阅读说明：本技术 一种无糖型独一味口服液制剂及其制备方法 (Sugar-free lamiophlomis rotata oral liquid preparation and preparation method thereof ) 是由 郭洋静 周红建 李俊霞 白艳鹤 于 2019-12-09 设计创作，主要内容包括：本发明公开了一种无糖型独一味口服液制剂,涉及制药领域,每1000ml独一味口服液包括以下组分：400～600g独一味、20～40g木糖醇、1～2g山梨酸钾、余量为纯化水,本制剂处方中仅加了木糖醇及少量防腐剂,更适合外科手术后的刀口疼痛、出血,外伤骨折,筋骨扭伤,风湿痹痛以及崩漏、痛经、牙龈肿痛、出血等症状的糖尿病患者服用,并具备活血止痛、化瘀止血效果。(The invention discloses a sugar-free lamiophlomis rotata oral liquid preparation, which relates to the field of pharmacy, wherein each 1000ml lamiophlomis rotata oral liquid comprises the following components: 400-600 g of lamiophlomis rotata, 20-40 g of xylitol, 1-2 g of potassium sorbate and the balance of purified water, and the preparation is only added with xylitol and a small amount of preservative, so that the preparation is more suitable for diabetics with symptoms of incision pain, bleeding, traumatic fracture, muscle and bone sprain, rheumatic arthralgia, metrorrhagia, dysmenorrhea, gingival swelling and pain, bleeding and the like after surgical operation, and has the effects of activating blood, relieving pain, removing blood stasis and stopping bleeding.)

1. A sugar-free lamiophlomis rotata oral liquid preparation is characterized in that each 1000ml of lamiophlomis rotata oral liquid comprises the following components: 400-600 g of lamiophlomis rotata, 20-40 g of xylitol, 1-2 g of potassium sorbate and the balance of purified water.

2. The sugar-free lamiophlomis rotata oral liquid preparation of claim 1, wherein: each 1000ml of the lamiophlomis rotata oral liquid comprises the following components: 500g of lamiophlomis rotata, 30g of xylitol, 2g of potassium sorbate and the balance of purified water.

3. A method for preparing the sugar-free lamiophlomis rotata oral liquid preparation of claim 1, comprising the steps of:

step A: cleaning and selecting the ingredients, namely removing impurities from the lamiophlomis rotata according to the proportion of the ingredients, chopping, and crushing and screening by adopting a screening machine with 10 meshes for later use;

and B: extracting and concentrating, adding 15 times of equivalent water, heating to about 45 ℃, adding the lamiophlomis rotata medicinal material cleaned and selected in the step A, soaking for 2 hours, filtering to obtain a filtrate a and a filter residue b, adding 12 times of equivalent water into the filter residue b, soaking for 2 hours, filtering to obtain a filtrate c, then combining the filtrate a and the filtrate c into a filtrate d, and concentrating the filtrate d into a clear paste with the relative density of 1.10-1.15 under the conditions of the temperature of 65-75 ℃ and the vacuum degree of 0.06-0.08Mpa, wherein the temperature is 70 ℃;

step C, adding 95% ethanol into the clear paste prepared in the step B to enable the ethanol content to reach 60% -80%, standing for 24 hours, filtering, and recovering ethanol from the filtrate until the relative density is 1.20-1.25 and the temperature is 70 ℃;

d, preparing a liquid, namely adding potassium sorbate into the filtrate obtained in the step C, stirring to dissolve the potassium sorbate, adding purified water to adjust the total amount to 1000ml, stirring uniformly, and filtering to obtain a reddish brown clear liquid; then filling 10ml of each bottle, sealing by a gland, and sterilizing in steam at 100 ℃ for 30 minutes.

Technical Field

The invention belongs to the field of pharmacy, and particularly relates to a sugar-free lamiophlomis rotata oral liquid preparation and a preparation method thereof.

Background

Lamiophlomis rotata, the name of traditional Chinese medicine. Is root, rhizome or whole plant of Lamiophlomis rotate (Benth.) kudo of Labiatae. Has effects of promoting blood circulation, removing blood stasis, and relieving swelling and pain. Can be used for treating traumatic injury, arthralgia and myalgia, joint swelling and pain, dysmenorrhea, and metrorrhagia. The products on the market have lamiophlomis rotata capsules and lamiophlomis rotata tablets, but the products have a plurality of problems; the bioavailability is not high; poor drug stability; small distribution area in gastrointestinal tract and large irritation; poor flowability, non-uniform size, and difficult dose division or coating; the disintegration time is long, the dissolution speed is slow, the dosage is large and the like, and the quality and the curative effect of the medicine are directly influenced. The lamiophlomis rotata oral liquid preparation has a prescription consisting of lamiophlomis rotata single medicinal materials, changes the traditional dosage forms of tablets, capsules, granules and the like, is an oral liquid which is more convenient to use, most of the oral liquids are added with cane sugar and other flavoring agents for improving the taste at present, and cannot be taken by diabetics.

Disclosure of Invention

The invention aims to provide a sugar-free lamiophlomis rotata oral liquid preparation and a preparation method thereof, which are suitable for diabetics to take and have the effects of promoting blood circulation, relieving pain, removing blood stasis and stopping bleeding.

