A traditional Chinese medicine composition, a preparation method and application thereof

Abstract

The present application provides a traditional Chinese medicine composition, a preparation method and application thereof. Specifically, the traditional Chinese medicine composition comprises an active ingredient and an auxiliary material, wherein the active ingredient is prepared from the following raw materials: pollen typhae, salvia miltiorrhiza, rehmannia glutinosa, eclipta prostrata, chrysanthemum, scutellaria baicalensis, semen cassiae, plantago, herba lycopi, ligustrum lucidum, prunella vulgaris, gentiana, curcuma, equisetum, red peony root, cortex moutan, hawthorn, angelica sinensis, chuanxiong; wherein the auxiliary material can comprise dextrin; and the weight of dextrin is less than or equal to 1% based on the total weight of the active ingredient. The traditional Chinese medicine composition and the preparation method thereof can meet the requirements of the pharmaceutical process, have better fluidity, and are more conducive to the preparation of subsequent preparations.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a traditional Chinese medicine composition, its preparation method, and its uses. Background Technology

[0002] Chinese patent CN1544074A discloses a traditional Chinese medicine composition comprising 65-80 parts of Typhae Pollen, 65-80 parts of Salvia miltiorrhiza, 50-70 parts of Rehmannia glutinosa, 50-70 parts of Eclipta prostrata, 40-60 parts of Chrysanthemum morifolium, 35-50 parts of Scutellaria baicalensis, 35-50 parts of Cassia tora, 35-50 parts of Plantago asiatica, 35-50 parts of Leonurus japonicus, 35-50 parts of Ligustrum lucidum, 35-50 parts of Prunella vulgaris, 35-50 parts of Gentiana scabra, 20-40 parts of Curcuma longa, 35-50 parts of Equisetum hyemale, 20-40 parts of Paeonia lactiflora, 20-40 parts of Paeonia suffruticosa, 20-40 parts of Crataegus pinnatifida, 20-40 parts of Angelica sinensis, and 5-15 parts of Ligusticum chuanxiong. This composition has the effects of cooling the blood and stopping bleeding, nourishing yin and removing blood stasis, and nourishing the liver and improving eyesight. The aforementioned patent also discloses a method for preparing the traditional Chinese medicine composition, specifically: Scutellaria baicalensis is stir-fried until charred; chrysanthemum, charred Scutellaria baicalensis, half the amount of Plantago asiatica seed, and half the amount of Typha pollen are mixed and pulverized into a fine powder; the remaining raw materials are soaked in water, decocted, and the decoctions are combined and filtered; the filtrate is concentrated into a thick paste, the paste is mixed with the fine powder, dried at 60°C, granulated, and 20-40 parts of dextrin are added as an excipient. Granulation is then performed using 85% ethanol, followed by drying at 60°C, granulation, and thorough mixing. Currently, the components and preparation method of the traditional Chinese medicine composition disclosed in this patent still require further optimization. Summary of the Invention

[0003] This invention provides a traditional Chinese medicine composition, its preparation method, and its uses. The technical solution is as follows:

[0004] In a first aspect, the present invention provides a traditional Chinese medicine composition comprising active ingredients and excipients;

[0005] The active ingredients are made from the following raw materials: Typha pollen, Salvia miltiorrhiza, Rehmannia glutinosa, Eclipta prostrata, Chrysanthemum morifolium, Scutellaria baicalensis, Cassia tora, Plantago asiatica, Leonurus japonicus, Ligustrum lucidum, Prunella vulgaris, Gentiana scabra, Curcuma longa, Equisetum hyemale, Paeonia lactiflora, Paeonia suffruticosa, Crataegus pinnatifida, Angelica sinensis, and Ligusticum chuanxiong.

[0006] in,

[0007] The weight ratio of Chuanxiong to Yujin, Chishao, Mudanpi, Shanzha or Danggui is 1:2 to 1:4, for example, 1:2, 1:2.5, 1:3, 1:3.5 or 1:4;

[0008] The weight ratio of Ligusticum chuanxiong to Scutellaria baicalensis, Cassia tora, Plantago asiatica, Leonurus japonicus, Ligustrum lucidum, Prunella vulgaris, Gentiana scabra, and Equisetum hyemale is 1:3 to 1:5, for example, 1:3, 1:3.5, 1:4, 1:4.5 or 1:5.

[0009] The weight ratio of Ligusticum chuanxiong to chrysanthemum is 1:4 to 1:5, for example, 1:4, 1:4.5 or 1:5;

[0010] The weight ratio of Ligusticum chuanxiong to Rehmannia glutinosa or Eclipta prostrata is 1:4.5 to 1:6, for example, 1:4.5, 1:5, 1:5.5 or 1:6; and / or

[0011] The weight ratio of Ligusticum chuanxiong to Typha pollen or Salvia miltiorrhiza is 1:5 to 1:8, for example, 1:5, 1:5.5, 1:6, 1:6.5, 1:7, 1:7.5 or 1:8;

[0012] in,

[0013] The excipients may include dextrin;

[0014] in,

[0015] Based on the total weight of the active ingredient, the weight of dextrin in the excipients is less than or equal to 1%, for example, less than or equal to 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.09%, 0.08%, 0.07%, 0.06%, 0.05%, 0.04%, 0.03%, 0.02%, 0.01% or lower.

