Shenshuaining dispersible tablet and preparation method thereof

Abstract

The invention discloses a Shenshuaining dispersible tablet and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The Shenshuaining dispersible tablet provided by the invention has the advantages of being convenient to carry and take and accurate in dosage, is excellent in moisture resistance, is quick to disintegrate, is excellent in dispersion state and is quick to dissolve out, and the bioavailability of the Shenshuaining dispersible tablet is improved. The key points of the technical scheme are as follows: by selecting specific types and dosages of a filling agent, a disintegrating agent and a lubricating agent, the consistency and reliability of the medicine quality are ensured, the disintegration is rapid, the dispersion state is good, the dissolution is rapid, and the dissolution and moisture resistance of effective components of the medicine are greatly improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and more particularly, relates to a Shenshuaining dispersible tablets and a preparation method thereof. Background Art

[0002] Research shows that rhubarb has good curative effects on treating kidney diseases. It can inhibit the hyperplasia of mesangial cells and renal tubular epithelial cells, reduce compensatory hypertrophy, delay glomerular sclerosis, improve the hypercoagulable and hyperviscous states of renal failure patients, improve renal blood flow, protect residual renal function, and reduce proteinuria. As a classic Chinese herbal medicine, rhubarb is bitter and cold in nature, and belongs to the spleen, stomach, large intestine, liver, and pericardium meridians. It has the functions of purging heat and promoting defecation, cooling blood and detoxifying, removing blood stasis and dredging channels. It is used for damp-heat constipation, stagnant abdominal pain, unsmooth diarrhea, damp-heat jaundice, hematemesis due to blood-heat, red eyes, pharyngeal swelling, appendicitis pain, carbuncle and furuncle, blood stasis amenorrhea, traumatic injury, external treatment of scalds by fire and water, and upper gastrointestinal bleeding. Many traditional Chinese medicine compositions for treating kidney diseases utilize the purging and discharging turbidity function of rhubarb to help toxins excrete from the intestine, so as to achieve the purposes of clearing heat and detoxifying, promoting blood circulation and removing stasis, expelling the old and bringing forth the new, harmonizing the five internal organs, and delaying the progression of chronic renal failure. A typical traditional Chinese patent medicine for treating kidney diseases using rhubarb is Shenshuaining.

[0003] The composition of Shenshuaining is complex, including the mixture of various substances, such as total alkaloids, anthraquinones, and flavonoids. It has the effects of replenishing qi and strengthening the spleen, promoting blood circulation to remove blood stasis, and purging the stomach and discharging turbidity. Shenshuaining tablets are yellowish-brown to brownish-brown; they taste bitter. It is used for low back pain and fatigue, sallow complexion, nausea and vomiting, loss of appetite, dysuria, sticky stools caused by spleen dysfunction in transportation, stasis and turbidity blockage, and failure of ascending and descending functions, and for patients with chronic renal insufficiency caused by various reasons showing the above syndromes.

[0004] At present, the commercially available oral preparations of Shenshuaining mainly include ordinary tablets, capsules, and granules. The traditional Chinese medicine extract or powder made from Shenshuaining has high viscosity and is easy to absorb moisture in the air. Moreover, ordinary tablets and capsules often affect the full absorption of drugs due to slow disintegration and drug dissolution. It is difficult for the elderly, children, and patients with swallowing difficulties to take them. The problem is particularly prominent when the drug dose and specification are large or a large number of tablets need to be taken at one time. Granules often need to be swallowed with water when taken, which is not convenient and it is not easy to accurately control the dosage.

