CN100484536C - Capsule for treating enteritis and dysentery and its preparing process - Google Patents

Abstract

A capsule for treating enteritis and dysentery and its preparation process, which comprises a prescription amount of the main drug berberine hydrochloride, dandelion extract and auxiliary material starch. The feature of the tablet is that it can cover the bitter taste of the medicine, can have various colors and can be printed, and is beautiful, easy to take, easy to carry and use, has high bioavailability of the medicine, and improves the stability of the medicine. The preparation process is to take berberine hydrochloride and dandelion extract, add 52.5g of starch and mix thoroughly, make granules with 75% ethanol, dry, and fill into 1000 capsules.

Description

A capsule for treating enteritis and dysentery and its preparation process

technical field

The invention relates to a capsule for treating enteritis and dysentery and a preparation process thereof.

Background technique

Lianpu Shuangqing Tablet, which is made of berberine hydrochloride and dandelion extract as the main raw materials, has a relatively good curative effect on the treatment of enteritis and dysentery, boils, traumatic inflammation, mastitis, and cholecystitis. It is very important to re-develop the Chinese patent medicine Lianpu Shuangqing Capsule, because changing it into a capsule has many advantages: it can mask the bitter taste of the medicine, it can have various colors and can be printed, and it is beautiful, easy to take, easy to carry and use, and the bioavailability of the medicine High degree, improve drug stability.

At present, there are relatively many Chinese patent medicines in China for the targeted treatment of enteritis and dysentery, boils, traumatic inflammation, mastitis, and cholecystitis. And treat enteritis dysentery at home and abroad, furuncle swollen wound inflammation, mastitis, the western medicine of diseases such as cholecystitis are sizable to the side effect of human body, even life-threatening, can not be used more often. The heat-clearing and toxic-drying, damp-dampness-relieving and dysentery Chinese patent medicine tablet of the present invention is refined by using modern preparation technology under the guidance of traditional Chinese medicine theories.

Contents of the invention

The object of the invention is to provide a capsule for treating enteritis and dysentery.

Another object of the present invention is to provide a capsule preparation method for treating enteritis and dysentery.

The present invention is realized in this way, it comprises main medicine and auxiliary material, and wherein main medicine is prepared by following raw material medicine by weight: berberine hydrochloride 7-13 dandelion extract 127.5-247.5

Wherein the auxiliary materials are 52.5 g of starch and ethanol with a concentration of 60-80%.

The preparation method of the present invention: take berberine hydrochloride and dandelion extract, add 52.5 g of starch and mix thoroughly, make granules with 75% ethanol, dry, fill into 1000 capsules, and get final product.

Preparation method of dandelion extract: Take dandelion medicinal material, grind it into fine powder, pass through a 100-mesh sieve, and set aside; take another dandelion medicinal material and add 12 times the amount of water to decoct twice, the first time is 1.5 hours, the second time is 1 hour, combined decoction liquid, filtered, and the filtrate was concentrated to a relative density of 1.20. The clear paste was measured at a temperature of 70-75°C. Take 1.2 parts of the clear paste and 1 part of dandelion fine powder, mix well, and dry to make a dry paste.

The invention has the advantages of high bioavailability of the medicine, good stability of the medicine, convenient taking, convenient carrying, and can cover the bitter taste of the medicine.

Detailed ways

Embodiment one,

Berberine Hydrochloride 10g Dandelion Extract 187.5g

The preparation method of the present invention: take berberine hydrochloride and dandelion extract, add 52.5 g of starch and mix thoroughly, make granules with 75% ethanol, dry, fill into 1000 capsules, and get final product.

Preparation method of dandelion extract: Take dandelion medicinal material, grind it into fine powder, pass through a 100-mesh sieve, and set aside; take another dandelion medicinal material and add 12 times the amount of water to decoct twice, the first time is 1.5 hours, the second time is 1 hour, combined decoction Liquid, filtered, the filtrate concentrated to a clear paste with a relative density of 1.20, measured at a temperature of 70-75°C, take 1.2 parts of the clear paste, 1 part of dandelion fine powder, mix well, dry, and make a dry paste.

Embodiment two,

Berberine Hydrochloride 7g Dandelion Extract 127.5g

The preparation method of the present invention: take berberine hydrochloride and dandelion extract, add 52.5 g of starch and mix thoroughly, make granules with 65% ethanol, dry, fill into 1000 capsules, and get final product.