[0016] Specifically, in the traditional Chinese medicine composition, the excipients further include a lubricant (such as magnesium stearate); preferably, based on the total weight of the active ingredient, the weight of the lubricant (such as magnesium stearate) in the excipients is 0.1%-1%, for example 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, or 1%.

[0017] Specifically, the traditional Chinese medicine composition may be in the form of granules, capsules, or tablets.

[0018] Specifically, the traditional Chinese medicine composition further includes a coating material; preferably, the coating material is a sugar coating material or a film coating material.

[0019] In this application, the sugar coating material includes or is selected from one or more of sucrose, colorants, barrier agents, and additives. For example, the colorant is at least one of activated carbon, red iron oxide, purple iron oxide, yellow iron oxide, black iron oxide, brown iron oxide, and lake. For example, the barrier agent is at least one of insect wax, beeswax, and carnauba wax. For example, the additive is at least one of talc, micronized silica gel, gelatin, magnesium stearate, and powdered sugar.

[0020] In this application, the film coating material includes or is selected from gastric-soluble film coating materials and enteric-soluble film coating materials. For example, gastric-soluble film coating materials may be one or more of the following: cellulose derivatives (such as hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, etc.), povidone, acrylic resins (such as acrylic resin IV), polyvinyl acetaldehyde diethylamine ethyl ester (AEA), polyethylene glycol, titanium dioxide, colorants, and plasticizers. For example, enteric-soluble film coating materials may be one or more of the following: shellac, cellulose acetate titanate (CAP), acrylic resins (such as Eudragit LI00 type, Eudragit SI00 type), hydroxypropyl methylcellulose titanate (HPMCP), plasticizers, and colorants.

[0021] The beneficial effects of the herbal composition of this invention are that, compared with the prior art, the herbal composition of this invention has better flowability, which is more conducive to the subsequent preparation of formulations. Moreover, in the field of formulation, dextrin is usually used as a filler to increase the volume and weight of tablets. Reducing the amount of dextrin during tablet preparation will lead to increased friability (i.e., tablets are more easily broken). However, the inventors have surprisingly discovered that, compared with the prior art, the content of the excipient dextrin in the herbal composition of this invention is significantly lower, but the friability of the tablets is actually reduced during the tableting process (i.e., tablets are less likely to break), and there are no broken, cracked, or pulverized tablets.

[0022] Secondly, the present invention provides a method for preparing a traditional Chinese medicine composition, comprising the following steps:

[0023] (1) Take chrysanthemum, (charred) scutellaria, a portion of plantain seed and a portion of cattail pollen, mix them together and grind them into fine powder;

[0024] (2) The remaining 15 ingredients and the remaining amount of plantain and cattail pollen are soaked in water, decocted, and filtered to obtain a decoction.

[0025] (3) Concentrate the decoction into a paste, mix the paste with the fine powder obtained in step (1), and granulate to obtain granules.

[0026] Specifically, the preparation method of the present invention may further include frying Scutellaria baicalensis into charcoal before step (1).

[0027] Specifically, in step (1), a portion of the plantain seed is 40%-60% (e.g., 40%, 45%, 50%, 55% or 60%) of the total plantain seed, and / or a portion of the cattail pollen is 40%-60% (e.g., 40%, 45%, 50%, 55% or 60%) of the total cattail pollen.

[0028] Specifically, the fine powder mentioned in step (1) is 80-120 mesh, for example, 80 mesh, 90 mesh, 100 mesh, 110 mesh or 120 mesh.

[0029] Specifically, the soaking time in step (2) is 0.25h-5h, for example 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h or 5h.

[0030] Specifically, the decoction method described in step (2) is as follows: decoct 1-4 times (e.g., once, twice, three times or four times), each time for 1-5 hours (e.g., 1 hour, 2 hours, 3 hours, 4 hours or 5 hours).

[0031] Specifically, the concentration temperature in step (3) is 50°C-80°C, for example, 50°C, 55°C, 60°C, 65°C, 70°C, 75°C or 80°C.

[0032] Specifically, in step (3), the paste may optionally be dried (e.g., spray dried) and then mixed with the fine powder obtained in step (1) for granulation.

[0033] Specifically, the paste in step (3) is a thick paste or a clear paste; preferably, the relative density of the paste is 1.35-1.39 or 1.10-1.15. Specifically, dextrin may be added in step (3), preferably the amount of dextrin added is less than or equal to 1% based on the total weight of the active ingredient raw materials, for example, less than 1%, 0.5%, 0.3%, 0.1%, 0.05%, 0.01% or lower. Preferably, the dextrin may be added after the granulation operation in step (3). Optionally, the granulation in step (3) may be performed by adding 85% ethanol after adding the dextrin for a second granulation.

[0034] Specifically, the granulation described in step (3) can be performed using a granulator (such as a fluidized bed granulation dryer).

[0035] Specifically, the granulation process in step (3) includes post-granulation drying (e.g., within the range of 50℃-80℃, such as 50℃, 55℃, 60℃, 65℃, 70℃, 75℃ or 80℃) and / or granulation; preferably, the post-granulation drying and / or granulation can be performed 1-3 times, such as once, twice or three times.

[0036] Specifically, the preparation method of the present invention may further include step (4), that is, adding magnesium stearate to the particles obtained in step (3), mixing evenly, and compressing into tablets. Preferably, the amount of magnesium stearate added is 0.1%-1% of the mass of the particles obtained in step (3), such as 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, or 1%; for example, the amount of magnesium stearate added may be 0.1%-0.3% of the mass of the particles obtained in step (3).