[0005] Dispersible tablets, also known as water-dispersible tablets, are tablets that rapidly disintegrate upon contact with water, forming a homogeneous, viscous suspension. Dispersible tablets combine the advantages of both tablets and liquid formulations, overcoming their shortcomings, and also offer higher bioavailability. Compared to ordinary tablets and capsules, dispersible tablets feature excellent dispersion, short disintegration time, rapid drug dissolution, fast absorption, high bioavailability, fewer adverse reactions, and convenient administration. They can be swallowed whole or dispersed in water and taken with fruit juice or milk, making them particularly suitable for the elderly, children, and patients with difficulty swallowing. With the development of the pharmaceutical industry, dispersible tablets have been included in pharmacopoeias of various countries. The British Pharmacopoeia began including three types of dispersible tablets, including aspirin, in 1980, and the Pharmacopoeia of the People's Republic of China began including dispersible tablets in the 2000 edition. However, dispersible tablets of traditional Chinese medicine are not commonly found in pharmacopoeias of various countries, especially since the preparation process is not standardized. The 2025 edition of the Chinese Pharmacopoeia stipulates that dispersible tablets require a stainless steel wire mesh with an inner diameter of 710 μm and a water temperature of 15-25℃. Six tablets of the test sample should disintegrate and pass through the sieve within 3 minutes. If a small amount cannot pass through the sieve, but has softened into a light and floating substance without a hard core, it meets the requirements. Compared with ordinary dosage forms, this greatly improves the bioavailability of the drug.

[0006] Therefore, making Shenshuai Ning tablets into dispersible tablets can completely preserve the efficacy and compatibility characteristics of Shenshuai Ning tablets, and has the advantages of dispersible tablets such as rapid disintegration, full absorption and improved bioavailability. It can not only enhance the therapeutic effect, but also overcome the disadvantages of decoctions, ordinary tablets and capsules, such as inconvenience of decoction before use, large oral dosage and poor compliance. It is also beneficial for elderly patients, infants and young children and other people with swallowing difficulties to take, providing patients with a convenient and efficient way of taking medicine.

[0007] The paper "Dosage Form Reform and Pharmacodynamic Study of Renal Failure Dispersible Tablets" was published in 2007. This paper discloses a dispersible form of Renal Failure Dispersible Tablets: Renal Failure Dispersible Tablets prepared with 10% microcrystalline cellulose, 20% cross-linked polyvinyl chloride and 1% micronized silica gel. Pharmaceutical studies were conducted, and the results showed that the disintegration time of Renal Failure Dispersible Tablets was relatively fast, but the amount of disintegrant was relatively high, and the moisture-proof properties and dissolution of active ingredients of the drug were not tested.

[0008] In solving the above problems or overcoming the above defects, the present invention encountered the following difficulties and obstacles: In the development of Shenshuining dispersible tablets, the most important task is to find fillers and disintegrants that can protect drug stability while improving disintegration time, dissolution rate, and dispersion, thereby effectively increasing bioavailability. Therefore, more stringent requirements need to be placed on the types and percentages of the added fillers and disintegrants.

[0009] Therefore, there is an urgent need for a renal failure dispersible tablet with short disintegration time, good dispersion uniformity, good dissolution of active ingredients and good moisture-proof properties, as well as a simple preparation method for the renal failure dispersible tablet. Summary of the Invention

[0010] The purpose of this invention is to provide: A renal failure dispersible tablet, its preparation method, and related technologies are disclosed to address the technical problems, such as the large amount of disintegrant used, poor dissolution of active ingredients, and poor moisture resistance in tablets produced by traditional renal failure tablet preparation methods, or a combination thereof.

[0011] Terminology Explanation: Unless otherwise defined, all technical terms in this document have the same meanings as commonly understood by one of ordinary skill in the art to which the subject matter of the claims pertains. Unless otherwise stated, all patents, patent inventions, and publications cited in this document are incorporated herein by reference in their entirety. If multiple definitions exist for terms in this document, the definitions in this chapter shall prevail.

[0012] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0013] Definitions of standard chemical terms can be found in the 2025 edition of the Pharmacopoeia of the People's Republic of China and the Complete Glossary of Pharmacological Terms. Unless otherwise stated, conventional methods within the scope of the art, such as the disintegration time test (General Rule 0921), shall be used.

[0014] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0015] The term "Shenshui Ning" as used in this article refers to a traditional Chinese medicine with the effects of invigorating qi and strengthening the spleen, clearing the bowels and eliminating turbidity, and promoting blood circulation and removing blood stasis. It is mainly used as an adjunct treatment for chronic renal insufficiency, which can delay the course of chronic renal failure, improve the patient's nutritional status, and help regulate inflammatory states. It is suitable for symptoms caused by spleen dysfunction and stagnation of turbidity, such as lower back pain, nausea, loss of appetite, and difficulty urinating. Common dosage forms include capsules and granules.

