CN100542597C - A preparation process and application of traditional Chinese medicine for treating symptoms of vocal cord nodules and vocal cord polyps - Google Patents

Abstract

The invention relates to a preparation process and application of a traditional Chinese medicine preparation, in particular to a preparation process and application of a traditional Chinese medicine for treating symptoms of vocal nodules and vocal cord polyps. The purpose of the invention is to provide a preparation process of a traditional Chinese medicine preparation for treating symptoms of vocal cord nodules and vocal cord polyps. Another object of the present invention is to provide the application in medicine for treating vocal cord nodules and vocal cord polyps. The preparation process of the present invention is stable and feasible, and the chlorogenic acid content of the finished product is higher than the original process, which improves the utilization rate of raw materials and the extraction rate of active ingredients; the present invention has the function of promoting blood circulation and removing stasis, and can reduce the viscosity of whole blood, plasma Viscosity, reduced viscosity of whole blood, fibrinogen content and platelet attachment rate; it has an inhibitory effect on chronic inflammatory granulation tissue hyperplasia.

Description

A preparation process and application of traditional Chinese medicine for treating symptoms of vocal cord nodules and vocal cord polyps

Technical field:

The invention relates to a preparation process and application of a traditional Chinese medicine preparation, in particular to a preparation process and application of a traditional Chinese medicine for treating symptoms of vocal nodules and vocal cord polyps.

Background technique:

Throat disease is a common clinical disease and frequently-occurring disease, and the incidence rate has been increasing nationwide in recent years. At present, the number of patients with throat disease in my country is increasing. About 12% of the total number of patients, the high incidence rate will cause the attention of the medical circle and the people of the country.

At present, there are not many pure Chinese medicine preparations for treating throat diseases in China, especially pure Chinese medicine varieties such as treating chronic laryngitis (vocal cord nodules, vocal cord polyps, and vocal cord mucosal thickening) are almost rare. The commonly used clinical method is Western medicine treatment, which uses antibiotics to control or surgical resection. In addition to adding and subtracting prescription drugs for clinical diagnosis and treatment, traditional Chinese medicine preparations with definite curative effects, syndrome differentiation, and both symptoms and root causes are rare.

CN1544077A discloses a kind of " Chinese medicine for the treatment of chronic and dull throat symptoms ", and its tablet, capsule preparation process loses more in the process of raw material concentration, and the concentrated extract density is unfavorable for mixing, is not easy to dry, takes a lot of work, It is time-consuming, and the utilization rate of raw materials and the extraction rate of active ingredients are not high. In industrial production, how to ensure that the total amount of finished products produced by each batch of materials can be kept stable within the range allowed by the national drug management, and at the same time, the data and results of the national statutory drug inspection are stable, and the reproducibility of the experiment is good. An important technical key point. Therefore it is of great practical significance to seek stable, efficient and long-acting series of medicines for the treatment of various throat diseases.

Invention content:

The purpose of the invention is to provide a preparation process of a traditional Chinese medicine preparation for treating symptoms of vocal cord nodules and vocal cord polyps.

Another object of the present invention is to provide the application in medicine for treating vocal cord nodules and vocal cord polyps.

The object of the invention is achieved through the following technical solutions:

Take 40%-60% of the prescription amount of honeysuckle, Fritillaria, safflower, and 10%-30% of the prescription amount of puffball, grind into fine powder, sieve, mix, and set aside; Add 8-12 times, 6 -10 times of water decocted twice, each time for 1-3 hours, combined decoction, filtered, the filtrate was concentrated to a thick paste with a relative density of 1.28-1.32 (60°C), and 90%-100% ethanol was added to make the alcohol-containing The amount reaches 50-70%, stir evenly, stand still for 12-36 hours, filter, recover ethanol from the filtrate, concentrate under reduced pressure to a clear paste with a relative density of 1.38-1.40 (60°C); add the prepared fine powder and appropriate amount of auxiliary materials Mixed, dried, crushed, made into fine particles, that is.

The preparation process of the present invention is stable and feasible, and the chlorogenic acid content of the finished product is higher than the original process, which improves the utilization rate of raw materials and the extraction rate of active ingredients; the present invention has the function of promoting blood circulation and removing stasis, and can reduce the viscosity of whole blood, plasma Viscosity, reduced viscosity of whole blood, fibrinogen content and platelet attachment rate; it has an inhibitory effect on chronic inflammatory granulation tissue hyperplasia. The finished product treated vocal cord summary prepared by the water extraction process has a total effective rate of 56.67%, and the total effective rate is 36.67% for the treatment of vocal cord polyps; The effective rate is 86.67%, thereby improving the clinical curative effect of treating vocal cord nodules and vocal cord polyposis.

