CN1265916A - Chinese patent drug for treating peridentitis - Google Patents

Abstract

The Chinese patent medicine for external application for curing periodontitis is made of the Chinese medicinal materials of Chinese gooseberry root bark, rhubarb, borneol, cutch and psoralea seed as raw material. When it is used, said medicine can be applied on affected region, and can obtain good therapeutic effect.

Description

The Chinese patent medicine of treatment periodontal disease

The present invention relates to a kind of Chinese medicine composition, particularly a kind of Chinese patent medicine for the treatment of periodontal disease.

Periodontal disease is one of human general oral disease.Periodontal disease mainly causes because of staphylococcus aureus, Lactobacillus lactis, Streptococcus mutans and bacteroides melanogenicus etc.

Chinese patent CN1190013A discloses a kind of " ointment for toothache and stomatocase ", is made by Cinnabaris, Borax, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Cortex Phellodendri, Radix Glycyrrhizae, Borneolum Syntheticum, Cera Flava, Oleum sesami, cures mainly toothache and stomatocace.

Purpose of the present invention has just provided a kind of Chinese patent medicine for the treatment of periodontal disease, and this Chinese patent medicine has stronger bacteriostasis to the above-mentioned pathogenic bacteria that causes the periodontal disease, and toxic and side effects is little.

Solution of the present invention is based on motherland's medical science to periodontal disease and pathogenetic understanding of relevant odontopathy and Therapeutic Principle, achieve with reference to modern pharmacological research, from motherland's medical treasure-house, filter out and let out gastric heat clearly, reducing swelling and alleviating pain, cooling blood for hemostasis, the convergence granulation promoting, the kidney invigorating teeth consolidating etc., pure Chinese medicine is formulated, by the theory of Chinese medical science prescription, skim the cream off milk, make the local and whole heat-clearing and toxic substances removing that combines of its performance, reducing swelling and alleviating pain, cooling blood for hemostasis, the convergence granulation promoting, the comprehensive therapeutic effect of the kidney invigorating teeth consolidating, reduce the sequela of periodontal disease, delay gingival atrophy, keep tooth firmly healthy, the facilitating digestion function.

The object of the present invention is achieved like this: a kind of Chinese patent medicine for the treatment of periodontal disease, this Chinese medicine are that the drug regimen by following weight parts forms:

Skin 3-9 part Radix Et Rhizoma Rhei 0.5-5 part Borneolum Syntheticum 0.5-4 part of Radix Actinidiae Chinensis

Catechu 0.5-8 part Fructus Psoraleae 0.5-8 part

Optimum weight part of this Chinese patent medicine:

2 parts of 2 parts of Fructus Psoraleaes of 6 parts of Radix Et Rhizoma Rhei of the skin of Radix Actinidiae Chinensis, 2 parts of Borneolum Syntheticums, 2 share tea

Optimum weight part of this Chinese patent medicine:

1 part of 1 part of Fructus Psoraleae of 5 parts of Radix Et Rhizoma Rhei of the skin of Radix Actinidiae Chinensis, 3 parts of Borneolum Syntheticums, 2 share tea

Chinese patent medicine of the present invention is good to the bactericidal effect of the main pathogenic bacteria that causes the periodontal disease, and toxic and side effects is little.

Preparation method of the present invention

Earlier Radix Et Rhizoma Rhei is made Radix et Rhizoma Rhei (stir-fried with wine) by the Chinese medicine processing method, then Radix et Rhizoma Rhei (stir-fried with wine) is crushed to 120 orders, Borneolum Syntheticum is ground into 120 orders, Radix Actinidiae Chinensis is cleaned, got its skin, oven dry and the corium farinosum of Radix Actinidiae Chinensis is broken to 120 orders, Fructus Psoraleae is removed impurity, mix thoroughly, run through with 2% saline solution, take out airing, pulverize 120 orders, catechu is pulverized ground to 120 orders, mix homogeneously.

Using method of the present invention;

Earlier patient's tooth, teeth space are cleaned, then medicine of the present invention is applied to by treatment periodontal place, mouth included about 20 minutes, swallowed, and was coated with 0.1-0.2g, every day 3-6 time at every turn.