[0016] The term "dissolution" as used in this article refers to the rate and extent to which an active drug dissolves from ordinary formulations such as tablets, capsules, or granules under specified conditions. In formulations such as sustained-release, controlled-release, enteric-coated, and transdermal patches, it is also called release rate.

[0017] The term "angle of repose" used in this article refers to the maximum angle between the inclined plane of the cone formed by the natural accumulation of powder and the horizontal plane. It is an important indicator of powder flowability and is used to evaluate the flowability of drug powders, granules, or excipients in their natural stacking state. The smaller the angle, the better the flowability. According to the General Rules, Part IV of the Pharmacopoeia of the People's Republic of China, the methods for determining the angle of repose mainly include three methods: the fixed funnel method, the fixed cone base method, and the tilting method. These methods are applicable to the flowability assessment of granules, powders, capsules, and other preparations in the pharmaceutical industry.

[0018] The term "filler" as used in this article refers to a component in a pharmaceutical preparation used to increase its volume or weight, also known as a diluent. Commonly used diluents include starch, sucrose, lactose, pregelatinized starch, microcrystalline cellulose, inorganic salts, and sugar alcohols. Diluents typically constitute a large proportion of pharmaceutical dosage forms, serving not only to ensure a specific volume but also to reduce dosage deviations of the active pharmaceutical ingredient and improve the compressibility of the drug. The selection of filler type and dosage usually depends on its physicochemical properties, which can affect the formability and performance of the preparation (such as powder flowability, wet or dry granulation formability, content uniformity, disintegration, dissolution, tablet appearance, tablet hardness and friability, physical and chemical stability, etc.).

[0019] The term "disintegrant" as used in this article refers to an ingredient added to a formulation that causes the preparation to rapidly disintegrate into smaller units and dissolve the drug more quickly. When disintegrants come into contact with water, gastric juice, or intestinal fluid, they absorb the liquid, swell, dissolve, or form a gel, causing disruption and disintegration of the formulation structure and promoting drug dissolution. There are four main mechanisms by which different disintegrants exert their effects: swelling, deformation, capillary action, and repulsion. The functionality of a disintegrant depends on several factors, such as its chemical properties, particle size and particle size distribution, and particle morphology. It is also influenced by important tablet factors, such as hardness and porosity. Disintegrants include natural, synthetic, or chemically modified natural polymers. Commonly used disintegrants include: dry starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, croscarmellose sodium, crospovidone, effervescent disintegrants, etc. Changes in gastrointestinal pH or the formation of complexes with ionic active pharmaceutical ingredients (APIs) will affect disintegration performance.

[0020] As used in this article, the term "lubricant" refers to a lubricant that reduces friction between particles and between the metal contact surfaces of particles and solid dosage form manufacturing equipment, such as tablet punches and dies. Lubricants can be classified into interfacial lubricants, fluid film lubricants, and liquid lubricants. Commonly used lubricants include: magnesium stearate, micronized silica gel, talc, hydrogenated vegetable oil, polyethylene glycol, and sodium lauryl sulfate.

[0021] The term "rhubarb" as used in this article refers to: rhubarb palmatum, also known as Huangliang, General, Western Rhubarb, and Jinjun, a plant belonging to the genus Rhubarb in the family Polygonaceae. Rheumatism L. Tangut rhubarb R. tanguticum Maxim. ex Balf. Or medicinal rhubarb R. officinale Baill. The root and rhizome of rhubarb. Rhubarb is cold in nature and bitter in taste, and enters the stomach, spleen, large intestine, liver, and pericardium meridians. The dried root and rhizome of rhubarb are used as medicine. It has the effects of purging and eliminating stagnation, clearing heat and purging fire, cooling blood and detoxifying, and removing blood stasis and promoting menstruation. It can be used for symptoms such as constipation due to stagnation, hematemesis and epistaxis due to blood heat, red eyes and sore throat, sores due to heat toxin, burns, scalds and scalds, dysentery due to damp heat, jaundice, urinary tract infection, and various symptoms of blood stasis.

[0022] The term "Prince Ginseng" as used in this article refers to *Pseudostellaria heterophylla*, a plant belonging to the genus *Pseudostellaria* in the family Caryophyllaceae. Pseudostellaria heterophylla (Miq.) pax ex pax et Hoffm. The tuberous root of the plant. It has the effects of invigorating qi and strengthening the spleen, promoting body fluid and moistening the lungs. It is mainly used to treat spleen deficiency and fatigue, loss of appetite, weakness after illness, qi and yin deficiency, spontaneous sweating and thirst, and dry cough due to lung dryness.