Detailed ways

The following experimental examples are used to further illustrate the present invention.

Experimental example 1 Water extraction process optimization

According to the analysis of the influencing factors of the water extraction process, the amount of water added, the decoction time, and the number of decoctions were selected as the main factors. Using the orthogonal test method, the amount of dry paste and the transfer rate of chlorogenic acid were used as indicators to screen out the best. process conditions.

1. Investigation on the water absorption of medicinal materials:

According to the above-mentioned prescription proportions, a total of 149.3 g of the medicinal materials extracted by water was weighed, soaked in 10 times the amount of water until thoroughly filtered, and the average water absorption rate was measured to be 208%.

2. Orthogonal experimental design

After analyzing and comparing the extraction times, extraction time, water addition and other factors involved in the extraction process, three levels were designed for each, and the design factor level table is shown in Table 1.

Table 1 Factor level table of water extraction orthogonal test

Note: ^* The amount of water added in the brackets is the 2nd and 3rd times

3. Test method

According to the proportion of the above prescription, weigh 149.3g of the water-extracted part of the medicinal materials, a total of 9 parts, according to the L ₉ (3 ⁴ ) orthogonal table design test (Table 2), add water to decoct, filter, and measure the volume of the filtrate. The ointment yield and chlorogenic acid transfer rate were measured, and the results are shown in Table 2 and Table 3.

Calculation of the amount of dry ointment: Precisely absorb 25ml of the filtrate, put it in an evaporating dish that has been dried to constant weight, evaporate to dryness in a water bath, dry at 105°C for 3 hours, cool in a desiccator for 30 minutes, weigh quickly, and calculate the amount of dry ointment.

Determination of chlorogenic acid content:

Chromatographic conditions and system suitability test used octadecylsilane bonded silica gel as filler; acetonitrile-0.4% phosphoric acid solution (10:90) as mobile phase; detection wavelength was 327nm. The number of theoretical plates should not be less than 2500 based on the chlorogenic acid peak.

Preparation of Reference Substance Solution Accurately weigh an appropriate amount of chlorogenic acid reference substance, put it in a brown volumetric flask, add 50% methanol to make a solution containing 10 μg per 1 ml, and obtain it.

Preparation of the test solution Precisely measure 10ml of the above-mentioned filtrate, put it in a 25ml measuring bottle, add 10ml of 50% methanol, sonicate for 30 minutes, let it cool, add 50% methanol to the mark, shake well, and obtain.

Determination method Precisely draw 5 μl each of the reference substance solution and the test solution, inject it into the liquid chromatograph, measure it, and obtain it.

Table 2 L ₉ (3) ⁴ Orthogonal Test Result Table

Table 3 Results of variance analysis

F _0.05 (2, 2) = 19.00 F _0.01 (2, 2) = 99.00

3. According to intuitive analysis combined with variance analysis, the optimal process condition for water extraction is A ₂ B ₂ C ₃ , but C ₂ is very close to C ₃ . From the perspective of saving energy and man-hours, the optimal extraction process condition is A ₂ B ₂ C ₂ , that is, decoct twice with water, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, 2 hours each time.

4. Verification of water extraction process

According to the proportion of the above prescription, weigh 149.3g of the water-extracted part of the medicinal material, a total of 3 parts, add water to decoct twice, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, each time for 2 hours. Filtrate, measure paste yield and chlorogenic acid transfer rate, the results are shown in Table 4

Table 4 Water extraction process verification results

It can be seen from Table 5 that the verification results are basically consistent with the orthogonal test results. It shows that this process is reasonable and feasible. Therefore, it is determined to decoct twice with water, add 10 times the amount of water for the first time, and add 8 times the amount of water for the second time, each time for 2 hours.

Experimental example 2 Alcohol precipitation process optimization

1. Screening of alcohol precipitation conditions

The water extract of medicinal materials, because the extract is easy to absorb moisture and has large impurities, it should be treated with alcohol during the preparation process to retain the active ingredients, remove impurities, and reduce the dosage. Therefore, for different concentrations of alcohol precipitation The total ointment output and chlorogenic acid content were investigated. The water decoction with starch and mucilage is purified by alcohol precipitation. After analyzing the influencing factors of alcohol precipitation, select the concentration of alcohol precipitation (A), the relative density of liquid medicine (B), and the standing time (C), and design an orthogonal experiment according to L9(3)4. The acid transfer rate was used as an evaluation index for comprehensive analysis. See Table 5 for the level table of design factors.

Table 5 4 Factor 3 Level Ranking Table

Note: The relative density is measured at 60°C.

