CN105726983A - Compound dendrobium eye drops for treating xerophthalmia and preparation method thereof - Google Patents

Abstract

The invention belongs to the traditional Chinese medicine field, relates to a traditional Chinese medicine prescription for treating xerophthalmia and a preparation method, and more specifically to a compound dendrobium eye drops for treating xerophthalmia and a preparation method thereof. The compound dendrobium eye drops are prepared from the following raw materials: 80-120g of caulis dendrobii, 80-120g of radix trichosanthis, 80-120g of folium isatidis, 50-100g of vitamin B1, and 10-20ml of honey. The eye drops are prepared by a modern advanced medicine pharmaceutical technology and have a reasonable formula which is scientific and advanced. The medicinal herb resource is abundant and the medicine cost is low. The traditional Chinese medicine prescription for treating xerophthalmia has the efficacy of improving eyesight and anti-inflammation, lubricating eye surface, and prompting cornea epithelium growth. A local drug delivery mode is employed, and the medicines directly reach the action position. The compound dendrobium eye drops for treating xerophthalmia provides a safe and effective eye medicinal preparation with convenient use for clinic treatment of the xerophthalmia. The treatment effect is reliable, and the compound dendrobium eye drops for treating xerophthalmia and the preparation method thereof can be popularized.

Description

A kind of compound recipe Herba Dendrobii eye drop treating xerophthalmia and preparation method thereof

Technical field

The invention belongs to the field of Chinese medicines, relate to a kind of Chinese medicinal formulae treating xerophthalmia and preparation method, be specifically related to a kind of compound recipe Herba Dendrobii eye drop treating xerophthalmia and preparation method thereof.

Background technology

Xerophthalmia is clinical common ocular chronic disease, refers to that tear quality and quantity or kinetics cause that tear film stability declines and ocular surface injury is thus causing the general name of a class disease of ophthalmic uncomfortable symptom extremely.Patient often has eye dry and astringent and foreign body sensation, and other symptoms have the symptoms such as burn feeling, gargalesthesia, photophobia, erythralgia, blurred vision fatiguability, haircuts shape secretions.Xerophthalmia belongs to the dry astringent eye, xerosis conjunctivitis of motherland's medical science, refers to the oculopathy of the not red pneumonedema of white of the eye and conscious ophthalmic dryness and discomfort of the eye.

Xerophthalmia sickness rate is more and more higher, also increasingly causes the attention of people, for one of world's difficult and complicated illness.The generation of xerophthalmia is relevant with many factors.Old people increases due to hormonal readiness significant change and various disease of immune system incidence rate and causes lacrimal secretion anomaly；Cataract operation and refractive surgery universal, postoperative xerophthalmia incidence rate increases substantially；Along with the extensive use of video terminal, xerophthalmia crowd occurs in that video terminal syndrome in expansion gradually.Additionally, under normal circumstances child to suffer from the probability of xerophthalmia very low, along with the pollution anaphylaxis eye surface diseases of environment increase, the factor such as the time lengthening of child getting in contact video display terminal, the child's xerophthalmia being similar to adult increasingly comes into one's own.

Owing to xerophthalmia pathogenesis is complicated, the relation between each factor it be not immediately clear.Its pathological process is complicated, and the pathologic of eye surface changes, is the principal element that development occurs xerophthalmia based on immune inflammatory reaction, the reduction of sex hormone level and the impact of external environment, but contact or the cause effect relation between each factor is not yet fully apparent from.Wherein, when tear film persistent anomaly and defense function damage, immune-related inflammation plays an important role.The factor of any infringement lacrimal gland function all may result in tear film composition and changes and tear film instability.Inflammatory stimulus can mediate the proinflammatory factor and medium is expressed, and makes the normal physiological microenvironment generation pathologic of lacrimal epithelial cell change, thus causing that tear film is abnormal, causes xerophthalmia.The traditional Chinese medical science thinks that xerophthalmia and traditional Chinese medical science dry astringent eye, xerosis conjunctivitis, dry and astringent dim-sighted disease, oligodacrya disease are similar.How most by the stop of diseases caused by exogenous pathogenic factor epidemic disease heresy or remaining heresy, latent spleen lung two warp, hinders the compress of body fluid；With the passing of time dust storm dust invasion and attack or be exposed to air conditioner surroundings and the sootiness of nearly fire etc. for a long time and stimulate, cause lung to defend the stagnation of QI and do not declare, dryness-transformation impairment of body fluid, and order is become homeless honor；Or overworked eyes, overanxious to think much, the impairment of the heart caused by overstrain too causes Liver and kidney loss, and order loses Ru Ze etc. to be caused.