Preparation method of dandelion extract: Take dandelion medicinal material, grind it into fine powder, pass through a 100-mesh sieve, and set aside; take another dandelion medicinal material and add 12 times the amount of water to decoct twice, the first time is 1.5 hours, the second time is 1 hour, combined decoction Liquid, filtered, the filtrate concentrated to a clear paste with a relative density of 1.20, measured at a temperature of 70-75°C, take 1.2 parts of the clear paste, 1 part of dandelion fine powder, mix well, dry, and make a dry paste.

Embodiment three,

Berberine Hydrochloride 13g Dandelion Extract 247.5g

The preparation method of the present invention: take berberine hydrochloride and dandelion extract, add 52.5 g of starch and mix thoroughly, make granules with 85% ethanol, dry, fill into 1000 capsules, and obtain.

Research result:

1. Preparation process research data

1 Discussion on the efficacy and ingredients related to process selection

This prescription is composed of berberine hydrochloride and dandelion extract.

1.1. Berberine hydrochloride is the raw material drug, which has strong antimicrobial and antiprotozoal effects; berberine hydrochloride has the effects of lowering blood pressure, relaxing vascular smooth muscle, promoting choleresis, antidiuresis, local anesthesia, sedation, and analgesia. Therefore, in order to retain its active ingredients to the greatest extent, it is more reasonable to adopt the direct addition process of berberine hydrochloride.

1.2. Dandelion whole herb contains fat-soluble and water-soluble components such as dandelion sterol, choline, inulin and pectin. Dandelion is a traditional medicine for clearing heat and detoxifying. In recent years, through further research, it has been proved that it has good anti-infection effect, and it is widely used in various clinical departments for various infectious inflammations. Therefore, the prescription adopts the process of powdering some medicinal materials and decocting some medicinal materials, which not only retains its active ingredients to the greatest extent, but also reduces the dosage.

2 Investigation of extraction process conditions

The prescription is composed of berberine hydrochloride and dandelion extract. Therefore, the process mainly examines the preparation conditions of dandelion extract. The dandelion extract is extracted by decoction, and the main factors affecting the water extraction process are decoction times, decoction time and water addition. In the experiment, the yield of dry extract and the content of caffeic acid in dandelion extract were used as the investigation indicators to study and determine the water extraction process.

Experimental materials: The original medicinal materials of dandelion were purchased from Zhangshu Pharmaceutical Company and produced in Ji'an, Jiangxi. According to the identification and testing of a dandelion medicinal material standard in "Chinese Pharmacopoeia" in 2000, the raw material is the dried whole herb of Compositae plant dandelion Taraxacum mongolicum Hand.-Mazz. The caffeic acid content in dandelion is determined to be 0.029%.

Determination method of caffeic acid content: according to the determination method of caffeic acid content under the standard content determination item of a dandelion medicinal material in "Chinese Pharmacopoeia" in 2000.

2.1 Determination of the times of decoction and extraction of dandelion: referring to the original process, when the decoction time is 2 hours and the amount of water added is 12 times (determined based on the fact that dandelion is a whole herbal medicinal material and occupies a large volume), the decoction Number of results (see Table 1)

Table 1 Investigation on the times of decoction and extraction of dandelion

From the results in the above table, it can be seen that the active ingredient caffeic acid can be fully extracted by decocting dandelion twice with 12 times the amount of water, so it is determined that the decoction extraction times of this process is 2 times.

2.2 Determination of decoction time for dandelion decoction extraction: refer to the original process, under the conditions of 2 times of extraction and 12 times the amount of water added, test the results of decoction time (see Table 2)

Table 2 Investigation on the decoction time of dandelion decoction and extraction

From the results in the table above, it can be seen that when dandelion is decocted with 12 times the amount of water, the caffeic acid can be fully extracted in 1.5 hours for the first time and 1 hour for the second time, so the decoction time of this process is determined to be 1.5 hours for the first time , the second 1 hour is the best decoction process.

2.3 Determination of the amount of water added for decoction of dandelion: refer to the original process, under the condition that the number of extractions is 2 times, the first time is 1.5 hours, and the second time is 1 hour, the results of water decoction are tested (see Table 3)

Table 3 Investigation on the amount of water added for decoction and extraction of dandelion

From the results in the table above, it can be seen that when dandelion is decocted with 12 times the amount of water, the caffeic acid can be fully extracted in 1.5 hours for the first time and 1 hour for the second time. Best decoction process.

3 Determination of the amount of excipients

According to the total amount of prescription feeding is 197.5g, 1000 capsules are made, and the test is carried out by loading 0.20g/capsule, 0.25g/capsule, and 0.30g/capsule in each capsule, and the result is 0.25g/capsule and 0.30g/capsule. The capsules with g/capsules have good content determination stability. In order to reduce the dosage and production cost, it is determined that the contents are filled with 0.25g/capsules, so 52.5g of starch should be added for every 1000 capsules.