Experimental method: According to the proportion of the prescription, weigh 1/2 of each of honeysuckle, fritillaria, and safflower, and sift out 6.7g of fine powder with puffball, and weigh the remaining 1493.1g of the remaining twelve herbs and the above four herbs. , add water and decoct twice, each time for 2 hours, the amount of water added is 10 times and 8 times of the total amount of medicinal materials respectively, the filtrate is combined, and then operated according to the requirements of the orthogonal test program. The results are shown in Tables 6 and 7.

Table 6 L ₉ (3) ⁴ Orthogonal Test Result Table

Comprehensive scoring standard: The transfer rate Y of chlorogenic acid is stipulated with a full score of 60 points. According to the transfer rate obtained from the water extraction test, the transfer rate is 40% as the full score, and every 1% is 1.5 points, and the score is Y×1.5; the cream yield X The full score is 40 points, according to the fluctuation range of the paste rate, 10% is 0 points, 6% is 40 points, every 1% increase minus 40/(10-6) points, the score is [40-40/4(X -6)]; the total score of the two indicators is 100 points, and the total score is Y×1.5+[40-40/4(X-6)].

Table 7 Results of variance analysis

F _0.05 (2, 2) = 19.00 F _0.01 (2, 2) = 99.00

According to visual analysis combined with variance analysis, factor A has a significant impact on the transfer rate of chlorogenic acid and the yield of ointment. Considering the reduction of ethanol consumption and shortening the production cycle in production, A ₂ B ₃ C ₁ is determined to be the best extraction process.

Experimental Example 3 Water Extraction and Alcohol Precipitation Process and Optimization of Water Extraction Process

According to the parameters determined by the above-mentioned water extraction process and water extraction and alcohol precipitation process, the pilot production was carried out according to 10 times the amount of the prescription, and the shaped particles were investigated to compare the similarities and differences of the two processes.

1. Comparison of test results of three batches of pilot products

The test results of the three batches of pilot products are shown in Table 8.

Table 8 Test results of three batches of pilot products with different processes

*A is the water extraction process, B is the water extraction and alcohol precipitation process

It can be seen from the above table that the water extraction process extracts a large amount of extract and dry paste, the difference between batches is large, the process is unstable, and the amount of dry paste is large, which does not achieve the purpose of reducing the dosage. The water extraction and alcohol precipitation process effectively removes the non-medicinal parts and retains the active ingredients. The parameters between the processes are stable, and the dosage meets the national drug dosage regulations.

2. Investigation on the hygroscopicity of particles

Weigh about 100g each of the shaped granules produced by the water extraction and alcohol precipitation process and the water extraction process of this product, place them under natural conditions (temperature 35°C, relative humidity 70%), and measure their water absorption once every 24 hours. The results are shown in Table 9.

Table 9 Humidity test of different processes

*A is the water extraction process, B is the water extraction and alcohol precipitation process

From the results in the above table, it can be seen that the average water absorption of the finished product prepared by the water extraction and alcohol precipitation process has little change, and the stability of the sample is better.

3. Investigation of particle fluidity

Use the self-made "funnel" method to check the fluidity of the shaped particles produced by the water extraction and alcohol precipitation process and the water extraction process. The results are shown in Tables 10 and 11.

Table 10 Fluidity tests of different processes

*A is the water extraction process, B is the water extraction and alcohol precipitation process

Table 11 Measurement results of angle of repose of content in different processes

*A is the water extraction process, B is the water extraction and alcohol precipitation process

It can be seen from the results in the above table that the finished granules prepared by the water extraction and alcohol precipitation process have better fluidity, are easy to fill and pack the granules, and are suitable for large-scale production.

4. Product quality analysis

The formed granules produced by the water extraction and alcohol precipitation process and the water extraction process are tested according to the proposed quality standards, and the influence of different processes on product quality is investigated, so as to determine a reasonable production process. The experimental results are shown in Table 12.

Table 12 Quality analysis of three batches of products with different processes

*A is the water extraction process, B is the water extraction and alcohol precipitation process

From the results in the above table, it can be seen that the water extraction process contains many non-medicinal ingredients, which interferes with the detection of drug quality standards, cannot accurately control the quality of drugs, and the process is unstable; the sample identification items of the water extraction and alcohol precipitation process are all It can be detected that the content of chlorogenic acid is relatively high, and the difference in content is small, indicating that the process stability after alcohol precipitation is good.

5. Product stability analysis

For the capsules made by water extraction and alcohol precipitation process and water extraction process, carry out accelerated test, place it under the conditions of temperature (40±2) ℃ and relative humidity (70±5)% for six months, and take samples for testing once a month , according to the key items of stability inspection, the results are shown in Tables 13 and 14.

