CN1244361C

CN1244361C - Medicinal composition for curing oral and throa diseases and its preparing method, use and quality control method

Info

Publication number: CN1244361C
Application number: CN 03122364
Authority: CN
Inventors: 邹节明
Original assignee: Guilin Sanjin Pharmaceuticals Co Ltd
Current assignee: Guilin Sanjin Pharmaceuticals Co Ltd
Priority date: 2003-04-29
Filing date: 2003-04-29
Publication date: 2006-03-08
Anticipated expiration: 2023-04-29
Also published as: CN1457833A

Abstract

The present invention relates to a Chinese medicinal composition for treating oral and gular diseases, a preparation method thereof and an application thereof. The treated disease symptoms comprise swelling and pain of throats, mouth and tongue sores, swelling and aching or hemorrhage of gums, nipple moth goose sores, hemorrhage of infant goose sores and light burns and scalds, acute and chronic laryngopharyngitis, tonsillitis, stomatitis and ulceratiue stomatitis, which belong to heat toxin pathogenic persons. The Chinese medicinal composition is prepared from watermelon pericarp, borax, phellodendron bark, Chinese goldthread, vietnamese sophora root, blackberrykiky rhizome, fritillaria, natural indigo, borneol, Chinese soapberry fruit carbon, rhubarb, baical skullcap root, licorice root and menthol. The quality of the Chinese medicinal composition as a control composition is qualitatively identified by measuring the content of berberine hydrochlori in the Chinese medicinal composition through spectrophotometry, thin layer chromatography, etc.

Description

A kind of pharmaceutical composition for the treatment of oral cavity and throat diseases and its production and use

Technical field

The present invention relates to a kind of compositions, be used for the treatment of laryngopharynx swelling and pain, aphtha of the mouth and tongue, gingival swelling and pain or hemorrhage, thrush, infantile facial sore and mild burn bleed, acute and chronic pharyngitis, tonsillitis, stomatitis, oral ulcer belongs to pyretic toxicity and causes the patient with heat-clearing and toxic substances removing, reducing swelling and alleviating pain effect.

Background technology

Throat and oral cavity diseases belongs to traditional Chinese medical science categories such as " tonsillitis, sore throat, aphonia due to throat disease ", be subordinate to ability to speak, larynx section, diseases such as the said acute and chronic pharyngitis of modern medicine, acute tonsillitis, oral ulcer, stomatitis, gingival swelling and pain, pathogeny Chinese medicine is thought " all diseases of throat all belong to fire ", mainly be body diseases caused by exogenous pathogenic factor pyretic toxicity and cause on the pathogenic fire scorchingly, or cause exopathogen because oral cavity and throat is unclean and invade.Moreover be exactly that plain body loses void, and cause hyperactivity of deficient fire.Modern medicine study thinks that the scorching card of oral cavity and throat disease mainly is an infected by microbes such as antibacterial, virus and causing, or body immunity is low, and antibacterial, virus are in the pathogenic microorganism growth imbalance of oral cavity and throat and cause infection.Also have due to the mechanical damage simultaneously, or excessively take place with throat.This disease can repeatedly take place, and can repeatedly take place.

The tradition Chinese medicine has much the commentary treatise of oral cavity throat disease, has also put down in writing many prescriptions, and as Yangyin Qingfei Tang, BINGPENG SAN etc., these prescriptions are to adopt according to concrete symptom, are the important component parts of Chinese medicine content.Ancient Chinese medicine medicine or Chinese medicine among the people are fully being summed up, excavating or utilized to the modern Chinese medicine theory also.Just introduce the many proved recipes of control oral cavity and throat diseases, typical prescription as Chinese medicine institution of higher learning teaching material " traditional Chinese medical science otolaryngology ", the control oral cavity and throat diseases is had directive function preferably.Some pharmaceutical factories and Chinese medicine research institution also release some medicines in recent years, as clear and rich lozenge of the four seasons, folk song buccal tablet etc.In view of market demand, we in conjunction with modern science and technology, develop a kind of Chinese medicine preparation for the treatment of the oral cavity and throat diseases determined curative effect according to traditional Chinese medicine theory.