Xerophthalmia can adopt the multiple method treatment such as medicine, operation, dissimilar, the different phase according to disease, selects different therapeutic schemes for each patient.Research fully confirms, and supplementary artificial tears is the basic skills for the treatment of xerophthalmia, and artificial tears is a line medication for the treatment of xerophthalmia.Alternative artificial tears is a lot of in the market, and the emphasis of its indication is had nothing in common with each other, and most of corneal epithelial can produce damage in various degree because of preservative.Although the medicine for the treatment of xerophthalmia is varied, the ophthalmic preparation Drug therapy of current xerophthalmia, conventional artificial tears's such as tear is right clinically, think the eye drops such as right, sodium carboxymethyl cellulose, hyaluronic acid sodium, but lacks the eye medicinal preparation of Chinese medicine aspect.Chinese medical discrimination is selected nourishing the liver and kidney to promote the production of body fluid to wait medicine whole body to nurse one's health and herb steam therapy etc..Result shows, Chinese medicine associating artificial tears treats the curative effect of xerophthalmia, is better than simple using artificial tear.Chinese medicine preparation coordinates artificial tears local application, and to reaching the good therapeutic effect for the treatment of both the principal and secondary aspects of a disease, for this, we fill up this blank, have developed the eye drop of Chinese herb medicine eye preparation for treating xerophthalmia.

Summary of the invention

According to above the deficiencies in the prior art, the present invention provides a kind of compound recipe Herba Dendrobii eye drop treating xerophthalmia and preparation method thereof, it is possible to has eyesight-strengthening and inflammation-resisting, lubricate ocular, promote effect of epithelial growth, thus reaching the purpose for the treatment of xerophthalmia.

A kind of compound recipe Herba Dendrobii eye drop treating xerophthalmia of the present invention, is formed by following preparation of raw material: Herba Dendrobii 80～120g, Radix Trichosanthis 80～120g, Folium Isatidis 80～120g, vitamin B₁50～100g and Mel 10～20ml.

Described Mel is the pure honey after filtering residue.

Wherein, it is preferable that scheme is as follows:

Preferably formed by following preparation of raw material: Herba Dendrobii 100g, Radix Trichosanthis 100g, Folium Isatidis 100g, vitamin B₁50g and Mel 15 milliliters

The preparation method of the compound recipe Herba Dendrobii eye drop for the treatment of xerophthalmia of the present invention, comprises the following steps:

(1) first add water 1000～2000ml by Herba Dendrobii, Radix Trichosanthis, Folium Isatidis, warm fire boil 15 minutes after filtering extracting liquid；

(2) in medicinal liquid, preservative ethyl hydroxybenzoate 0.05g is added, heating for dissolving, after filtering with sintered filter funnel, then scalding, take 200 milliliters of subpackages standby as solvent agent；

(3), after 200 milliliters of solvent agent being boiled, vitamin B is added immediately₁And Mel, place after fully dissolving to room temperature, regulate osmotic pressure with distilled water and be equivalent to the osmotic pressure of 0.8～1.2 sodium chloride concentration, be filtered to remove precipitate filtrate check pH value be equivalent to 7.0 ±, sequentially pass through fine straining, ultrafiltration when molecular cut off 10k after qualified, inflated with nitrogen embedding, 110～120 DEG C of sterilizing 20～30min, last subpackage, 5 mls/branch.

During use, every day eye drip 3～5 times, each 1～2.