[0023] The term "Poria cocos" as used in this article refers to the fungus *Poria cocos*, belonging to the Polyporaceae family. Poria cocos (Schw.) Wolf The dried sclerotium has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind. It is mainly used to treat edema, phlegm retention, spleen deficiency diarrhea, palpitations, and insomnia.

[0024] The term "Pinellia" used in this article refers to: Pinellia ternata, a plant of the Araceae family (Araceae). Pinellia ternata (Thunb) Breit. The tuber of [unclear - possibly a plant name]. Found in most parts of China. Mainly produced in Sichuan, Hubei, Jiangsu, and Anhui provinces. Harvested in summer and autumn when the stems and leaves are lush, the outer skin and fibrous roots are removed, and then dried. It is spherical or broken into irregular granules. The surface is pale yellowish-white, yellow, or brownish-yellow. The texture is relatively loose and brittle or hard and brittle. It is mainly used to treat dampness and phlegm. Used for cough and asthma with excessive phlegm, dizziness and palpitations due to phlegm retention, vertigo due to wind-phlegm, and headache due to phlegm syncope.

[0025] The term "dried tangerine peel" used in this article refers to: *Citrus reticulata*, a plant belonging to the Rutaceae family and the Citrus genus. Citrus reticulata Blanco The dried, mature pericarp of the fruit and its cultivated varieties is warm in nature, pungent and bitter in taste, and enters the spleen and lung meridians. It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It is mainly used to treat spleen and stomach qi stagnation syndrome, vomiting, hiccups, damp phlegm, cold phlegm cough, chest pain, etc.

[0026] The term "Coptis chinensis" as used in this article refers to: Coptis chinensis, a commonly used medicinal herb for clearing heat and drying dampness, specifically the plant Coptis chinensis belonging to the genus Coptis of the Ranunculaceae family. Coptis chinensis Franch. Coptis chinensis triangularis Coptis deltoid CY Cheng and Hsiao Or Cloud Link Coptis teeta Wall. The dried rhizome. It is cold in nature and bitter in taste. It enters the heart, liver, stomach, and large intestine meridians. It has the functions of clearing heat and drying dampness, purging fire and detoxifying. When taken internally, it can be used to treat damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and delirium, excessive heart fire, restlessness and insomnia, palpitations, hematemesis due to blood heat, red eyes, toothache, diabetes, carbuncles and boils. When used externally, it can treat eczema, damp sores, and ear discharge.

[0027] The term "Salvia miltiorrhiza" as used in this article refers to Salvia miltiorrhiza, a medicinal herb that invigorates blood circulation and regulates menstruation, belonging to the genus Salvia of the Lamiaceae family. Salvia miltiorrhiza Bge. The dried roots and rhizomes of the plant. Slightly cold in nature and bitter in taste, it enters the heart and liver meridians, and has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling. It is mainly used for chest pain, abdominal and hypochondriac pain, abdominal masses, painful arthralgia, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0028] The term "safflower" as used in this article refers to: a medicinal herb that promotes blood circulation and regulates menstruation, specifically the safflower plant (Carthamus tinctorius) belonging to the genus Carthamus tinctorius in the family Asteraceae. Safflower L. Dried flowers. They are warm in nature and pungent in taste, entering the heart and liver meridians. They have the functions of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain. They are mainly used for amenorrhea, dysmenorrhea, lochia retention, abdominal masses, chest pain, abdominal pain due to blood stasis, chest and rib pain, traumatic injuries, and sores and swellings.

[0029] The term "Achyranthes bidentata" as used in this article refers to the plant Achyranthes bidentata, belonging to the Amaranthaceae family. Achyranthes bidentataBl. The dried root of the plant. It is neutral in nature, bitter and sour in taste, and enters the liver and kidney meridians. It has the effects of tonifying the liver and kidneys, strengthening tendons and bones, guiding blood downward, and promoting urination. It is often used for lower back and knee pain, weakness of tendons and bones, amenorrhea, abdominal masses, and urinary tract infections.

