DE112022006830T5 - USE OF A COMPOSITION OF TRADITIONAL CHINESE MEDICINE TO PREVENT AND TREAT RETINITIS PIGMENTOSA - Google Patents

Abstract

A composition of traditional Chinese medicine and its application. The composition of traditional Chinese medicine is prepared from: grass-leaved calamus root, cassia seed, desert cistanche, kopou bean root, feathery cockscomb, root of pilose asiabell, chasteberry fruit, fruit of Chinese boxthorn, seed of Asiatic plantain, root of white peony, fruit of Asiatic cornelian cherry, licorice root, silk seed, rhizome of largetrifoliolious bugbane, nut of thorn cherry, chrysanthemum flowers, flowers of pale butterfly bush, chuanxiong rhizome, wine-prepared rhizome of fragrant salmon seal, prepared rehmannia root, Amur cork tree, and tragacanth root. The composition of traditional Chinese medicine has a protective effect on visual function and the shape of retinal tissue, and can delay the rate of progression of retinitis pigmentosa to a certain extent.

Description

TECHNICAL FIELD

The present disclosure relates to the field of biomedicine, and more particularly to the use of a traditional Chinese medicine composition for the manufacture of a medicament for the prevention and treatment of retinitis pigmentosa.

BACKGROUND

Retinitis pigmentosa (RP) is a common hereditary eye disease characterized by progressive apoptosis of rod cells followed by involvement of cone cells, resulting in gradual loss of vision. The loss of photoreceptor cells is accompanied by degeneration of the retinal pigment epithelium. Most patients initially experience symptoms of dark adaptation disorder or night blindness, followed by gradual narrowing of the visual field. As the visual field fails and spreads to the macular area, central vision is also lost. RP is the most common hereditary eye disease, with a prevalence rate of 117,000 to 1/3,000 worldwide and about 1/3,784 in China. There is currently no effective treatment for RP, so it is of great clinical and sociological value to study the prevention and treatment of RP.

In some patients with RP, gene therapy is more effective. However, gene therapy technology is difficult, treatment costs are likely to be high, and the curative effect varies greatly between patients, making it not universally applicable.

Therefore, different therapies must be developed to prevent and treat retinitis pigmentosa.

SUMMARY

An object of the present disclosure is to provide a traditional Chinese medicine therapy for the prevention and treatment of retinitis pigmentosa.

The above object of the present disclosure can be achieved by the following technical solutions.

One aspect of the present disclosure provides the use of a traditional Chinese medicine composition for the manufacture of a medicament for the prevention and treatment of retinitis pigmentosa. The composition of traditional Chinese medicine includes the following components: 20 parts to 30 parts of Rhizoma Acori Tatarinowii, 30 parts to 40 parts of Semen Cassiae, 30 parts to 40 parts of Herba Cistanches, 30 parts to 40 parts of Radix Puerariae Lobatae, 30 parts to 40 parts of Semen Celosiae, 40 parts to 50 parts Radix Codonopsis, 30 parts to 40 parts Fructus Viticis, 40 parts to 50 parts Fructus Lycii, 30 parts to 40 parts Semen Plantaginis, 40 parts to 50 parts Radix Paeoniae Alba, 20 parts to 30 parts Fructus Corni, 20 parts to 30 parts Radix et Rhizoma Glycyrrhizae, 60 parts to 70 parts Semen Cuscutae, 1 part to 10 parts Rhizoma Cimicifugae, 30 parts to 40 parts Nux Prinsepiae, 30 parts to 40 parts Flos Chrysanthemi, 30 parts to 40 parts Flos Buddlejae, 30 parts to 40 parts Rhizoma Chuanxiong, 30 parts to 40 parts Rhizoma Polygonati, steamed with liquor, 60 parts to 70 parts Radix Rehmanniae Praeparata, 30 parts to 40 parts Cortex Phellodendri Amurensis and 40 parts to 50 parts Radix Astragali.

In some embodiments, the traditional Chinese medicine composition contains the following ingredients: 22±m parts of Rhizoma Acori Tatarinowii, 30±m parts of Semen Cassiae, 37±m parts of Herba Cistanches, 37±m parts of Radix Puerariae Lobatae, 30±m parts of Semen Celosiae, 48±m parts of Radix Codonopsis, 30±m parts of Fructus Viticis, 48±m parts of Fructus Lycii, 37±m parts of Semen Plantaginis, 45±m parts of Radix Paeoniae Alba, 24±m parts of Fructus Corni, 22±m parts of Radix et Rhizoma Glycyrrhizae, 61±m parts of Semen Cuscutae, 7±m parts of Rhizoma Cimicifugae, 37±m Parts of Nux Prinsepiae, 37±m parts of Flos Chrysanthemi, 37±m parts of Flos Buddlejae, 30±m parts of Rhizoma Chuanxiong, 37±m parts of Rhizoma Polygonati steamed with cerebrospinal fluid, 61±m parts of Radix Rehmanniae Praeparata, 30±m parts of Cortex Phellodendri Amurensis and 48±m parts of Radix Astragali, all m are equal and m is 1, 0.5, 0.2, 0.1 or 0.

In some embodiments, the traditional Chinese medicine composition is a Zhangyanming tablet.

In some embodiments, retinitis pigmentosa is autosomal recessive retinitis pigmentosa.

In some embodiments, autosomal recessive retinitis pigmentosa is caused by a mutation in the PDE6b gene.

In some embodiments, the medicament is a solid formulation.

In some embodiments, the solid formulation is selected from the group consisting of regular tablets, dispersible tablets, sustained release tablets, capsules, granules, and powders.

In some embodiments, the medicament is a Zhangyanming tablet.

In some embodiments, the medicament contains an effective amount of the traditional Chinese medicine composition.

In some embodiments, a subject of the medicament is a mammal.

In some embodiments, the subject is a mouse or a human.

In the present disclosure, the traditional Chinese medicine composition according to the present disclosure can significantly improve visual function and retinal tissue morphology, effectively delay the progression of retinitis pigmentosa, and have important value in the prevention and treatment of retinitis pigmentosa.