Table 13 Stability testing of finished products made by water extraction process

Table 14 Stability testing of finished products made by water extraction and alcohol precipitation process

*A is the water extraction process, B is the water extraction and alcohol precipitation process

It can be seen from Tables 10 and 11 that the samples of the water extraction process have more non-medicinal ingredients, which interfere with the detection of drug quality standards, and have large content differences and large hygroscopicity; the samples of the water extraction and alcohol precipitation process according to The proposed quality standard was tested, and the identification items could be detected. The content of hesperidin was relatively high, and the difference in content was small, indicating that the process stability after alcohol precipitation was good.

Experimental Example 4 Research on anti-inflammatory effect

Anti-chronic inflammation test (rat cotton ball subcutaneous implantation method)

Test drug:

Name: Jinsang Sanjie Capsules

Properties: The content is brown granule and powder; slight gas, slightly bitter taste.

Provider: Xi'an Beilin Traditional Chinese Medicine Factory

Batch No.: Water Extraction and Alcohol Precipitation Extract Capsules 940303; Water Extract Capsules 940301

Content: water extraction and alcohol precipitation extract capsule 940303 0.4g/capsule

  Water extract capsule 940301 0.4g/capsule

Control drug and main reagent methods: Prednisone Tablets [Shaanwei Zhunzi (1993) No. 000532], produced by Xi’an Pharmaceutical Factory, batch number 9303145; No.], produced by Guangzhou Baiyunshan Pharmaceutical Factory, batch number: 94021436.

Instrument LG-III rotating cylinder blood viscosity tester, produced by Sensing Technology Company of Chinese Academy of Sciences; 9103-B Platelet Adhesion Instrument, produced by Sensing Technology Company of Chinese Academy of Sciences; 3F-3 high-speed microcentrifuge, produced by Huaxing Jilun Company Production; reading microscope, produced by Changchun No. 1 Optical Instrument Factory; JA1003 electronic balance, produced by Shanghai Precision Scientific Instrument Co., Ltd.

Test animals SD strain rats, body weight: 200-250g ♂♀ half and half. Shanyi Dongzhengzi No. 08-005, provided by the Experimental Animal Center of Xi'an Medical University.

Laboratory temperature: 20-26°C Relative humidity: 42-76%.

Experimental method and results

80 rats, half male and half male, were randomly divided into 8 groups, 10 rats in each group. The first group is a blank control group, which gives equal volume of normal saline; the second group is a positive control group (prednisone tablet 8mg/kg); g, 0.4284g, 0.8568g/kg crude drug); the 6th, 7th, and 8th groups were Jinsang Sanjie water extraction and alcohol precipitation extract capsule group (0.2142g, 0.4284g, 0.8568g/kg crude drug). Under light anesthesia with ether, the shearing was disinfected. Aseptic operation, the skin was cut in the middle of the lower abdomen, and 50 mg sterile cotton balls were implanted under the skin of the groin on both sides, and then the skin was sutured and disinfected. From 3 days before the operation, ig administration was started, 2ml/100g, 1 time/day, for 10 consecutive days. Rats were sacrificed on day 11, the cotton balls and wrapped granulation tissue were carefully peeled off, dried at 60°C for 12 hours, and then weighed. Subtracting the weight of the original cotton balls was the weight of granulation tissue, expressed as the weight of granulation tissue contained in 100 g of body weight (both sides). Tested by t. The results are shown in Table 15.

Table 15 Effects of two kinds of Jinsang Sanjie Capsules on chronic hyperplasia and inflammation in rats (X±S)

Compared with blank control group *P<0.05 **P<0.01

It can be seen from Table 15 that Jinsang Sanjie Water Extraction and Precipitation Extract Capsules and Water Extract Capsules inhibit the hyperplasia of cotton ball granuloma tissue in rats, and reduce the weight of granulation tissue compared with the blank control group, there are significant differences (P<0.01 ); the results showed that Jinsang Sanjie Capsules produced by two different processes had inhibitory effect on chronic cotton ball proliferative inflammation in rats, but the efficacy of Jinsang Sanjie water-extracted and alcohol-precipitated capsules was better than that of water-extracted capsules .

Experimental Example 5 Study on the effect of promoting blood circulation and removing blood stasis

Effects on Hemorheology of Rats with Acute Blood Stasis Syndrome

Test drug:

Name: Jinsang Sanjie Capsules

Properties: The content is brown granule and powder; slight gas, slightly bitter taste.