4 Effect of different concentrations of ethanol on particle formation

Different concentrations of ethanol are the key factors for granulation. The experiments were carried out with three ethanol concentrations of 65%, 75%, and 85%. The results are as follows:

Table 4 The investigation of different concentrations of ethanol on the preparation of particles

According to the test results in the above table, our company determines that granulation with 75% ethanol is the best granulation process.

4.5 Determination of capsule type

In the test, No. 0 capsules were used for trial loading, and the content was 0.25g per capsule. The difference in the filling volume was in compliance with the regulations, so the capsule model was determined to be No. 0.

4.6 Determination of preparation process

Through the process optimization test above, it is determined that the preparation process of Lianpu Shuangqing Capsules is:

Take 10 g of berberine hydrochloride, 187.5 g of dandelion extract and 52.5 g of starch, mix them evenly, granulate with 75% ethanol, dry, fill into 1000 capsules, and get final product.

Note the preparation method of dandelion extract: Take dandelion medicinal materials, grind them into fine powder, pass through a 100-mesh sieve, and set aside; take another dandelion medicinal materials and add 12 times the amount of water to decoct twice, the first time is 1.5 hours, the second time is 1 hour, and combined decoction Boil the liquid, filter, and concentrate the filtrate to a clear paste with a relative density of 1.20 (70-75°C thermal measurement), take 1.2 parts of the clear paste, 1 part of dandelion fine powder, mix well, dry, and make a dry paste.

2. Quality stability test

Take this product according to the commercially available package and place it in a constant temperature and humidity box at 40°C and a relative humidity of 75% for 6 months. After sampling in 0, 1, 2, 3, and 6 months, the inspection items are traits, identification, and disintegration. Time limit, content determination, microbial limit check. There is no significant change in all indicators, relatively stable, and the validity period can reach three years. The results are shown in Table 5.

Table 5 Accelerated test of capsule stability of the present invention (batch number: 20040418)

3. The clinical application effect of Lianpu Shuangqing capsule:

1. Use Lianpu Shuangqing Capsules as the observation group (100 cases) and Lianpu Shuangqing Tablets as the control group (50 cases) to conduct clinical comparisons in the treatment of enteritis and dysentery, and observe the frequency of stool, stool properties, course of disease, degree of diarrhea, abdominal pain, and intestinal mucosal damage The degree of efficacy is compared as follows:

Table 6 Comparison of clinical efficacy of Lianpu Shuangqing Capsules in the treatment of enteritis and dysentery

Number of cases Number of cured Number of markedly effective number Effective number Ineffective number Effective rate Observation group 100 51 30 13 6 94% Control group 50 23 21 2 4 92%

2. Using Lianpu Shuangqing Capsules as the observation group (80 cases), and Lianpu Shuangqing Tablets as the control group (40 cases), clinical comparison was carried out in the treatment of mastitis, and the course of mammary gland disease was observed and analyzed. The curative effects were compared as follows:

Table 7 Comparison of clinical efficacy of Lianpu Shuangqing Capsules in the treatment of mastitis

Number of cases Number of cured Number of markedly effective number Effective number Ineffective number Effective rate Observation group 80 41 32 4 3 96.25% Control group 40 18 15 5 2 95%

Claims (3)

1, a kind of capsule for the treatment of enteritis and dysentery is characterized in that it comprises principal agent and adjuvant, and wherein principal agent is formulated by the following raw materials in part by weight medicine:

Berberine hydrochloride 7-13 extract of taraxacum 127.5-247.5

Wherein adjuvant is that starch 52.5g, concentration are the ethanol of 60-80%;

The extract of taraxacum method for making is: gets the Herba Taraxaci medical material and breaks into fine powder, cross 100 mesh sieves, and standby; Other gets the Herba Taraxaci medical material and adds 12 times of water gagings decoctions 2 times, 1.5 hours for the first time, 1 hour for the second time, merges decoction liquor, filter, filtrate is concentrated into relative density 1.20 clear paste and surveys in temperature 70～75 ℃ of heat, 1.2 parts of qinghuo reagents, 1 part of Herba Taraxaci fine powder, mixing, drying is made dried cream, promptly.

2,, it is characterized in that concentration of ethanol is 75% according to the capsule of claims 1 described treatment enteritis and dysentery.

3, a kind of capsule preparation method thereof of claims 1 described treatment enteritis and dysentery is characterized in that: get berberine hydrochloride, extract of taraxacum two medicines add the abundant mixing of starch 52.5g, make granule with 75% ethanol, and drying, fill becomes capsule.