In order to achieve the above purpose, the invention adopts the technical scheme that: a sugar-free radix Lamiophlomidis Rotatae oral liquid preparation comprises the following components per 1000ml of radix Lamiophlomidis Rotatae oral liquid: 400-600 g of lamiophlomis rotata, 20-40 g of xylitol, 1-2 g of potassium sorbate and the balance of purified water.

In order to further optimize the present invention, the following technical solutions may be preferably selected:

preferably, each 1000ml of the lamiophlomis rotata oral liquid comprises the following components: 500g of lamiophlomis rotata, 30g of xylitol, 2g of potassium sorbate and the balance of purified water.

A method for preparing sugar-free lamiophlomis rotata oral liquid preparation comprises the following steps:

step A: cleaning and selecting the ingredients, namely removing impurities from the lamiophlomis rotata according to the proportion of the ingredients, chopping, and crushing and screening by adopting a screening machine with 10 meshes for later use;

and B: extracting and concentrating, adding 15 times of equivalent water, heating to about 45 ℃, adding the lamiophlomis rotata medicinal material cleaned and selected in the step A, soaking for 2 hours, filtering to obtain a filtrate a and a filter residue b, adding 12 times of equivalent water into the filter residue b, soaking for 2 hours, filtering to obtain a filtrate c, then combining the filtrate a and the filtrate c into a filtrate d, and concentrating the filtrate d into a clear paste with the relative density of 1.10-1.15 under the conditions of the temperature of 65-75 ℃ and the vacuum degree of 0.06-0.08Mpa, wherein the temperature is 70 ℃;

step C, adding 95% ethanol into the clear paste prepared in the step B to enable the ethanol content to reach 60% -80%, standing for 24 hours, filtering, and then recovering the ethanol until the relative density is 1.20-1.25 and the temperature is 70 ℃;

d, preparing a liquid, namely adding potassium sorbate into the filtrate obtained in the step C, stirring to dissolve the potassium sorbate, adding purified water to adjust the total amount to 1000ml, stirring uniformly, and filtering to obtain a reddish brown clear liquid; then filling 10ml of each bottle, sealing by a gland, and sterilizing in steam at 100 ℃ for 30 minutes.

The invention has the beneficial effects that:

1. the invention is a pure traditional Chinese medicine preparation, only adds xylitol and a small amount of preservative, is more suitable for diabetics with symptoms of incision pain, bleeding, traumatic fracture, sprain of muscles and bones, rheumatic arthralgia, metrorrhagia, dysmenorrhea, swelling and aching of gum, bleeding and the like after surgical operation, and is suitable for diabetics.

2. The oral liquid is convenient for children, the old and some special patients with dysphagia to take.

3. In the production process, the traditional method is used for water extraction to obtain the components of total flavone, iridoid glycoside, luteolin and the like which are easy to dissolve in water, and then ethanol is added for standing to further remove impurities, so that the extraction rate of the effective components is improved, and the method is suitable for large-scale production.

Detailed Description

Lamiophlomis rotata, the name of traditional Chinese medicine. Is root, rhizome or whole plant of Lamiophlomis rotate (Benth.) kudo of Labiatae. Has effects of promoting blood circulation, removing blood stasis, and relieving swelling and pain. Can be used for treating traumatic injury, arthralgia and myalgia, joint swelling and pain, dysmenorrhea, and metrorrhagia. The pharmacological actions of lamiophlomis rotata comprise: 1) effect on immune function: the lamiophlomis rotata saponin 500 mg/(kg d), lamiophlomis rotata alcohol extract is injected into the abdominal cavity of tumor-bearing mice by 300 mg/(kg d) or 150 mg/(kg d), and the injection lasts for 10 days, which has obvious inhibiting effect on transplanted tumor EC and saponin on Hep solid tumor strains. The same dose of saponin can be continuously administered to S180 sarcoma mouse for 12 days, and has certain therapeutic effect. The saponin can also increase spleen weight, thymus weight and body weight of tumor-bearing mice to a certain extent. Saponins extracted from the lamiophlomis rotata extract are 50 mg/(kg.d) and 100 mg/(kg.d), and are continuously injected into the abdominal cavity of an animal for 5d, so that the phagocytosis rate and the phagocytosis index of macrophages, the formation rate of E-rosettes and the positive rate of esterase staining are all obviously improved, and the lamiophlomis rotata has the function of obviously improving nonspecific immunity and specific cellular immunity.

2) The analgesic effect is as follows: the lamiophlomis rotata extract with the concentration of 10 percent is used for gastric lavage of mice with the concentration of 0.28ml/10g and the concentration of 0.14ml/10g, has obvious analgesic effect and lasts for about 2 hours. The extract can also obviously inhibit the acetic writhing reaction of mice, and the analgesic effect of 0.19-3.0g/kg is equivalent to that of 0.23g/kg aspirin.

3) Hemostasis effect: in a mouse tail vein hemostasis experiment, the 10 percent and 5 percent extractum are respectively 0.14ml/10g for intragastric administration to a mouse, and the hemostatic effect is obvious. The lamiophlomis rotata has a local hemostatic effect on incised wounds of the liver of a rat.

4) The antibacterial effect is as follows: the Lamiophlomis rotate extract has antibacterial effect on beta hemolytic streptococcus and aerobacter in filter paper sheet method. The lamiophlomis rotata saponin has obvious bacteriostatic action on dysentery bacillus, pseudomonas aeruginosa, aerobacter, bacillus subtilis and beta hemolytic streptococcus.