Provider: Xi'an Beilin Traditional Chinese Medicine Factory

Batch No.: Water Extraction and Alcohol Precipitation Extract Capsules 940303; Water Extract Capsules 940301

Content: water extraction and alcohol precipitation extract capsule 940303 0.4g/capsule

  Water extract capsule 940301 0.4g/capsule

90 rats, half male and half male, were randomly divided into 9 groups, 10 rats in each group. The first group is the blank control group, which is given equal volume of normal saline; the second group is the model control group, which is given equal volume of normal saline; Group 6 is Jinsang Sanjie water extract group (0.2142g, 0.4284g, 0.8568g/kg crude drug); Groups 7, 8, and 9 are Jinsang Sanjie water extraction and alcohol precipitation extract group (0.2142g, 0.4284g , 0.8568g/kg crude drug). Ig administration, equal volume 2ml/100g, 1 time/day, for 7 consecutive days. On test d8, except for the blank control group, the other groups copied the acute blood stasis model according to the literature method. Each rat Sc adrenaline 8 μg/kg, 2 hours later, the rats were immersed in ice water at 0°C for 5 minutes, and after another 2 hours, the same amount of adrenaline was Sc for the second time. After 12 hours of fasting, blood was collected from the carotid artery under ether anesthesia, anticoagulated with heparin, and used to measure high shear (200S ^-1 ) and low shear viscosity (40S ^-1 ), erythrocyte sedimentation rate, hematocrit and calculate whole blood reduced viscosity Determination of blood fibrinogen content by thermal precipitation method; take heparin anticoagulant blood and centrifuge plasma to measure plasma viscosity; take sodium citrate anticoagulant blood for determination of platelet adhesion rate. Tested by t. The results are shown in Table 16 and Table 17.

Table 16 Effects of two kinds of Jinsang Sanjie Capsules on blood viscosity of rats with acute blood stasis syndrome (X±S)

Compared with normal control group, **P<0.01; compared with model control group, *P<0.05, **P<0.01

Table 17 Effects of two kinds of Jinsang Sanjie Capsules on blood fibrinogen content, erythrocyte sedimentation rate, platelet adhesion rate and cell volume in acute blood stasis rats (X±S)

Compared with normal control group, **P<0.01; compared with model control group, *P<0.05, **P<0.01

It can be seen from Table 16 and Table 17 that the whole blood high shear and low shear rate viscosity, plasma viscosity and whole blood reduced viscosity of acute blood stasis model rats were significantly increased, blood fibrinogen increased, platelet adhesion rate increased, Compared with the normal control group, there was statistically significant difference (P<0.01). Compared with the model control group, the two Jinsang Sanjie capsules both reduced the high-shear and low-shear rate viscosity, plasma viscosity and whole blood reduced viscosity of rats with acute blood stasis syndrome, and reduced the blood fibrinogen content. The high-dose group had significant difference (P<0.05 or P<0.01); and Jinsang Sanjie water-extracted alcohol-precipitated extract capsules were better than water-extracted capsules. There was no significant effect on erythrocyte sedimentation rate and hematocrit.

Experimental Example 6 Clinical Study of Jinsang Sanjie Capsules in Treating Vocal Cord Nodules and Vocal Cord Polyps

1. Clinical trials

experiment method

(1) Experimental design

Randomized controlled clinical trials. The test group consists of 60 cases in group A and 60 cases in group B to determine the best preparation process.

(2) Treatment methods

Group A: Jinsang Sanjie Capsules produced by water extraction and alcohol precipitation process, specifications: each capsule contains 0.4g, and each capsule contains 2.5g of raw medicine, usage and dosage: oral, 3 capsules at a time, twice a day.

Group B: Jinsang Sanjie Capsules produced by water extraction process, specifications: each capsule contains 0.4g, each capsule contains 1.25g of crude drug, usage and dosage: oral, 6 capsules at a time, twice a day.

The daily dose of crude drug in the two groups was 15g, which was comparable.

Course of treatment: one month.

(3) Observation method

Before the start of the clinical trial, provide unified training to the clinicians participating in the trial, so that they can have a full understanding of the trial protocol and a unified understanding to ensure the consistency of the observed indicators.

1. Strict control of variable factors in outpatient medical records.

2. Unified design of the observation form.

3. Anyone who meets the selection criteria of the medical records and is listed as the observation object shall fill in the symptoms and signs and relevant inspection results according to the requirements of the observation plan and observation form.

4. Physicians participating in the clinical trial must provide the subjects with detailed information about the clinical trial, including the purpose of the trial, the nature of the trial, possible benefits and risks, other treatments available and the conditions of the subjects who meet the requirements of the Declaration of Helsinki. Rights and obligations, etc., so that the subjects can express their consent after understanding.

Observation indicators:

1. Safety observation: general physical examination.

2. Curative effect observation: related symptoms and local examination.

3. Observation points:

Relevant symptoms and signs: observe once 14 days and 30 days after treatment.

Efficacy Judgment Criteria:

1. Clinical recovery: vocal cord nodules, vocal cord polyps disappeared, and symptoms disappeared.

2. Significant effect: Vocal cord nodules, vocal cord polyps, and symptoms are reduced by more than 2/3.

3. Effective: Vocal cord nodules, vocal cord polyps, symptoms reduced by more than 1/3.

4. Ineffective: Vocal cord nodules, vocal cord polyps, no change or aggravation of symptoms.

Safety Evaluation Criteria:

Level 1: Safe, without any adverse reactions.