[0037] Specifically, the traditional Chinese medicine composition is as defined in the first aspect of this application.

[0038] The beneficial effects of the preparation method of the traditional Chinese medicine composition of the present invention are as follows: compared with the prior art, the preparation method of the traditional Chinese medicine composition of the present invention reduces the amount of dextrin added and lowers the cost; the traditional Chinese medicine composition of the present invention prepared thereby has better fluidity and is more conducive to the preparation of subsequent formulations.

[0039] Thirdly, the present invention provides a traditional Chinese medicine preparation, comprising the traditional Chinese medicine composition of the first aspect of the present invention or the traditional Chinese medicine composition prepared by the preparation method of the second aspect of the present invention, and a coating material.

[0040] Specifically, the coating material is a sugar coating material or a film coating material.

[0041] In this application, the sugar coating material includes or is selected from one or more of sucrose, colorants, barrier agents, and additives. For example, the colorant is at least one of activated carbon, red iron oxide, purple iron oxide, yellow iron oxide, black iron oxide, brown iron oxide, and lake. For example, the barrier agent is at least one of insect wax, beeswax, and carnauba wax. For example, the additive is at least one of talc, micronized silica gel, gelatin, magnesium stearate, and powdered sugar.

[0042] In this application, the film coating material includes or is selected from gastric-soluble film coating materials and enteric-soluble film coating materials. For example, gastric-soluble film coating materials may be one or more of the following: cellulose derivatives (such as hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, etc.), povidone, acrylic resins (such as acrylic resin IV), polyvinyl acetaldehyde diethylamine ethyl ester (AEA), polyethylene glycol, titanium dioxide, colorants, and plasticizers. For example, enteric-soluble film coating materials may be one or more of the following: shellac, cellulose acetate titanate (CAP), acrylic resins (such as Eudragit LI00 type, Eudragit SI00 type), hydroxypropyl methylcellulose titanate (HPMCP), plasticizers, and colorants.

[0043] Fourthly, the present invention provides the use of the traditional Chinese medicine composition of the first aspect of the present invention, the traditional Chinese medicine composition prepared by the preparation method of the second aspect of the present invention, or the traditional Chinese medicine preparation of the third aspect of the present invention in the preparation of medicaments for treating and / or preventing retinal hemorrhage, diabetic retinopathy, retinal vein occlusion, macular degeneration, glaucoma, vitreous hemorrhage, pterygium, creeping choroiditis, punctate inner choroidal lesions, keratitis, and / or ocular hypertension.

[0044] In this application, the term "fundus hemorrhage" refers to bleeding in the retina, choroid, or vitreous body of the eye, especially in patients with underlying diseases such as hypertension, diabetes, nephritis, or blood disorders, which may lead to complications such as blurred vision, narrowed visual field, and decreased dark adaptation.

[0045] In this application, the term "diabetic retinopathy" is often referred to as diabetic retinopathy, which refers to a series of lesions caused by damage to the microvessels of the retina due to diabetes. It is one of the common chronic complications of diabetes and one of the leading causes of blindness in adults.

[0046] In this application, the term "retinal vein occlusion" refers to an ocular vascular disease characterized by partial or complete blockage of the retinal veins, leading to restricted retinal blood flow and hypoxia. The blockage can occur at any venous site in the retina, and therefore retinal vein occlusion is generally classified into two types: central retinal vein occlusion and branch retinal vein occlusion.

[0047] In this application, the term "macular degeneration" refers to a lesion occurring in the macular region of the retina, also known as macular disease, which can cause symptoms such as decreased vision, distorted vision, or black spots in the field of vision. Clinically, macular diseases can be classified into several types, including age-related macular degeneration and central serous chorioretinopathy (hereinafter referred to as "central serous chorioretinopathy").

[0048] In this application, the term "glaucoma" refers to a group of diseases characterized by optic nerve atrophy and visual field defects. Glaucoma has a certain genetic predisposition, and pathological intraocular pressure elevation is its main risk factor. Therefore, glaucoma can generally be divided into three categories: primary glaucoma, secondary glaucoma, and congenital glaucoma.

[0049] In this application, the term "vitreous hemorrhage" refers to blood entering the vitreous cavity. It is a common complication of various eye diseases, such as ocular trauma or fundus vascular diseases, that can impair vision. On the one hand, the hemorrhage obscures the refractive media, hindering light from reaching the retina, and also affects the vitreous structure and adjacent tissues; on the other hand, the body's response to the hemorrhage can gradually clear the blood.

[0050] In this application, the term "pterygium" refers to a benign proliferative lesion in which localized fibrovascular tissue of the bulbar conjunctiva invades the cornea, named for its resemblance to the wings of an insect.

[0051] In this application, the term "creeping choroiditis," also known as peripapillary geographic spiral choroidal lesion or geographic choroiditis, is a rare, chronic, relapsing inflammatory disease that usually affects both eyes, primarily involving the choroid and retinal pigment epithelium (RPE), and whose etiology is unknown.

[0052] In this application, the term "punctate inner choroidal lesion" refers to an inflammatory disease affecting the inner choroidal layer (i.e., the choroidal capillaries and Bruch's membrane) and the retinal pigment epithelium (RPE). First reported by Watzke in 1984, its etiology and pathogenesis remain unclear. It manifests as scattered yellowish-white lesions in the posterior pole, located at the level of the retinal pigment epithelium and inner choroidal layer. It is a self-limiting process, usually without anterior segment and vitreous inflammation, and most patients have a good visual prognosis.