The acute toxicity test of this Chinese patent medicine is as follows:

One experiment material

Animal: Kunming mouse male and female half and half, body weight 20.0 ± 2.0g is bought by Lanzhou Institute of Biological Products, the animal quality certification number: the general CAC001 of Gansu Province's laboratory animal administration commission (96).

Medicine: it is standby that this Chinese patent medicine grinds the preparation variable concentrations with distilled water.

Method

Mtd test

20 of mices, male and female half and half, in testing the previous day, water is can't help in fasting overnight, under the condition of 20 ± 2 ℃ of room temperatures, gastric infusion twice in 24 hours, drug level is 0.33g/kg, (Cmax) 0.8Ml/20g, (maximum volume 1, dosage is 13.2g/kg, observes a week after the administration.

Mice in 30 minutes, because the administration volume is bigger than normal, has discomfort slightly after administration as a result, and it shows as mice and has loose bowels, back of a bow phenomenon recovers normal subsequently rapidly, and comparatively quiet, observes continuously 15 days, mice all survives, and cuts open inspection, the careful main inner internal organs of perusal, no abnormality seen.

Brief summary

Replenish to require (1) according to new drug (Chinese medicine) toxicological study, can accept maximum volume under the Cmax, carry out the maximum tolerated dose experiment mice.The mice dosage is 13.2g/kg as a result, is 660 times of clinical maximum dosage (0.02g/kg), and overt toxicity is not seen in all survivals in the observation period, shows that this poison of drug is less, and is clinical safe in utilization.

List of references

(1) Ministry of Public Health " provisions for new drugs approval " three, new drug (Chinese medicine) pharmacology, the technique complementary explanation of toxicological study.

Two are subjected to the reagent thing

Title: the Chinese patent medicine specification 4-4.5g/ bottle of this invention

Compound method: take by weighing the Chinese patent medicine of an amount of this invention, be mixed with pasty state with distilled water and get final product.

Positive control: periodontal is clear, is provided by Gansu Lan Pu pharmaceutcal corporation, Ltd, uses for animal skin hypersensitive test positive control.

Animal;

1, Japanese white big ear rabbit, body weight 2.5 ± 0.2kg, Cavia porcellus 250 ± 20g plants in Britain, and male and female half and half are bought by Lanzhou Institute of Biological Products, the laboratory animal quality certification number, Gansu Province's laboratory animal administration commission 001.

2, the Animal Lab. quality certification number, Gansu Province's laboratory animal administration commission 004.

(experimental technique and result)

1, skin acute toxicity test

Select 12 of rabbit, in administration spinal column left and right sides depilation in preceding 24 hours, area is 15cm ²Be divided into 3 groups at random, i.e. intact skin, negative control group, behind damaged skin group and the negative control group right side skin degerming, draw the well word gently with aseptic syringe needle,, press the 1g/kg administration to scratch skin oozing of blood degree of being, this dosage is equivalent to 50 times of clinical consumption, the lake agent evenly is applied in depilation district, right side, and the negative control left and right sides is evenly smeared distilled water, observes the whole body poisoning situation of rabbit every day.

The result observes all interior administration groups continuously searches for food, breathe, and activity, body weight is normal, depilation district skin, eyes, oral cavity sticking to mould no abnormality seen.Damaged skin is formed a scab rapidly, and none animal dead cuts open the careful macroscopy of inspection main organs, does not see obvious pathological changes.

Above result shows that this product is lower to animal skin toxicity.

2, skin irritation test

Select 12 of rabbit, animal depilation, grouping, the skin injury mode is the same, and drug paste evenly is applied in two groups of administration depilation districts, and drug level is the 0.6g/kg administration, be equivalent to 30 times of clinical dosage, once a day, continuous three days, matched group is smeared distilled water, smears the back every day and sees and to look into skin conditions, after the last administration 1, saw the skin irritation degree of looking in 24,48,72 hours, connect table 1,2 pairs of skin irritation reactions are marked and the stimulus intensity evaluation, and scoring sees Table 3.