Pharmacology analysis:

Herba Dendrobii: for Chinese medicine, derives from the orchid family Herba Dendrobii, belongs to the stem of Dendrobium various plants, cold nature.Effect reinforcing stomach reg fluid, clearing away heat and nourishing YIN, cure mainly consumption of body fluid caused by febrile disease, xerostomia excessive thirst, after being ill deficiency-heat, that the moon hinders order is dark.Containing multiple alkaloid, polysaccharide, aminoacid and starch etc. in stem of Dendrobium, there is certain antipyretic effect；Gastric secretion can be promoted, aid digestion；There are enhancing metabolism, the anti-ageing effect of waiting for a long time.The traditional Chinese medical science is thought, the vital essence of the vital organs of the human body is all passed through to note in eyes on blood vessels, and liver " having one's ideas straightened out in order ", the physiological and pathological of eyes and the cloudy essence of liver fill whether contain in close relations.The cloudy essence of liver fills Sheng, then eye is fair bright and eagle-eyed, rotates flexibly, and full of vigor, people also seems hale and hearty；If cloudy insufficiency of essence, eye is fine will be intense darkness without light, or two are dry and astringent, or blurring of vision, or nyctalopia etc..Radix Stephaniae Tetrandrae has the function of YIN nourishing nourishing the liver, therefore is used as the good merchantable brand of eye-protecting by ancient Chinese medicine doctor.

Radix Trichosanthis: sweet in the mouth, micro-hardship, cold nature, attaches to the lung and stomach meridians；Concrete effect is clearing away heat-fire, promoting the production of body fluid to quench thirst, clearing away lung-heat and moistening for dryness, removing toxicity for eliminating carbuncles etc..It is hot and suffocating that Radix Trichosanthis moves back the five internal organs, and as heart-fire is contained and dry tongue and mouth, lung-fire is contained and pharyngeal swelling sore throat, spleen-fire is contained and dispute tooth swells, phlegm-fire is contained and is coughed not peaceful.If the side of body of liver-fire is swollen migratory arthralgia caused by wind, the hectic fever due to YIN-deficiency dysphoria with smothery sensation of kidney fire, or carbuncle are not burst, and pyretic toxicity does not dissipate, or five types of jaundice yellow skin and eye, and if if little water drenches puckery, be caused by all burning hot pent-up, only this agent energy relieving stagnation, drop phlegm-fire, and can be controlled it.Its property is sweet cold again, kind can control thirsty, controls from tonic empty thirsty, controls fire from the medicine of a cold nature thirsty, controls from gas medicine and strongly fragrant yearningly controls excessive thirst from blood medicine, is control thirsty key medicine also.

Folium Isatidis: enter liver, the heart, stomach warp.Heat clearing away, removing toxic substances, removing heat from blood, hemostasis.Control epidemic febrile disease intenseness of heat excessive thirst, influenza, acute infectious hepatitis, bacillary dysentery, acute gastroenteritis, acute pneumonia, erysipelas, spit blood, epistaxis, jaundice, dysentery, sore throat, aphtha, swollen ulcer drug.Staphylococcus aureus, alpha streptococcus, meningococcus, streptococcus pneumoniae, micrococcus catarrhalis, Bacillus typhi, escherichia coli, hemophilus influenza, diphtheria corynebacterium and dysentery bacterium there is certain inhibitory action；Encephalitis b virus, mumps virus, influenza virus etc. are also had inhibitory action by Folium Isatidis.In addition Folium Isatidis kills leptospiral effect.

Vitamin B₁: being primarily present in crust and the plumule of seed, in Testa oryzae and wheat bran, content is very abundant, and in yeast, content is also extremely abundant.In lean meat, Chinese cabbage and Herba Apii graveolentis, content is also abundanter.The product of presently used vitamin B1 all chemosynthesis.In vivo, vitamin B₁Participate in catabolism of carbohydrate with co-enzyme form, have the neural effect of protection；Enterogastric peristalsis can also be promoted, increase appetite.Vitamin B₁It is one of optic nerve and perineural source of nutrition, it is possible to improve ophthalmoplegia, nystagmus and asthenopia.