BRIEF DESCRIPTION OF THE DRAWINGS

• Fig.. 1 zeigt Farbfotografien der Netzhaut von Mäusen in verschiedenen Gruppen nach 7-tägiger intragastrischer Verabreichung, gemäß einer Ausführungsform der vorliegenden Offenbarung, wobei A eine normale Kontrollgruppe, B eine experimentelle Kontrollgruppe und C eine Zhangyanming-Tablettengruppe darstellt.
• Fig.. 2 zeigt Farbfotografien der Netzhaut von Mäusen in verschiedenen Gruppen nach 14-tägiger intragastrischer Verabreichung, gemäß einer Ausführungsform der vorliegenden Offenbarung, wobei A eine normale Kontrollgruppe, B eine experimentelle Kontrollgruppe und C eine Zhangyanming-Tablettengruppe darstellt.
• Fig.. 3 zeigt Netzhaut-HE-Färbungsdiagramme von Mäusen in verschiedenen Gruppen nach 7-tägiger intragastrischer Verabreichung, gemäß einer Ausführungsform der vorliegenden Offenbarung, wobei A eine normale Kontrollgruppe, B eine experimentelle Kontrollgruppe und C eine Zhangyanming-Tablettengruppe darstellt.
• Fig.. 4 zeigt Netzhaut-HE-Färbungsdiagramme der Mäuse in verschiedenen Gruppen nach 14-tägiger intragastrischer Verabreichung, gemäß einer Ausführungsform der vorliegenden Offenbarung, wobei A eine normale Kontrollgruppe, B eine experimentelle Kontrollgruppe und C eine Zhangyanming-Tablettengruppe darstellt.

In order to make the technical solutions in the embodiments of the present disclosure or in the prior art more clear, the drawings used in the embodiments or in the prior art are briefly described below. Obviously, the drawings described below are only for some embodiments of the present disclosure, and other drawings can be derived by those skilled in the art having ordinary skill in the art without creative efforts.

• Fig. 1 shows color photographs of the retinas of mice in different groups after 7 days of intragastric administration according to an embodiment of the present disclosure, wherein A represents a normal control group, B represents an experimental control group, and C represents a Zhangyanming tablet group.
• Fig. 2 shows color photographs of the retinas of mice in different groups after 14 days of intragastric administration according to an embodiment of the present disclosure, wherein A represents a normal control group, B represents an experimental control group, and C represents a Zhangyanming tablet group.
• Fig. 3 shows retinal HE staining diagrams of mice in different groups after 7 days of intragastric administration according to an embodiment of the present disclosure, wherein A represents a normal control group, B represents an experimental control group, and C represents a Zhangyanming tablet group.
• Fig. 4 shows retinal HE staining diagrams of mice in different groups after 14 days of intragastric administration according to an embodiment of the present disclosure, wherein A represents a normal control group, B represents an experimental control group, and C represents a Zhangyanming tablet group.

DETAILED DESCRIPTION

The present disclosure will be described in more detail below with reference to the accompanying drawings, embodiments and examples. It should be noted that the embodiments examples are for illustrative purposes only and are not intended to limit the scope of the present disclosure. Those skilled in the art may make various changes or modifications to the present disclosure after reading the contents of the present disclosure, and these equivalent forms also fall within the scope of the present disclosure as defined by the appended claims.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure relates. The terms used in the description of the present disclosure are for the purpose of describing embodiments or examples only and are not intended to limit the present disclosure.

terms

The terms “and/or”, “or/and”, “both/and” as used herein mean that their selection ranges include any of two or more relevant listed items, as well as any or all combinations of the relevant listed items. The any or all combinations include combinations of any two of the relevant listed items, combinations of several of the relevant listed items, or combinations of all relevant listed items. When at least three items are connected with the combination of at least two conjunctions selected from “and/or” and “or/and”, the technical solution in the present disclosure undoubtedly includes technical solutions all connected by “logical and”, and it also undoubtedly includes technical solutions all connected by “logical or”. For example, “A and/or B” includes three parallel solutions, i.e. A, B and a combination of A and B. For example, the technical solution “A, and/or, B, and/or, C, and/or, D” includes any of A, B, C and D (i.e., technical solutions connected by “logical or”), as well as any or all combinations of A, B, C and D, i.e. including combinations of two or three of A, B, C and D, and also the combination of A, B, C and D (i.e. technical solutions connected by “logical and”).

The terms "preferably," "better," and "excellent" are used herein only to describe embodiments or examples having better effects and do not represent a limitation on the scope of the present disclosure.

In the present disclosure, the terms "first", "second", "third", etc. in "first aspect", "second aspect", "third aspect", etc. are used for descriptive purposes only and are not to be understood as indicating a relative importance or quantity or implicitly specifying the importance or quantity of the technical features recited. Furthermore, "first", "second", "third", etc. are for non-exhaustive listing only and do not represent an exhaustive quantity limitation.

In the present disclosure, an open description of the technical features includes both a closed technical solution consisting of the listed features and an open technical solution with the listed features.

In the present disclosure, “prevention (or prevention) and treatment (or treatment)” includes concepts such as prophylaxis, treatment and adjuvant therapy.

In the present disclosure, the “composition” may be a combination of plural substances, may be used in combination, or may be a mixture obtained by combining these substances.

In the present disclosure, the "effective amount" refers to a dosage of an ingredient that meets the term to achieve the treatment, prevention, mitigation and/or alleviation of a particular disease, disorder and/or symptom in a patient. In the present disclosure, unless otherwise specified, the term refers to a dosage that achieves the treatment, prevention, mitigation and/or cure of intestinal ischemia-reperfusion injury.

In the present disclosure, the term “subject” refers to an animal, preferably a mammal, and more preferably a human. The subject includes, among others, a life product consumer, a user of a nutraceutical product, and a patient with a disease, disorder, and/or symptom. In the present disclosure, the subject preferably refers to a mammal. The term "mammal" refers to a warm-blooded vertebrate including, but not limited to, e.g., a cat, dog, rabbit, bear, fox, wolf, monkey, deer, murine rodent (such as rat and mouse), pig, cow, sheep, horse, human, etc., preferably a primate, more preferably a human. For example, a steviol amino acid preparation refers to an animal receiving steviol amino acid or a composition containing it to treat, prevent, alleviate, and/or eliminate a disease, disorder, or symptom.

In the present disclosure, the term "patient" refers to an animal, preferably a mammal, and more preferably a human. The term "mammal" refers primarily to a warm-blooded vertebrate, including but not limited to, e.g., a cat, a dog, a rabbit, a bear, a fox, a wolf, a monkey, a deer, a mouse-like rodent, a pig, a cow, a sheep, a horse, a human, etc., preferably a primate, most preferably a human.

In the present disclosure, the term “pharmaceutical composition” refers to a composition that has a pharmaceutical prophylactic and/or therapeutic effect and can be used in a medicament.

The term "drug" as used herein includes any agent, compound, composition or mixture that produces physiological and/or pharmacological effects in vivo or in vitro, often with a beneficial effect. There is no particular limitation on the extent to which "the drug" produces physiological and/or pharmacological effects in vivo, which may be a systemic effect or a topical effect. There is no particular limitation on the activity of the "drug," and the drug may contain an active ingredient that interacts with other ingredients or a non-interacting inert ingredient.