[0030] The term "licorice" used in this article refers to the legume plant *Glycyrrhiza uralensis*. Glycyrrhiza uralensis Fisch ., Licorice inflata Glycyrrhiza inflata Bat. Or licorice root Glycyrrhiza glabra L. The dried roots and rhizomes of the plant. Harvested in spring and autumn, the fibrous roots are removed, and then dried in the sun. It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing the effects of other herbs. It is used for spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other drugs.

[0031] The term "dispersion uniformity" used in this article refers to the ability of a dispersible tablet to rapidly disintegrate and disperse uniformly in water, making it easier to take and absorb.

[0032] The term “bioavailability” as used in this article refers to the relative amount and rate at which a drug or nutrient is absorbed by the body and enters the systemic circulation after administration via extravascular routes (such as oral or intramuscular injection).

[0033] The term "pharmaceutically acceptable" as used in this article means that, within the normal range of medical judgment, contact with a patient's tissues will not cause inappropriate toxicity, irritation, allergic reactions, etc., and that it has a reasonable benefit-risk ratio and is effective for its intended use.

[0034] As used in this article, the term “selected from” means: one or more elements from the groups listed below, selected independently, and may include combinations of two or more elements.

[0035] As used in this article, the term "disintegration" refers to the complete disintegration or fragmentation of a dispersible tablet under specified conditions, with all particles passing through a sieve except for insoluble excipients (such as coating materials or film materials) or broken excipients. This definition of "disintegration" corresponds to the definition of "disintegration" in the Chinese Pharmacopoeia.

[0036] As used herein, the term "disintegration time" refers to the time required for the dispersible tablet to undergo the aforementioned "disintegration". The disintegration time of the oral film formulation of the present invention can be detected using the methods described in the embodiments of the present invention.

[0037] The term "mixing" as used in this article refers to the process of combining two or more different substances (which may be solid, liquid, gas, or a combination of different states) through physical or mechanical means to form a uniform or relatively uniform dispersion system on a macroscopic scale.

[0038] The term "stirring" as used in this article refers to the operation of mixing multiple substances evenly by means of machinery or manual agitation. Specifically, it involves using external forces (such as rotating blades, stirring rods, airflow, etc.) to create flow within a container, thereby achieving uniform mixing of solids, liquids, or gases.

[0039] In a first aspect, the present invention provides: a renal failure-relieving dispersible tablet, comprising the following components by weight: 90-140 parts of raw materials for Shensui Ning (a traditional Chinese medicine); 10-60 parts of filler; 5-20 parts disintegrant; and 1-5 parts lubricant.

[0040] Preferably, the raw material for renal failure relief is any value or range between 100 and 130 parts by weight; More preferably, the raw material for renal failure relief is 115 parts by weight.

[0041] Preferably, the filler is selected from any value or range between 20 and 45 parts by weight; More preferably, the filler is selected from any value or range between 25 and 30 parts by weight; More preferably, the filler is 27 parts by weight.

[0042] Preferably, the disintegrant is selected from any value or range between 10 and 18 parts by weight; More preferably, the disintegrant is selected from any value or range between 14 and 16 parts by weight; More preferably, the disintegrant is 15 parts by weight.

[0043] Preferably, the lubricant is selected from any value or range between 2 and 4 parts by weight; More preferably, the lubricant is 3 parts by weight.

[0044] Preferably, the raw material for Renal Failure Relief comprises the following components by weight: 400 parts rhubarb, 250 parts codonopsis, 200 parts poria cocos, 250 parts prepared pinellia ternata, 100 parts tangerine peel, 100 parts coptis chinensis, 700 parts salvia miltiorrhiza, 100 parts safflower, 200 parts achyranthes bidentata, and 100 parts licorice.

[0045] Preferably, the filler is selected from one or more of lactolide, dextrin, and lactose; More preferably, the filler is lacritol.

[0046] Preferably, the disintegrant is selected from one or more of polacrine potassium, polacrine sodium, croscarmellose sodium, sodium carboxymethyl cellulose, and calcium carboxymethyl cellulose; More preferably, the disintegrant is potassium plutonium.

[0047] Preferably, the lubricant is selected from one or more of magnesium stearate and micronized silica gel; More preferably, the lubricant is magnesium stearate.