[0053] In this application, the term "keratitis" refers to inflammation of the corneal tissue caused by exogenous or endogenous pathogenic factors when the cornea's defense capabilities are weakened. Patients primarily present with ocular irritation symptoms such as eye pain, photophobia, tearing, and blepharospasm.

[0054] In this application, the term "ocular hypertension," also known as suspected glaucoma, refers to intraocular pressure that is higher than the statistical upper limit of normal (21 mmHg), but with no detectable damage to the optic disc or visual field and an open anterior chamber angle. Detailed Implementation

[0055] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0056] I. Preparation Examples and Comparative Examples

[0057] Example 1

[0058] 80g of Typha pollen, 80g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 50g of Scutellaria baicalensis, 50g of Cassia tora, 50g of Plantago asiatica, 50g of Leonurus japonicus, 50g of Ligustrum lucidum, 50g of Prunella vulgaris, 50g of Gentiana scabra, 40g of Curcuma longa, 50g of Equisetum hyemale, 40g of Paeonia lactiflora, 40g of Paeonia suffruticosa, 40g of Crataegus pinnatifida, 40g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0059] The preparation method is as follows:

[0060] (1) Take 50g of chrysanthemum, 50g of (charred) scutellaria baicalensis, 25g of plantain seed, and 40g of cattail pollen, mix and grind them into 80-120 mesh fine powder, and set aside.

[0061] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0062] (3) The filtrate is concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (60℃). The thick paste is mixed evenly with the fine powder obtained in step (1) above, dried at 60℃, granulated, and 0.47g of dextrin is added. The paste is then granulated with 85% ethanol, dried at 60℃, and granulated to obtain granules.

[0063] (4) Add 0.94g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0064] Example 2

[0065] 80g of Typha pollen, 80g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 50g of Scutellaria baicalensis, 50g of Cassia tora, 50g of Plantago asiatica, 50g of Leonurus japonicus, 50g of Ligustrum lucidum, 50g of Prunella vulgaris, 50g of Gentiana scabra, 40g of Curcuma longa, 50g of Equisetum hyemale, 40g of Paeonia lactiflora, 40g of Paeonia suffruticosa, 40g of Crataegus pinnatifida, 40g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0066] The preparation method is as follows:

[0067] (1) Take 50g of chrysanthemum, 50g of (charred) scutellaria baicalensis, 25g of plantain seed, and 40g of cattail pollen, mix and grind them into 80-120 mesh fine powder, and set aside.

[0068] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0069] (3) The filtrate was concentrated under reduced pressure to a clear paste with a relative density of 1.10-1.15 (60℃), spray-dried, and the paste powder was granulated with the fine powder obtained in step (1) and 0.47g of dextrin.

[0070] (4) Add 0.94g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0071] Example 3

[0072] 50g of Typha pollen, 50g of Salvia miltiorrhiza, 45g of Rehmannia glutinosa, 45g of Eclipta prostrata, 40g of Chrysanthemum morifolium, 30g of Scutellaria baicalensis, 30g of Cassia tora, 30g of Plantago asiatica, 30g of Leonurus japonicus, 30g of Ligustrum lucidum, 30g of Prunella vulgaris, 30g of Gentiana scabra, 20g of Curcuma longa, 30g of Equisetum hyemale, 20g of Paeonia lactiflora, 20g of Paeonia suffruticosa, 20g of Crataegus pinnatifida, 20g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0073] The preparation method is as follows:

[0074] (1) Take 40g of chrysanthemum, 30g of (charred) scutellaria baicalensis, 15g of plantain seed and 25g of cattail pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0075] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0076] (3) The filtrate was concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (60℃). The thick paste was mixed evenly with the fine powder obtained in step (1) above, dried at 60℃, granulated, and 5.9g of dextrin was added. The paste was then granulated with 85% ethanol, dried at 60℃, and granulated to obtain granules.

[0077] (4) Add 1.77g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0078] Example 4

[0079] 50g of Typha pollen, 50g of Salvia miltiorrhiza, 45g of Rehmannia glutinosa, 45g of Eclipta prostrata, 40g of Chrysanthemum morifolium, 30g of Scutellaria baicalensis, 30g of Cassia tora, 30g of Plantago asiatica, 30g of Leonurus japonicus, 30g of Ligustrum lucidum, 30g of Prunella vulgaris, 30g of Gentiana scabra, 20g of Curcuma longa, 30g of Equisetum hyemale, 20g of Paeonia lactiflora, 20g of Paeonia suffruticosa, 20g of Crataegus pinnatifida, 20g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0080] The preparation method is as follows:

[0081] (1) Take 40g of chrysanthemum, 30g of (charred) scutellaria baicalensis, 15g of plantain seed and 25g of cattail pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0082] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 60 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0083] (3) The filtrate was concentrated under reduced pressure to form a clear paste with a relative density of 1.10-1.15 (60℃), spray-dried, and the paste powder was granulated with the fine powder obtained in step (1) and 5.9g of dextrin.