As used herein, the "therapeutically effective amount" means an amount of a pharmaceutical agent that produces a biological or medical response in an individual in response to a disease, disorder and/or symptom, such as an amount of a compound of the present disclosure that results in a physiological and/or pharmacological beneficial effect in the individual. The physiological and/or pharmacological beneficial effect includes, but is not limited to, reducing or inhibiting the activity of an enzyme or a protein, or improving a symptom, alleviating a condition, slowing or delaying the progression of a disease, or preventing a disease, etc.

In the present disclosure, “pharmaceutically acceptable” means a ligand, material, composition or dosage form that is suitable for administration to a patient within the scope of reasonable medical judgment and that meets an appropriate benefit/risk balance.

In the present disclosure, the term "pharmaceutically acceptable carrier" means a pharmaceutically acceptable material, composition or agent, such as a liquid or solid filler, diluent, excipient, solvent or encapsulating material. As used herein, the term "pharmaceutically acceptable carrier" includes buffers, sterile water for injections, solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic agents, absorption delaying agents and the like that are compatible with the administration of the medicament. Any carrier must be "pharmaceutically acceptable" in the sense of being compatible with the other ingredients of the formulation and not harmful to the patient. Suitable examples include: (1) sugars such as lactose, glucose and sucrose; (2) starches such as corn starch, potato starch and substituted or unsubstituted β-cyclodextrin; (3) cellulose and its derivatives such as sodium carboxymethylcellulose, ethylcellulose and cellulose acetate; (4) gum tragacanth powder; (5) malt; (6) gelatin; (7) talc; (8) excipients such as cocoa butter and suppository waxes; (9) oils such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; (10) glycols such as propylene glycol; (11) polyols such as glycerin, sorbitol, mannitol and polyethylene glycol; (12) esters such as ethyl oleate and ethyl laurate; (13) agar; (14) buffers such as magnesium hydroxide and aluminum hydroxide; (15) alginic acid; (16) pyrogen-free water; (17) isotonic saline; (18) Ringer's solution; (19) ethanol; (20) phosphate buffer solutions; and (21) other non-toxic and compatible Substances used in pharmaceutical formulations. In the present disclosure, the “pharmaceutically acceptable carrier” can be selected from, but not limited to, the group consisting of: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, mercaptoacetic acid, methionine, vitamin C, EDTA disodium, EDTA calcium sodium, carbonates, acetates, phosphates or their aqueous solutions of monovalent alkali metals, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicic acid derivatives, cellulose and its derivatives, alginates, gelatin, polyvinylpyrrolidone, glycerin, Tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, Phospholipids, kaolin, talc, calcium stearate and magnesium stearate.

Retinitis pigmentosa (RP) is an inherited blinding disease of the fundus of the eye, which can be divided into typical RP patients and atypical RP patients according to the clinical phenotype. Typical RP patients account for 80% to 90% of RP patients. The pathological features of typical RP patients include rod cell death followed by cone cell death, photoreceptor cell damage and degeneration, and thinning of the outer nuclear layer of the retina until it disappears, accompanied by corresponding pathological changes in other related cell layers of the retina. Patients suffer from night blindness in the early stage and progressive visual field damage, which gradually develops into tubular visual field and eventually leads to blindness.

First aspect of the present disclosure

A first aspect of the present disclosure provides the use of a traditional Chinese medicine composition (also referred to as traditional Chinese medicine composition I) in the manufacture of a medicament (also referred to as medicament II) for the prevention and treatment of retinitis pigmentosa.

Unless otherwise specified, the “traditional Chinese medicine composition I” in the present disclosure refers to a traditional Chinese medicine composition containing the following ingredients: Rhizoma Acori Tatarinowii, Semen Cassiae, Herba Cistanches, Radix Puerariae Lobatae, Semen Celosiae, Radix Codonopsis, Fructus Viticis, Fructus Lycii, Semen Plantaginis, Radix Paeoniae Alba, Fructus Corni, Radix et Rhizoma Glycyrrhizae, Semen Cuscutae, Rhizoma Cimicifugae, Nux Prinsepiae, Flos Chrysanthemi, Flos Buddlejae, Rhizoma Chuanxiong, Rhizoma Polygonati steamed with liquor, Radix Rehmanniae Praeparata, Cortex Phellodendri Amurensis and Radix Astragali.

Unless otherwise specified, the term “Drug II” in the present disclosure refers to a medicament for the prevention and treatment of retinitis pigmentosa.

After extensive research, the inventors unexpectedly found that the pharmaceutical composition of the present disclosure (such as Zhangyanming tablet, that is, an eye whitening tablet) can shorten the latency period of electroretinogram of subjects, inhibit retinal atrophy in subjects, increase the number of cells in the outer nuclear layer of retina of subjects, and thus have the effect of preventing and treating retinitis pigmentosa. It is speculated by the inventors that the composition according to the present disclosure plays an important role in the prevention and treatment of retinitis pigmentosa through the following mechanism: Retinitis pigmentosa (RP), which belongs to the category of “high-wind cataract” in the field of traditional Chinese medicine, is the result of insufficient congenital fortune and acquired weakness of spleen and stomach, resulting in loss of essence, qi and blood, and causing disorders in liver, spleen and kidney. The pharmaceutical composition according to the present disclosure contains multiple drugs used in combination, which can warm and tonify the kidney yang, nourish the liver and kidney, and tonify the spleen and qi. It should be noted that although those skilled in the art know that Zhangyanming tablets can tonify the liver and kidney, replenish qi, and improve vision, it is not predictable whether Zhangyanming tablets can be used to prevent and treat retinitis pigmentosa due to the following conditions: the theory of traditional Chinese medicine mainly talks about "treating different diseases with the same therapy", however, "liver and kidney yin deficiency" is a very big concept, and many diseases have dialectical liver and kidney yin deficiency. For example, in " Liu Bing, et al. Overview of Diagnosis and Treatment of Thyroid Associated Ophthalmopathy in Traditional Chinese and Western Medicine, Journal of Practical Internal Medicine of Tradi tional Chinese Medicine, 2015, 29 (07), 165-166 “It is noted that in patients suffering from thyroid-associated ophthalmopathy who are dialectically diagnosed with “liver and kidney yin deficiency”, traditional Chinese medicine therapy requires a long course of treatment and that changes may occur during the treatment process, leading to insignificant effects.