Table 3 is the result show: by the skin irritation intensity evaluation, this product contacts equal nonirritant to intact skin.

3, skin allergy experiment

Select 30 of Cavia porcelluss, white, both sides depilation 3.3cm ², be divided into 3 groups, i.e. this Chinese patent medicine administration group sensitization, booster dose is 0.4g/kg, is equivalent to 20 times of clinical dosages, the clear positive controls of periodontal (make pasty state equally, smearing the depilation district), distilled water negative control group.In the 0th, 7,14 days left side sensitization contact 0.1g/ml, 1ml/ only, after last sensitization 14 days, the right side excited contact, 1ml/, promptly considerable looking into, and in 24, saw in 48,72 hours again and look into the anaphylaxis situation, the skin allergy standards of grading see Table 4, tried the thing reaction property with judgement, the reaction meansigma methods is that erythema forms total points divided by adding up to number of animals, carries out sensitivity response intensity par by table 5, and the sensitization rate is that the routine number of skin erythema or edema animal is divided by the animal subject sum in the table.The results are shown in Table 6.

The result shows that this Chinese patent medicine is weak sensitization to guinea pig skin.

Conclusion

This product carries out animal skin toxicity with reference to pertinent regulations in the specification requirement of new drug toxicity, stimulates, and hypersensitive test, experimental result show, and is complete lower with damaged skin toxicity to rabbit, to the skin nonirritant, guinea pig skin is weak sensitization.

List of references

Clinical research guideline compilation, bureau of drug administration of Ministry of Health of the People's Republic of China.

Table 1 skin irritation reaction scoring

Irritant reaction score value erythema

No erythema 0

Inadequate visible 1

In strong erythema 2

Serious erythema 3

The aubergine erythema also has eschar to form 4 edema

No edema 0

Inadequate visible 1

Cutaneous protuberance profile clear 2

Edema about 1mm of protuberance and expanded range 3

Table 2 skin irritation intensity evaluation

The intensity score value

Nonirritant＜0.5

Slight excitant＜2.09 moderate excitants＜6.0 intensity excitants＜6.0 tables 3 Chinese patent drug of the present invention smear the skin irritation test scoring as a result the group rabbit count erythema and form the score value oedema and form score value total points intact skin administration group 4000 control groups 4000 damaged skin administration groups 4 0.2 0 0.2 control groups 4000

Table 4 skin allergy standards of grading dermoreaction score value does not have erythema and forms 0 slight erythema 1 moderate erythema 2 severe erythema 3 edematous erythemas 4

The high degree sensitization of the weak slight sensitization 40-60 moderate of the sensitization 20-30 sensitization 70-80 height sensitization 90-100 of table 5 sensitization rate classification sensitization rate (%) response intensity 0-10

The clear group of each these Chinese patent medicine group 00 periodontal of treated animal sensitization rate group anaphylaxis mean scores K sensitization rate % of table 6 2.5 100 distilled water groups 00

The external bacteriostatic experiment of this Chinese patent medicine is as follows:

One, experiment material

1.1 the medicinal liquid preparation takes by weighing this Chinese patent medicine 5g, adds 50 milliliters in water, soaks 2 hours, boils 10 minutes, filters, filtrate is after 8 pounds of sterilizations of flowing steam, and is standby.

1.2 strain staphylococcus aureus (26003), Lactobacillus lactis over sixty years of age (34102), Streptococcus mutans (32471) and bacteroides melanogenicus provide by Nat'l Pharmaceutical ﹠ Biological Products Control Institute.

1.3 the culture medium Nutrient agar, sulfur ethylate agar culture medium.The increase liquid of detesting bacteria is to add people's chlorhematin (5ug/ml) in thioglycollate solution medium, adds NaoH (1mg/ml) before the sterilization, faces with preceding adding vitamin K1 (0.1ug/ml).Detest the bacteria diluent for containing the brucella broth of 5%Filches Digestive system and vitamin K1 (0.1UG/ML).