[0084] (4) Add 1.77g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0085] Example 5

[0086] 65g of Typha pollen, 65g of Salvia miltiorrhiza, 55g of Rehmannia glutinosa, 55g of Eclipta prostrata, 45g of Chrysanthemum morifolium, 40g of Scutellaria baicalensis, 40g of Cassia tora, 40g of Plantago asiatica, 40g of Leonurus japonicus, 40g of Ligustrum lucidum, 40g of Prunella vulgaris, 40g of Gentiana scabra, 30g of Curcuma longa, 40g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0087] The preparation method is as follows:

[0088] (1) Take 45g of chrysanthemum, 40g of (charred) Scutellaria baicalensis, 20g of Plantago asiatica and 32.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0089] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0090] (3) The filtrate is concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (60℃). The thick paste is mixed evenly with the fine powder obtained in step (1) above, dried at 60℃, granulated, and 0.76g of dextrin is added. The paste is then granulated with 85% ethanol, dried at 60℃, and granulated to obtain granules.

[0091] (4) Add 1.15g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0092] Example 6

[0093] 65g of Typha pollen, 65g of Salvia miltiorrhiza, 55g of Rehmannia glutinosa, 55g of Eclipta prostrata, 45g of Chrysanthemum morifolium, 40g of Scutellaria baicalensis, 40g of Cassia tora, 40g of Plantago asiatica, 40g of Leonurus japonicus, 40g of Ligustrum lucidum, 40g of Prunella vulgaris, 40g of Gentiana scabra, 30g of Curcuma longa, 40g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0094] The preparation method is as follows:

[0095] (1) Take 45g of chrysanthemum, 40g of (charred) Scutellaria baicalensis, 20g of Plantago asiatica and 32.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0096] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0097] (3) The filtrate was concentrated under reduced pressure to a clear paste with a relative density of 1.10-1.15 (60℃), spray-dried, and the paste powder was granulated with the fine powder obtained in step (1) and 0.76g of dextrin.

[0098] (4) Add 1.15g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0099] Example 7

[0100] 75g of Typha pollen, 75g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 45g of Scutellaria baicalensis, 45g of Cassia tora, 45g of Plantago asiatica, 45g of Leonurus japonicus, 45g of Ligustrum lucidum, 45g of Prunella vulgaris, 45g of Gentiana scabra, 30g of Curcuma longa, 45g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0101] The preparation method is as follows:

[0102] (1) Take 50g of chrysanthemum, 45g of (charred) Scutellaria baicalensis, 22.5g of Plantago asiatica and 37.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0103] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0104] (3) The filtrate was concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (60℃). The thick paste was mixed with the fine powder obtained in step (1) above, dried at 60℃, granulated, and 2.52g of dextrin was added. The paste was then granulated with 85% ethanol, dried at 60℃, and granulated to obtain granules.

[0105] (4) Add 1.5g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0106] Example 8

[0107] 75g of Typha pollen, 75g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 45g of Scutellaria baicalensis, 45g of Cassia tora, 45g of Plantago asiatica, 45g of Leonurus japonicus, 45g of Ligustrum lucidum, 45g of Prunella vulgaris, 45g of Gentiana scabra, 30g of Curcuma longa, 45g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0108] The preparation method is as follows:

[0109] (1) Take 50g of chrysanthemum, 45g of (charred) Scutellaria baicalensis, 22.5g of Plantago asiatica and 37.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0110] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0111] (3) The filtrate was concentrated under reduced pressure to a clear paste with a relative density of 1.10-1.15 (60℃), spray-dried, and the paste powder was granulated with the fine powder obtained in step (1) and 2.52g of dextrin.

[0112] (4) Add 1.5g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0113] Example 9

[0114] 65g of Typha pollen, 65g of Salvia miltiorrhiza, 50g of Rehmannia glutinosa, 50g of Eclipta prostrata, 40g of Chrysanthemum morifolium, 35g of Scutellaria baicalensis, 35g of Cassia tora, 35g of Plantago asiatica, 35g of Leonurus japonicus, 35g of Ligustrum lucidum, 35g of Prunella vulgaris, 35g of Gentiana scabra, 20g of Curcuma longa, 35g of Equisetum hyemale, 20g of Paeonia lactiflora, 20g of Paeonia suffruticosa, 20g of Crataegus pinnatifida, 20g of Angelica sinensis, and 5g of Ligusticum chuanxiong.

[0115] The preparation method is as follows:

[0116] (1) Take 40g of chrysanthemum, 35g of (charred) Scutellaria baicalensis, 17.5g of Plantago asiatica and 32.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0117] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0118] (3) The filtrate was concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (60℃). The thick paste was mixed evenly with the fine powder obtained in step (1) above, dried at 60℃, granulated, and 3.3g of dextrin was added. The paste was then granulated with 85% ethanol, dried at 60℃, and granulated to obtain granules.

[0119] (4) Add 1.65g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0120] Example 10

[0121] 65g of Typha pollen, 65g of Salvia miltiorrhiza, 50g of Rehmannia glutinosa, 50g of Eclipta prostrata, 40g of Chrysanthemum morifolium, 35g of Scutellaria baicalensis, 35g of Cassia tora, 35g of Plantago asiatica, 35g of Leonurus japonicus, 35g of Ligustrum lucidum, 35g of Prunella vulgaris, 35g of Gentiana scabra, 20g of Curcuma longa, 35g of Equisetum hyemale, 20g of Paeonia lactiflora, 20g of Paeonia suffruticosa, 20g of Crataegus pinnatifida, 20g of Angelica sinensis, and 5g of Ligusticum chuanxiong.

