Fenugreek formula granules and preparation method thereof

Abstract

The invention discloses fenugreek formula granules and a preparation method thereof. The preparation method of the trigonella foenum-graecum formula granules comprises the following steps: taking 100 parts by mass of trigonella foenum-graecum decoction pieces, adding 2000-3000 parts by mass of water, carrying out warm immersion extraction, and collecting liquid medicine; concentrating the liquid medicine, filtering, collecting paste, and performing spray drying to obtain fenugreek powder; and adding a proper amount of excipient to 20 parts by mass into the obtained medicinal powder, uniformly mixing, granulating by a dry method, and sieving to obtain the fenugreek formula granules. By adopting a warm immersion extraction process, the dissolution of mucus in fenugreek can be effectively avoided, and the dissolubility of the fenugreek formula granules can be improved, so that the dissolubility of the product meets the requirements of Chinese Pharmacopoeia standards.

Description

Technical Field

[0001] The invention relates to traditional Chinese medicine formula granules, in particular to fenugreek formula granules and a preparation method thereof. Background Art

[0002] Chinese medicine formula granules are Chinese medicine preparations that can be clinically prepared by boiling, concentrating, separating, drying, granulating, and packaging Chinese medicine slices. Chinese medicine formula granules have the advantages of safety, effectiveness, and ease of administration. Fenugreek formula granules have the effects of warming the kidney and supporting yang, dispelling cold and relieving pain. It is used for kidney yang deficiency, coldness in the lower abdomen, cold pain in the lower abdomen, abdominal pain caused by cold hernia, and cold and damp athlete's foot. Although there is no national standard for fenugreek formula granules, most provinces have already issued provincial standards. The conventional preparation process of fenugreek formula granules is water extraction, reduced pressure concentration, fluid paste separation, drying, mixing and granulation. The traditional preparation process is prone to the problem that the solubility of fenugreek formula granules does not meet the requirements.

[0003] This paper studies the content of the invention based on the quality standards of Guangdong Province Fenugreek Formula Granules. The provincial standards of Fenugreek Formula Granules have consistent requirements for solubility inspection items). Figure 1 As shown, according to the quality standard requirements of Guangdong Province Fenugreek Formula Granules, the solubility should comply with the relevant provisions under the granules. The standard requirements of General Chapter 0104 of the 2020 Edition of the Chinese Pharmacopoeia are: Take 10g of the test sample (take 1 bag of single-dose packaging of traditional Chinese medicine), add 200ml of hot water, stir for 5 minutes, and observe immediately. The soluble granules should be completely dissolved or slightly turbid.

[0004] The solubility of fenugreek formula granules produced by traditional technology is difficult to meet the provincial fenugreek formula granule standard requirements. The main reason is that fenugreek medicinal materials contain a gum component, which is fenugreek gum, in a mucus state and mainly distributed in the fenugreek endosperm. This gum component is easily soluble in water, but after drying, the gum component becomes insoluble in water. During the water extraction process of conventional technology, high-temperature boiling extraction at 100°C will cause a large amount of fenugreek gum in the fenugreek endosperm to dissolve. After concentration and drying, the solubility of the dry paste powder will become very poor, and it will not meet the solubility performance requirements of the Chinese Pharmacopoeia standard. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a method for preparing fenugreek formula granules whose dissolution performance meets the requirements of Chinese Pharmacopoeia standards.

[0006] Another technical problem to be solved by the present invention is to provide a fenugreek formula granule whose dissolution performance meets the requirements of the Chinese Pharmacopoeia standards.

[0007] In order to solve the above technical problems, the technical solution adopted by the present invention is a method for preparing fenugreek formula granules, comprising the following steps: 101) Take 100 parts by weight of fenugreek slices, add 2000-3000 parts by weight of water, perform warm immersion extraction, and collect the medicinal liquid; 102) Concentrating the medicinal liquid, filtering to collect the paste, and spray drying to obtain fenugreek powder; 103) Add appropriate amount of excipients to the obtained fenugreek powder to make it 20 parts by weight, mix well, and dry granulate to obtain the fenugreek formula granules.