[0048] Secondly, the present invention provides a method for preparing the above-mentioned renal failure dispersible tablets, the method comprising the following steps: Preparation of raw materials for Renal Failure Relief: This product was prepared according to the method described in the "Preparation Method" section of Part I of the Chinese Pharmacopoeia 2025 edition, under the category of Shenshuai Ning Capsules.

[0049] Preparation of Renal Failure Dispersible Tablets (1) Weigh out the raw materials, fillers, disintegrants and lubricants of the renal failure-relieving agent; (2) Mixing: Mix evenly and sieve to obtain powder; (3) Tableting: The powder is compressed into tablets to obtain the product.

[0050] Preferably, the mesh size of the sieve in step (2) is 80-100 mesh.

[0051] Preferably, the weight of the tablet compressed in step (3) is 0.435g-0.583g.

[0052] Preferably, the hardness of the tablet compressed in step (3) is 35±5N.

[0053] The beneficial effects of this invention are as follows: The present invention has at least the following beneficial effects: 1. This invention prepares Renal Failure Relief into dispersible tablets, which have the advantages of being convenient to carry and take, having accurate dosage, and excellent moisture resistance.

[0054] 2. The dispersible tablets prepared by this invention reduce the amount of disintegrant used. Through reasonable formulation of excipients, they can achieve rapid disintegration, good dispersion, and fast dissolution. The dissolution rate of salvianolic acid B and rhubarb free anthraquinone is higher, which effectively improves bioavailability. Detailed Implementation

[0055] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0056] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0057] The manufacturers and models of the raw materials used in the following examples are shown in Table 1 below.

[0058] Table 1

[0059] Basic Example 1: Preparation of raw materials for Renal Failure Relief Prepared according to the method described in the "Preparation Method" section of Part I of the Chinese Pharmacopoeia 2025 edition, specifically as follows: S1. Prepare the raw materials: Weigh out 400 parts of rhubarb, 250 parts of codonopsis, 200 parts of poria cocos, 250 parts of pinellia ternata, 100 parts of tangerine peel, 100 parts of coptis chinensis, 750 parts of salvia miltiorrhiza, 100 parts of safflower, 200 parts of achyranthes bidentata and 100 parts of licorice. S2. Crushing and percolating: Crush 200 parts of rhubarb to obtain rhubarb powder; soak 200 parts of rhubarb in 70% ethanol for 24 hours, then slowly percolate, collect the percolate, and concentrate it into a thick paste 1 with a relative density of 1.25-1.30 (measured at 90-95℃). S3, Water Extraction: The remaining nine ingredients, including Codonopsis pilosula, are decocted three times with water. The first decoction is 3 hours, the second is 2 hours, and the third is 1 hour. The decoction is filtered, the filtrates are combined, and the mixture is concentrated under reduced pressure to a thick paste with a relative density of 1.10-1.20 (65-70℃). S4, alcohol precipitation and concentration: Add ethanol to the thick paste 2 from step (1.3) to make the alcohol content reach 60%, stir thoroughly, let stand for 72 hours, filter, and concentrate the filtrate under reduced pressure to thick paste 3 with a relative density of 1.25~1.30 (95-98℃); S5. Drying: Mix the thick paste 3 with the above thick paste 1 and rhubarb powder, granulate, and dry to obtain the final product.

[0060] Examples 1-6: Preparation of a Renal Failure Dispersible Tablet The prescription and its dosage are shown in Table 2: Table 2. Prescription and dosage of Shensuining Dispersible Tablets

[0061] Preparation method of Renal Failure Dispersible Tablets: (1) Weigh out the raw materials, fillers, disintegrants and lubricants of the renal failure-relieving agent; (2) Mixing: Mix evenly and pass through a 100-mesh sieve to obtain powder; (3) Tableting: The powder is compressed into tablets with a weight of 0.44±0.05g-0.58±0.03g and a hardness of 35±5N.

[0062] Examples 7-13: Preparation of a Renal Failure Dispersible Tablet The prescription and its dosage are shown in Table 3: Table 3. Prescription and dosage of Shensuining Dispersible Tablets

[0063] Preparation method of Renal Failure Dispersible Tablets: (1) Weigh out the raw materials, fillers, disintegrants and lubricants of the renal failure-relieving agent; (2) Mixing: Mix evenly and pass through an 80-mesh sieve to obtain powder; (3) Tableting: The powder is compressed into tablets with a weight of 0.44±0.05g-0.58±0.03g and a hardness of 35±5N.