Mel: containing a kind of antimicrobial, can prevent antibacterial from growing in vivo.Additionally, Mel can also produce hydrogen peroxide, this can contain that bacteria infection is at your internal diffusion enzyme.Prove after deliberation, Mel contains multivitamin and the abundant and bioactive substance of uniqueness makes it have the several functions such as antibacterial, antiinflammatory, antioxidation, elimination free radical, immunomodulating, antitumor, promotion tissue regeneration, human body is had medical treatment widely, health-care effect, and immunity and inflammatory factor are closely related with the pathogenic factors of xerophthalmia, now become the focus of research at present.

Eye drop of the present invention adopts modern advanced medical pharmaceutical technology to make, formula is reasonable, possessing science, advance, selected materials medicine source is enriched, and medical material is with low cost, there is eyesight-strengthening and inflammation-resisting, lubricate ocular, promote effect of epithelial growth, adopting the mode of topical, medicine directly arrives site of action, and the clinical treatment for xerophthalmia provides a kind of eye medicinal preparation safe and effective, easy to use, therapeutic effect is reliable, possesses replicability.

Outcome measure:

1. object of study:

Analyzing medical patients with dry eye 305 example 610 my Out-patient Department in March ,-2014 in January, 2013, patient is randomly divided into two groups, treatment by Chinese herbs group 169 example and western medicine group 136 example.Two groups of sexes, age comparing difference not statistically significants (P > 0.05).Patients with dry eye is responsible for observing treatment by special messenger in outpatient service, and treatment group patient is male 86 examples wherein, female 83 example；25～83 years old age；The course of disease 32～126 days, average 46.35 ± 26.36 days.Matched group patient is male 66 examples wherein, female 70 example；26～85 years old age；The course of disease 33～128 days, average 46.28 ± 26.26 days.

2. inclusion criteria:

1. xerophthalmia selects case to meet following diagnosis person.Diagnostic criteria with reference to Liu Zuguo etc.: (1) subjective symptom (has more than 1 for the positive): dry sensation, foreign body sensation, feeling of fatigue, sense of discomfort；(2) breakup time of tear film (breakinguptime, BUT): positive BUT < 10s (strong positive < 5s).(3) basis Schimer's test (Schirmerltest, Slt): positive Slt≤10mm/5min (strong positive: Slt≤5mm/5min).Repeatedly check for three times and confirm this inspection result.(4) corneal fluorescein dyeing (fuorescentstaining, FL): observe anterior corneal surface under slit lamp with or without fluorescent staining, standards of grading: corneal epithelium dye-free is 0 point；Stained area < 25% is 1 point；Stained area 25%～50% is 2 points；Stained area 50%～75% is 3 points；Stained area > 75% is 4 points.Positive is that fluorescent staining is marked >=1 point.

In above-mentioned several, getting rid of after other reasons and have the eye symptom positive, add that any 2 positives in (2), (3), (4) or 1 strong positive are diagnosed as the patient of xerophthalmia, above mensuration is the same timing in 1d all.

2. in strict accordance with doctor's advice medication, all information, midway does not stop, and does not accept other oral drug therapies person before treatment.

3. reception test Informed Consent Form person.

Exclusion standard:

1. not by doctor's advice medication, treat lack of standardization, midway discontinue medication.

2. the patients with dry eye of other pattern of syndrome.

3. Therapeutic Method:

3.1 treatment group 169 examples, the application compound recipe Herba Dendrobii eye drop prepared of the present invention, every day eye drip 3～5 times, each 1～2,10 days be a course for the treatment of, and interval carried out for second course for the treatment of for 5～7 days, 2～3 courses for the treatment of of ordinary circumstance.

3.2 matched group 136 examples, apply sodium hyaluronate eye drops, every day eye drip 3～5 times, each 1～2.Within 10 days, being a course for the treatment of, interval carried out for second course for the treatment of for 5～7 days, 2～3 courses for the treatment of of ordinary circumstance.