In some embodiments, the traditional Chinese medicine composition I contains the following ingredients: 20 parts to 30 parts of Rhizoma Acori Tatarinowii, 30 parts to 40 parts of Semen Cassiae, 30 parts to 40 parts of Herba Cistanches, 30 parts to 40 parts of Radix Puerariae Lobatae, 30 parts to 40 parts of Semen Celosiae, 40 parts to 50 parts Radix Codonopsis, 30 parts to 40 parts Fructus Viticis, 40 parts to 50 parts Fructus Lycii, 30 parts to 40 parts Semen Plantaginis, 40 parts to 50 parts Radix Paeoniae Alba, 20 parts to 30 parts Fructus Corni, 20 parts to 30 parts Radix et Rhizoma Glycyrrhizae, 60 parts to 70 parts Semen Cuscutae, 1 part up to 10 parts Rhizoma Cimicifugae, 30 parts to 40 parts Nux Prinsepiae, 30 parts to 40 parts Flos Chrysanthemi, 30 parts to 40 parts Flos Buddlejae, 30 parts to 40 parts Rhizoma Chuanxiong, 30 parts to 40 parts Rhizoma Polygonati, steamed with liquor, 60 parts to 70 parts Radix Rehmanniae Praeparata, 30 parts to 40 parts Cortex Phellodendri Amurensis and 40 parts to 50 parts Radix Astragali.

In some embodiments, the traditional Chinese medicine composition I contains the following ingredients: 22±m parts of Rhizoma Acori Tatarinowii, 30±m parts of Semen Cassiae, 37±m parts of Herba Cistanches, 37±m parts of Radix Puerariae Lobatae, 30±m parts of Semen Celosiae, 48±m parts of Radix Codonopsis, 30±m parts of Fructus Viticis, 48±m parts of Fructus Lycii, 37±m parts of Semen Plantaginis, 45±m parts of Radix Paeoniae Alba, 24±m parts of Fructus Corni, 22±m parts of Radix et Rhizoma Glycyrrhizae, 61±m parts of Semen Cuscutae, 7±m parts of Rhizoma Cimicifugae, 37±m parts of Nux Prinsepiae, 37±m parts of Flos Chrysanthemi, 37±m parts of Flos Buddlejae, 30±m parts of Rhizoma Chuanxiong, 37±m parts of Rhizoma Polygonati steamed with cerebrospinal fluid, 61±m parts of Radix Rehmanniae Praeparata, 30±m parts of Cortex Phellodendri Amurensis and 48±m parts of Radix Astragali, m is 1, 0.5, 0.2, 0.1 or 0.

In some embodiments, m is a value selected from the following values or a range of values (including endpoints) between any two of the following values: 1, 0.5, 0.2, 0.1, or 0, e.g., 0 to 1, 0 to 0.5, 0.5 to 1, 0.2 to 0.5, 0.1 to 0.2, 0.1 to 0.5, etc.

In some embodiments, the traditional Chinese medicine composition is a Zhangyanming tablet.

Retinitis pigmentosa is a genetic disease, and the inheritance pattern includes autosomal recessive inheritance, autosomal dominant inheritance, and X-linked recessive inheritance.

In some cases, retinitis pigmentosa is an autosomal recessive retinitis pigmentosa.

In some embodiments, autosomal recessive retinitis pigmentosa is caused by a mutation in the PDE6b gene. The protein encoded by the rod cell cGMP phosphodiesterase type 6 β subunit (PDE6b) plays an important role in cGMP hydrolysis and is an essential component of phototransduction. A mutation in this gene can result in impaired photoreceptor cell function.

In some cases, drug II is a solid formulation.

In some embodiments, the solid formulation is selected from the group consisting of regular tablets, dispersible tablets, sustained release tablets, capsules, granules, and powders.

In some embodiments, medicament II contains an effective amount of traditional Chinese medicine composition I.

In some embodiments, the medicament II contains: (a) the composition of traditional Chinese medicine I; and (b) a pharmaceutically acceptable excipient and/or a pharmaceutically acceptable carrier. In some embodiments, the medicament II contains: the composition of traditional Chinese medicine I; and (b) a pharmaceutically acceptable excipient and/or a pharmaceutically acceptable carrier. ditional Chinese medicine I and a pharmaceutically acceptable excipient. In some embodiments, the medicament II contains the composition of traditional Chinese medicine I and a pharmaceutically acceptable carrier. In some embodiments, the medicament II contains the composition of traditional Chinese medicine I, a pharmaceutically acceptable excipient and a pharmaceutically acceptable carrier.

In some embodiments, drug II is a Zhangyanming tablet.

In some embodiments, the mass percentage of the traditional Chinese medicine composition I in the drug II is in the range of 85% to 90%. The mass percentage is exemplary 85%, 86%, 87%, 88%, 89%, 90%, etc.

In some embodiments, a subject of drug II is a mammal.

In some embodiments, a subject of drug II is a mouse or a human.

One of the characteristics of retinitis pigmentosa (RP) is retinal atrophy in the patient. In some embodiments, drug II inhibits retinal atrophy in the subject.

In some embodiments, drug II increases the number of cells in the outer nuclear layer of the subject's retina.

Second aspect of the present disclosure

A second aspect of the present disclosure provides a method for preventing or treating retinitis pigmentosa, which includes administering a therapeutically effective amount of the traditional Chinese medicine composition I to a patient in need thereof. That is, the patient is administered a therapeutically effective amount of the traditional Chinese medicine composition I.

route of administration

The dosage form and administration route of the traditional Chinese medicine composition (i.e., the traditional Chinese medicine composition I) of the present disclosure are not particularly limited.

Representative routes of administration include oral administration, rectal administration, parenteral (such as intravenous, intramuscular or subcutaneous) injection, topical administration or inhalation.

Solid dosage forms for oral administration include capsules, tablets, pills, powders and granules. In these solid dosage forms, the active ingredient is mixed with at least one conventional inert excipient (or a carrier) such as sodium citrate or dicalcium phosphate; or the active ingredient is mixed with any of the following: (a) fillers or bulking agents, e.g. starch, lactose, sucrose, glucose, mannitol and silica; (b) binders, e.g. hydroxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose and gum arabic; (c) humectants, e.g. glycerol; (d) disintegrants, e.g. agar, calcium carbonate, potato or tapioca starch, alginic acid, certain compound silicates and sodium carbonate; (e) dissolution-retarding agents, such as paraffin; (f) absorption enhancers, e.g. quaternary ammonium compounds; (g) wetting agents such as cetyl alcohol and glyceryl monostearate; (h) adsorbents, e.g. kaolin; and (i) lubricants such as talc, calcium stearate, magnesium stearate, solid polyethylene glycol, sodium dodecyl sulfate or mixtures thereof. In capsules, tablets and pills, the dosage forms may also contain buffering agents. The solid dosage forms such as tablets, sugar pills, capsules, pills and granules may be prepared using coating and shell materials such as enteric coatings and other materials known in the art. They may contain an opaque agent. The release of the active ingredients or compounds in the compositions may be delayed in a specific portion of the digestive tract. Examples of embedding components that may be used are polymers and waxes. If necessary, the active ingredients may form microcapsules with one or more of the above-mentioned excipients.