Level 2: It is relatively safe. If there is any adverse reaction, the drug can be continued without any treatment.

Grade 3: There are safety problems and moderate adverse reactions, and the drug can be continued after treatment.

Grade 4: The trial was discontinued due to adverse reactions.

2. Case information

Gender: The gender distribution of patients in the two groups is compared, see Table 1.

Table 1-1 Comparison of gender distribution of patients with vocal cord nodules between the two groups

Comparison between group A and group B: X ² =0.625, P>0.05, no statistical significance.

Table 1-2 Comparison of gender distribution of patients with vocal cord polyps in the two groups

Comparison between group A and group B: X ² =1.674, P>0.05, no statistical significance.

Age: see Table 2 for comparison of the age distribution of the two groups of patients.

Table 2-1 Comparison of age distribution of patients with vocal cord nodules between the two groups (years)

Comparison between group A and group B: X2=4.132, P>0.05, no statistical significance.

Table 2-2 Comparison of age distribution of patients with vocal cord polyps in the two groups (years)

Comparison between group A and group B: X ² =0.552, P>0.05, no statistical significance.

Disease course: the comparison of the disease course distribution of the two groups is shown in Table 3.

Table 3-1 Comparison of disease course distribution of patients with vocal cord nodules between the two groups (months)

Comparison between group A and group B: X ² =0.119, P>0.05, no statistical significance.

Table 3-2 Comparison of disease course distribution in two groups of patients with vocal cord polyps (months)

There is a comparison between group A and group B: X ² =3.005, P>0.05, no statistical significance.

Conditions: The conditions of the two groups were compared, see Table 4.

Table 4-1 Comparison of the condition of patients with vocal cord nodules between the two groups

Comparison between group A and group B: X ² =2.767, P>0.05, no statistical significance.

Table 4-2 Comparison of the condition of patients with vocal cord polyps in the two groups

Comparison between group A and group B: X ² =4.571, P>0.05, no statistical significance.

3. Treatment results

The clinical curative effect comparison of the two groups of patients is shown in Table 5.

Table 5-1 Comparison of clinical curative effect of two groups of patients with vocal cord nodules

Compared with group A and group B: U=2.1317, P<0.01, there is a significant difference.

Table 5-2 Comparison of clinical curative effect of two groups of patients with vocal cord polyps

Compared with group A and group B: U=2.5938, P<0.01, there is a significant difference.

The curative effect of each symptom after treatment in the two groups was compared, as shown in Table 6.

Table 6-1 Comparison of curative effects of various symptoms after treatment in patients with vocal cord nodules between the two groups

The symptoms of the two groups of patients with vocal cord nodules were significantly improved after treatment. Compared between the two groups, hoarseness and dry throat were <0.05, with a significant difference; language fatigue was P<0.01, with a very significant difference, and throat itching was P> 0.05, no significant difference.

Table 6-2 Comparison of curative effects of various symptoms after treatment in two groups of patients with vocal cord polyps

All the symptoms of patients with vocal cord polyps in the two groups were significantly improved after treatment. Compared between the two groups, hoarseness and dry throat were <0.05, with significant differences; throat itching and speech fatigue were P>0.05, with no significant difference. Adverse reactions: During clinical verification, no adverse reactions occurred.

4. Experimental conclusion

Jinsang Sanjie Capsules was used to treat vocal cord nodules, and a total of 120 cases of vocal cord polyps were observed, including 60 cases of vocal cord polyps and 60 cases of vocal cord nodules. Clinical observation results: Jinsang Sanjie Capsules (group A) produced by water extraction and alcohol precipitation process treated vocal cord nodules, among which 7 cases were cured, 12 cases were markedly effective, 18 cases were effective, and 3 cases were ineffective, with a total effective rate of 90.00%. The produced Jinsang Sanjie Capsules (group B) treated vocal cord nodules, among which 3 cases were cured, 4 cases were markedly effective, 10 cases were effective, and 13 cases were ineffective, with a total effective rate of 56.67%. Jinsang Sanjie Capsules (Group A) produced by water extraction and alcohol precipitation process treated vocal cord polyps, among which 3 cases were cured, 13 cases were markedly effective, 10 cases were effective, and 4 cases were ineffective, with a total effective rate of 86.67%. Sanjie Capsules (group B) treated vocal cord polyps, among which 0 cases were cured, 2 cases were markedly effective, 9 cases were effective, and 19 cases were ineffective, with a total effective rate of 36.67%. All TCM symptoms were significantly improved before and after treatment.