[0122] The preparation method is as follows:

[0123] (1) Take 40g of chrysanthemum, 35g of (charred) Scutellaria baicalensis, 17.5g of Plantago asiatica and 32.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0124] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0125] (3) The filtrate was concentrated under reduced pressure to a clear paste with a relative density of 1.10-1.15 (60℃), spray-dried, and the paste powder was granulated with the fine powder obtained in step (1) and 3.3g of dextrin.

[0126] (4) Add 1.65g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0127] Example 11

[0128] 80g of Typha pollen, 80g of Salvia miltiorrhiza, 70g of Rehmannia glutinosa, 70g of Eclipta prostrata, 60g of Chrysanthemum morifolium, 50g of Scutellaria baicalensis, 50g of Cassia tora, 50g of Plantago asiatica, 50g of Leonurus japonicus, 50g of Ligustrum lucidum, 50g of Prunella vulgaris, 50g of Gentiana scabra, 40g of Curcuma longa, 50g of Equisetum hyemale, 40g of Paeonia lactiflora, 40g of Paeonia suffruticosa, 40g of Crataegus pinnatifida, 40g of Angelica sinensis, and 15g of Ligusticum chuanxiong.

[0129] The preparation method is as follows:

[0130] (1) Take 60g of chrysanthemum, 50g of (charred) scutellaria baicalensis, 25g of plantain seed and 40g of cattail pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0131] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0132] (3) The filtrate is concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (60℃). The thick paste is mixed evenly with the fine powder obtained in step (1) above, dried at 60℃, granulated, 0.1g of dextrin is added, and granules are made with 85% ethanol. The granules are dried at 60℃ and granulated to obtain granules.

[0133] (4) Add 2g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0134] Example 12

[0135] 80g of Typha pollen, 80g of Salvia miltiorrhiza, 70g of Rehmannia glutinosa, 70g of Eclipta prostrata, 60g of Chrysanthemum morifolium, 50g of Scutellaria baicalensis, 50g of Cassia tora, 50g of Plantago asiatica, 50g of Leonurus japonicus, 50g of Ligustrum lucidum, 50g of Prunella vulgaris, 50g of Gentiana scabra, 40g of Curcuma longa, 50g of Equisetum hyemale, 40g of Paeonia lactiflora, 40g of Paeonia suffruticosa, 40g of Crataegus pinnatifida, 40g of Angelica sinensis, and 15g of Ligusticum chuanxiong.

[0136] The preparation method is as follows:

[0137] (1) Take 60g of chrysanthemum, 50g of (charred) scutellaria baicalensis, 25g of plantain seed and 40g of cattail pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0138] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0139] (3) The filtrate was concentrated under reduced pressure to a clear paste with a relative density of 1.10-1.15 (60℃), spray-dried, and the paste powder was granulated with the fine powder obtained in step (1) and 0.1g of dextrin.

[0140] (4) Add 2g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0141] Example 13

[0142] 75g of Typha pollen, 75g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 45g of Scutellaria baicalensis, 45g of Cassia tora, 45g of Plantago asiatica, 45g of Leonurus japonicus, 45g of Ligustrum lucidum, 45g of Prunella vulgaris, 45g of Gentiana scabra, 30g of Curcuma longa, 45g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0143] The preparation method is as follows:

[0144] (1) Take 50g of chrysanthemum, 45g of (charred) scutellaria baicalensis, 18g of plantain seed and 45g of cattail pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0145] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 15 minutes, decoct four times for 1 hour each time, and filter the decoction.

[0146] (3) The filtrate was concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (80℃). The thick paste was mixed with the fine powder obtained in step (1) above, dried at 60℃, granulated, and 2.52g of dextrin was added. The paste was then granulated with 85% ethanol, dried at 60℃, and granulated to obtain granules.

[0147] (4) Add 1.5g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0148] Example 14

[0149] 75g of Typha pollen, 75g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 45g of Scutellaria baicalensis, 45g of Cassia tora, 45g of Plantago asiatica, 45g of Leonurus japonicus, 45g of Ligustrum lucidum, 45g of Prunella vulgaris, 45g of Gentiana scabra, 30g of Curcuma longa, 45g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0150] The preparation method is as follows:

[0151] (1) Take 50g of chrysanthemum, 45g of (charred) scutellaria baicalensis, 18g of plantain seed and 45g of cattail pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0152] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 15 minutes, decoct four times for 1 hour each time, and filter the decoction.

[0153] (3) The filtrate was concentrated under reduced pressure to a clear paste with a relative density of 1.10-1.15 (80℃), spray-dried, and the paste powder was granulated with the fine powder obtained in step (1) and 2.52g of dextrin.

[0154] (4) Add 1.5g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0155] Example 15

[0156] 75g of Typha pollen, 75g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 45g of Scutellaria baicalensis, 45g of Cassia tora, 45g of Plantago asiatica, 45g of Leonurus japonicus, 45g of Ligustrum lucidum, 45g of Prunella vulgaris, 45g of Gentiana scabra, 30g of Curcuma longa, 45g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0157] The preparation method is as follows:

[0158] (1) Take 50g of chrysanthemum, 45g of (charred) scutellaria baicalensis, 27g of plantain seed and 30g of cattail pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0159] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 120 minutes, decoct once, each time for 5 hours, and filter the decoction.