Liquid dosage forms for oral administration include pharmaceutically acceptable emulsions, solutions, suspensions, syrups or tinctures. In addition to the active ingredients, the liquid dosage forms may contain conventional, inert diluents such as water or other solvents, solubilizers and emulsifiers, in particular ethanol, isopropanol, ethyl carbonate, ethyl acetate, propylene glycol, 1,3-butanediol, dimethylformamide, and oils, in particular cottonseed oil, peanut oil, corn germ oil, olive oil, castor oil and sesame oil, or mixtures thereof. In addition to these inert diluents, the composition may contain other additives such as wetting agents, emulsifiers and suspending agents, sweeteners, flavorings and perfume. For example, the suspension may contain a suspending agent, in particular ethoxylated isooctadecanol, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose, methanol aluminum and agar, or mixtures thereof.

Compositions for parenteral injection may include physiologically acceptable sterile aqueous or anhydrous solutions, dispersions, suspensions or emulsions, as well as sterile powders capable of being reconstituted into sterile injectable solutions or dispersions. Suitable aqueous or non-aqueous carriers, diluents, solvents or excipients include water, ethanol, polyols and any suitable mixtures thereof.

Dosage forms for topical administration include ointments, powders, patches, sprays and inhalants. The active ingredient is mixed with physiologically acceptable carriers and any necessary preservatives, buffers or propellants under sterile conditions.

It should be understood that the medicament in the embodiments of the present disclosure can be made into suitable clinical dosage forms by the addition of various pharmaceutically acceptable excipients. These clinical dosage forms include, but are not limited to, the dosage forms described above. These pharmaceutically acceptable excipients include, but are not limited to, diluents, wetting agents, binders, disintegrants, lubricants, color and flavor modifiers, solvents, solubilizers, co-solvents, emulsifiers, antioxidants, metal chelating agents, inert gases, preservatives, topical analgesics, pH adjusters, isotonic regulators, and the like. Diluents include, for example, starch, sucrose, cellulose, inorganic salts, etc.; wetting agents include, for example, water, ethanol, etc.; the binders include, for example, starch slurries, dextrin, sugar, cellulose derivatives, gelatin, povidone, polyethylene glycols, etc.The disintegrants include, for example, starch, sodium carboxymethyl starch, low substituted hydroxypropyl cellulose, croscarmellose sodium, crospovidone, surfactants, effervescent disintegrants, etc.The lubricants include, for example, talc, calcium stearate, magnesium stearate, magnesium lauryl sulfate, micronized silica gel, polyethylene glycol, etc.; the color and flavor enhancers include, for example, pigments, spices, sweeteners, adhesives, odor correctors, etc.The solvents include, for example, water, oil, ethanol, glycerin, propylene glycol, polyethylene glycol, dimethyl sulfoxide, liquid paraffin, fixed oil, ethyl acetate, etc.The solubilizers include, for example, Tweens, Myrijs, polyoxyethylene fatty alcohol ethers, soaps, sulfates, sulfonates, etc.; Co-solvents include, for example, organic acids (e.g. citric acid) and their salts, amide and amine compounds, inorganic salts, polyethylene glycol, povidone, glycerin, etc. Emulsifiers include, for example: E.g. Spans, Tweens, Myrijs, Brijs, glycerol fatty acid esters, higher fatty acid salts, sulfates, sulfonates, gum arabic, gum tragacanth, gelatin, pectin, phospholipids, agar, sodium alginate, hydroxides, silica, bentonite, etc.Suspending agents include, for example, glycerol, syrup, gum arabic, gum tragacanthae, agar, sodium alginate, cellulose derivatives, povidone, carbopol, polyvinyl alcohol, thixotropic gum, etc. Antioxidants include, for example, sulfite, metasulfite, bisulfite, ascorbic acid, gallic acid and their esters, etc.; metal complexing agents include, for example, disodium ethylenediaminetetraacetate, polycarboxylic acid compounds, etc.; inert gases include, for example, nitrogen gas, carbon dioxide, etc. preservatives include parabens, organic acids and their salts (e.g., sodium benzoate), quaternary ammonium compounds, chlorhexidine acetate, alcohols, phenols, and volatile oils; topical analgesics include, for example, benzyl alcohol, chlorobutanol, lidocaine, and procaine, etc. pH adjusters include, for example, hydrochloric acid, sulfuric acid, phosphoric acid, tartaric acid, acetic acid, sodium hydroxide, sodium bicarbonate, ethylenediamine, meglumine, phosphate, acetate, citric acid, citrate, etc.; isotonic regulators include, for example, glucose, sodium chloride, sodium citrate, sorbitol, and xylitol, etc. It should be understood that the diluents described in the embodiments of the present disclosure may also be referred to as fillers and play the same role in pharmaceutical formulations. The water described in the embodiments of the present disclosure is water that meets the requirements of the medicament, such as B. Water for injection, purified water, etc. The oil is oil for injection. The preservative described in the embodiments of the present disclosure may also be used as antibacterial agent and helps inhibit the growth of microorganisms and prolong the shelf life of the formulations. The lubricant described in the embodiment of the present disclosure includes a lubricant, an anti-sticking agent, etc. The sugar described in the embodiment of the present disclosure may be powdered sugar or syrup, and the type of sugar is not limited to glucose. The spices described in the embodiments of the present disclosure include, but are not limited to, flavorings.

In some embodiments, the frequency of administration is from 1 time/day to 3 times/day, for example, 1 time/day, 2 times/day, or 3 times/day.

In some cases the administration dose is 0.42 g/dose.

In some embodiments, the traditional Chinese medicine composition I is administered orally.

In some embodiments, the traditional Chinese medicine composition I is administered intragastrically.

As used herein, "intragastric administration" refers to a liquid, suspension, semi-liquid, etc., dripped directly into the stomach through the oral or nasal cavity and esophagus by means of a catheter. In some embodiments, the dosage consists of intragastric administration of 5 ml/kg of the suspension of traditional Chinese medicine composition I, which is prepared by adding traditional Chinese medicine composition I to distilled water in a ratio of 0.0378 g/ml, shaking, and dissolving at room temperature.