4. statistical analysis:

Adopting SPSS17.0 statistical software to process, measurement data represents with x ± s, compares employing t inspection before and after two groups of treatments, and the comparison of rate adopts X 2 test, and P < 0.05 is that difference is statistically significant.

5. result:

5.1 curative effect judgment criteria: work out with reference to pertinent literatures such as Liu Zuguo " eye surface diseases ".

1. cure: clinical symptoms is wholly absent, repeated detection BUT > 10s, Slt > 10mm/5min, FL (-).2. take a turn for the better: clinical symptom relief, repeated detection BUT > 5s, Slt > 5mm/5min, FL (+/-).3. invalid: clinical symptom relief, repeated detection BUT≤5s, Slt≤5mm/5min, FL (+).

Cure and improvement person is effectively.The follow up time 3-6 month.

After 5.2 liang of group cases are treated and terminated 2～3 courses for the treatment of, statistical result is in Table 1.

Treatment group cure rate 80.47%, improvement rate 17.16%, total effective rate is 97.65%；Matched group cure rate 65.44%, improvement rate 26.47%, total effective rate is 91.91%.Through statistical analysis, two groups of patient's comparitive study, two group differences have significant (p < 0.05), and treatment group is better than matched group.

1 liang of table group patients with dry eye Comparison of therapeutic

After 5.3 liang of group treatments, cornea fluorescent staining compares, and statistical result is in Table 2.

Matched group compares with treatment group, and through statistical analysis, two groups of corneal fluorescein dyeing difference statistically significant (p < 0.05), after treatment by Chinese herbs, corneal epithelium is clearly better before substantially relatively treating.

(x ± s) is compared in the group patients with dry eye corneal fluorescein dyeing scoring of 2 liang of table

Group	Number of cases	Before treatment	After treatment
				Treatment group	169	4.31±2.11	1.85±0.57
Matched group	136	4.43±2.20	2.74±0.89

As can be seen from the table above, adopt compound recipe Herba Dendrobii eye drop ophtalmic treatments xerophthalmia of the present invention, with conventional medicine sodium hyaluronate eye liquor ratio relatively, confirm that compound recipe Herba Dendrobii eye drop can effectively extend BUT, improve basis lacrimal secretion, compare with concurrent control group and have significant difference (P < 0.05) its curative effect to be better than hyaluronic acid sodium collyrium.Additionally, the present invention shows that compound recipe Herba Dendrobii eye drop substantially reduces corneal fluorescein dyeing scoring, corneal epithelial reparation has facilitation, and corneal epithelium reparation is the important content of dry eye treatment.Therefore, compound recipe Herba Dendrobii eye drop can promote that corneal epithelium heals, and treatment ocular epithelium caused by xerophthalmia is abnormal, evident in efficacy.

It is exemplified below 2 model cases:

1, Lee, man, 23 years old, latter 1 month of excimer laser treatment myopia, conscious eyes dry, sense of discomfort, test eyesight right eye 1.2, left vision 1.2, external eyes show no obvious abnormalities, optical fundus is normal, Schimer's test (Slt): right eye 6mm/5min, left eye 7mm/5min, breakup time of tear film (BUT): BUT < 5s,, cornea FL (-).Diagnosis is xerophthalmia.Application compound recipe Herba Dendrobii eye drop eye dripping, every day 3 times.After 2 courses for the treatment of, symptom is wholly absent, Slt right eye 14mm/5min, left eye 13mm/5min, BUT13s, cornea FL (-).Patient cures.