[0160] (3) The filtrate was concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (50℃). The thick paste was mixed with the fine powder obtained in step (1) above, dried at 60℃, granulated, and 2.52g of dextrin was added. The paste was then granulated with 85% ethanol, dried at 60℃, and granulated to obtain granules.

[0161] (4) Add 1.5g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0162] Example 16

[0163] 75g of Typha pollen, 75g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 45g of Scutellaria baicalensis, 45g of Cassia tora, 45g of Plantago asiatica, 45g of Leonurus japonicus, 45g of Ligustrum lucidum, 45g of Prunella vulgaris, 45g of Gentiana scabra, 30g of Curcuma longa, 45g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0164] The preparation method is as follows:

[0165] (1) Take 50g of chrysanthemum, 45g of (charred) scutellaria baicalensis, 27g of plantain seed and 30g of cattail pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0166] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 120 minutes, decoct once, each time for 4 hours, and filter the decoction.

[0167] (3) The filtrate was concentrated under reduced pressure to form a clear paste with a relative density of 1.10-1.15 (50℃), spray-dried, and the paste powder was granulated with the fine powder obtained in step (1) and 2.52g of dextrin.

[0168] (4) Add 1.5g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0169] Comparative Example 1

[0170] 75g of Typha pollen, 75g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 45g of Scutellaria baicalensis, 45g of Cassia tora, 45g of Plantago asiatica, 45g of Leonurus japonicus, 45g of Ligustrum lucidum, 45g of Prunella vulgaris, 45g of Gentiana scabra, 30g of Curcuma longa, 45g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0171] The preparation method is as follows:

[0172] (1) Take 50g of chrysanthemum, 45g of (charred) Scutellaria baicalensis, 22.5g of Plantago asiatica and 37.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0173] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter to obtain the decoction.

[0174] (3) The decoction is concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (60℃). The thick paste is mixed evenly with the fine powder prepared in step (1) above, dried at 60℃, granulated, 30g of dextrin is added as an excipient, and granulated with 85% ethanol. The granules are dried at 60℃ and granulated to obtain granules.

[0175] (4) Add 1.5g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets to obtain the product.

[0176] Comparative Example 2

[0177] 75g of Typha pollen, 75g of Salvia miltiorrhiza, 60g of Rehmannia glutinosa, 60g of Eclipta prostrata, 50g of Chrysanthemum morifolium, 45g of Scutellaria baicalensis, 45g of Cassia tora, 45g of Plantago asiatica, 45g of Leonurus japonicus, 45g of Ligustrum lucidum, 45g of Prunella vulgaris, 45g of Gentiana scabra, 30g of Curcuma longa, 45g of Equisetum hyemale, 30g of Paeonia lactiflora, 30g of Paeonia suffruticosa, 30g of Crataegus pinnatifida, 30g of Angelica sinensis, and 10g of Ligusticum chuanxiong.

[0178] The preparation method is as follows:

[0179] (1) Take 50g of chrysanthemum, 45g of (charred) Scutellaria baicalensis, 22.5g of Plantago asiatica and 37.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0180] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen for 30 minutes, decoct twice for 2 hours each time, and filter to obtain the decoction.

[0181] (3) The decoction is concentrated under reduced pressure to form a clear paste with a relative density of 1.10-1.15 (60℃), spray-dried, and the paste powder is granulated with the fine powder prepared in step (1) above and 30g of dextrin.

[0182] (4) Add 1.5g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0183] Comparative Example 3

[0184] 80g of Typha pollen, 80g of Salvia miltiorrhiza, 70g of Rehmannia glutinosa, 70g of Eclipta prostrata, 60g of Chrysanthemum morifolium, 50g of Scutellaria baicalensis, 50g of Cassia tora, 50g of Plantago asiatica, 50g of Leonurus japonicus, 50g of Ligustrum lucidum, 50g of Prunella vulgaris, 50g of Gentiana scabra, 40g of Curcuma longa, 50g of Equisetum hyemale, 40g of Paeonia lactiflora, 40g of Paeonia suffruticosa, 40g of Crataegus pinnatifida, 40g of Angelica sinensis, and 15g of Ligusticum chuanxiong.

[0185] The preparation method is as follows:

[0186] (1) Take 60g of chrysanthemum, 50g of (charred) Scutellaria baicalensis, 22.5g of Plantago asiatica and 37.5g of Typha pollen, mix and grind into 80-120 mesh fine powder, and set aside;

[0187] (2) Soak the remaining 15 ingredients, including Salvia miltiorrhiza, and the remaining amount of Plantago asiatica and Typha pollen in water for 30 minutes, decoct twice for 2 hours each time, and filter the decoction.

[0188] (3) The decoction is concentrated under reduced pressure to form a thick paste with a relative density of 1.35-1.39 (60℃). The thick paste is mixed evenly with the fine powder prepared in step (1) above, dried at 60℃, granulated, 20g of dextrin is added as an excipient, and granulated with 85% ethanol. The granules are dried at 60℃ and granulated to obtain granules.

[0189] (4) Add 2g of magnesium stearate to the granules obtained in step (3), mix well, and compress 300mg into tablets.

[0190] II. Analysis and Testing

[0191] 1. Comparison of particle properties

[0192] The particles prepared in step (3) of Examples 1-16 and Comparative Examples 1-3 were tested for their bulk density, tap density and angle of repose according to the general method of the 2020 edition of the Chinese Pharmacopoeia. The results are shown in Table 1.