The “traditional Chinese medicine composition I” in the second aspect of the present disclosure can be selected from, but is not limited to, the traditional Chinese medicine composition I as described above, and can be referred to the first aspect of the present disclosure.

In some embodiments, the traditional Chinese medicine composition I is a solid formulation. In some embodiments, the solid formulation is selected from the group consisting of regular tablets, dispersible tablets, sustained release tablets, capsules, granules, and powders.

In some cases the patient is a human or a mouse-like rodent.

In some embodiments, the patient is a human.

In some embodiments, the patient is a mouse.

Third aspect of the present disclosure

A third aspect of the present disclosure provides a traditional Chinese medicine composition I for use in the prevention and/or treatment of retinitis pigmentosa.

The “traditional Chinese medicine composition I” in the third aspect of the present disclosure can be selected from, but is not limited to, the traditional Chinese medicine composition I as described above, and can be referred to the first aspect of the present disclosure.

Some concrete examples are given below.

Experimental parameters not specified in the following examples primarily refer to the guidelines provided in the present disclosure or may be in accordance with experimental manuals or other experimental methods known in the art or in accordance with experimental conditions suggested by the manufacturers.

The raw materials and reagents used in the following specific examples are commercially available or can be prepared by any method known to those skilled in the art.

The animal model used in the following specific examples is a mouse with PDE6B gene mutation (i.e., an RP mouse). The RP phenotype of the model mouse is relatively consistent with that of human RP lesions, so the RP model mouse can be used to study the treatment of human RP lesions. In this experiment, mice are intragastrically dosed at 7 days after birth, and the relevant indices are observed at 14 days after birth (i.e., 7 days after intragastric dose) and 21 days after birth (i.e., 14 days after intragastric dose).

Example 1 Gavaging pretreatment

1.1 Experimental materials

1.1.1 Laboratory animals

Eight 7-day-old wild-type Kunming mice (i.e., normal mice), half male and half female, weighing 9 g to 11 g, were selected for the experiment. These mice were purchased from Beijing Vital River Laboratory Animal Technology Co.

Sixteen 7-day-old RP model mice (i.e., PDE6b gene mutants), half male and half female, weighing 9 to 11 g, were obtained from the Experimental Animal Center of Eye Hospital, Chinese Academy of Chinese Medical Sciences.

The mice were fed in the animal room of the Experimental Animal Center of Eye Hospital, Chinese Academy of Chinese Medical Sciences. All procedures involved in animal feeding were approved by the ethics committee and conform to the requirements of animal ethics.

1.1.2 Reagents and instruments

Zhangyanming tablets were manufactured by Guangzhou Baiyunshan Zhongyi Pharmaceutical company limited with product lot number P00042. They were crushed before testing, passed through a 100-mesh sieve and made into an oral suspension with a concentration of 0.0378 g/mL with double-distilled water. 1 mL syringe. Needles for injection.

1.2 Experimental Methods

1.2.1 Animal groups

Normal mice were used as a normal control group with a total of 8 mice. PDE6b gene mutant mice were randomly divided into an experimental control group and a Zhangyanming tablet group with 8 mice in each group.

1.2.2 Gavaging pretreatment

For later use, an oral suspension of Zhangyanming tablet with a content of 0.0378 g/ml was prepared and shaken to ensure uniformity before use.

The Zhangyanming tablet group received the oral suspension of Zhangyanming tablet by administering 5 ml/kg per day based on the weight of the mice.

The experimental control group received the same amount of distilled water as an infusion once daily.

The normal control group received the same amount of distilled water as an infusion once daily.

Example 2 Electroretinogram (ERG) test

2.1 Detection method

The pretreated mice of each group were subjected to electroretinogram (ERG) testing at different time points. Test instrument: small animal visual electrophysiological detector (Diagnostic, Model D430). Test method: After 12 hours of dark adaptation, the mice of each group were treated with tropicamide-phenylephrine eye drops for both eyes for routine pupil dilation and anesthetized by intraperitoneal injection (2 ml/kg) with a mixture of ketamine hydrochloride and xyazine hydrochloride in a volume ratio of 1:7. The entire procedure was performed under dim red light. The bilateral corneal electrodes were placed in the center of the cornea of both eyes of the mice, and the resistance between the electrodes was always less than 5 kΩ. According to the latest international standards of the International Society for Clinical Electrophysiology of Vision (ISCEV), the rod response, the maximum combined rod-cone response, the scotopic oscillatory potentials, the cone response (after 5 minutes of automatic light adaptation), and the 10 Hz photopic flicker were recorded. The peak time values (ms) and amplitude values (µV) of each group of a-, b-, and P-waves were recorded sequentially.

2.2 Test results

The test results are shown in Table 1 and Table 2. Table 1. Changes in ERG amplitudes at different stages after 7 days and 14 days of intragastric administration amplitudes After 7 days of intragastric administration After 14 days of intragastric administration Normal control group experimental control group Zhangyanming tablet group Normal control group Experimental control group Zhangyanming tablet group b-waves of the rod reaction 61.70±38.13 17.68±3.17* 18.12±4.67* 128.56±50.93 18.45±8.00* 17.19±8.28* b-waves of the maximum combined rod-cone response 173.31±81.13 21.83±12.19* 23.75±11.40* 276.64±35.62 24.95±13.66* 18.74±8.28* Oscillatory potentials 62.15±34.07 11.99±5.42* 12.34±6.94* 77.44±17.78 14.50±7.37* 13.41±5.09* b-waves of the cone response 21.80±1.10 14.03±3.53* 16.35±5.38* 23.20±1.85 15.30±4.81* 14.22±2.70* P waves of the photopic 10 Hz flicker 9.10±0.80 7.24±1.65* 7.93±3.14* 10.47±0.49 7.59±1.49* 8.78±2.00* * P<0.05, compared with normal control group.

In Table 1, the amplitudes at different stages of the electroretinogram were analyzed, and each group conformed to the normal distribution, and the data were expressed as mean ± standard deviation. Compared with the model control group, no significant changes in the amplitudes were observed in the Zhangyanming tablet group (P > 0.05) after 7 and 14 days of intragastric administration. The above-mentioned amplitudes in both the model control group and the Zhangyanming tablet group were significantly lower than those in the normal control group (P < 0.05). However, after 7 days of intragastric administration, the average amplitudes in the different stages of the Zhangyanming tablet group were higher than those of the experimental control group.