[0064] Examples 14-15: Preparation of a Renal Failure Dispersible Tablet The prescription and its dosage are shown in Table 4: Table 4. Prescription and dosage of Shensuining Dispersible Tablets

[0065] Preparation method of Renal Failure Dispersible Tablets: (1) Weigh out the raw materials, fillers, disintegrants and lubricants of the renal failure-relieving agent; (2) Mixing: Mix evenly and pass through a 100-mesh sieve to obtain powder; (3) Tableting: The powder is compressed into tablets with a weight of 0.44±0.05g-0.58±0.03g and a hardness of 35±5N.

[0066] Examples 16-18: Preparation of a Renal Failure Dispersible Tablet The prescription and its dosage are shown in Table 5: Table 5. Prescription and dosage of Shensuining Dispersible Tablets

[0067] Preparation method of Renal Failure Dispersible Tablets: (1) Weigh out the raw materials, fillers, disintegrants and lubricants of the renal failure-relieving agent; (2) Mixing: Mix evenly and pass through a 100-mesh sieve to obtain powder; (3) Tableting: The powder is compressed into tablets with a weight of 0.44±0.05g-0.58±0.03g and a hardness of 35±5N.

[0068] Comparative Examples 1-4 The prescription and its dosage are shown in Table 6: Table 6. Prescription and dosage of Shensuining Dispersible Tablets

[0069] Comparative Example 1 uses the optimal composition recorded in "Dosage Form Reform and Pharmacodynamic Study of Traditional Chinese Medicine Shenshuining Dispersible Tablets" and is prepared according to the method recorded in "Dosage Form Reform and Pharmacodynamic Study of Traditional Chinese Medicine Shenshuining Dispersible Tablets"; Comparative Examples 2-4 use the same preparation methods as Examples 1-18 for Shenshuining Dispersible Tablets.

[0070] Example 1: Tests for moldability, angle of repose, and disintegration time. 1. Experimental Methods Formability test: Observe whether the prepared renal failure dispersible tablets are easy to form.

[0071] Appearance observation: Observe the color of the prepared renal failure dispersible tablets.

[0072] Dispersion uniformity: Tested according to the disintegration time limit test method (Chinese Pharmacopoeia, Part IV, General Chapter 0921), with a stainless steel wire mesh sieve inner diameter of 710 μm and a water temperature of 15-25℃; take 6 tablets of the renal failure dispersible tablets prepared in each example and comparative example, and they should all disintegrate and pass through the sieve within 3 minutes. If a small amount cannot pass through the sieve, but has softened into a light and floating substance without a hard core, it meets the requirements.

[0073] Disintegration time limit test: The test was conducted according to the disintegration time limit test method (Chinese Pharmacopoeia, Part IV, General Chapter 0921). Six tablets of the renal failure dispersible tablets prepared in each example and comparative example were placed in glass tubes of a hanging basket, and the disintegration tester was started to test and record the time for each tablet to completely disintegrate.

[0074] Angle of repose test: The angle of repose of the receptive tablets was measured using a BT-1000 powder comprehensive property tester.

[0075] 2. Experimental Results Based on the test results of formability, appearance, angle of repose, and disintegration time in Table 7 below, compared with Comparative Examples 1-4, the renal dispersible tablets prepared in Examples 1-18 had better appearance and formability. With a reduction in the amount of disintegrant, the disintegration time decreased. The renal dispersible tablets prepared in Comparative Examples 3-4 were difficult to form. Compared with Comparative Examples 1-4, the angle of repose of the renal dispersible tablets prepared in Examples 1-18 was less than 30°. The angle of repose of the renal dispersible tablets prepared in Comparative Examples 1-4 was larger, making them difficult to form and resulting in longer disintegration times. The results show that the content and combination of specific fillers, disintegrants, and lubricants have a significant impact on the angle of repose of the subsequently prepared dispersible tablets.

[0076] Table 7. Test results for formability, appearance, dispersion uniformity, angle of repose, and disintegration time.