Summary of the invention

The application's purpose just provides a kind of heat-clearing and toxic substances removing that has, the compositions of reducing swelling and alleviating pain effect is used for the treatment of laryngopharynx swelling and pain, aphtha of the mouth and tongue, gingival swelling and pain or hemorrhage, thrush, infantile facial sore and mild burn bleed, acute and chronic pharyngitis, tonsillitis, stomatitis, oral ulcer belongs to pyretic toxicity and causes the patient.Raw material is formed:

The application's medicine is made by watermelon crystal, Borax (forging), Cortex Phellodendri, Rhizoma Coptidis, Radix Sophorae Tonkinensis, Rhizoma Belamcandae, Bulbus Fritillariae Uninbracteatae, Indigo Naturalis, Borneolum Syntheticum, Fructus Sapindi Mukouossi fruit (parch to black), Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, Mentholum.The weight proportion of each raw material is:

Watermelon crystal 30-50, Borax(calcined) 15-28, Cortex Phellodendri 6-15, Rhizoma Coptidis 6-14, Radix Scutellariae 5-14, Bulbus Fritillariae Uninbracteatae 7-15, Radix Sophorae Tonkinensis 13-19, Rhizoma Belamcandae 6-13, Indigo Naturalis 10-16, Borneolum Syntheticum 15-19, Fructus Sapindi Mukouossi fruit (charcoal) 6-15, Radix Et Rhizoma Rhei 3-7, Radix Glycyrrhizae 7-14, Mentholum 6-12.

Preferred weight proportion is:

Watermelon crystal 40 Indigo Naturaliss 14 Radix Scutellariaes 11

Radix Glycyrrhizae 9.5 Cortex Phellodendris 12 carbonized fructus sapindi mukouossis 10

Borax(calcined) 20 Radix Sophorae Tonkinensiss 15 Rhizoma Coptidis 12.5

Bulbus Fritillariae Uninbracteatae 9 Rhizoma Belamcandae 8 Radix Et Rhizoma Rhei 5

Borneolum Syntheticum 15 Mentholums 8.5

The preferred Bulbus Fritillariae Thunbergii of Bulbus Fritillariae Uninbracteatae

The application's compositions can adopt the conventional method of galenic pharmacy to make regular dosage form, and as powder, capsule, tablet, concentrated pill, granule, oral liquid, syrup, drop pill, paster etc., preferred dosage form is a powder.

Method for making: above 14 flavors, except that Borneolum Syntheticum, Mentholum, all the other raw material powders are broken into fine powder; With Borneolum Syntheticum and Mentholum difference porphyrize, with above-mentioned fine powder and an amount of adjuvant facing-up, sieve, mixing, promptly.

Fine powder except that Borneolum Syntheticum, Mentholum should be sterilized under 80-120 degree centigrade environment before mixing, and takes conventional method to carry out drying.

Function with cure mainly: heat-clearing and toxic substances removing, reducing swelling and alleviating pain.Be used for laryngopharynx swelling and pain, aphtha of the mouth and tongue, gingival swelling and pain or hemorrhage, thrush, infantile facial sore and mild burn bleed; Acute and chronic pharyngitis, tonsillitis, stomatitis, oral ulcer are seen above-mentioned patient.

The pharmacological action of GUILIN XIGUA SHUANG

We carry out pharmacological research to the GUILIN XIGUA SHUANG (powder) that makes by above method, and the result shows that GUILIN XIGUA SHUANG has stronger antibiotic, antiinflammatory and promotes all effects of ulcer healing.It has stronger antibacterial action and wider bactericidal range to adopt medicated powder directly to be coated with the method for spreading, medicated powder " abnormal smells from the patient " diffusion method, dish dilution method proof, and alpha streptococcus, group B streptococcus, staphylococcus aureus, Bacillus typhi, escherichia coli, Candida albicans are all had bactericidal action.To Mice Auricle Oleum Tiglii cause inflammation, rat Ovum Gallus domesticus album inflammation through outside be coated with, irritate stomach or intraperitoneal injection all presents stronger anti-inflammatory effect, the ip GUILIN XIGUA SHUANG increases the mouse skin capillary permeability significant antagonism.To the experimental therapy of oral ulcer due to the carbolic acid, the result shows and can shorten the ulcer healing time significantly.Cavia porcellus intradermal injection GUILIN XIGUA SHUANG has certain topical pain relief effect, and the persistent period can reach more than 90 minutes.

Influence (lung tissue hyporrhea) and powder to pulmonary after this drug spray suck, and it is relevant to stimulate air flue to cause cough, can recover gradually after the drug withdrawal, and filling stomach and lumbar injection GUILIN XIGUA SHUANG toxicity are little, and the internal organs microscopy is not seen significant change.