Prescription: Puffball 25g, Zedoary (stir-fried with vinegar) 50g, honeysuckle 125g, peach kernel 50g, Scrophulariaceae 125g, Sanleng (stir-fried with vinegar) 50g, safflower 50g, Salvia miltiorrhiza 75g, Radix Radix 125g, Ophiopogon japonicus 100g, Fritillaria 75g, Alisma 75g, cicada slough 75g, gallinaceous gold (fried) 50g, wood butterfly 75g, dandelion 125g;

Specific embodiment 1 The processing step of preparing tablet is as follows:

Take 50% of the prescription amount of honeysuckle, Zhejiang Fritillaria, safflower, and 2% of the prescription amount of puffballs, crush them into fine powder, sieve, mix, and set aside; use curcuma, peach kernels, scrophulariaceae, trigonum, salvia miltiorrhiza, and isatis root , Ophiopogon japonicus, Alisma, gallinacea, cicada slough, wood butterfly, dandelion, honeysuckle, fritillaria, safflower, and puffball. After crushing, add 10 times and 8 times the remaining amount of water to decoct twice. Combine the decoctions for 2 hours each time, filter, concentrate the filtrate to a thick paste with a relative density of 1.28-1.32 (60°C), add 95% ethanol to make the alcohol content reach 60%, stir evenly, let stand for 24 hours, filter After filtration, the ethanol is recovered from the filtrate, concentrated under reduced pressure to a clear paste with a relative density of 1.38-1.40 (60°C); the prepared fine powder and appropriate amount of auxiliary materials are added, mixed evenly, compressed into tablets, and film-coated to obtain the product.

Embodiment 2 The processing steps of preparing capsules are as follows:

Take 50% of the prescription amount of honeysuckle, Zhejiang Fritillaria, safflower, and 2% of the prescription amount of puffballs, crush them into fine powder, sieve, mix, and set aside; use curcuma, peach kernels, scrophulariaceae, trigonum, salvia miltiorrhiza, and isatis root , Ophiopogon japonicus, Alisma, gallinacea, cicada slough, wood butterfly, dandelion, honeysuckle, fritillaria, safflower, and puffball. After crushing, add 10 times and 8 times the remaining amount of water to decoct twice. Combine the decoctions for 2 hours each time, filter, concentrate the filtrate to a thick paste with a relative density of 1.28-1.32 (60°C), add 95% ethanol to make the alcohol content reach 60%, stir evenly, let stand for 24 hours, filter After filtration, the filtrate recovered ethanol, concentrated under reduced pressure to a clear paste with a relative density of 1.38-1.40 (60°C); added the prepared fine powder and appropriate amount of auxiliary materials, mixed evenly, dried, crushed, made into fine particles, and packed into capsules to obtain .

Embodiment 3 The processing steps of preparing granules are as follows:

Take 50% of the prescription amount of honeysuckle, Zhejiang Fritillaria, safflower, and 2% of the prescription amount of puffballs, crush them into fine powder, sieve, mix, and set aside; use curcuma, peach kernels, scrophulariaceae, trigonum, salvia miltiorrhiza, and isatis root , Ophiopogon japonicus, Alisma, gallinacea, cicada slough, wood butterfly, dandelion, honeysuckle, fritillaria, safflower, and puffball. After crushing, add 10 times and 8 times the remaining amount of water to decoct twice. Combine the decoctions for 2 hours each time, filter, concentrate the filtrate to a thick paste with a relative density of 1.28-1.32 (60°C), add 95% ethanol to make the alcohol content reach 60%, stir evenly, let stand for 24 hours, filter After filtration, ethanol is recovered from the filtrate, concentrated under reduced pressure to a clear paste with a relative density of 1.38-1.40 (60°C); the prepared fine powder is added, mixed, dried, crushed, made into fine particles, and packaged.

Embodiment 4 The processing steps of preparing soft capsules are as follows:

Take 50% of the prescription amount of honeysuckle, Zhejiang Fritillaria, safflower, and 2% of the prescription amount of puffballs, crush them into fine powder, sieve, mix, and set aside; use curcuma, peach kernels, scrophulariaceae, trigonum, salvia miltiorrhiza, and isatis root , Ophiopogon japonicus, Alisma, gallinacea, cicada slough, wood butterfly, dandelion, honeysuckle, fritillaria, safflower, and puffball. After crushing, add 10 times and 8 times the remaining amount of water to decoct twice. Combine the decoctions for 2 hours each time, filter, concentrate the filtrate to a thick paste with a relative density of 1.28-1.32 (60°C), add 95% ethanol to make the alcohol content reach 60%, stir evenly, let stand for 24 hours, filter After filtering, the filtrate recovers ethanol, and concentrates under reduced pressure to a clear paste with a relative density of 1.38-1.40 (60°C); add the prepared fine powder and appropriate amount of auxiliary materials, mix evenly, dry, pulverize, make fine particles, add vegetable oil, and make a soft paste. capsules, ready to serve.