In Table 1, the ERG is a bundle of electrical responses recorded after stimulation of the retina by light and before the electrical impulse of the retinal ganglion cells. It reflects the electrical activity of all retinal layers from the photoreceptors to the amacrine cells. len. The rod ERG (e.g., the b-wave of the rod response) mainly reflects the electrical response of the rod cell system. The ERG of the maximum combined rod-cone response (e.g., the b-wave of the maximum combined rod-cone response) represents the comprehensive electrical response of the entire retina, including the rod and cone systems. The oscillatory potential originates from the inner nuclear layer of the retina and mainly reflects the blood flow state of the retina. The cone response ERG (e.g., the b-wave of the cone response) mainly reflects the response of the cone system with a small number of rod cells. 10 Hz flicker is considered a complete response of the cone system because the rod cells cannot respond to light flashes of this frequency. Table 2. Changes in ERG latency at different stages after 7 days of intragastric administration latency times After 7 days of intragastric administration experimental control group Zhangyanming tablet group P-value b-waves of the maximum combined rod-cone response 82.35±25.25 58.26±9.82 0.004 a-waves of the cone response 45.10±30.77 21.32±9.20 0.014 b-waves of the cone response 73.56±31.91 47.30±17.22 0.014

In Table 2, after analyzing the latency times of different stages, it was found that the data of each group at the b-wave peak of the maximum combined rod-cone response, the a-wave peak of the cone response, and the b-wave peak of the cone response conformed to the normal distribution, and the data are expressed in mean ± standard deviation. After 7 days of gastric administration, the shortening of the latency time of the Zhangyanming tablet group compared with the model control group was statistically significant (P<0.05).

In Table 2, the latencies of the a- and b-waves in the different stages mainly reflect the time required for the corresponding photoreceptor cells to respond to different stimulation thresholds. When the function of the photoreceptor cells is impaired, the latency of the corresponding wave is prolonged.

According to the data results in Table 1 and Table 2, the traditional Chinese medicine composition according to the present disclosure can delay the deterioration of the function of retinal photoreceptor cells and has a protective effect on retinal function.

Example 3 Recognition of retinal morphology

3.1 Fundus photography

The small animal retina imaging system (OPTOPROBE SCIENCE LTD, UK, OPTO-RIS-CN) was used to take fundus photographs of mice in each group after pretreatment and obtain fundus photographs (see FIG. 1 and FIG. 2). A in FIG. 1 is a fundus photograph of mice 14 days after birth in the normal control group, in which the retinal blood vessels were uniformly thick and clearly visible, while the choroidal blood vessels were not visible. B and C in FIG. 1 are, respectively, the fundus photograph of the mice 14 days after birth in the experimental control group and the fundus photograph of the mice 14 days after birth in the Zhangyanming tablet group, in which the retinas were atrophic and thinner and the choroidal blood vessels could be directly observed. A in FIG. 2 is a fundus photograph of the mice 21 days after birth in the normal control group, in which the retinal blood vessels were uniformly thick and clearly seen, and the choroidal blood vessels were not visible. B and C in FIG. 1 are, respectively, the fundus photograph of the mice 21 days after birth in the experimental control group and the fundus photograph of the mice 21 days after birth in the Zhangyanming tablet group, in which the retina was further thinned, the choroidal blood vessels could be directly observed, and the white scleral tissue could also be observed.

According to 1 and 2 It is found that the degree of retinal atrophy of the mice in the Zhangyanming tablet group is lower compared with the experimental control group, indicating that the traditional Chinese medicine composition of the present disclosure has a certain effect on delaying retinal atrophy and degeneration.

3.2 Histopathological examination

3.2.1 Test procedures and test data

Mice were sacrificed under general anesthesia, the eyeballs were quickly enucleated and immersed in Davidson's fixative. The anterior segment of the eye and part of the vitreous were carefully removed under a dissecting microscope. The remaining tissue was dehydrated and embedded in paraffin. Sections (4 µm) were made, deparaffinized and then stained with H&E. The pathological changes in the individual retinal layers were observed under the light microscope (Leica, DM2500).

3.2.2 Test results

As shown in the HE-stained tissue section diagram in FIG. 3, after 7 days of pretreatment, there are no abnormal changes in the outer nuclear layer of the retina and the RPE of the mice in the normal group (A in FIG. 3). In contrast, the outer nuclear layer of the mice in the model group was significantly thinner, and the apoptosis of the photoreceptor cells was severe (B in FIG. 3). The outer nuclear layer of the mice in the Zhangyanming tablet group was significantly thinner but slightly thicker than that in the model group, indicating that the degree of degeneration of the photoreceptor cells was less than that in the model group (C in FIG. 3).

Statistical analysis of the number of cells of the outer nuclear layer in the images of each group shows that the data of each group do not conform to normal distribution, and the difference is statistically significant by nonparametric test (H=73.267, P<0.001). The average rank of the normal group is 74 (n=29), the average rank of the model group is 16.15 (n=26), and the average rank of the Zhangyanming tablet group is 40.91 (n=33). Pairwise comparison shows that the number of cell layers of the outer nuclear layer in the model group and the Zhangyanming tablet group was significantly smaller than that in the normal group, and the difference is statistically significant (adjusted P<0.001), while the number of cell layers of the outer nuclear layer in the Zhangyanming tablet group was significantly larger than that in the model group, and the difference is statistically significant (adjusted P=0.001).

As seen in the HE-stained tissue section diagram in FIG. 4, after 14 days of pretreatment, there are no abnormal changes in the outer nuclear layer of the retina and the RPE of the mice in the normal group (A in FIG. 4). However, in the model group, only one layer of the outer nuclear layer of the retina remained, suggesting that the photoreceptor cells continue to undergo apoptosis (B in FIG. 4). In the Zhangyanming tablet group, only one layer of the outer nuclear layer of the retina remained, but the cells were closely arranged, suggesting that the apoptosis rate was slower than that in the model group (C in FIG. 4).

The Kruskal-Wallis (KW) test shows that the distribution of the number of cell layers of the outer nuclear layer in each group is not the same, and the difference is statistically significant (H=72.831, P<0.001). The average rank of the normal group is 68.5 (n=28), the average rank of the model group is 26 (n=24), and the average rank of the Zhangyanming tablet group is 28.7 (n=30). Compared with the model group, the Zhangyanming tablet group shows an increasing trend, but the difference is not statistically different (adjusted P>0.05).