[0077] Example 2: Hygroscopicity test 1. Experimental Methods The hygroscopicity of a drug refers to the property of a substance to absorb moisture under certain temperature and humidity conditions.

[0078] (1) Take a dry stoppered glass weighing bottle (outer diameter 50mm, height 15mm) and place it in an artificial climate chamber (set temperature 25℃±1℃, relative humidity 80%±2%) one day before the test, and accurately weigh it (m1).

[0079] (2) Take an appropriate amount of the test sample and spread it evenly in the weighing bottle. The thickness of the test sample is generally about 1 mm. Accurately weigh the sample (m2).

[0080] (3) Leave the weighing bottle open and place it together with the bottle cap under the above constant temperature and humidity conditions for 24 hours.

[0081] (4) Close the weighing bottle cap and accurately weigh the weight (m3).

[0082] Weight gain percentage = (m3 - m2) / (m2 - m1) * 100% 2. Experimental Results According to the hygroscopicity test results of the drugs in Table 8 below, the weight gain percentage of the renal failure dispersible tablets prepared in Examples 1-18 is less than 9% compared with Comparative Examples 1-4. Examples 1-18 used different combinations and contents of fillers and different combinations and contents of disintegrants. Compared with Comparative Examples 1-4, the hygroscopicity of Examples 1-18 was significantly reduced.

[0083] Table 8. Results of hygroscopicity test

[0084] Example 3: Dissolution testing of various indicator components in the formulation 1. Experimental Methods The test was conducted according to the third method (small cup method) of General Chapter 0931, Part IV, Chinese Pharmacopoeia 2025 Edition. 2. Experimental Results According to the dissolution test results of each index in Table 9 below, compared with Comparative Examples 1-4, the dissolution rates of salvianolic acid B and free anthraquinone from rhubarb in the renal failure dispersible tablets prepared in Examples 1-18 are all higher than 80%, indicating better bioavailability and reliable efficacy. Comparative Examples 1-4, by changing the type and amount of excipients, showed significantly limited dissolution. Therefore, it can be concluded that specific amounts of renal failure raw materials, fillers, disintegrants, and the type of filler all have a significant impact on the dissolution rates of salvianolic acid B and free anthraquinone from rhubarb in the renal failure dispersible tablets.

[0085] Table 9. Dissolution test results for each indicator.

[0086] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A Shenshuai dispersible tablet, characterized in that, by weight parts comprising: Shenshuaining raw material 90-140 parts; Filling agent 10-60 parts; Disintegrant 5-20 parts; and Lubricant 1-5 parts.

2. The Shenshuaining dispersible tablet according to claim 1, characterized in that, by weight parts comprising: Shenshuaining raw material 100-130 parts; Filling agent 20-45 parts; Disintegrant 10-18 parts; and Lubricant 2-4 parts.

3. The Shenshuaining dispersible tablet according to claim 2, characterized in that, by weight parts comprising: Shenshuaining raw material 115 parts; Filling agent 27 parts; Disintegrant 15 parts; and Lubricant 3 parts.

4. The dispersible tablets according to any one of claims 1 to 3, characterized in that, The filling agent is selected from one or more of lactitol, dextrin and lactose.

5. The Shenshuaining dispersible tablet according to claim 4, characterized in that, The filling agent is lactitol.

6. The Shenshuaiyin dispersible tablets according to any one of claims 1-3, characterized in that, The disintegrant is selected from one or more of polacure potassium, polacure sodium, croscarmellose sodium, sodium carboxymethyl cellulose and calcium carboxymethyl cellulose.

7. The Shenshuaining dispersible tablet according to claim 6, characterized in that, The disintegrant is polacure potassium.

8. The Shenshuaiyin dispersible tablets according to any one of claims 1-3, characterized in that, The lubricant is magnesium stearate and / or microfine silica.

9. The Shenshuaining dispersible tablet according to claim 8, characterized in that, The lubricant is magnesium stearate.

10. A process for the preparation of the dispersible tablets of EPO according to any one of claims 1 to 9, characterized in that, comprising the following steps: (1) weighing Shenshuaining raw material, filling agent, disintegrant and lubricant; (2) mixing: mixing uniformly and sieving, to obtain powder; (3) tabletting: tabletting the powder, to obtain the product.

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