Example 5 Application of the invention in the treatment of vocal cord nodules and vocal cord polyposis

25g of puffball, 50g of curcuma (stir-fried with vinegar), 125g of honeysuckle, 50g of peach kernel, 125g of scrophulariae, 50g of three-lens (stir-fried with vinegar), 50g of safflower, 75g of salvia miltiorrhiza, 125g of Radix Radix, 100g of Ophiopogon japonicus, 75g of fritillaria, Alisma 75g, cicada slough 75g, gallinaceous gold (fried) 50g, wood butterfly 75g, dandelion 125g, made into 1000 capsules, 0.4g/capsule, for patients with vocal cord nodules and vocal cord polyps, take orally, 2-4 capsules each time, daily 2 times.

Claims (4)

1, a kind of preparation technology who treats the Chinese medicine of vocal nodule, polyp of vocal cord symptom is characterized in that this preparation technology is:

The prescription: Lasiosphaera Seu Calvatia 25g, Rhizoma Curcumae 50g, Flos Lonicerae 125g, Semen Persicae 50g, Radix Scrophulariae 125g, rhizoma sparganic 50g, Flos Carthami 50g, Radix Salviae Miltiorrhizae 75g, Radix Isatidis 125g, Radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 75g, Rhizoma Alismatis 75g, Periostracum Cicadae 75g, Endothelium Corneum Gigeriae Galli 50g, Semen Oroxyli 75g, Herba Taraxaci 125g;

Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 40%-60%, the Lasiosphaera Seu Calvatia of recipe quantity 10%-30% is ground into fine powder, sieve, and mixing, standby; With Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, surplus adds 8-12 doubly after the pulverizing of Lasiosphaera Seu Calvatia four Chinese medicine, 6-10 times of decocting boils secondary, each 1-3 hour, collecting decoction, filter, in the time of 50-70 ℃, it is 1.28～1.32 thick paste that filtrate is concentrated into relative density, adding 90%-100% ethanol makes the alcohol amount of containing reach 50-70%, stir, left standstill 12-36 hour, and filtered filtrate recycling ethanol, in the time of 50-70 ℃, be evaporated to relative density and be 1.38～1.40 clear paste; The fine powder and the appropriate amount of auxiliary materials mixing that add preparation, drying is pulverized, and makes fine particle, promptly.

2, a kind of preparation technology who treats the Chinese medicine of vocal nodule, polyp of vocal cord symptom as claimed in claim 1 is characterized in that this preparation technology is:

The prescription: Lasiosphaera Seu Calvatia 25g, Rhizoma Curcumae 50g, Flos Lonicerae 125g, Semen Persicae 50g, Radix Scrophulariae 125g, rhizoma sparganic 50g, Flos Carthami 50g, Radix Salviae Miltiorrhizae 75g, Radix Isatidis 125g, Radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 75g, Rhizoma Alismatis 75g, Periostracum Cicadae 75g, Endothelium Corneum Gigeriae Galli 50g, Semen Oroxyli 75g, Herba Taraxaci 125g;

Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 50%, the Lasiosphaera Seu Calvatia of recipe quantity 20% is ground into fine powder, sieve, and mixing, standby; Surplus after the pulverizing of Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, Lasiosphaera Seu Calvatia four Chinese medicine is added 10 times, 8 times decoctings boil secondary, each 2 hours, collecting decoction, filter, in the time of 60 ℃, it is 1.28～1.32 thick paste that filtrate is concentrated into relative density, adding 95% ethanol makes and contains alcohol amount and reach 60%, stir, left standstill 24 hours, and filtered filtrate recycling ethanol, in the time of 60 ℃, be evaporated to relative density and be 1.38～1.40 clear paste; The fine powder and the appropriate amount of auxiliary materials mixing that add preparation, drying is pulverized, and makes fine particle, promptly.

3, Chinese medicine as claimed in claim 1 or 2 is in the application of the medicine of preparation treatment vocal nodule, polyp of vocal cord symptom, it is characterized in that: this medicine has the activating blood circulation to dissipate blood stasis function, can reduce whole blood viscosity, plasma viscosity, whole blood reduced viscosity, fibrinogen content and the attached rate of platelet; Inhibited to the chronic inflammatory disease granulation tissue hyperplasia.

4, Chinese medicine as claimed in claim 1 or 2 is characterized in that in the application of the medicine of preparation treatment vocal nodule, polyp of vocal cord symptom: this medicine is any in tablet, capsule, the granule.