The brief summary of GUILIN XIGUA SHUANG clinical data

By first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi, second Affiliated Hospital and three tame hospitals of the Guangxi People's Hospital of the Autonomous Region, relevant requirements by " provisions for new drugs approval " and " new Chinese medicine clinical research guideline ", this product has been carried out the clinical verification of 360 examples with the form of matched group, the result shows, this product is to acute pharyngitis, acute catarrhal tonsillitis, acute gingivitis and papillary gingivitis, the total effective rate of minor aphtha is respectively 91.1%, 91.1%, 90%, 92.2%, do not see that during clinical observation obvious adverse reaction and side effect take place.

In addition, this product is carried out clinical verification in Affiliated Hospital of Medical Colleges Of Guilin and second Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi, relevant requirements by " provisions for new drugs approval " and " new Chinese medicine clinical research guideline ", this product has been carried out the clinical verification of 100 examples, the result shows, this product is respectively 100% and 96% to the total effective rate of wind heat (attacking lung) card acute pharyngitis and minor aphtha, and is clinical safe and reliable, do not see obvious adverse reaction.

In sum, this product has been carried out the clinical verification of 460 examples altogether after listing, and the result shows that this product is at the treatment acute/chronic pharyngitis, tonsillitis, show definite curative effect on the aditus laryngis illness such as minor aphtha, and clinical safe in utilization, do not see obvious toxic-side effects and untoward reaction.

Specific embodiments

Embodiment 1 preparation GUILIN XIGUA SHUANG

Raw material:

Watermelon crystal 199g Indigo Naturalis 64g Radix Scutellariae 40g

Radix Glycyrrhizae 45g Cortex Phellodendri 42g Fructus Sapindi Mukouossi fruit (charcoal) 33g

Borax (forging) 125g Radix Sophorae Tonkinensis 85g Rhizoma Coptidis 43g

Bulbus Fritillariae Thunbergii 42g Rhizoma Belamcandae 44g Radix Et Rhizoma Rhei 20g

Borneolum Syntheticum 86g Mentholum 32g

Make product 1000 grams altogether

Method for making:

1. get the raw material except that Borneolum Syntheticum, Mentholum, pulverize separately becomes fine powder, crosses 140～180 mesh sieves, and sterilization is 30 minutes under 80-120 degree centigrade environment, is dried to water content≤8%;

Borneolum Syntheticum, Mentholum respectively with an amount of above-mentioned fine powder and adjuvant facing-up, cross 140 mesh sieves;

3. each fine powder mixing gets product.

Claims

1. a Chinese medicine composition for the treatment of oral cavity and throat diseases is characterized in that being made by following materials of weight proportions: watermelon crystal 30-50, Borax(calcined) 15-28, Cortex Phellodendri 6-15, Rhizoma Coptidis 6-14, Radix Scutellariae 5-14, Bulbus Fritillariae Uninbracteatae 7-15, Radix Sophorae Tonkinensis 13-19, Rhizoma Belamcandae 6-13, Indigo Naturalis 10-16, Borneolum Syntheticum 15-19, carbonized fructus sapindi mukouossi 6-15, Radix Et Rhizoma Rhei 3-7, Radix Glycyrrhizae 7-14, Mentholum 6-12.

2. compositions according to claim 1 is characterized in that the weight proportion of each raw material is:

Watermelon crystal 40 Indigo Naturaliss 14 Radix Scutellariaes 11

Borax(calcined) 20 Radix Sophorae Tonkinensiss 15 Rhizoma Coptidis 12.5

Borneolum Syntheticum 15 Mentholums 8.5.

3. prepare claim 1 or 2 described method for compositions, it is characterized in that carrying out according to the following steps: get raw material, the raw material powder except that Borneolum Syntheticum, Mentholum is broken into fine powder; With Borneolum Syntheticum and Mentholum difference porphyrize, the appropriate amount of auxiliary materials facing-up with above-mentioned fine powder reaches or selects sieves, mixing, that is and, the fine powder except that Borneolum Syntheticum, Mentholum is sterilized under 80-120 ℃ environment before mixing, and takes conventional method to carry out drying.

4. Chinese medicine composition according to claim 1 and 2 is characterized in that wherein used Bulbus Fritillariae Uninbracteatae is a Bulbus Fritillariae Thunbergii.

5. according to claim 1,2 or 3 described compositionss, it is characterized in that dosage form is a powder.

6. belong to the purposes in the morbific medicine of pyretic toxicity according to claim 1 or 2 described compositionss in preparation treatment laryngopharynx swelling and pain, aphtha of the mouth and tongue, gingival swelling and pain or hemorrhage, thrush, infantile facial sore and mild burn bleed, acute and chronic pharyngitis, tonsillitis, stomatitis, oral ulcer.