The changes in the number of outer nuclear layer cells between the administration group and the model group are shown in Table 3. The cell count results of outer nuclear layer cells show that the data of each group conform to the normal distribution, and the data are expressed in mean ± standard deviation. After 7 days of intragastric administration, the number of outer nuclear layer cells in the Zhangyanming tablet group was significantly higher than that in the model group, and the difference is statistically significant (P<0.001). After 14 days of intragastric administration, the number of outer nuclear layer cells in both groups shows the same trend as after 7 days. The number of cells in the Zhangyanming tablet group was significantly higher than that in the model group, and the difference is statistically significant (P=0.001), indicating that the retinal photoreceptor cells of mice slowly degenerated after treatment with composition I and composition I has a certain effect on morphology in the treatment of RP. Table 3. Changes in the number of outer nuclear layer cells between the administration group and the model group group After 7 days of intragastric administration After 14 days of intragastric administration experimental control group 149.5±11.22 42.43±3.87 Zhangyanming tablet group 234.67±28.66 51.71±3.55 P-value < 0.001 0.001

The above experimental results showed that the traditional Chinese medicine composition according to the present disclosure has a protective effect on the visual function and retinal tissue morphology of the retinitis pigmentosa animal model, and can delay the progression of retinitis pigmentosa to a certain extent.

All documents referred to in the present disclosure are cited as references in the present disclosure as if each document were cited as references individually. Unless it conflicts with the purpose of the present disclosure or the technical solution of the present disclosure, the documents cited in the present disclosure are cited in their entirety and for their entire purpose. When the present disclosure includes cited documents, the definitions of the relevant technical features, terms, standards, phrases, and the like in the cited documents are also cited. When the present disclosure includes the cited documents, the cited examples and preferred embodiments of the relevant technical features may also be incorporated into the present disclosure as references, but only to the extent that the present disclosure can be implemented. It is understood that if the cited contents conflict with the description in the present disclosure, the cited contents shall be governed by the present disclosure or shall be adjusted according to the description in the present disclosure.

The technical features of the above-mentioned embodiments and examples can be arbitrarily combined. In order to keep the description concise, all possible combinations of the technical features in the embodiments or examples are not described. However, as long as there is no contradiction in the combination of these technical features, the combinations should be considered to be within the scope of the present disclosure.

The examples described above are only some embodiments of the present disclosure, but they should not be construed as limiting the scope of the present disclosure. It should be understood that various modifications and improvements can be made by those skilled in the art without departing from the concept of the present disclosure, and all fall within the scope of the present disclosure. Moreover, it should be understood that after reading the contents of the present disclosure described above, various changes or improvements to the present disclosure can be made by those skilled in the art, and the equivalent forms obtained also fall within the scope of the present disclosure. It should also be understood that the technical solutions obtained by those skilled in the art through logical analysis, reasoning, or limited experiments based on the technical solutions provided by the present disclosure fall within the scope of the appended claims of the present disclosure. Therefore, the scope of the present disclosure patent is defined by the appended claims, and the description and drawings can be used to explain the content of the claims.

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions.

Cited non-patent literature

• Liu Bing, et al. Overview of Diagnosis and Treatment of Thyroid Associated Ophthalmopathy in Traditional Chinese and Western Medicine, Journal of Practical Internal Medicine of Traditional Chinese Medicine, 2015, 29 (07), 165-166 [0040]

Claims (10)

Use of a traditional Chinese medicine composition for the manufacture of a medicament for the prevention and treatment of retinitis pigmentosa, wherein the traditional Chinese medicine composition comprises the following components: 20 parts to 30 parts Rhizoma Acori Tatarinowii, 30 parts to 40 parts Semen Cassiae, 30 parts to 40 parts Herba Cistanches, 30 parts to 40 parts Radix Puerariae Lobatae, 30 parts to 40 parts Semen Celosiae, 40 parts to 50 parts Radix Codonopsis, 30 parts to 40 parts Fructus Viticis, 40 parts to 50 parts Fructus Lycii, 30 parts to 40 parts of Semen Plantaginis, 40 parts to 50 parts Radix Paeoniae Alba, 20 parts to 30 parts Fructus Corni, 20 parts to 30 parts Radix et Rhizoma Glycyrrhizae, 60 Parts to 70 parts Semen Cuscutae, 1 part to 10 parts Rhizoma Cimicifugae, 30 parts to 40 parts Nux Prinsepiae, 30 parts to 40 parts Flos Chrysanthemi, 30 parts to 40 parts Flos Buddlejae, 30 parts to 40 parts Rhizoma Chuanxiong, 30 parts to 40 parts Rhizoma Polygonati steamed with liquor, 60 parts to 70 parts Radix Rehmanniae Praeparata, 30 parts to 40 parts Cortex Phellodendri Amurensis, and 40 parts to 50 parts Radix Astragali. Use after claim 1 , the composition of traditional Chinese medicine includes the following components: 22±m parts of Rhizoma Acori Tatarinowii, 30±m parts of Semen Cassiae, 37±m parts of Herba Cistanches, 37±m parts of Radix Puerariae Lobatae, 30±m parts of Semen Celosiae, 48±m parts of Radix Codonopsis, 30±m parts of Fructus Viticis, 48±m parts of Fructus Lycii, 37±m parts of Semen Plantaginis, 45±m parts of Radix Paeoniae Alba, 24±m parts of Fructus Corni, 22±m parts of Radix et Rhizoma Glycyrrhizae, 61±m parts of Semen Cuscutae, 7±m parts of Rhizoma Cimicifugae, 37±m parts of Nux Prinsepiae, 37±m parts of Flos Chrysanthemi, 37±m parts of Flos Buddlejae, 30±m parts of Rhizoma Chuanxiong, 37±m parts of Rhizoma Polygonati steamed with lye, 61±m parts of Radix Rehmanniae Praeparata, 30±m parts of Cortex Phellodendri Amurensis, and 48±m parts of Radix Astragali, where all m are equal and m is 1, 0.5, 0.2, 0.1 or 0. Use after claim 1 , the composition of traditional Chinese medicine is Zhangyanming tablet. Use after claim 1 , whereby retinitis pigmentosa is an autosomal recessive retinitis pigmentosa. Use after claim 4 , with autosomal recessive retinitis pigmentosa being caused by a mutation in the PDE6b gene. Use according to one of the Claims 1 until 5 , where the drug is a solid formulation. Use after claim 6 , wherein the solid formulation is selected from the group consisting of regular tablets, dispersible tablets, sustained release tablets, capsules, granules and powders. Use according to one of the Claims 1 until 5 , where the drug is Zhangyanming tablet. Use according to one of the Claims 1 until 5 , the drug contains an effective amount of the composition of traditional Chinese medicine. Use according to one of the Claims 1 until 5 , wherein a subject of the medicament is a mammal, preferably a mouse or a human.