter through 100 mesh to obtain the extract.

6. The preparation method according to claim 4, characterized in that, In step 2, the filtered extract is concentrated under reduced pressure at a temperature below 70°C to a paste with a relative density of 1.28-1.32, wherein the relative density is the relative density at 65°C.

7. The preparation method according to claim 4, characterized in that, In step 3, the extract obtained in step 2 is vacuum dried at 65°C, pulverized under a vacuum of -0.08 MPa, and passed through an 80-mesh sieve to obtain dry extract powder.

8. The preparation method according to claim 4, characterized in that, In step 4, the dry extract powder and dextrin in a mass ratio of 7:2 are added to the triple eccentric mixer, and the mixture is stirred at 20 rpm for 30 minutes.

9. The preparation method according to claim 4, characterized in that, In step 5, a dry granulator is used, with the main pressure of the pressure roller set to 2~28 MPa, the extrusion speed to 2~7 rpm, the feeding speed to 2~14 rpm, and the cooling zone water temperature to 10℃, to dry granulate the premixed material; the preparation method also includes step 6, where the granules obtained in step 5 are sized by passing them through 12-mesh and 60-mesh sieves, and the material collected on the sieves is the qualified granules, while the material under the sieves is recycled and pressed.

10. The traditional Chinese medicine composition according to any one of claims 1-3, and the preparation method according to any one of claims 4-9, are used in the preparation of a medicine for stroke with phlegm-dampness stagnation.

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