1.4 bacteria suspension is got bacterium platform-oese on the inclined working in the corresponding liquid culture medium, needs 37 hours with dilution meat soup, makes the bacteria suspension that becomes to give prominence to 10cfu/ml.

Two, experimental technique and result

2.1 method experimentizes by the liquid doubling dilution, add bacteria suspension 0.1ml in each pipe, cultivated 24.8 hours in 37 degree, the least concentration that can not grow with antibacterial is minimum antibacterial dense (MZC), is minimum bactericidal concentration (MZC) with least concentration that can killing bacteria.

2.2 the results are shown in Table 7 and table 8

Three conclusions

Periodontal disease mainly shows as gingival swelling and pain, chews pain, periodontal pocket formation and gingiva pyorrhea etc.This Chinese patent medicine all has stronger bacteriostasis external to several pathogenic bacterias that cause periodontal disease, so this Chinese patent medicine has therapeutical effect to the various microbial periodontal disease of causing a disease.

List of references

Clinical research guideline compilation, bureau of drug administration of Ministry of Health of the People's Republic of China.Surplus he medical hygiene thing is learned precious medicine microbiology of People's Health Publisher 1,983 235 251 Zheng Jun a large bell Wang Guang and inspection technology People's Health Publisher 1,989 349 353

This Chinese patent drug of table 7 is to minimum bacteriostatic experiment (g/100ml) concentration 5 2.5 1.25 0.625 0.312 0.196 0.8 0.4 staphylococcus aureuses of pathogenic bacteria---++++ over sixty years of age Lactobacillus lactis---++++ bacteroides melanogenicus---+++Streptococcus mutans----++++ annotate: "+" expression has bacteria growing

"-" expression asepsis growth

This Chinese patent drug of table 8 is to the minimum bactericidals of pathogenic bacteria experiment (g/100ml) concentration 5 2.5 1.25 0.625 0.312 0.16 0.8 0.4 staphylococcus aureuses---+++++over sixty years of age Lactobacillus lactis---++++ bacteroides melanogenicus---+++++Streptococcus mutans---+++++annotate: "+" expression has bacteria growing

"-" expression asepsis growth

Embodiment

Earlier Radix Et Rhizoma Rhei is made Radix et Rhizoma Rhei (stir-fried with wine) by the Chinese medicine processing method, then Radix et Rhizoma Rhei (stir-fried with wine) is crushed to 120 orders, Borneolum Syntheticum is ground into 120 orders, Radix Actinidiae Chinensis is cleaned, got its skin, oven dry and the corium farinosum of Radix Actinidiae Chinensis is broken to 120 orders, Fructus Psoraleae is removed impurity, mix thoroughly, run through, take out airing with 2% saline solution, pulverize 120 orders, catechu is pulverized ground to 120 orders.

Take by weighing skin 6kg, Radix Et Rhizoma Rhei 2kg, Borneolum Syntheticum 2kg, catechu 2kg, the Fructus Psoraleae 2kg of the Radix Actinidiae Chinensis that processes, and with each flavor raw material of Chinese medicine mix homogeneously.

Claims (3)

1, a kind of Chinese patent medicine for the treatment of periodontal disease is characterized in that this Chinese medicine is that drug regimen by following weight parts forms:

Skin 3-9 part Radix Et Rhizoma Rhei 0.5-5 part Borneolum Syntheticum 0.5-4 part of Radix Actinidiae Chinensis

Catechu 0.5-8 part Fructus Psoraleae 0.5-8 part

2,, it is characterized in that optimum weight part of this Chinese patent medicine according to the Chinese patent medicine described in the claim 1:

2 parts of 2 parts of Fructus Psoraleaes of 6 parts of Radix Et Rhizoma Rhei of the skin of Radix Actinidiae Chinensis, 2 parts of Borneolum Syntheticums, 2 share tea

3,, it is characterized in that optimum weight part of this Chinese patent medicine according to the Chinese patent medicine described in the claim 1:

1 part of 1 part of Fructus Psoraleae of 5 parts of Radix Et Rhizoma Rhei of the skin of Radix Actinidiae Chinensis, 3 parts of Borneolum Syntheticums, 2 share tea