2, king, female, 67 years old, eyes were repeatedly furious with dry and astringent 5 years, increased the weight of and had furious pain to go to a doctor March.Once outer court's repeatedly ophthalmology outpatient clinic, gives the eye dripping such as antiinflammatory collyrium such as levofloxacin antibiotic, diclofenac sodium, without being clearly better.Previously rheumatoid arthritis disease history 10 years.Testing eyesight right eye 0.5, left vision 0.25, Dual-eyelid conjunctival congestion, nipple hypertrophy is obvious.Corneal epithelium is coarse, and spot film columnar epithelium strips off.Anterior chamber depth can, the uneven muddiness of crystalline lens, pupil is circular, and photoreaction is sensitive, and examination of ocular fundus shows no obvious abnormalities.Schimer's test Slt: right eye 3mm/5min, left eye 1mm/5min, BUT right eye 5s, BUT right eye 4s, corneal fluorescein dyeing have a FL (-), left eye FL (+), scoring is 2 points.Diagnosis is xerophthalmia, senile cataract.Application compound recipe Herba Dendrobii eye drop eye dripping, every day 4 times, after 3 courses for the treatment of, symptom disappears substantially, vision right eye 0.5, left vision 0.5, and Dual-eyelid conjunctival congestion is inconspicuous, corneal epithelium glossy clear.Slt right eye 14mm/5min, left eye 13mm/5min, BUT right eye 10s, BUT right eye 8s, cornea FL (-).Patient cures.

Detailed description of the invention

Below in conjunction with embodiment, the invention will be further described.

Embodiment 1:

A kind of compound recipe Herba Dendrobii eye drop treating xerophthalmia, is formed by following preparation of raw material: Herba Dendrobii 100g, Radix Trichosanthis 100g, Folium Isatidis 100g, vitamin B₁50g and Mel 15 milliliters.

Embodiment 2:

The compound recipe Herba Dendrobii eye drop of the treatment xerophthalmia described in embodiment 1, prepares according to following steps:

(1) first add water 1500ml by Herba Dendrobii, Radix Trichosanthis, Folium Isatidis, warm fire boil 15 minutes after filtering extracting liquid；

(2) in medicinal liquid, preservative ethyl hydroxybenzoate 0.05g is added, heating for dissolving, after filtering with sintered filter funnel, then scalding, take 200 milliliters of subpackages standby as solvent agent；

(3), after 200 milliliters of solvent agent being boiled, vitamin B is added immediately₁50g, Mel 15ml, place after fully dissolving to room temperature, regulate osmotic pressure with distilled water and be equivalent to the osmotic pressure of 1.0 sodium chloride concentrations, be filtered to remove precipitate filtrate check pH value be equivalent to 7.0 ±, sequentially pass through fine straining, ultrafiltration when molecular cut off 10k after qualified, inflated with nitrogen embedding, 115 DEG C of sterilizing 25min, last subpackage, 5 mls/branch.

During use, every day eye drip 3～5 times, each 1～2.

Claims (3)

1. the compound recipe Herba Dendrobii eye drop treating xerophthalmia, it is characterised in that formed by following preparation of raw material: Herba Dendrobii 80～120g, Radix Trichosanthis 80～120g, Folium Isatidis 80～120g, vitamin B₁50～100g and Mel 10～20ml.

2. a kind of compound recipe Herba Dendrobii eye drop treating xerophthalmia according to claim 1, it is characterised in that formed by following preparation of raw material: Herba Dendrobii 100g, Radix Trichosanthis 100g, Folium Isatidis 100g, vitamin B₁50g and Mel 15 milliliters.

3. the preparation method of the compound recipe Herba Dendrobii eye drop of a treatment xerophthalmia as claimed in claim 1, it is characterised in that comprise the following steps:

(1) first add water 1000～2000ml by Herba Dendrobii, Radix Trichosanthis, Folium Isatidis, warm fire boil 15 minutes after filtering extracting liquid；

(2) in medicinal liquid, preservative ethyl hydroxybenzoate 0.05g is added, heating for dissolving, after filtering with sintered filter funnel, then scalding, take 200 milliliters of subpackages standby as solvent agent；

(3), after 200 milliliters of solvent agent being boiled, vitamin B is added immediately₁And Mel, place after fully dissolving to room temperature, regulate osmotic pressure with distilled water and be equivalent to the osmotic pressure of 0.8～1.2 sodium chloride concentration, be filtered to remove precipitate filtrate check pH value be equivalent to 7.0 ±, sequentially pass through fine straining, ultrafiltration when molecular cut off 10k after qualified, inflated with nitrogen embedding, 110～120 DEG C of sterilizing 20～30min, last subpackage, 5 mls/branch.