[0008] In the above-mentioned method for preparing fenugreek formula granules, in step 101, the temperature of the warm soaking one-time extraction is 85-95° C., and the duration is 40-100 minutes.

[0009] In the preparation method of the fenugreek formula granules described above, in step 102, the liquid medicine is concentrated to a fluid paste density of 1.02-1.04 g / ml, filtered to collect the paste, and spray-dried; the filter cloth is 300 mesh.

[0010] In the above-mentioned method for preparing fenugreek formula granules, in step 102, 13 to 20 parts by weight of fenugreek powder are obtained.

[0011] In the method for preparing the fenugreek formula granules described above, in step 103, the excipient is lactose.

[0012] A fenugreek formula granule, wherein the fenugreek formula granule is obtained by the above-mentioned preparation method.

[0013] The preparation method of the fenugreek formula granules of the present invention adopts a warm immersion extraction process, which can effectively avoid the dissolution of fenugreek mucus, improve the solubility of the fenugreek formula granules, and make the solubility of the product meet the requirements of the Chinese Pharmacopoeia standard. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0015] Figure 1 The present invention is a diagram of the transparent film wrapping state of fenugreek in the prior art.

[0016] Figure 2 This is a solubility observation diagram of the fenugreek formula granules in Example 1 of the present invention.

[0017] Figure 3 This is a solubility observation diagram of the fenugreek formula granules in Example 2 of the present invention.

[0018] Figure 4 This is a solubility observation diagram of the fenugreek formula granules in Example 3 of the present invention.

[0019] Figure 5 This is a solubility observation diagram of the fenugreek formula granules of the comparative example of the present invention. DETAILED DESCRIPTION

[0020] 1. Raw materials: Fenugreek slices, lactose 2. Equipment: extraction tank, vacuum concentrator, spray dryer, dry granulator, mixer; 3. Process steps: 1. Take 100g of fenugreek slices and perform warm immersion extraction. The extraction process is as follows: extract once, add 25±5 times the amount of water (equivalent to the amount of slices), heat to 90±5°C, maintain the temperature and soak for 1 hour, collect the liquid, add and concentrate to a flowable paste density of 1.02-1.04g / ml, filter the paste with a 300-mesh filter cloth, spray dry, and obtain 13-20g of fenugreek powder; 2. Add appropriate amount of lactose to the obtained powder to make the weight 20g, mix for 15 minutes, dry granulate and sieve to obtain fenugreek formula granules.

[0021] 3. Test the fenugreek formula granules according to the Guangdong Provincial Standard for Fenugreek Formula Granules (Guangdong PFKL20210077), and summarize and analyze the test results.

[0022] Example 1: Take 100g of fenugreek slices, extract with warm immersion, extract once, add 20 times the amount (equivalent to the amount of slices) of water, heat to 85°C, keep the temperature and soak for 1 hour, collect the liquid, concentrate to a flow paste density of 1.02g / ml, filter the paste with a 300-mesh filter cloth, spray dry, and obtain 13.2g of fenugreek powder, add 6.8g of lactose, dry granulate, sieve, and obtain fenugreek formula granules. According to the Guangdong Provincial Standard for Fenugreek Formula Granules (Guangdong PFKL20210077), the results are as follows:

[0023] Example 2: Take 100g of fenugreek slices, extract with warm immersion, extract once, add 30 times the amount of water (equivalent to the amount of slices), heat to 95°C, keep the temperature and soak for 1 hour, collect the liquid, concentrate to a flow paste density of 1.04, filter the paste with a 300-mesh filter cloth, spray dry, and obtain 15.1g of fenugreek powder, add 4.9g of lactose, dry granulate, sieve, and obtain fenugreek formula granules. According to the Guangdong Provincial Standard for Fenugreek Formula Granules (Guangdong PFKL20210077), the results are as follows:

[0024] Example 3: Take 100g of fenugreek slices, extract with warm immersion, extract once, add 25 times the amount (equivalent to the amount of slices) of water, heat to 90°C, keep the temperature and soak for 1 hour, collect the liquid, concentrate to a flow paste density of 1.02g / ml, filter the paste with a 300-mesh filter cloth, spray dry, and obtain 14.5g of fenugreek powder, add 5.5g of lactose, dry granulate, sieve, and obtain fenugreek formula granules. According to the Guangdong Provincial Standard for Fenugreek Formula Granules (Guangdong PFKL20210077), the results are as follows:

[0025] Comparative Example (Conventional Water Extraction Process): Take 100g of fenugreek slices and extract twice. For the first time, add 8 times the amount of water (equivalent to 8 times the amount of slices) and soak for 0.5 hours, then heat to 100°C, keep boiling for 0.5 hours, collect the liquid, and add 6 times the amount of water (equivalent to 6 times the amount of slices) for the second time. Heat to 100°C, keep boiling for 0.5 hours, and collect the liquid; combine the two liquids, concentrate to a flow paste density of 1.02g / ml, filter with a 300-mesh filter cloth to collect the paste, spray dry, and obtain 16.8g of fenugreek powder, add 3.2g of lactose, dry granulate, sieve, and obtain fenugreek formula granules. According to the Guangdong Provincial Standard for Fenugreek Formula Granules (Guangdong PFKL20210077), the results are as follows:

[0026] in conclusion: The reason why the solubility of fenugreek formula granules does not meet the requirements according to the conventional preparation process is that a large amount of fenugreek gum in the fenugreek slices is dissolved, so the idea to solve this problem is how to effectively solve the problem of no or little dissolution of fenugreek gum. During the water extraction process of fenugreek medicinal materials, the fenugreek endosperm absorbs water and swells, forming a transparent membrane wrapped state (see Figure 1 ), the main component wrapped in the transparent film is fenugreek mucus, how to effectively prevent the transparent film from breaking is the key to solving the problem. The above embodiments of the present invention change the extraction process from the conventional decoction extraction process to the warm immersion extraction process. Since the warm immersion extraction process is not violent, the dissolution of fenugreek mucus can be effectively avoided, and the solubility of fenugreek formula granules can be improved, so that the solubility of the product meets the requirements of the Chinese Pharmacopoeia standard.

Claims

1. A method for preparing fenugreek formula granules, characterized in that: The following steps are involved: 101) Take 100 parts by weight of fenugreek slices, add 2000-3000 parts by weight of water, perform warm immersion extraction, and collect the medicinal liquid; 102) Concentrating the medicinal liquid, filtering to collect the paste, and spray drying to obtain fenugreek powder; 103) Add appropriate amount of excipients to the obtained fenugreek powder to make it 20 parts by weight, mix well, and dry granulate to obtain the fenugreek formula granules.

2. The method for preparing the fenugreek formula granules according to claim 1, characterized in that: In step 101, the temperature of the warm soaking one-time extraction is 85-95° C., and the duration is 40-100 minutes.

3. The method for preparing the fenugreek formula granules according to claim 1, characterized in that: In step 102, the drug solution is concentrated to a fluid paste density of 1.02-1.04 g / ml, filtered to collect the paste, and spray-dried; the filter cloth is 300 mesh.

4. The method for preparing the fenugreek formula granules according to claim 1, characterized in that: In step 102, 13 to 20 parts by weight of fenugreek powder are obtained.

5. The method for preparing the fenugreek formula granules according to claim 1, characterized in that: In step 103, the excipient is lactose.

6. A fenugreek formula granule, characterized in that: The fenugreek formula granules are obtained by the preparation method described in any one of claims 1 to 5.

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