[0193] Table 1. Particle properties of Examples 1-16 and Comparative Examples 1-3

[0194]

[0195]

[0196] The results showed that, compared with Comparative Examples 1-3, the particles obtained in Examples 1-16 had smaller bulk density, tap density, and angle of repose. Specifically, regarding the angle of repose, the particles obtained in Comparative Examples 1-3 all had an angle of repose greater than 40°, indicating poor flowability; in contrast, the particles obtained in Examples 1-16 all had an angle of repose less than 40°, indicating that the particles obtained in Examples 1-16 had better flowability, which is more conducive to the preparation of subsequent formulations (such as tablets and granules).

[0197] 2. Comparison of tablet properties of unprocessed tablets (i.e., the samples obtained after compression into tablets in step (4) of the embodiments and comparative examples of the present invention)

[0198] The disintegration time test method was conducted according to the 2020 edition of the Pharmacopoeia of the People's Republic of China, Part IV, 0921, Tablet Disintegration Time Test Method. The friability test method was conducted according to the 2020 edition of the Pharmacopoeia of the People's Republic of China, Part IV, 0923, Tablet Friability Test Method, using a friability tester (purchased from Ningbo Xinzhi Technology Co., Ltd., model CSD01). The results are shown in Table 2.

[0199] Table 2 Comparison results of raw film detection in Examples 1-16 and Comparative Examples 1-3

[0200]

[0201] The results showed that the tablets of Examples 1-16 had shorter disintegration times compared to Comparative Examples 1-3, indicating that the time required for disintegration, dissolution, and absorption after oral administration was shorter. The friability of tablets from both Comparative Examples 1-3 and Examples 1-16 met the pharmacopoeia standard (less than 1%), but there were differences in appearance. Comparative Examples 1-3 showed the presence of broken, cracked, and pulverized tablets. In contrast, the inventors surprisingly found that reducing the amount of dextrin in the traditional Chinese medicine compositions of Examples 1-16 actually led to a decrease in tablet friability (i.e., the tablets were less prone to breakage), with no broken, cracked, or pulverized tablets.

[0202] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition, characterized in that, Including active ingredients and excipients; The active ingredients are made from the following raw materials: Typha pollen, Salvia miltiorrhiza, Rehmannia glutinosa, Eclipta prostrata, Chrysanthemum morifolium, Scutellaria baicalensis, Cassia tora, Plantago asiatica, Leonurus japonicus, Ligustrum lucidum, Prunella vulgaris, Gentiana scabra, Curcuma longa, Equisetum hyemale, Paeonia lactiflora, Paeonia suffruticosa, Crataegus pinnatifida, Angelica sinensis, and Ligusticum chuanxiong. in, The weight ratio of Chuanxiong to Yujin, Chishao, Mudanpi, Shanzha or Danggui is 1:2 to 1:4; The weight ratio of Ligusticum chuanxiong to Scutellaria baicalensis, Cassia tora, Plantago asiatica, Leonurus japonicus, Ligustrum lucidum, Prunella vulgaris, Gentiana scabra, and Equisetum hyemale is 1:3 to 1:

5. The weight ratio of Ligusticum chuanxiong to chrysanthemum is 1:4 to 1:5; The weight ratio of Ligusticum chuanxiong to Rehmannia glutinosa or Eclipta prostrata is 1:4.5 to 1:6; and / or The weight ratio of Ligusticum chuanxiong to Typha pollen or Salvia miltiorrhiza is 1:5 to 1:8; in, The excipients may include dextrin; in, Based on the total weight of the raw materials containing the active ingredient, the weight of dextrin is less than or equal to 1%.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The excipients also include a lubricant; preferably, the weight of the lubricant in the excipients is 0.1%-1% based on the total weight of the active ingredients.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It is available in granule, capsule, or tablet form.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It also includes coating materials, such as sugar coating materials or film coating materials.

5. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Take chrysanthemum, (charred) scutellaria, a portion of plantain seed and a portion of cattail pollen, mix them together and grind them into fine powder; (2) The remaining 15 ingredients and the remaining amount of plantain and cattail pollen are soaked in water, decocted, and filtered to obtain a decoction. (3) Concentrate the decoction into a paste, mix the paste with the fine powder obtained in step (1), and granulate to obtain granules.

6. The preparation method according to claim 5, characterized in that, In step (1), a portion of the plantain seed is 40%-60% of the total plantain seed, and / or a portion of the cattail pollen is 40%-60% of the total cattail pollen; And / or, The fine powder mentioned in step (1) is 80-120 mesh.

7. The preparation method according to claim 5, characterized in that, The soaking time in step (2) is 0.25-5 hours; And / or, The decoction method described in step (2) is as follows: decoct 1-4 times, 1-5 hours each time.

8. The preparation method according to claim 5, characterized in that, The concentration temperature described in step (3) is 50℃-80℃; And / or, The paste mentioned in step (3) is a thick paste or a clear paste.

9. The preparation method according to claim 5, characterized in that, It also includes step (4), which is to add magnesium stearate to the granules obtained in step (3), mix them, and compress them into tablets.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-4 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 5-9 in the preparation of a medicament for the prevention and / or treatment of retinal hemorrhage, diabetic retinopathy, retinal vein occlusion, macular degeneration, glaucoma, vitreous hemorrhage, pterygium, creeping choroiditis, punctate inner choroidal lesions, keratitis and / or ocular hypertension.

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